Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 898

[Docket No. 94N-0078]

Medical Devices; Establishment of a Performance Standard for

Electrode Lead Wires and Patient Cables

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule

establishing a performance standard for electrode lead wires and

patient cables. The agency is taking this action because it has

determined that a performance standard is needed to prevent electrical

connections between patients and electrical power sources. The final

rule will substantially reduce the risk of electrocution from

unprotected electrode lead wires and patient cables.

DATES: This regulation is effective August 7, 1997, except that

Sec. 898.14 (21 CFR 898.14) is stayed pending Office of Management and

Budget (OMB) clearance for information collection. FDA will announce

the effective date of Sec. 898.14 in the Federal Register. Submit

written comments on the information collection provisions of this final

rule by July 8, 1997.

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For information on the compliance dates, see 21 CFR 898.13(a) and (b).

ADDRESSES: Submit written comments on the information collection

provisions of this final rule to the Dockets Management Branch (HFA-

305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ-215), Food and Drug Administration, 1350

Piccard Ave., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 19, 1994 (59 FR 26352), FDA

published an advance notice of proposed rulemaking (ANPRM) and

announced the need for further FDA action to address the risk of

patient exposure to macro shock or electrocution due to the

inappropriate connection of a patient-connected cable or electrode lead

wire to an alternating current (AC) power source. In that ANPRM, FDA

described various regulatory actions it had taken since the first

reported incidents in 1985 of exposed male connector pins of electrode

lead wires being inserted into either AC power cords or a wall outlet,

rather than into the patient cable that connects to the device monitor.

The ANPRM also described actions that various organizations, such as,

the Emergency Care Research Institute (ECRI) and outside standard

setting bodies have taken to prevent electrode lead wires from being

connected to electrical power sources. A summary of these actions is

provided in section VII. of this document. In the ANPRM, FDA stated

that ``despite efforts to eliminate the risk, unprotected electrode

lead wires and patient cabling systems are still distributed by some

manufacturers as replacements for existing equipment, and may also be

interchangeable among various medical devices.'' (See 59 FR 26352 at

26353.) In the ANPRM, FDA further announced that it, in conjunction

with the Health Industry Manufacturers Association and the American

Hospital Association (AHA), was sponsoring a public conference entitled

``Unprotected Patient Cables and Electrode Lead Wires.'' The conference

was held on July 15, 1994, and provided a forum for device users,

manufacturers, and other health care professionals to offer and to hear

comments for FDA's consideration during the rulemaking process.

The need for FDA action to resolve the hazard of the use of

unprotected electrode lead wires and patient cables with medical

devices was further emphasized in a letter dated August 2, 1994, to FDA

Commissioner David A. Kessler, from the Honorable Ron Wyden, then

Chairman, U.S. House of Representatives, Committee on Small Business,

Subcommittee on Regulation, Business Opportunities, and Technology

(Ref. 1). In that letter, Mr. Wyden stated that ``shocks, burns, and

electrocutions occur despite warnings issued by the FDA to hospitals,

manufacturers, and others.''

Specifically, Mr. Wyden wrote that:

Hospitals have been told to purchase and use only protected

wires and cables. They have also been told to remove unprotected

equipment and to alert staff members of possible hazards to

patients.

Manufacturers have been encouraged to modify their designs to

prevent lead wires from being inserted into electrical outlets.

Despite warnings and other communications, some manufacturers

still distribute to hospitals unprotected [patient cables and] lead

wires as replacements for deteriorated equipment.

It is clear that regulatory action, as well as additional

education and training, is needed to stop the slow but steady flow

of children (and adults) who are burned or electrocuted.

FDA's records of incidents with unprotected electrode lead wires

and patient cables reveal the following:

Between 1985 and 1994, 24 infants or children received ``macro-

shock'' (large externally applied currents) from electrode lead wires

or cables, including five children who died by electrocution (Ref. 2).

The most recent death (1993), of a 12-day old infant, occurred in a

hospital. The apnea monitor involved in the incident had been sold to

the hospital with a protected electrode lead wire and patient cable.

However, when the infant was electrocuted, an unprotected patient cable

from a second manufacturer and unprotected prewired electrodes from a

third manufacturer were being used instead of the protected

configuration.

There are reports of injuries associated with unsafe electrode lead

wires and patient cables involving medical devices other than apnea

monitors (Ref. 3). In 1986, for example, a death occurred when the

electrocardiogram (ECG) lead wires were inserted into a pulse oximeter

power cord. FDA has received additional reports of similar events that

resulted in electrical shocks, burns, and possible brain damage to

patients.

In response to the death and electrical burns that occurred in

1985, FDA issued an alert to home-use apnea monitor manufacturers, home

user support organizations, and apnea monitor users, announcing, among

other things, the agency's intent to embark on a cooperative effort

with industry and the medical profession to resolve the problem of

users making a hazardous electrical connection between the patient and

an electrical power source. FDA also requested each home-use apnea

monitor manufacturer to assess its device for potential electrode lead

wire and patient cable connection hazards and, when necessary, to

consider design changes to preclude insertion of electrode lead wire

connectors into AC power cords and outlets. In addition to issuing the

alert, FDA's Center for Devices and Radiological Health's (CDRH's) July

1985 ``Medical Devices Bulletin'' was devoted primarily to publicizing

the unprotected electrode lead wire and patient cable connection

hazard.

Since 1985, FDA has not cleared for marketing any home-use apnea

monitor that features an unprotected electrode lead wire and patient

cable configuration. For all apnea monitors cleared for marketing since

1989, FDA has required a protected electrode lead wire and patient

cable design, whether or not the device was intended for home use.

Despite these efforts, some hospitals continue to use older units, or

electrode lead wires and patient cables from other devices, which do

not have the protected cable and electrode lead wire design. Even with

the new protected models, as evidenced by the 1993 incident, it may be

possible to switch to use of an unprotected electrode lead wire and

patient cable configuration, thereby recreating the hazard.

On September 3, 1993, FDA issued a safety alert to hospital

administrators, risk managers, and pediatric department directors,

warning them that the use of unprotected electrode lead wires and

patient cables with an apnea monitor may be dangerous to the patient,

and may be in violation of section 518(a) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C. 360h(a)) (Ref. 4). FDA included

in the alert a number of recommendations to help prevent these

accidents. FDA also sent all apnea monitor manufacturers a notification

letter under section 518(a) of the act (Ref. 5).

Section 518(a) of the act authorizes the agency to issue an order

to ensure that adequate notification is provided in an appropriate

form, by the means best suited under the circumstances involved, to all

health care professionals who prescribe or use a particular device and

to any other person who should properly receive such notification, in

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order to eliminate an unreasonable and substantial harm to the public

health when no other practicable means is available under the act to

eliminate such risk. FDA stated that, for these devices, notification

should include replacement of unprotected apnea monitor electrode lead

wires and patient cables, and that a warning label should be

permanently affixed to all apnea monitors stating that unprotected

electrode lead wires and patient cables should not be used with the

device because inappropriate electrical connections may pose an

unreasonable risk of adverse health consequences or death. FDA also

requested manufacturers of all apnea monitors to cease further

distribution of unprotected electrode lead wires and patient cables. On

September 20, 1993, FDA issued a similar letter to all known third-

party manufacturers of electrode lead wires and patient cables (Ref.

6).

On December 28, 1993, FDA issued a Public Health Advisory to

hospital nursing directors, risk managers, and biomedical/clinical

engineering departments for distribution to all units in their

hospitals and outpatient clinics, as well as to home health care

providers and suppliers affiliated with those facilities, advising them

of the hazards associated with use of electrode lead wires with

unprotected male connector pins (Ref. 7). In the Public Health

Advisory, FDA expanded the scope of its September 3, 1993, apnea

monitor safety alert to include all devices using unprotected electrode

lead wires and patient cables. FDA noted that, even though many

manufacturers have changed the design of their devices to minimize the

potential hazard, some facilities are still using older models that

make it possible for staff to switch to unprotected patient cables and

lead wires, thus recreating the hazard. FDA recommended various

precautions be taken to prevent the use of unprotected electrode lead

wires and patient cables.

Manufacturers of devices other than apnea monitors that utilize

patient-connected electrode lead wires, e.g., ECG monitors, have been

encouraged by various organizations to modify their electrode lead

wires and patient cables so that they cannot be inserted into AC power

cords or outlets. For example, in February 1987 and May 1993, ECRI

issued hazard reports concerning electrical shock hazards from

unprotected electrode lead wires and patient cables. Further,

standards-setting bodies have developed various standards, both in

draft and final form, that have the same goal in mind--safety

requirements for electrode lead wires and patient cables.

In March 1995, the International Electrotechnical Commission (IEC)

published a second amendment to IEC 601-1 (1988), the safety standard

for electromedical equipment, which includes a requirement that

electrode lead wires be unable to make contact with hazardous voltages.

The Underwriters Laboratories (UL) adopted a modified version of

IEC 601-1 by issuing its standard 2601-1, which became effective on

August 31, 1994. This standard superseded UL 544 (referenced in the

ANPRM). In adopting the IEC standard, UL included a deviation requiring

that patient-connected electrodes be designed to avoid connection to

electrical power sources. (See UL 2601-1, Medical Electrical Equipment

Part 1: General Requirements for Safety.) The UL standard states in the

rationale section that ``this is a basic safety concern prompted by

recent accidents involving patient injury, including infant deaths.

Patients were being accidently connected to hazardous circuits while

being connected to applied parts of medical equipment, such as an apnea

monitor.'' FDA has been advised that it is possible that UL will modify

its requirement to be equivalent to the one included in the second

amendment to IEC 601-1 (1988).

There is also a German DIN standard for touch proof connectors for

electromedical applications. This design standard was also referenced

in the ANPRM and states that it was developed because of the accidents

that occurred with infants in 1985 and 1986.

The National Fire Protection Agency (NFPA) is also proposing a

standard for patient electrode lead wire connectors. FDA has received

information that, even though it is voluntary, this NFPA standard will

be adopted by many States and municipalities as a mandatory standard

for health care facilities. Further, this standard is referenced by the

hospital accrediting body, the Joint Commission on Accreditation of

Health Care Organizations.

Finally, the Association for the Advancement of Medical

Instrumentation (AAMI) has developed a standard that covers electrode

lead wires and patient cables for surface electrocardiographic

monitoring in cardiac monitor applications (ECG cables and lead wires,

ANSI/AAMI EC53-1995). This design standard addresses safety and

performance of electrode lead wires and patient cables with the added

purpose of discouraging the availability of unprotected patient cable

and lead wire configurations for ECG monitoring applications. The

standard defines a safe (no exposed metal pins) common interface at the

cable yoke and electrode lead wire connector. The standard was approved

by ANSI on December 7, 1995.

FDA believes that industry also recognizes the importance of

addressing this hazard. In response to FDA's alert letter in June 1985,

manufacturers voluntarily began to redesign their electrode lead wires

and patient cables for home apnea monitors. More recently, many firms

have taken voluntary action to recall electrode lead wires and patient

cables with unprotected exposed metal pins. Apnea monitor firms are

replacing their male pin lead wires and associated cables with safety

cable systems, usually free of charge, while other device manufacturers

are making adapters and warning labels available. Some device

manufacturers have ceased supplying unprotected electrode lead wires

and patient cables altogether.

II. The Proposed Rule

Despite repeated efforts to reduce the risk associated with the use

of unprotected electrode lead wires and patient cables, these products

are still available and in use in homes and in various health care

settings.

In the Federal Register of June 21, 1995 (60 FR 32406), FDA issued

a proposed rule designed to allow the orderly removal of unprotected

electrode lead wires and patient cables from the marketplace. The

proposal set forth a phased-in approach for removing unprotected lead

wires and patient cables while seeking to minimize the economic impact

to manufacturers and user facilities during the transition to a

protected cabling configuration.

