Medical Devices; Protective Restraints; Revocation of Exemptions From the 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 91N-0487]

21 CFR Parts 880 and 890

Medical Devices; Protective Restraints; Revocation of Exemptions

From the 510(k) Premarket Notification Procedures and Current Good

Manufacturing Practice Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising the

classification regulations for protective restraints and wheelchair

accessories intended for use as restraints, by revoking the existing

exemptions for these devices from premarket notification and current

good manufacturing practices (CGMP) regulations. FDA is also modifying

the classification regulations for protective restraints and for

wheelchair accessories to clarify the definitions of these devices. FDA

is taking these actions in response to a number of recent reports of

deaths and serious injuries that may have been associated with improper

supervision of restrained patients or improper application of

protective restraints. FDA believes that these actions will have

minimal economic effect and will not disrupt the supply of these

devices. In a notice published elsewhere in this issue of the Federal

Register, FDA is announcing the availability of a draft guidance

document for the preparation of premarket notification (510(k))

submissions for protective restraints.

DATES: Effective September 3, 1996.

FOR FURTHER INFORMATION CONTACT: Viola S. Hibbard, Center for Devices

and Radiological Health (HFZ-410), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-1287.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of October 21, 1980 (45 FR 69678 at 69729),

FDA published a final rule, in accordance with the procedures contained

in section 513 of the Federal Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360c), classifying as a device a protective restraint,

usually a wristlet, anklet, or other type of strap, that is intended

for medical purposes and that limits a patient's movement to the extent

necessary for treatment, examination, or protection of the patient. In

that regulation, FDA exempted manufacturers of protective restraints,

which are class I devices, from the premarket notification procedures

in part 807 (21 CFR part 807), and the CGMP regulations in part 820 (21

CFR part 820), with the exception of Secs. 820.180 and 820.198,

relating to general requirements concerning records and complaint

files, respectively. FDA granted these exemptions because, at that

time, FDA did not have information that caused serious concerns about

safety problems related to the use of protective restraint devices.

Since the October 1980 publication of these classifications that

exempted protective restraints from premarket notification and CGMP

requirements, FDA has become aware of numerous reports of serious

injuries and deaths that have been attributed to incorrect supervision,

handling, or application of protective restraints. In the Federal

Register of June 19, 1992 (57 FR 27397), FDA, in response to these

adverse event reports, published a proposed rule to revoke the

exemptions from premarket notification procedures and CGMP regulations

for protective restraints and wheelchair accessories intended for use

as protective restraints. FDA's proposed revocations complement the

Health Care Financing Administration (HCFA) regulations (42 CFR part

483) and HCFA's February 5, 1992 (57 FR 4516), proposed rulemaking that

address clinical indications for use of restraints that protect

individuals from inappropriate use of restraints for discipline or

convenience. The revocation of the exemption from the premarket

notification procedures will permit the agency to monitor the marketing

of these devices, and review and identify unclear labeling that may

result in incorrect application of the devices. The revocation of the

exemption from CGMP requirements will help ensure that restraints are

safe by conforming to appropriate specifications for design, materials,

performance, and labeling. A 60-day comment period, ending on August

18, 1992, was provided to allow interested persons an opportunity to

submit comments on the proposed changes.

In addition to this rule, FDA has taken other steps to ensure that

protective restraints are used safely. On July 15, 1992, FDA issued a

Safety Alert on potential hazards with restraint devices (Ref. 1) to

hospital administrators, directors of nursing, directors of emergency

room services, and long-term care facilities. FDA also issued a letter

to manufacturers in February 1992 stating that FDA considered

restraints to be prescription devices which must bear a prescription

legend as prescribed in Sec. 801.109 (21 CFR 801.109) to help ensure

appropriate medical intervention in the application and use of

restraints (Ref. 2).

FDA received 24 comments in response to the proposal of June 19,

1992, from individuals, manufacturers, professional societies, and

consumer and health associations. The comments were primarily

supportive of FDA's proposed actions. Several comments, however, stated

that FDA should consider additional regulation of protective

restraints. These comments are discussed below.