Under FDA's proposed phased-in approach, unprotected lead wires and

patient cables would be subject to a proposed performance standard,

developed by FDA. The effective date for any final regulation based on

the proposal was to be phased-in over 1 or 3 years, depending on the

device type. Under the proposed rule, any devices that did not meet the

standard on its effective date would be banned.

Devices that were to be subject to the 1-year effective date were

those devices believed to present the greatest potential risk of harm

as demonstrated by use in environments where accidental inappropriate

connections could reasonably be anticipated, and by frequent use of the

devices and frequent connections of electrode lead wires. Devices

subject to the 1-year effective date included all devices that had been

the subject of reported adverse events, as well as other devices

believed to present the greatest potential risk of

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harm. Devices that were proposed to be subject to the 3-year effective

date were those devices that did not satisfy the criteria for the 1-

year effective date but also utilized unprotected electrode lead wires.

As stated earlier, the agency proposed to ban those devices that did

not meet the standard on its effective date.

FDA received comments on various aspects of the proposed rule,

including: (1) The cost of conversion for manufacturers and user

facilities; (2) the placement of a given device on the 1-year or the 3-

year list; (3) the appropriate list for devices that were not

specifically mentioned on either list, as well as for future devices;

and (4) whether the agency might adopt one of the consensus performance

standards mentioned in the proposed rule instead of issuing a new one.

This final rule addresses these concerns and others in providing a cost

effective remedy to eliminate an inappropriate, but preventable

occurrence of macro shock or electrocution due to the accidental

connection of an electrode lead wire or patient cable to an AC power

source.

III. Highlights of the Final Rule

In response to comments, the agency has revised and clarified

certain provisions of the final regulation. The final rule establishes

a performance standard that FDA believes will eliminate the risk, to

the extent possible, of unprotected electrode lead wires and patient

cables being inadvertently inserted or manipulated so as to make

contact with live parts of an AC power cord or electrical outlet. This

standard applies to all electrode lead wires and patient cables. The

revisions in the final rule are based on focusing the regulation on the

most cost-effective mechanism of accomplishing its important public

health goal. The most significant changes from the proposed rule

follow:

1. The performance standard being established applies directly to

electrode lead wires and patient cables, rather than to the medical

equipment to which they are attached. This revision focuses the

standard on the actual products that could create a patient hazard.

2. In issuing this standard, the agency is adopting the relevant

portion of a recently updated international standard (IEC 601-1). This

standard contains all the necessary provisions for patient protection.

Moreover, by adopting an existing and widely followed international

standard, the cost to industry in complying with this standard is

minimized.

3. The agency is revising the effective date so that only the

electrode lead wires and patient cables used with those devices

presenting the greatest potential risk will be required to conform to

the standard within 1 year. Specifically, the 1-year category has been

limited to 10 devices that, if unprotected, present the greatest

potential risk of harm as demonstrated by past incidents, their use in

environments where accidental inappropriate connections could most

likely be anticipated, or by the frequency with which the devices are

used and the frequency of connections of the patient-connected

electrode lead wires. Electrode lead wires and patient cables that are

intended for use with those 10 devices will be required to conform to

the standard within 1 year. FDA has placed all remaining devices in the

3-year category. Electrode lead wires and patient cables that are

subject to the 3-year effective date are those used with, or intended

for use with devices that are not subject to the 1-year effective date.

4. The agency has deleted the provision banning devices that do not

meet the standard because such a provision is unnecessary. Under

section 501(e) of the act (21 U.S.C. 351(e)) electrode lead wires and

patient cables not meeting the performance standard on or following the

effective date are adulterated.

5. This rule constitutes the first mandatory performance standard

established by FDA under section 514 of the act (21 U.S.C. 360d).

IV. The Framework

In order to eliminate the risk of macro shock and electrocution in

the future, the agency is establishing a performance standard for all

electrode lead wires and patient cables. In reaching this decision, the

agency reviewed several standards that are in various stages of

development before deciding to adopt a provision of the international

performance standard of IEC 601-1 on lead wires for medical devices.

Firms whose electrode lead wire and patient cable systems are

subject to this performance standard should begin to adapt existing

products to meet the standard, if they have not already done so, before

the effective date of the standard. These efforts are consistent with

Congress' admonition that ``stockpiling of nonconforming devices is

discouraged, since standards will apply to all devices in commercial

channels on their effective date.'' (See H. Rept. 853, 94th Cong., 2d

sess. 30; see also 45 FR 7474, February 1, 1980, final standards

regulation.)

Later in this document, FDA is publishing a list of the 10 devices

at highest risk of a user inadvertently connecting the device's

electrode lead wire(s) or patient cable to an AC power source. One year

from the publication date of this rule, unprotected electrode lead

wires and patient cables intended for use with, or used with, any of

these 10 devices will be subject to FDA's performance standard. Three

years after the publication date of this rule, unprotected patient

cable and lead wire systems intended for use with any other medical

device, absent an FDA waiver or exemption, will be subject to FDA's

performance standard. FDA reserves the right, upon proper notification

to interested parties, to amend the list of devices in the future. FDA

believes the effective dates are reasonable and consistent with the

congressional intent in enacting section 514 of the act, as well as

with comments received at the public conference and written comments on

the proposed rule.

The agency anticipates a smooth, but rapid, transition for the vast

majority of existing devices to a protected electrode lead wire and

patient cable configuration following publication of the final rule.

V. Performance Standard

The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629)

prescribes changes to the act (21 U.S.C. 321-394), as amended, that

improve the regulation of medical devices and strengthen the Medical

Device Amendments of 1976, which established a comprehensive framework

for the regulation of medical devices.

The SMDA amended section 513 of the act (21 U.S.C. 360c) to

redefine class II as the class of devices that is or will be subject to

special controls, and amended section 514 of the act to simplify the

requirements for establishing performance standards. Section 513 of the

act states that the ``special controls * * * shall include performance

standards for a class II device if the Secretary determines that a

performance standard is necessary to provide reasonable assurance of

the safety and effectiveness of the device.'' The legislative history

of the SMDA states that:

by simplifying the process for establishing performance standards,

and by allowing the Secretary discretion to employ such standards as

one of a variety of additional controls to assure the safety and

effectiveness of Class II devices, performance standards will become

valuable tools to regulate those devices for which they are most

needed.

(S. Rept. 513, 101st Cong., 2d sess. 19 (1990))

Under this rule, the mandatory performance standard applies to all

electrode lead wires and patient cables intended for use with medical

devices and is phased-in over a period of 1 or

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3 years. New Sec. 898.12(a) and (b) identifies the devices that are

subject to the performance standard, with the applicable effective

dates of the standard.

A. The Standard

FDA is issuing the following standard for electrode lead wires or

patient cables:

Electrode lead wires and patient cables shall comply with the

International Electrotechnical Commission (IEC) standard 601-1

subclause 56.3, paragraph c (1995).

Compliance with this standard shall be determined by inspection

and by applying the test requirements also found in IEC 601-1,

subclause 56.3(c). This standard is available from the American

National Standards Institute (ANSI), 11 West 42nd Street, New York,

NY 10036.

B. The Effective Date for Compliance

21 CFR 861.36 states that:

A regulation establishing * * * a performance standard will set

forth the date upon which it will take effect. To the extent

practical, consistent with the public health and safety, such

effective date will be established so as to minimize economic loss

to, and disruption or dislocation of, domestic and international

trade.

(See also section 514(b)(3)(B) of the act)

FDA has determined that the cost of converting or adapting unsafe

electrode lead wire configurations in order to comply with the

performance standard being established minimizes economic loss to, and

disruption or dislocation of, domestic and international trade because

the standard is to be phased in over a 1- or 3-year period, depending

on the device(s) with which the electrode lead wire or patient cable is

intended to be used, and the vast majority of devices fall under the 3-

year rule. Furthermore, FDA believes that this cost is justifiable

given the severity of the adverse events that have occurred and the

fact that such adverse events are entirely preventable.

VI. The Banning Action

FDA proposed to ban devices under section 516 of the act (21 U.S.C.

360f) that did not meet the standard on the applicable effective date.

Upon reconsideration, FDA has determined that a ban is unnecessary.

Under section 501(e) of the act, devices not meeting the performance

standard on its effective date are adulterated. Furthermore, original

equipment manufacturers (OEM's) and third-party suppliers will not be

permitted to supply replacement cables and lead systems that fail to

meet the standard, absent an FDA waiver or exemption.

VII. Summary and Analysis of Comments and FDA's Response

The agency received 27 written comments from manufacturers,

distributors, user facilities, and trade associations in response to

the proposed rule. A summary of the written comments is provided below.

1. In general, several comments supported FDA's efforts to resolve

the problem of macro shock or electrocution due to an improper

connection of a patient-connected electrode lead wire to an AC power

source. However, a few comments expressed concern that the proposed

banning action would apply to the devices that utilize unprotected

electrode lead wires and patient cables instead of the lead wire

systems themselves.

FDA has shifted the applicability of the performance standard from

the device utilizing the electrode lead wires and patient cables onto

the electrode lead wires and patient cables themselves. Moreover, FDA

has withdrawn the banning action from the final rule, because it was

determined not to be necessary.

2. FDA received several comments questioning which devices should

be subject to the 1-year effective date and which should be subject to

the 3-year effective date. One comment suggested that the two lists of

devices in the proposed rule be eliminated from the final rule and that

the ban simply be made effective for all devices 1 year from the

publication date of the final rule. Other comments questioned whether

particular devices should be placed on the 1-year list and, thus,

subjected to the ban and performance standard after 1 year or whether

the devices should properly be included in the 3-year list and thus be

given additional time to meet the standard.

In response to the comments, FDA has limited the devices on the 1-

year list to the 10-device types that the agency believes to be most

likely to expose persons to macro shock or electrocution based on the

reported adverse events and the environments in which the devices are

used. Electrode lead wires or patient cables intended for use with any

other device will be subject to the performance standard 3 years from

the date of publication.

3. One comment suggested replacing the word ``protected'' in the

proposed performance standard (Sec. 898.11) with the word ``designed''

to allow greater flexibility for electrode lead wire designers.

FDA advises that, although the standard that the agency is issuing

in this final rule has been modified from the proposed standard, the

word ``protected'' in the proposed rule was intended to encompass

creative design changes to devices as well as the development of

adapters for use with existing devices in order to achieve a safe

electrode lead wire and patient cable configuration. The agency

believes that the mandatory performance standard being established in

this final rule accomplishes the goal of providing manufacturers

flexibility in achieving the desired protected configuration. It is

anticipated that the marketplace will determine one or more suitable

design standards for the manufacture of new equipment and adapters

which will provide safe and effective protected electrode lead wire and

patient cable configurations.

4. One comment suggested that, instead of instituting a ban on

unprotected electrode lead wires and patient cables and establishing a

mandatory performance standard, it would be easier to simply fire the

hospital employee who plugs a patient into a receptacle.

FDA disagrees with this comment. The agency believes that proactive

measures are appropriate to address the risk of harm presented by

unprotected electrode lead wires and patient cables, particularly when

it is reasonably foreseeable that risk of misuse of a device will

result in serious adverse health consequences or death. Imposing

sanctions after adverse incidents would not necessarily reduce the risk

presented by those devices, nor would it address the risks presented by

them when used in a home environment. The agency has determined that a

change in the design of electrode lead wires and patient cables to a

protected configuration is both technologically and economically

feasible, if given a reasonable time for implementation.

5. One comment questioned whether devices that utilize unprotected

patient cables and/or electrode lead wires which simply contact the

patient during operation, as opposed to being directly attached to him

or her, are included in this rule.

FDA has determined that, because the electrical contact between a

patient and an unprotected cable or electrode lead wire that is plugged

into an AC power source need only be momentary to produce disastrous

results, devices that simply contact the patient during operation are

also hazardous and, consequently, are included within the scope of the

performance standard.

6. One comment suggested that a company should be allowed to label

its conforming product as registered and approved by FDA so that

physicians

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could buy from an FDA approved manufacturer.

The act specifically prohibits a manufacturer from representing its

medical device as having been approved. (See section 301(l) of the act

(21 U.S.C. 331(l)); and see also 21 CFR 807.97, regarding premarket

notifications.) In addition, compliance with a mandatory performance

standard is different from FDA approval of a device.

7. Several comments expressed concern over the ability of their

health care facilities to absorb the cost of either adapting old

equipment to the protected configuration or purchasing new equipment to

meet the performance standard in a 1-year timeframe. These comments

requested that a particular device be moved from the proposed 1-year

list to the 3-year list in order to have an adequate opportunity for

compliance.

It is not the intent of the agency to create undue economic

hardship on facilities in its efforts to minimize the risk of injury or

death from an improper connection of a patient cable or electrode lead

wire to an AC power source. The agency is interested in balancing the

cost of implementing this rule with the demonstrated risk. The agency

has addressed the issue of cost to facilities in the following two

ways. First, in the final rule, FDA has significantly reduced the

number of devices subject to the performance standard in the 1-year

timeframe. Due to the higher level of risk they present, unprotected

electrode lead wires and patient cables cannot be used with the 10-

device types that remain in this category 1 year after the publication

date of this rule. However, 3 years from the date of publication of

this rule, unprotected electrode lead wires and patient cables cannot

be manufactured, distributed, sold, resold, or used on patients unless

they meet the performance standard. On the effective date of the

performance standard, electrode lead wire and patient cable

manufacturers can no longer produce or supply unprotected electrode

lead wires and patient cables as replacements for use with these

existing devices.

FDA encourages the entrepreneurial development of suitable adapters

that can be used with existing equipment to speed the creation of a

safer environment for patients.

8. Several comments have cited the professionalism of their health

care staff as evidence of the improbability that an adverse event such

as a macro shock or electrocution would occur in their facility. These

comments believe that their devices should not be subject to the ban or

performance standard.

FDA disagrees with these statements. Since 1985, when the first

incident occurred, various groups have made the argument that such

events do not, have not, and would not happen at their facility. After

the first death in 1985 in a patient's home, it was argued that these

events could only happen outside of a health care facility, away from

the watchful eye of a professional. However, since that time, at least

23 additional cases of macro shock or electrocution have occurred,

including 3 electrocutions by nurses. FDA believes that, while some

areas of a health care setting are more stressful than others, human

error can and does occur. A patient should not needlessly be exposed to

a known and preventable risk simply because it has not happened yet in

a particular area of a facility. However, in an effort to address the

cost considerations for health care facilities, the agency has moved

most devices to the 3-year effective date.

9. One comment suggested that FDA simply encourage manufacturers to

comply with one of the existing voluntary standards (e.g., IEC 601-1),

rather than issuing its own mandatory standard. Other comments

suggested that enforcement of a voluntary standard could be achieved

through manufacturer ``self-certification'' of compliance with IEC 601-

1. It was further suggested that compliance with a voluntary standard

could be monitored through the 510(k) review process.

FDA disagrees with a voluntary approach. The agency has determined

that a mandatory performance standard is necessary to address the

significant risk of harm presented by unprotected electrode lead wires

and patient cables. However, FDA has taken the suggestion that the

agency adopt an existing consensus standard rather than develop its own

and possibly conflicting standard.

10. Two comments questioned the need for a protected electrode lead

wire performance standard to apply to battery-powered devices, such as

a transcutaneous electrical nerve stimulator (TENS) device. The

comments indicated that TENS devices use a lead wire with a 2.5

millimeters (mm) coaxial pin connection that is not universally

interchangeable with apnea monitors and ECG lead systems.

FDA disagrees with these comments. Two electrocutions occurred when

one child plugged his own attached lead wire into a wall socket and

when a second child plugged a sibling's attached lead wire into a power

cord. These incidents happened with a 2.0 mm exposed pin, but could

easily have happened with a 2.5 mm plug. The point that these devices

are battery-powered is not relevant because it is the dangling patient-

connected cable or electrode lead wire that is dangerous, not the

battery-powered device.

11. Several comments suggested that each electrode lead wire or

cable simply be labeled with specific warnings about exposed pins and

the potential hazard of electrocution when connected to an AC power

source.

FDA is aware that, in response to the section 518(a) of the act

letters that the agency issued in 1993 (Ref. 7), many firms conducted

voluntary recalls of unprotected electrode lead wires to correct the

labeling on these devices. However, FDA has determined that the

continued marketing of unprotected electrode lead wires and patient

cables, no matter how they are labeled, presents an unreasonable and

substantial risk of illness or injury to individuals, and provides no

benefit to the public health that is not provided by protected

electrode lead wires and patient cables. Use of unprotected electrode

lead wire and patient cable configurations have resulted in, and can be

expected to continue to result in, serious adverse health consequences

or death because these devices are inherently dangerous when used in a

reasonably foreseeable, albeit inappropriate, manner. There are no

labeling requirements that can reliably prevent inappropriate

connections of unprotected electrode lead wires and patient cables and,

thus, unprotected electrode lead wire configurations cannot be safely

marketed for their intended purpose.

Accordingly, FDA determined that a change in labeling will not

suffice. Indeed, labeling warnings are meaningless when unprotected

electrode lead wires and patient cables are available to preschool

children or individuals with limitations such as vision problems or

cognitive impairments. Further, labeling is often an inadequate

solution in certain hospital settings when health care professionals

find themselves in busy, stressful situations in which they may not be

provided with, or could inadvertently overlook, instructions.

12. Two comments questioned whether 2.5 mm coaxial pin electrode

lead wires should be subject to the performance standard because these

lead wires may not produce the same potentially damaging result. These

comments cited a 1994 class II recall and labeling action by CDRH's

Office of Compliance in which the agency did not call for user

notification and labeling of

[[Page 25483]]

2.5 mm coaxial plugs. In addition, one comment stated that there is no

reasonable possibility of substitution of a 2.5 mm coaxial plug for use

with an apnea monitor patient cable designed to accept individually

exposed 2.0 mm pins.

FDA disagrees. The August 1993 incident in which a protected 2.0 mm

electrode lead wire and patient cable system for an apnea monitor had

been replaced by an unprotected 2.0 mm cable and lead wire

configuration had disastrous results. In this incident, an infant was

electrocuted when the replacement unprotected electrode lead wire was

directly connected to an AC power cord. CDRH's Office of Compliance

required contraindication labeling of exposed 2.0 mm pin lead wires

which, in short, warned users not to use unprotected 2.0 mm pin lead

wires with apnea monitors. Older apnea monitor designs use electrode

lead wires with individual 2.0 mm pins and a patient cable with 2.0 mm

sockets. Unprotected electrode lead wires having a 2.5 mm pin (such as

those used with TENS devices) were exempted from the labeling

requirement because it was believed to be physically impossible to fit

a 2.5 mm plug into a 2.0 mm patient cable socket. FDA accepted the

firm's argument against labeling an unprotected lead wire with a 2.5 mm

pin to warn against its use with an apnea monitor.

In view of the information available to the agency at the time, on

March 8, 1994, the agency informed a contract leads manufacturer that,

``It is our understanding from discussions with other manufacturers

that a 2.5 mm pin plug is too large to fit into an electrical power

cord or wall outlet, and therefore would not need to be labeled.''

However, that assessment was subsequently changed following test

results submitted by two TENS/national medical equipment supplies

manufacturers, both of whom confirmed that the 2.5 mm coaxial pin could

be inserted into power cords and wall outlets. One manufacturer also

showed the same results for flexible 2.75 mm ``banana'' plugs. One test

showed no electrical current flow for the 2.5 mm pins, while a second

test showed that an electrical connection was made.

Because it is physically possible to insert a 2.5 mm pin into an AC

power source, these devices are subject to the performance standard

established in this rule.

13. One comment sought clarification of FDA's assertion in the

proposal that, ``if an adapter is used, it should prevent removal by

the user.'' The comment suggested that ``like the patient cable, an

adapter can trap blood and other contaminants during use. A reusable

adapter must be easily and thoroughly cleaned and sterilized. The

adapter should be submersible, capable of being abrasively scrubbed,

and autoclavable.''

FDA agrees that, in some applications, it may be necessary to have

an adapter that is capable of being removed from the device for

cleaning purposes. However, because reported adverse events have shown

a propensity for individuals to simply remove a protected configuration

from a device and replace it with an unprotected configuration for the

sake of convenience, the agency recommends use of adapters that are not

easily removed by the user (e.g., only detachable with the use of a

tool). The agency believes that, for those applications where device

contamination is of concern, the adapter should be disposable, if

possible, and that the device should not be suited to accept and

function with an unprotected electrode lead wire and patient cable

configuration.

14. One comment sought to clarify whether only electrodes with

preattached lead wires were unprotected or whether the ``snap-on''

electrodes without the lead wires are also considered unprotected.

Another comment questioned whether patient-connected electrodes with

exposed wires were covered under the standard or only those having a

pin attached at the end distal to the patient.

FDA considers any patient cable or electrode lead wire having a

distal end that is capable of making conductive contact with an AC

power source (e.g., a power cord, or wall outlet) to be unprotected

and, therefore, subject to the performance standard. The standard

applies to the lead wires themselves, and not to detachable ``snap-on''

electrodes with which they may be used.

15. One comment questioned who would be responsible for product

inventory once the banning action becomes effective. Another comment

expressed opposition to manufacturers having to recover product from

the field. Yet another comment sought clarification of the

responsibility of the manufacturer for a device that was introduced

into the marketplace prior to the effective date of the standard but

the user returns the device for repair or maintenance under a

maintenance agreement and the device has not yet been modified in

accordance with the standard.

As mentioned in section VI. of this document, FDA has eliminated

the proposed banning action in this final rule. FDA believes that the

manufacturer, distributor, seller, and user should share in the

responsibility for removing adulterated goods under their control from

the marketplace. Because many of the devices that are affected by the

performance standard may be retrofitted in the field, or perhaps

equipped with a suitable adapter, the agency has not determined that a

device recall is warranted at this time. The agency believes that each

participant in the chain of commerce has a role to play in ensuring

that the devices under their control meet the performance standard by

the effective date. The responsibility for equipping a device that is

returned to the manufacturer under a maintenance agreement such that it

conforms to the standard would likely depend upon the specific terms of

the agreement. As both users and manufacturers are equally concerned

for the safety and welfare of the patients that they serve, FDA

anticipates that they will work cooperatively to ensure that these

devices are in compliance with the performance standard. FDA reiterates

that the performance standard in the final rule applies to the lead

wire and patient cable, not to the medical equipment to which they are

attached.

16. One comment suggested that the agency adopt the comparable IEC

601-1 standard (i.e., IEC 601-1, subclause 56.3(c)) as the performance

standard because it addresses test methods that were not included in

FDA's proposed performance standard. The comment believed that adoption

of this international standard would also promote global harmonization

of standards.

FDA agrees with this comment. Prior to drafting the proposed

standard, FDA evaluated the voluntary standards that were then in

existence to determine whether any of these standards might be adopted

to address the concerns of the agency with unprotected electrode lead

wires. At the time of publication of the proposed rule, IEC 601-1 was

being amended and it could not be determined whether the amended

standard would be adopted by the membership and, if so, when it would

be published. However, in March 1995, IEC published the second

amendment to IEC 601-1, including subclause 56.3(c), which prohibits

electrode lead wires and patient cables from having the capacity to

make conductive contact with hazardous voltages. After examination of

this ratified amendment, the agency has determined that adherence to

the IEC 601-1 as amended would provide acceptable protection of

patients from connections to hazardous

[[Page 25484]]

voltages. In addition, FDA's adoption of this requirement of the IEC

standard demonstrates the agency's continued interest in promoting the

adoption of international voluntary standards, where feasible, to

satisfy safety and effectiveness requirements for medical devices.

17. One comment asked whether, for a preamendment device, FDA would

accept a letter of notification of a change to a protected

configuration. The comment believed that it would be unreasonable to

subject a preamendment device, that has been modified to incorporate a

protected configuration, to additional regulatory requirements while

those devices under a 510(k) require only an addendum.

FDA is establishing the following procedures for notifying the

agency of device modifications in compliance with the following

performance standard:

For a device reviewed through the premarket notification (510(k))

process or for a preamendment device, information regarding

modification of the device from an unprotected electrode lead wire and

patient cable configuration to a protected configuration, and

information demonstrating compliance with the performance standard,

should be documented in the manufacturer's device master records in

accordance with the current good manufacturing practice regulation. FDA

recognizes that a change from the unprotected to the protected

configuration is a change that under 21 CFR 807.81(a)(3) could affect

safety and effectiveness. However, in the interest of public health,

and due to the straightforward nature of the device modification and

demonstration of compliance with the performance standard, the agency

is not requiring prior clearance for this specific device modification.

FDA recognizes that this procedure differs from the agency's previous

recommendation that manufacturers who were voluntarily making changes

from the unprotected to the protected configuration submit

documentation of the changes as an addendum to their existing premarket

notification (510(k)) files. Because compliance with the performance

standard will no longer be voluntary, but will be mandatory, placement

of documentation of the device modification from an unprotected

configuration to a protected configuration and of documentation

demonstrating compliance with the performance standard into the device

master records will be sufficient.

For devices reviewed through the premarket approval process,

modifications from an unprotected electrode lead wire and patient cable

configuration to a protected configuration also may be implemented

without prior approval by FDA. FDA has determined under 21 CFR

814.39(e) that an alternate submission, a periodic report, is

appropriate. Thus, in the interest of public health, and due to the

straightforward nature of the device modification, information

regarding modifications to the protected configuration and information

demonstrating compliance with the performance standard should be

provided in the next annual report to the applicable premarket approval

application (PMA). The modification can be made prior to submission of

the annual report.

The information provided in the manufacturer's device master record

or the PMA annual report should include engineering drawings and a

description of the change(s), an explanation of how the change(s)

prevents connection to a power source, and documentation demonstrating

compliance with the performance standard. If an adapter design is

implemented, an explanation of how the signal acquisition and

processing is not compromised by the addition of the adapter, and how

the design of the adapter prevents removal by the user, should also be

provided.

18. One comment sought clarification of the manner in which the

agency would identify those devices that would be subject to this rule,

but have not yet been classified (e.g., electrode lead wires and

patient cables intended for use with dental TENS units).

All devices that meet the applicability section of the standard

(Sec. 898.11) are subject to the requirements under the rule, whether

or not they have been formally classified.

19. One comment wrote that implementation of the ban and

performance standard in 1 year might not provide the time needed for

design changes, validation, and manufacturing, and for production of a

device inventory sufficient to meet global demand. The comment believed

that difficulties in meeting the 1-year timeline may cause some

manufacturers to abandon businesses associated with the affected

devices, which potentially could affect supply.

The agency believes that changes made to the final rule adequately

balance public health concerns with the economic impact of making this

transition. Under the final rule, the devices for which the performance

standard will become effective in 1 year are only those electrode lead

wires and patient cables associated with the 10 devices presenting the

highest risk of a user inappropriately connecting the electrode lead

wire or patient cable to an AC power source. Of these 10 devices,

electrode lead wires and patient cables intended for use with apnea

monitors are largely in compliance with the standard. Because of their

early involvement with electrocution and macro shock incidents, new

apnea monitor devices without a protected electrode lead wire

configuration have not received agency clearance for marketing since

1989. ECG manufacturers have also been encouraged by the agency to

provide protected electrode lead wire and patient cable systems with

their devices. In addition, the agency published the ANPRM in the

Federal Register of May 19, 1994, held a public conference on the issue

in July 1994, and advised the manufacturing and medical user community

of efforts to address this problem through wide dissemination of public

health advisories, direct mailings to the users and the manufacturing

communities, and published its proposal to establish a performance

standard and a ban in the June 21, 1995, proposed rule. The agency

believes that both manufacturers and the medical user community have

had ample time to begin modifying these 10-device types, and electrode

lead wires and patient cables intended for use with them, to avoid this

potential problem. The agency is establishing the effective date of the

performance standard for electrode lead wire and patient cables for use

with these 10 devices at 1 year from the date of publication of the

final rule to provide further time for a steady transition to a safe

electrode lead wire and patient cable configuration. Finally, for

exceptional circumstances that are not adequately addressed in the 1-

year timeframe, the agency has established a variance procedure in

which affected parties may request an exemption or additional time in

which to meet the standard.

20. One comment stated that the marginal replacement costs

mentioned in section IX. of the proposed rule (60 FR 32406 at 32414)

assume an appropriate replacement accessory is available through the

manufacturer at costs comparable to the original lead system. According

to the comment, because lead wire manufacturers do not have to produce

replacement leads, but rather must cease producing unprotected patient

cables and leads, the costs of unplanned replacement of even a small

fraction of expensive diagnostic devices as a result of the

unavailability of the protected style

[[Page 25485]]

accessories is exponentially greater than the lead-for-lead replacement

costs alluded to section IX. of the proposed rule.

FDA disagrees with this statement. Several lead wire manufacturers

have already informed the agency that they are now, or soon will be,

producing protected electrode lead wire and patient cable

configurations. The agency does not have any evidence to show that

manufacturers will simply cease manufacturing unprotected electrode

lead wires and patient cables and fail to produce a protected electrode

lead wire configuration as a replacement.

21. One comment suggested that in cases where the electrode lead

wires are permanently attached to incontinence electrodes, the leads

could not migrate to other uses or environments and, therefore, the

lead wire cannot be detached from the uniquely shaped electrodes.

Sections 898.11 and 898.13 specify the applicability of the

performance standard. If a device meets the applicability requirements

under Sec. 898.11 and an interested party believes, due to the unique

circumstances of the device, its intended use, or its reasonably

foreseeable misuse, that no electrical hazard is presented to a

patient, the party may petition the agency under the variance procedure

for review of these unique circumstances.

22. One comment expressed concern about not having a sufficient

manufacturing staff to retrofit its devices. Concern was also expressed

that hospital staffs lack qualifications to perform and validate

changes to installed medical devices. The comment contended that making

these changes increases the risk of device failure due to unapproved or

improperly tested device adaptations, and increases legal liability for

the institution.

FDA disagrees with this comment. It is imperative that the

manufacturer of a device that utilizes electrode lead wires and patient

cables provide a connection arrangement from the patient to the

monitoring or treatment device which cannot be conductively connected

to a hazardous voltage. The manufacturer has a choice of modifying the

design of the equipment to accept only a protected cable and electrode

lead wire, of providing an adapter for the equipment interface to

receive only a protected electrode lead wire configuration, or of

directing the user of its medical device to a third-party manufacturer

of protected electrode lead wires and patient cables or suitable

adapters. Hospital staff with ability to make an unprotected patient

cable and lead wire connection from the patient to the device are

equally capable of making a protected connection. It is up to the

manufacturer to ensure that the device change is in conformity with its

specifications and labeling.

23. One comment noted that lead wires are not always class II

devices and, therefore, it is not clear that FDA has the authority to

regulate all electrode lead wires with a mandatory standard.

FDA agrees that a few unprotected cable and electrode lead wire

systems are class I devices, and, as such, are not subject to a

mandatory performance standard. Specifically, these devices include:

Table 1.

----------------------------------------------------------------------------------------------------------------

Product

Phase code 21 CFR section Class Device name

----------------------------------------------------------------------------------------------------------------

2................................ 89 IKD 890.1175 I Cable, Electrode (for Use With

Diagnostic Physical Medicine

Devices).

2................................ 74 KARI 870.4200 I Accessory Equipment, Cardiopulmonary

Bypass.

2................................ 87 KQX 888.1500 I Goniometer, AC-Powered.

----------------------------------------------------------------------------------------------------------------

Because of the degree of the health risk, the agency plans to initiate

procedures to reclassify these devices into class II so that all

electrode lead wires and patient cables will be subject to the

mandatory performance standard.

24. Another comment questioned whether a manufacturer would be in

violation of the banning action for repairing a user's banned device.

As stated above, FDA is not banning these devices. Therefore, this

comment is now moot.

25. One comment suggested that there may be cases where the OEM is

out of business and protected replacement cables and electrode lead

wires cannot be obtained.

FDA has no evidence to suggest that the absence of the OEM would

pose a significant obstacle to obtaining suitable lead wire

replacements. Replacement cables and electrode lead wires may often be

obtained from third-party manufacturers, or an adapter set may be used

to convert the unprotected pin configuration to a protected one. In

rare cases, where a user finds that the OEM is unwilling or unable to

supply a protected electrode lead wire and patient cable system, and

that there exists no thirdparty equivalent, the user has the option of

petitioning the agency under the variance procedure by documenting the

special circumstances that warrant an exception to the standard.

VIII. Enforcement

FDA's statutory authority to issue performance standards is derived

from section 514 of the act. Section 701(a) of the act (21 U.S.C.

371(a)) authorizes FDA to issue binding regulations for the efficient

enforcement of the act. (Weinberger v. Hynson, Westcott & Dunning,

Inc., 412 U.S. 609 (1973); see also Weinberger v. Bentex

Pharmaceuticals Inc., 412 U.S. 645, 653 (1973); National Assn. of

Pharmaceutical Manufacturer v. FDA, 637 F.2d 877 (2d Cir.), cert.

denied, 423 U.S. 827 (1975).) Section 519(a) of the act (21 U.S.C.

360i(a)) also authorizes the agency to issue regulations requiring

manufacturers of devices to maintain and provide records to ensure that

devices are not adulterated, misbranded, unsafe, or ineffective. FDA's

performance standards for medical devices are substantive regulations

with the force and effect of law. (See United States v. Undetermined

Quantities of Various Articles of Device * * * Proplast II, 800 F.

Supp. 499, 502 (S.D. Tex. 1992); United States v. 789 Cases * * * Latex

Surgeons' Gloves, 799 F. Supp. 1275, 1287 (D.P.R. 1982).)

Section 501(e) of the act deems a device to be adulterated, and

thus prohibited from commerce, if it is a device subject to a

performance standard established under section 514 of the act, unless

such device is in all respects in conformity with such standard.

Introduction into interstate commerce of a device that fails to comply

with the requirements established by section 514 of the act is a

prohibited act under section 301(a) of the act (21 U.S.C. 331(a)), and

the agency will use its enforcement powers to deter noncompliance.

Persons who violate section 301 of the act may be subject to injunction

under section 302(a) of the act (21 U.S.C. 332(a)). In addition, any

person responsible for

[[Page 25486]]

violating section 301 of the act may be subject to civil penalties

under section 303(f) of the act (21 U.S.C. 333(f)) and criminal

prosecution under section 303(a).

IX. Environmental Impact

The agency has determined under 21 CFR 25.24(e)(3) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

X. Unfunded Mandates Reform Act of 1995

Under the Unfunded Mandates Reform Act, FDA concludes that the

substantial benefits of this regulation will greatly exceed the

compliance costs that it imposes on the U.S. economy. In addition, the

agency has considered other alternatives and determined that the final

rule is the least burdensome and the most cost effective alternative

that would meet the objectives of this rule. Because FDA anticipates no

significant additional costs to State, local, or tribal governments,

this regulatory action does not require an assessment under the

Unfunded Mandates Reform Act.

XI. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this rule is consistent with the regulatory philosophy and principles

identified in the Executive Order. The Regulatory Flexibility Act

requires agencies to analyze regulatory options that would minimize any

significant impact on small entities. As a result of its analysis, FDA

has determined that this final rule is not a significant regulatory

action as defined by Executive Order 12866. In addition, the

Commissioner of Food and Drugs certifies that the rule will not have a

significant economic impact on a substantial number of small entities.

XII. Introduction to Economic Analysis

FDA believes that the presence of unprotected lead wires in a home,

hospital, or other user facility creates an unreasonable risk to

patients of hazardous electrical connections from electrical power

sources. In the proposed rule of June 21, 1995, FDA proposed to create

a performance standard for electrode lead wires, and to ban the use of

unprotected leads. Many comments supported the intent of the proposal,

and agreed with the phased approach toward eliminating the problem.

Other comments, however, expressed the view that the benefits would be

outweighed by the costs associated with converting the large number of

device types listed in the proposed rule. For example, AHA wrote that

``[when] all costs from all devices are considered, the total cost

impact to a facility would be at least $45 per licensed bed * * *. For

the over one million hospital beds in the United States, the impact

would be greater than $45 million.'' AHA called this a conservative

estimate, and requested that a comprehensive impact analysis be

performed by FDA, which would include logistical costs, stocking costs,

cost for ongoing surveillance, and the capital cost to replace

equipment for which protected style lead systems are not available. In

this economic analysis, FDA considers those costs and benefits that

would be incurred as a direct result of this final regulation.

Due to liability concerns, many of today's manufacturers are

already moving toward protected lead and cable pin configurations for

select devices. In order to prevent future adverse incidents, however,

FDA is issuing a new regulation that will ensure the movement toward

protected electrode lead wires and patient cables. Phase I of the

regulation applies to unprotected lead wires used with the 10 devices

for which there is the highest risk of accidental connection to

hazardous voltages. In 1 year from the publication date of this rule,

electrode lead wires and patient cables used with or intended for use

with the following devices will be subject to a performance standard:

Patient cable, apnea/breathing frequency monitor, ECG monitor, cardiac

monitor, multi-parameter/vital signs monitor, ECG electrode with

attached lead wire, arrhythmia monitor, transmitters and receivers/

physiological signal/radiofrequency, recorder/magnetic tape/medical,

and transmitters and receivers, electrocardiograph/telephone. Phase II

applies to electrode lead wires and patient cables used with or

intended for use with all other medical devices. Three years from the

effective date of this rule, lead wires and patient cables that do not

meet the performance standard may no longer be used or sold. The rule

also states that exemptions may be requested for devices that

justifiably cannot meet the standard on the date it goes into effect.

A. Regulatory Benefits

Since 1985, there have been at least 24 reported incidents

involving the use of unprotected electrode lead wires and patient

cables. These incidents occurred with both infants and children who

received ``macro-shock'' due to the improper use of these leads and

cables. Such occurrences have caused burns to the skin under the

electrodes, cardiorespiratory arrest, comas, neurological damage, or

other serious injuries. In five of these incidents, children died by

electrocution. Less significant incidents are probably underreported as

FDA typically receives reports on only a fraction of all events.\1\

---------------------------------------------------------------------------

\1\ ``Medical Devices: Early Warning of Problems is Hampered by

Severe Underreporting,'' United States General Accounting Office

Report to the Chairman, Committee on Governmental Affairs, U.S.

Senate, p. 61, December 1986.

---------------------------------------------------------------------------

FDA believes that this regulation will eliminate, to the extent

possible, the hazard associated with unprotected lead wires and patient

cables. While most comments acknowledged the unacceptable risk

attributable to the unprotected Phase I devices, many denied the need

to extend the scope of the rule to the Phase II devices. FDA, however,

finds that the interchangeability of electrode lead wires and patient

cables among medical equipment establishes the need to encompass such a

large number of devices. Regardless of where or what device they are

used with, unprotected electrode lead wires themselves can be plugged

into a receptacle and become hazardous. Through the implementation of

this regulation, FDA expects to prevent another incident of ``macro-

shock'' or death.

B. Regulatory Costs

In order to comply with this final rule, unprotected devices will

either be replaced or modified to accept only protected leads, and all

new devices under development will need to be designed to accept only

protected leads. The agency received no comments indicating that

incremental cost to manufacturers for the redesign of new devices would

be substantial, if adequate time was allowed. Moreover, few existing

devices will need to be prematurely replaced because virtually all

devices can be made safe through the use of protected lead wires and

either adaptors or other modifications of the connecting equipment.

Where adaptors or modifications are not feasible, FDA

[[Page 25487]]

will consider individual variance requests. A number of manufacturers

have indicated that adaptors are inexpensive and easy to install, and

provide no loss of signal integrity. Adaptors are not presently

available for all existing devices, because there is inadequate current

demand. The regulation, however, will create strong incentives for

device manufacturers or other suppliers to develop adequate adaptors,

and the extended phase-in periods will provide sufficient time for such

conversions to be made. Thus, FDA expects that there will be minimal

costs for redesigning the new devices currently under development, and

most existing devices will comply by obtaining appropriate adaptors. As

derived below, FDA estimates the total cost of bringing all of these

devices into compliance to be about $21 million.

1. Phase I

a. Devices. For the purpose of this analysis, the lead wires and

patient cables used with or intended for use with the 10 previously

mentioned Phase I devices have been grouped into two categories. The

first category consists solely of the lead wires and patient cables

used with the apnea/breathing frequency monitor. In the early 1990's, a

Federal performance standard was proposed to phase out the use of

unprotected lead wires with apnea monitors. Encouraged by the intense

liability concerns among industry, almost all of the lead wires for

these monitors are now protected. Therefore, FDA assumes no costs

associated with bringing this first category of lead wires into

compliance.

The second category consists of the lead wires used with the

remaining nine devices (hereinafter referred to as ECG-type devices).

The useful life for these devices reportedly ranges from 7 to 10 years.

Using an average useful life of 8 years 6 months, the 1-year phase-in

period implies that about 88 percent of these devices will have to be

converted. According to a survey by AHA conducted in early 1994,\2\

approximately 78 percent of their responding members indicated that

steps have already been taken to replace the unprotected lead wires on

their ECG devices. In this cost analysis, therefore, FDA only counts

the costs associated with bringing into compliance the lead wires on

the remaining 22 percent of those devices that would still have some

remaining useful life by the conclusion of the 1-year timeframe

following publication of this rule.

---------------------------------------------------------------------------

\2\ ``Electrode Leadwire Survey,'' distributed by the American

Society for Hospital Engineering of AHA, early 1994.

---------------------------------------------------------------------------

b. Lead wires. All of the ECG-type devices have three lead wires

except for the arrhythmia monitors and the Holter monitors (classified

under transmitters and receivers/physiological signal/radiofrequency,

recorder/magnetic tape/medical, and transmitters and receivers,

electrocardiograph/telephone). The number of lead wires on an

arrhythmia monitor could range from 5 to 12. For analysis, FDA

estimates the mean number of lead wires on an arrhythmia monitor to be

8.5. The number of lead wires on a Holter monitor generally ranges from

three to five. Thus, FDA estimates the mean number of lead wires on a

Holter monitor to be four.

Lead wires are generally sold in pairs, sets, or bulk quantities.

For this analysis, FDA uses an average price of $7 for a set of three

lead wires, or $2.33 per unit. This estimate may be too high as some

user facilities may purchase lead wires in bulk at less expensive per

unit prices.

There is only an incidental price difference between the protected

lead wires and those that are not protected. Therefore, no incremental

costs have been added for the purchase of the protected leads as

compared to the unprotected leads. As costs are counted only for leads

that need to be replaced while they still have some useful life, FDA

charges only half the cost of the purchase of these lead wires to the

regulation. Because the lead wires for ECG-type devices have a useful

life of approximately 2 years, 50 percent of these lead wires will be

replaced on average within the 1-year timeframe after the publication

date of this final rule.

c. Adaptors. For all ECG-type devices, FDA assumes that adaptors

will be available to connect the cables and lead wires. Only one cable

is used per ECG-type device, with the exception of the Holter monitor.

These cables cost between $50 to $100 to be replaced. Because it is

less costly to purchase adaptors than to purchase new cables to fit the

protected lead wires, FDA assumes that user facilities would purchase

adaptors to use for the remaining useful life of the cables. For Holter

monitors, FDA assumes that adaptors will be used between the lead wires

and the device itself. The costs of purchasing adaptors is

approximately $5 each. One adaptor is needed for each lead wire used

with or intended for use with the device. Therefore, most ECG-type

devices would require three adaptors, the arrhythmia monitor would use

8.5 adaptors, and the Holter monitor would use four adaptors on

average. A block of adaptors may be purchased, however, FDA assumes the

unit price will remain unchanged. After discussions with various

manufacturers, FDA finds that the distal ends of most cables are either

already protected or too large to be forced into contact with a

hazardous voltage. Thus, no costs were assigned for attaching adaptors

to the distal end of the cables.

Because the useful life of cables for ECG-type devices is

approximately from 2 to 3 years, FDA estimates that 40 percent of these

original cables will need to be replaced with cables that accept the

protected lead wires within 1 year after the publication date of this

final rule. As redesigned cables are sold at about the same price as

the older cables, no added cost is attributable to these cables.

Therefore, only about 60 percent of these devices will require an

adaptor due to the regulation. Some facilities whose cables have little

remaining useful life may opt to replace their cables earlier, even

though the price of new cables are significantly higher than that of

adaptors. Nevertheless, this analysis assumes that users would purchase

new cables only if they were a less costly option.

d. Adaptor installation. FDA uses the 1995 median weekly earnings

of $598\3\ for engineering and related technologists and technicians as

the base for the costs associated with affixing the adaptors onto the

unprotected cables. Adding 40 percent for benefits, total hourly

earnings are estimated at $20.93. The following tables show a per

minute salary rate of $0.35. Based on discussions with industry

representatives, FDA estimates that it will take a total of about 5

minutes to thoroughly clean the connector area on the cable or device

itself, and then to affix the adaptor to the cable or device. For those

instances where the adaptor is to be affixed onto a cable, FDA allots 5

minutes per device, regardless of the number of lead wires utilized by

the device. This time should be adequate because one block of adaptors

could be used to convert the entire device. For those instances where

the adaptors are to be affixed onto the device itself, FDA allots 5

minutes per lead wire. FDA also added a one-time cost for each facility

to capture the amount of time they would need to familiarize themselves

with the conversion process and to locate the affected devices.

---------------------------------------------------------------------------

\3\ Employment and Earnings, U.S. Department of Labor Bureau of

Labor Statistics, Table 39, p. 206, January 1996.

---------------------------------------------------------------------------

e. User facilities. The user facilities examined are hospitals,

nursing homes,

[[Page 25488]]

ambulances, and doctor's offices, and clinics. It is in these

facilities that the majority of ECG-type devices are found. ECG-type

devices found in Free-Standing Ambulatory Care Centers and in Cardiac

Labs of Hospital Outpatient Centers are accounted for under costs to

doctor's offices and clinics.

(i). Cost to hospitals. In 1993, 6,467 hospitals were accepted for

registration by AHA, with an average number of 179 beds in each of

these hospitals.\4\ According to several clinical engineers and

bioengineering directors at various hospitals, one ECG-type device is

found at approximately 30 percent of these beds. Therefore, FDA

calculates that approximately 347,278 ECG-type devices are used in

hospitals across the United States. Because the arrhythmia monitors

were estimated to make up about 10 to 20 percent of the ECG-type

devices used in the average hospital, FDA assumes that 15 percent of

ECG-type devices in all hospitals are arrhythmia monitors. Holter

monitors were estimated to make up another 15 percent of the ECG-type

devices used in the average hospital. In addition, assuming that it

might take roughly 1 minute to scan the devices in each room, FDA adds

3 hours per facility to account for the time it will take an average

hospital to locate the appropriate devices. As shown in the table

below, the total cost of this rule to hospitals comes to about $1.6

million.

---------------------------------------------------------------------------

\4\ The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 183, p. 125, 1995.

Table 2.--Cost of Protected Lead Wires to Hospitals

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) of Percent (%) of Percent (%) of Percent (%) of

Hospitals Number of ECG's ECG's not leads to be ECG's with Cost per lead Number of leads useful lead life Total cost

per hospital protected replaced useful life remaining

--------------------------------------------------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor

6,467....... 38 22% 50% 88% $2.33 3 50% $82,581

The Arrhythmia Monitor

6,467....... 8 22% 50% 88% $2.33 8.5 50% $50,138

The Holter Monitor

6,467....... 8 22% 50% 88% $2.33 4 50% $23,594

--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 3.--Cost of Adaptors to Hospitals

----------------------------------------------------------------------------------------------------------------

Number of Percent (%) of Percent (%) Percent (%)

Hospitals ECG's per ECG's not of cables to of ECG's with Cost per Number of Total

hospital protected be converted useful life adaptor adaptors cost

----------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor

6,467..... 38 22% 60% 88% $5.00 3 $424,700

The Arrhythmia Monitor

6,467..... 8 22% 60% 88% $5.00 8.5 $257,854

The Holter Monitor

6,467..... 8 22% N/A 88% $5.00 4 $202,238

----------------------------------------------------------------------------------------------------------------

[[Page 25489]]

Table 4.--Cost to Install Adaptors to Hospitals

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) of Percent (%) of Percent (%) of Installation

Hospitals Number of ECG's ECG's not cables to be ECG's with Salary per time (in Learning cost Total cost

per hospital protected converted useful life minute minutes) per hospital

--------------------------------------------------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Holter Monitor

6,467....... 46 22% 60% 88% $0.35 5 N/A $59,965

The Holter Monitor

6,467....... 8 22% N/A 88% $0.35 20 N/A $70,547

Learning Time

6,467....... N/A N/A N/A N/A N/A N/A $62.79 $406,063

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost to Hospitals (Tables 1 through 3) = $1,577,680

--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 25490]]

(ii). Cost to nursing homes. In 1993, there were approximately

11,309 skilled nursing facilities\5\ in the United States. FDA

estimates that there are approximately one to two ECG-type devices per

nursing home (assuming no arrhythmia monitors or Holter monitors). FDA

adds one-half hour to account for the time it would take each

individual facility to learn how to convert their devices. As shown

below, the total cost of this rule to the nursing homes amounts to

about $157,000.

---------------------------------------------------------------------------

\5\ The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 200, p. 134, 1995.

Table 5.--Cost of Protected Lead Wires to Nursing Homes

--------------------------------------------------------------------------------------------------------------------------------------------------------

Skilled Percent (%) of Percent (%) of Percent (%) of Percent (%) of

nursing Number of ECG's ECG's not leads to be ECG's with Cost per lead Number of leads useful lead life Total cost

facilities per nursing home protected replaced useful life per device remaining

--------------------------------------------------------------------------------------------------------------------------------------------------------

11,309....... 1.5 22% 50% 88% $2.33 3 50% $5,763

--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 6.--Cost of Adaptors to Nursing Homes

----------------------------------------------------------------------------------------------------------------

Skilled Number of Percent (%) Percent (%) Percent (%)

nursing ECG's per of ECG's not of cables to of ECG's with Cost per Number of Total

facilities nursing home protected be converted useful life adaptor adaptors cost

----------------------------------------------------------------------------------------------------------------

11,309..... 1.5 22% 60% 88% $5.00 3 $29,636

----------------------------------------------------------------------------------------------------------------

Table 7.--Cost to Install Adaptors to Nursing Homes

--------------------------------------------------------------------------------------------------------------------------------------------------------

Skilled Percent (%) of Percent (%) of Percent (%) of Installation

nursing Number of ECG's ECG's not cables to be ECG's with Salary per time (in Learning cost Total cost

facilities per nursing home protected converted useful life minute minutes) per facility

--------------------------------------------------------------------------------------------------------------------------------------------------------

11,309....... 1.5 22% 60% 88% $0.35 5 N/A $3,446

Learning Time

11,309....... N/A N/A N/A N/A N/A N/A $10.47 $118,349

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost to Nursing Homes (Tables 4 through 6) = $157,194

--------------------------------------------------------------------------------------------------------------------------------------------------------

(iii). Cost to ambulances and other ground transport vehicles. In

1995, the United States was reported to have 59,640 active and reserve

ground transport vehicles for emergency purposes.\6\ This figure does

not include emergency vehicles designed to extinguish fires. Of this

total number of vehicles, some are classified with advanced life

support (ALS) services. These vehicles carry a manual defibrillator

with an ECG monitor. These ECG-type devices have three lead wires and a

screen with the ability to print a tape. The other vehicles have basic

life support (BLS) services. Of these BLS transport vehicles, some have

an automated external defibrillator (AED) which fires shocks

automatically. These ECG-type devices have two lead wires, but do not

have a screen or the capability to print a tape.

---------------------------------------------------------------------------

\6\ ``The United States Emergency Medical Services Market

Report,'' based on data gathered from EMS Census 1995, prepared by

Emergency Care Information Center and JEMS Communications, p. 40.

---------------------------------------------------------------------------

According to a survey completed by the National Association of

State Emergency Medical Services (EMS) Directors in 1992, 59 percent of

all emergency transport vehicles have ALS transport services.\7\

Therefore, FDA estimates that 35,188 vehicles are ALS transport

systems. Of the reporting organizations in 1995, 48 percent are

classified as BLS with AED.\8\ To determine the number of BLS vehicles

with AED, FDA assumes that all 30,000 organizations with emergency

transport vehicles identified in the 1995 survey\9\ have two vehicles

per organization. If all organizations reporting BLS with AED services

have at least one vehicle offering this service, 14,314 BLS transport

vehicles have AED. FDA adds one-half hour to account for the time it

would take each individual organization to learn to convert its

devices. Because FDA assumed two vehicles per organization, the costs

associated with one-quarter hour per vehicle are shown in the table

below. The total cost of this regulation amounts to approximately

$362,000 for ambulances and other ground transport vehicles.

___________

\7\ ``Transportation Systems, 1994,'' produced by the National

Association of State EMS Directors, p. 2, 1994.

\8\ ``The United States Emergency Medical Services Market Report,''

based on data gathered from EMS Census 1995, prepared by Emergency

Care Information Center and JEMS Communications, p. 17.

\9\ ``The United States Emergency Medical Services Market Report,''

based on data gathered from EMS Census 1995, prepared by Emergency

Care Information Center and JEMS Communications.

[[Page 25491]]

Table 8.--Cost of Protected Lead Wires to Ambulances

--------------------------------------------------------------------------------------------------------------------------------------------------------

Ground Percent (%) of Percent (%) of Percent (%) of Percent (%) of

transport Number of ECG's ECG's not leads to be ECG's with Cost per lead Number of leads useful lead life Total cost

vehicles per vehicle protected replaced useful life per device remaining

--------------------------------------------------------------------------------------------------------------------------------------------------------

ECG-Type Devices on ALS Transport Vehicles

35,188....... 1 22% 50% 88% $2.33 3 50% $11,954

ECG-Type Devices on BLS Transport Vehicles

14,314....... 1 22% 50% 88% $2.33 2 50% $3,242

--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 9.--Cost of Adaptors to Ambulances

----------------------------------------------------------------------------------------------------------------

Ground Number of Percent (%) of Percent (%) Percent (%)

transport ECG's per ECG's not of cables to of ECG's with Cost per Number of Total

vehicles vehicle protected be converted useful life adaptor adaptors cost

----------------------------------------------------------------------------------------------------------------

ECG-Type Devices on ALS Transport Vehicles

35,188.... 1 22% 60% 88% $5.00 3 $61,476

ECG-Type Devices on BLS Transport Vehicles

14,314.... 1 22% 60% 88% $5.00 2 $16,671

----------------------------------------------------------------------------------------------------------------

Table 10.--Cost to Install Adaptors to Ambulances

--------------------------------------------------------------------------------------------------------------------------------------------------------

Ground Percent (%) of Percent (%) of Percent (%) of Installation

transport Number of ECG's ECG's not cables to be ECG's with Salary per time (in Learning cost Total cost

vehicles per vehicle protected converted useful life minute minutes) per organization

--------------------------------------------------------------------------------------------------------------------------------------------------------

49,502....... 1 22% 60% 88% $0.35 5 N/A $10,056

Learning Time

49,502....... N/A N/A N/A N/A N/A N/A $5.23 $259,019

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost to Ambulances and Other Ground Transport Vehicles (Tables 7 through 9) = $362,418

--------------------------------------------------------------------------------------------------------------------------------------------------------

(iv). Cost to doctor's offices and clinics. In 1992, there were

approximately 199,500 offices and clinics of medical doctors\10\ in the

United States. FDA estimates that, on average, there is at most one

Holter monitor and/or ECG-type device per office, and one to two ECG-

type devices per clinic. For analysis, FDA assumes 1.25 ECG-type

devices per doctor's office and clinic. FDA further assumes an equal

proportion of Holter monitors and other ECG-type devices would be found

in both doctor's offices and clinics. FDA adds one-half hour to account

for the time it would take each individual facility to learn how to

convert their devices. The total cost of this rule to the doctor's

offices and clinics comes to about $3 million.

___________

\10\ The Statistical Abstract of the United States, U.S. Department

of Commerce Economics and Statistics Administration, Bureau of

Census, No. 1316, p. 795, 1995.

[[Page 25492]]

Table 11.--Cost of Protected Lead Wires to Offices and Clinics

--------------------------------------------------------------------------------------------------------------------------------------------------------

Doctor's Number of ECG's Percent (%) of Percent (%) of Percent (%) of Percent (%) of

offices and per office and ECG's not leads to be ECG's with Cost per lead Number of leads useful lead life Total cost

clinics clinic protected replaced useful life remaining

--------------------------------------------------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor

199,500...... 0.6 22% 50% 88% $2.33 3 50% $40,605

The Holter Monitor

199,500...... 0.6 22% 50% 88% $2.33 4 50% $54,140

--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 12.--Cost of Adaptors to Offices and Clinics

----------------------------------------------------------------------------------------------------------------

Doctor's Number of

offices ECG's per Percent (%) Percent (%) Percent (%) Cost per Number of Total

and office and of ECG's not of cables to of ECG's with adaptor adaptors cost

clinics clinic protected be converted useful life

----------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Arrhythmia Monitor and the Holter Monitor:

199,500... 0.6 22% 60% 88% $5.00 3 $209,123

The Holter Monitor

190.600... 22% N/A 88% $5.00 4 $464,718

----------------------------------------------------------------------------------------------------------------

[[Page 25493]]

Table 13.--Cost to Install Adaptors to Offices and Clinics

--------------------------------------------------------------------------------------------------------------------------------------------------------

Doctor's Number of ECG's Percent (%) of Percent (%) of Percent (%) of Installation

offices and per office and ECG's not cables to be ECG's with Salary per time (in Learning cost Total cost

clinics clinic protected replaced useful life minute minutes) per facility

--------------------------------------------------------------------------------------------------------------------------------------------------------

ECG-Type Devices Except the Holter Monitor

199,500..... 0.6 22% 60% 88% $0.35 5 N/A $24,316

The Holter Monitor

199,500..... 0.6 22% N/A 88% $0.35 20 N/A $162,109

Learning Time

199,500..... N/A N/A N/A N/A N/A N/A $10.47 2,087,768

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost to Doctor's Offices and Clinics (Tables 10 through 12) = $3,042,779

--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 25494]]

2. Phase II

This section examines the cost to user facilities for Phase II of

this regulation. Although FDA believes that the use of adaptors will be

an effective and available conversion method for most affected devices,

facilities are permitted to request a variance for those devices that

cannot be modified to accept protected leads. Therefore, the agency has

not counted the cost of conversion methods other than adaptors.

For analysis, FDA has grouped most of the devices into the

following general categories: Electrosurgery appliances, telemetry

transmitters, external pacemakers, supervised diagnostic equipment,

stimulators, and patient monitoring devices. While FDA recognizes that

a small number of devices may not be represented in these categories,

these device categories are based on the categories used in a survey

distributed by AHA in 1995.\11\ FDA assumes that at the end of 3 years,

adaptors will be available for all devices. Therefore, the only costs

identified as a direct result of the regulation are the cost of the

adaptors, and the costs associated with their installation. FDA

continues to assume that the distal ends of these cables have either

previously been protected or are too large to be forced into a

connection with a hazardous voltage, and therefore, no adaptor will be

needed to attach the distal ends of these cables to the face plates of

the devices. FDA has not included the costs of purchasing new cables or

new lead wires because the 3-year phase-in period allows adequate time

for protected models to be purchased through general attrition. The

percentage of devices that utilize patient cables are estimated for

each category. For example, all machines in the category of patient

monitoring devices, typically have cables. As these devices move toward

protected lead wire and patient cable designs, they will incur no extra

costs as a direct result of this regulation.

___________

\11\ ``Electrode Leadwire Survey II,'' distributed by the American

Society for Hospital Engineering of AHA, fall 1995.

Because specific data on the number of all affected devices are

unavailable, FDA examines the cost to hospitals for Phase II of the

rule by again estimating the device quantities as a percentage of

hospital beds. As in Phase I, FDA's estimates are based upon the 6,467

hospitals in the United States and the reported average number of 179

beds in each hospital.\12\ To determine the total number of devices in

each category, FDA relied on estimates from clinical and biomedical

engineering directors for the percentage of beds that would have these

devices. The estimates are: Six percent for electrosurgery appliances,

15 percent for telemetry transmitters, 5 percent for external

pacemakers, 13 percent for supervised diagnostic equipment, and 6

percent for stimulators. FDA assumed that between 90 percent to 100

percent of the devices have not already been converted to protected

styles, and that a general useful life ranges from 7 to 10 years. Also,

only devices without cables would need modification. These percentages

were estimated to be approximately 75 percent for electrosurgery

appliances, 100 percent for telemetry transmitters, 60 percent for

external pacemakers, 50 percent for supervised diagnostic equipment,

and 100 percent for stimulators. As previously noted, FDA uses a $20.93

hourly compensation figure to estimate incremental labor costs, or a

per minute salary rate of $0.35.

---------------------------------------------------------------------------

\12\ The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 183, p. 125, 1995.

---------------------------------------------------------------------------

The agency once more estimates it will take a total of 5 minutes

per lead wire to both thoroughly clean the connector area on the device

itself and to affix the adaptor to the device. The number of adaptors

needed for each of the device categories is based on estimates of the

average number of lead wires found on all devices in each category. FDA

estimates that the adaptors cost $5 apiece and that it will take each

hospital twice as long as for the Phase I devices, or 6 additional

hours, to locate all of the Phase II devices. This adds $812,126 to the

total cost of Phase II of this regulation. Using an average useful life

of 8 years 6 months, the 3-year phase-in period implies that about 65

percent of these devices would have to be converted. The total costs to

hospitals are illustrated in the following tables.

Table 14.--Cost of Adaptors to Hospitals Only

--------------------------------------------------------------------------------------------------------------------------------------------------------

Electrosurgery Supervised diagnostic

appliances Telemetry transmitters External pacemakers equipment Stimulators

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of hospitals............. 6,467 6,467 6,467 6,467 6,467

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of beds.................. 179 179 179 179 179

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) of beds............. 6% 15% 5% 13% 6%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) not protected....... 90% to 100% 90% to 100% 90% to 100% 90% to 100% 90% to 100%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) without cables...... 70% to 80% 100% 55% to 65% 50% 100%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) to be converted..... 65% 65% 65% 65% 65%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Cost per adaptor................ $5 $5 $5 $5 $5

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of adaptors (average).... 1.5 10.5 3.5 10 3

--------------------------------------------------------------------------------------------------------------------------------------------------------

TOTAL COST...................... $213,315-$270,877 $5,332,886-$5,925,429 $325,899-$427,948 $2,200,874-$2,445,415 $609,473-$677,192

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost of Adaptors =........ $8,682,447-$9,746,861

--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 25495]]

Table 15.--Cost of Install Adaptors to Hospitals Only

--------------------------------------------------------------------------------------------------------------------------------------------------------

Electrosurgery Supervised diagnostic

appliances Telemetry transmitters External pacemakers equipment Stimulators

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of hospitals............. 6,467 6,467 6,467 6,467 6,467

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of beds.................. 179 179 179 179 179

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) of beds............. 6% 15% 5% 13% 6%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) not protected....... 90% to 100% 90% to 100% 90% to 100% 90% to 100% 90% to 100%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) without cables...... 70% to 80% 100% 55% to 65% 50% 100%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Percent (%) with useful life.... 65% 65% 65% 65% 65%

--------------------------------------------------------------------------------------------------------------------------------------------------------

Salary per minute............... $0.35 $0.35 $0.35 $0.35 $0.35

--------------------------------------------------------------------------------------------------------------------------------------------------------

Installation time per adaptor... 5 minutes 5 minutes 5 minutes 5 minutes 5 minutes

--------------------------------------------------------------------------------------------------------------------------------------------------------

Number of adaptors.............. 1.5 10.5 3.5 10 3

--------------------------------------------------------------------------------------------------------------------------------------------------------

TOTAL COST...................... $14,882-$18,898 $372,058-$413,397 $22,737-$29,856 $153,548-$170,608 $42,520-$47,245

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total Cost to Install Adaptors =

............................... $605,745-$680,008

--------------------------------------------------------------------------------------------------------------------------------------------------------

Because these numbers account for the cost to hospitals only, FDA

uses quantity of shipment data from the 1994 Current Industrial Report

for Electromedical and Irradiation Equipment\13\ to establish a

proportion between the number of the devices found in a hospital

setting versus all other user facilities. To make the Current

Industrial Report data more applicable, FDA derived some quantity

estimates from the value of shipment data, made categorical

adjustments, corrected for exports, and consulted additional sources to

customize the categorical adjustments, corrected for exports, and

consulted additional sources to customize the estimates. In instances

where no quantity data was given, FDA used the average price of

equipment in the particular device category and the value of shipments

data to derive a quantity of shipments. The average prices used are as

follows: Electrosurgery appliances, $10,000; telemetry transmitters,

$4,000; external pacemakers, $5,000; supervised diagnostic equipment,

$35,000; and stimulators, $3,500. To account for the telemetry

transmitters, which were not specifically mentioned in the Current

Industrial Reports, FDA used worldwide sales data for total cardiac

diagnostic equipment and the telemetry monitoring markets.\14\ This

figure includes sales data on electrocardiographs, long-term

electrocardiographs, and cardiac telemetry systems. The agency

multiplied this figure by 55 percent to account for U.S. sales in this

market.\15\ To break out the sales data for the telemetry products, FDA

subtracted the U.S. sales data for electrocardiographs in 1994 as given

by the Current Industrial Report. To break out data for the external

pacemakers covered by this rule, FDA used the sales data for all

pacemakers in the Current Industrial Report, and subtracted out the

sales for implantable cardiac pacemakers.\16\ Since this 1990 sales

data for cardiac pacemakers is worldwide, FDA multiplied this data by

43 percent, which represents the percentage of the world medical device

market held by the United States in 1990.\17\ The following categories

were counted under the Supervised Diagnostic Equipment category:

Magnetic resonance imaging equipment, electroencephalograph,

electromyograph, and respiratory analysis equipment. The value of

shipment data for all other medical therapy equipment was used to

derive FDA's stimulator estimate. Total quantity data estimates by FDA

for 1994 are as follows: Electrosurgery appliances, 24,447; telemetry

transmitters, 6,432; external pacemakers, 5,813; supervised diagnostic

equipment, 9,325; and stimulators, 132,340. To adjust for exports, FDA

multiplied these numbers by 57 percent in accordance with the U.S.

Industrial Outlook forecast that 43 percent of U.S. electromedical

equipment production would be exported in 1994.\18\ The estimated total

number of devices sold in the United States per year were then

multiplied by the average useful life to make the data comparable to

the number of devices found in a hospital setting. An analysis of both

data sources indicates that 60 percent of all of the above devices are

located in hospitals. Therefore, the hospital cost estimates are

assumed to be 60 percent of the total costs of Phase II of this rule,

and the total costs are increased to account for the 40 percent of

devices found in other user facilities.

---------------------------------------------------------------------------

\13\ ``Current Industrial Reports--Electromedical Equipment and

Irradiation Equipment (including x-ray)--MA38R,'' U.S. Department of

Commerce News, Bureau of the Census, issued September 1995.

\14\ ``Forecasts of the Total World Cardiac Diagnostic Equipment

and Telemetry Monitoring Market,'' Frost and Sullivan, 1992, April

1995.

\15\ Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th ed., p. 92, 1992.

\16\ Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th ed., p. 75, 1992.

\17\ Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th ed., p. 69, 1992.

\18\ U.S. Industrial Outlook, U.S. Department of Commerce,

International Trade Administration, pp. 44-113, 1994.

---------------------------------------------------------------------------

The analysis assumes that Phase II costs will be incurred in equal

increments for the first 3 years after the regulation is issued.

Therefore, annual costs of $6 million will be incurred for 3 years.

Using a 7 percent discount rate, the present value of the total costs

for Phase II is approximately $16 million.

[[Page 25496]]

C. Small Business Impact

FDA certifies that the rule will not have a significant economic

impact on a substantial number of small entities. To illustrate this

result, the agency examined the potential impact of the rule on small

entities by using the highest cost scenario for analysis. Hospitals

will absorb an approximate total of $11 million over both phases of

this regulation. The cost for an average-sized 179 bed hospital would

be about $1,723, or less than $10 per bed. According to the Small

Business Administration, profit-making hospitals with revenue at $5

million or less per year are considered a small business. Using this

criteria and 1993 data from AHA\19\, FDA finds that most hospitals with

6 to 24 beds are small businesses. Because the individual cost to

hospitals with 6, 24, 50, or 100 beds would be approximately $230,

$394, $629, and $1,084 respectively, it would be less than 1 percent of

the total net revenue for any of these bed size categories, and far

less than 1 percent of gross revenue. Nursing homes would absorb

approximately $157,000 of the total costs, or about $14 per nursing

home. Ambulances and other ground transport vehicles would incur

approximately $362,000 or about $7 per vehicle, and approximately $15

per organization. If doctor's offices and clinics incur the remainder

of the costs, they absorb approximately $3 million under Phase I of the

rule and approximately $6 million under Phase II. These estimates

amount to about $47 per office and clinic. While some user facilities

will incur a greater share of these costs than others, all of the above

cost figures represent far less than 1 percent of total gross revenue

per facility. As a result, FDA finds that the magnitude of the

individual costs determined above would not represent a significant

impact for a substantial number of small user facilities.

---------------------------------------------------------------------------

\19\ ``Hospital Statistics,'' The American Hospital Association

Profile of U.S. Hospitals, Table 11, p. 206, 1994.

---------------------------------------------------------------------------

D. Conclusion

FDA estimates the total costs for Phase I of the regulation to be

$5 million. The Phase II costs are approximately $6 million per year

for 3 years, or a total present value cost of $16 million. All cost

estimates are based upon the use of adaptors as a viable conversion

method. Adding costs for Phase I and Phase II, total costs for this

rule are $21 million.

As shown in section XIII. of this document, the reporting and

recordkeeping burden is minimal for user facilities. Using the

previously mentioned $20.93 hourly compensation figure, FDA calculates

the recordkeeping burden to user facilities and manufacturers for

filing an exemption or variance. FDA estimates these reporting costs

under Sec. 10.30 to be $10,465 per year. Such a minimal amount does not

significantly add to the final costs of this regulation.

XIII. Paperwork Reduction Act 1995

This final rule contains information collection provisions that are

subject to review by OMB under the Paperwork Reduction Act of 1995 (44

U.S.C. 3501-3520). The title, description, and respondent description

of the information collection provisions are shown below with an

estimate of the annual reporting burden. Included in the estimate is

the time for reviewing instructions, searching existing data sources,

gathering and maintaining the data needed, and completing and reviewing

each collection of information.

Title: Exemptions and Variances from the Performance Standard for

Electrode Lead Wires and Patient Cables

Description: Section 898.14 provides that any person subject to the

standard may submit a petition under Sec. 10.30 (21 CFR 10.30)

requesting an exemption or variance from the standard. The petition

must demonstrate why compliance with the standard is unnecessary or

unfeasible and what alternate means will be used to protect the public

health. FDA will use this information to determine whether granting an

exemption is in the best interests of the public health. Allowing for

exemptions and variances will provide for flexibility while assuring

public health protection.

Description of Respondents: Manufacturers, distributors, health

care facilities.

Table 16--Estimated Additional Annual Reporting Burden

----------------------------------------------------------------------------------------------------------------

Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

10.30 50 1 50 10 500

----------------------------------------------------------------------------------------------------------------

There are no capital costs or operating and maintenance costs expected as a result of this rule.

The proposed rule did not include a Paperwork Reduction Act burden

estimate because it contained no information collection provisions. In

the final rule, a new regulation, providing that requests for

exemptions and variances from the performance standard may be submitted

under Sec. 10.30, has been added. Because of the resulting anticipated

additional reporting burden under Sec. 10.30, FDA is providing a burden

estimate and an opportunity for public comment, as required by the

Paperwork Reduction Act of 1995. Therefore, FDA now invites comments

on: (1) Whether the proposed collection of information is necessary for

the proper performance of FDA's functions, including whether the

information will have practical utility; (2) the accuracy of FDA's

estimate of the burden of the proposed collection of information,

including the validity of the methodology and assumptions used; (3)

ways to enhance the quality, utility, and clarity of the information to

be collected; and (4) ways to minimize the burden of the collection of

information on respondents, including through the use of automated

collection techniques, when appropriate, and other forms of information

technology. Individuals and organizations may submit comments on the

information collection provisions of this final rule by July 8, 1997.

Comments should be directed to the Dockets Management Branch (address

above).

At the close of the 60-day comment period, FDA will review the

comments received, revise the information collection provision as

necessary, and submit these provisions to OMB for review. FDA will

publish a notice in the Federal Register when the information

collection provisions are submitted to OMB, and an opportunity for

public

[[Page 25497]]

comment to OMB will be provided at that time. After receiving OMB's

decision, FDA will publish a notice in the Federal Register of OMB's

decision to approve, modify, or disapprove the information collection

provisions. The effective date of Sec. 898.14 will be announced in the

Federal Register after OMB approval has been received. An agency may

not conduct or sponsor, and a person is not required to respond to, a

collection of information unless it displays a currently valid OMB

control number.

XIV. References

The following references have been placed on display in the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by

interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Letter to FDA Commissioner David A. Kessler from Ron Wyden,

then Chairman, U.S. House of Representatives, Committee on Small

Business, Subcommittee on Regulation, Business Opportunities, and

Technology, dated August 2, 1994.

2. Information from FDA's medical device reporting (MDR) data

base, Rockville, MD.

3. Information from FDA's MDR data base, Rockville, MD.

4. ``FDA Safety Alert: Unsafe Patient Lead Wires and Cables,''

FDA's September 3, 1993, Safety Alert.

5. Section 518(a) notification letter to apnea monitor

manufacturers, September 3, 1993.

6. Section 518(a) notification letter to patient cable and lead

wire manufacturers, September 20, 1993.

7. FDA Public Health Advisory: Unsafe Electrode Lead Wires and

Patient Cables Used With Medical Devices, December 28, 1993.

8. Proceedings, Unprotected Patient Cables and Electrode Lead

Wires Conference, July 15, 1994.

9. ``Medical Devices: Early Warning of Problems is Hampered by

Severe Underreporting,'' United States General Accounting Office

Report to the Chairman, Committee on Governmental Affairs, U.S.

Senate, p. 61, December 1986.

10. Fran Hos ``Electrode Leadwire Survey,'' distributed by the

American Society for Hospital Engineering of AHA, early 1994.

11. Employment and Earnings, U.S. Department of Labor Bureau of

Labor Statistics, Table 39, p. 206, January 1996.

12. The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 183, p. 125, 1995.

13. The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 200, p. 134, 1995.

14. ``The United States Emergency Medical Services Market

Report,'' based on data gathered from EMS Census 1995, prepared by

Emergency Care Information Center and JEMS Communications, p. 40.

15. ``Transportation Systems, 1994,'' produced by the National

Association of State EMS Directors, p. 2, 1994.

16. ``The United States Emergency Medical Services Market

Report,'' based on data gathered from EMS Census 1995, prepared by

Emergency Care Information Center and JEMS Communications, p. 17.

17. ``The United States Emergency Medical Services Market

Report,'' based on data gathered from EMS Census 1995, prepared by

Emergency Care Information Center and JEMS Communications.

18. ``The Statistical Abstract of the United States,'' U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 1316. p. 795, 1995.

19. The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 183. p. 125, 1995.

20. ``Electrode Leadwire Survey II,'' distributed by the

American Society for Hospital Engineering of AHA, fall 1995.

21. The Statistical Abstract of the United States, U.S.

Department of Commerce Economics and Statistics Administration,

Bureau of Census, No. 183, p. 125, 1995.

22. ``Current Industrial Reports--Electromedical Equipment and

Irradiation Equipment (including x-ray)--MA38R,'' U.S. Department of

Commerce News, Bureau of the Census, issued September 1995.

23. ``Forecasts of the Total World Cardiac Diagnostic Equipment

and Telemetry Monitoring Market,'' Frost and Sullivan, April 1995.

24. Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th edition, p. 92, 1992.

25. Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th edition, p. 75, 1992.

26. Medical and Healthcare Marketplace Guide, MLR Biomedical

Information Services, 8th edition, p. 69, 1992.

27. U.S. Industrial Outlook, U.S. Department of Commerce,

International Trade Administration, pp. 44-113, 1994.

List of Subjects in 21 CFR Part 898

Administrative practice and procedure, Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the

Public Health Service Act, and under authority delegated to the

Commissioner of Food and Drugs, Chapter I of Title 21 of the Code of

Federal Regulations is amended as follows:

1. Part 898 is added to read as follows:

PART 898-PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT

CABLES

Sec.

898.11 Applicability.

898.12 Performance standard.

898.13 Compliance dates.

898.14 Exemptions and variances.

Authority: Secs. 501, 502, 513, 514, 530-542, 701, 704 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360c,

360d, 360gg-360ss, 371, 374); secs. 351, 361 of the Public Health

Service Act (42 U.S.C. 262, 264).

Sec. 898.11 Applicability.

Electrode lead wires and patient cables intended for use with a

medical device shall be subject to the performance standard set forth

in Sec. 898.12.

Sec. 898.12 Performance standard.

(a) Any connector in a cable or electrode lead wire having a

conductive connection to a patient shall be constructed in such a

manner as to comply with subclause 56.3(c) of the following standard:

International Electrotechnical Commission (IEC)

601-1: Medical Electrical Equipment

601-1 (1988) Part 1: General requirements for safety

Amendment No. 1 (1991)

Amendment No. 2 (1995).

(b) Compliance with the standard shall be determined by inspection

and by applying the test requirements and test methods of subclause

56.3(c) of the standard set forth in paragraph (a) of this section.

Sec. 898.13 Compliance dates.

The dates for compliance with the standard set forth in

Sec. 898.12(a) shall be as follows:

(a) For electrode lead wires and patient cables used with, or

intended for use with, the following devices, the date for which

compliance is required is May 11, 1998:

Listing of Devices for Which Compliance is Required Effective

May 11, 1998

----------------------------------------------------------------------------------------------------------------

21 CFR

Phase Product code section Class Device name

----------------------------------------------------------------------------------------------------------------

1.................................... 73 BZQ 868.2375 II Monitor, Breathing

Frequency.

1.................................... 73 FLS 868.2375 II Monitor (Apnea

Detector), Ventilatory

Effort.

[[Page 25498]]

1.................................... 74 DPS 870.2340 II Electrocardiograph.

1.................................... 74 DRG 870.2910 II Transmitters and

Receivers,

Physiological Signal,

Radio Frequency.

1.................................... 74 DRT 870.2300 II Monitor, Cardiac

(including

Cardiotachometer and

Rate Alarm).

1.................................... 74 DRX 870.2360 II Electrode,

Electrocardiograph.

1.................................... 74 DSA 870.2900 II Cable, Transducer and

Electrode, Patient

(including Connector).

1.................................... 74 DSH 870.2800 II Recorder, Magnetic Tape,

Medical.

1.................................... 74 DSI 870.1025 III Detector and Alarm,

Arrhythmia.

1.................................... 74 DXH 870.2920 II Transmitters and

Receivers,

Electrocardiograph,

Telephone.

----------------------------------------------------------------------------------------------------------------

(b) For electrode lead wires and patient cables used with, or

intended for use with, any other device, the date for which compliance

is required is May 9, 2000.

Sec. 898.14 Exemptions and variances.

(a) A request for an exemption or variance shall be submitted in

the form of a petition under Sec. 10.30 of this chapter and shall

comply with the requirements set out therein. The petition shall also

contain the following:

(1) The name of the device, the class in which the device has been

classified, and representative labeling showing the intended uses(s) of

the device;

(2) The reasons why compliance with the performance standard is

unnecessary or unfeasible;

(3) A complete description of alternative steps that are available,

or that the petitioner has already taken, to ensure that a patient will

not be inadvertently connected to hazardous voltages via an unprotected

patient cable or electrode lead wire for intended use with the device;

and

(4) Other information justifying the exemption or variance.

(b) An exemption or variance is not effective until the agency

approves the request under Sec. 10.30(e)(2)(i) of this chapter.

Dated: April 28, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97-11967 Filed 5-7-97; 8:45 am]

BILLING CODE 4160-01-F