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

A. General Comments

1. One comment stated that it would be helpful for FDA to recommend

that facilities use one standard brand of each type of restraint (e.g.,

vest) to provide consistency and increase the likelihood that the

restraint would be applied correctly. Another comment suggested

restraints be uniformly designed so the front and back are easily

identifiable.

Although standardization of brands in a facility may increase the

likelihood that restraints will be applied correctly, it is critical

that the correct type and size restraint be applied to maximize the

safety of these devices. Accordingly, FDA encourages standardization as

long as it can be achieved without compromising the use of the

appropriate restraint type and size. Ultimately, however, this decision

must be made by each facility. FDA cannot endorse one uniform design.

Restraints used under different circumstances must necessarily

incorporate different designs.

2. Several comments indicated support for a prescription

requirement by licensed health care practitioners, specifying the

appropriate restraint type, duration of application, and circumstances

for use. One comment stated that FDA has avoided the issue of whether

anyone other than a licensed health care worker should be permitted to

apply restraints. Another comment stated that FDA did not address the

issue of appropriate frequency of monitoring.

The determination of appropriate individuals to apply restraints or

appropriate frequency of monitoring is beyond the scope of this

regulation. However, FDA believes the use of restraints should be

limited to those circumstances when they are clearly clinically

indicated, and that they

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should be used only for a strictly defined period of time and only

under the supervision of a licensed health care provider. For these

reasons, FDA informed protective restraint manufacturers in February

1992 that it considered these devices to be prescription devices that

may only be used under the direction of a licensed health care

practitioner. In addition, FDA strongly encourages that after

restraints are prescribed by a licensed health care practitioner, they

be applied only by adequately trained personnel, in accordance with

State licensure and Federal certification requirements for facilities.

3. While several comments were supportive of FDA's proposal to

revoke 510(k) and CGMP exemptions, three comments opposed the

revocation of the exemptions. One comment suggested withdrawing the

proposed regulations until more complete information is available.

Another comment stated that the revocations are unjustified based on

the relatively small number of associated deaths and injuries compared

to the large annual usage of restraints. Another comment by a

manufacturer stated that the revocations were unwarranted because it

was unaware of any deaths or serious injuries associated with its

restraint products.

FDA disagrees that it needs to have more complete information

before it revokes premarket notification and CGMP requirements.

Although complete information concerning the problems associated with

restraints is not available, FDA does have sufficient information about

these problems to warrant revocation of the exemptions from premarket

notification and CGMP requirements. As explained in the preamble to the

proposed rule, the revocation of these exemptions will allow FDA to

gather more information to help ensure the safety of these devices.

FDA believes that the exemption revocations are justified based on

the numbers of reports of deaths and injuries associated with

protective restraint use. FDA notes that since publication of the

proposed rule of June 19, 1992, the total numbers of deaths and serious

injuries reported under the Device Experience Network (DEN), which

includes the mandatory Medical Device Reporting Program and the

MedWatch Reporting Program, have increased from 41 deaths and 16

serious injuries to 130 deaths and 48 injuries. In addition, several

comments support FDA's belief that injuries and deaths associated with

protective restraints are seriously underreported.

FDA does not agree with the comment from one manufacturer that

revocations of the exemptions were not warranted for its restraints

because the manufacturer was not aware of any deaths or serious

injuries associated with its products. Reports of these problems

encompass many different restraint types, regardless of manufacturer or

design; various types of patient populations, regardless of clinical

indications for the use of the restraint; and various types of health

care facilities, including hospitals, home use situations, and nursing

homes. The fact that problems have been reported from a wide spectrum

of protective restraint types and situations indicates that the

problems associated with protective restraints are not specific to one

particular type of restraint. Moreover, given the probability of

underreporting of protective restraint-associated deaths and injuries,

the absence of complaints for one particular manufacturer does not

indicate that that manufacturer's devices are free of the problems

associated with other restraints.

4. One comment from a restraint manufacturer disagreed with the

economic impact analysis of the proposed rule and stated that

revocations of the exemptions would result in substantial economic

costs. To avoid incurring the costs associated with compliance with the

regulation, the manufacturer stated that their company may disavow the

``medical device'' classification of their product line and continue to

sell their restraint devices to interested members of the health care

industry.

FDA advises that protective restraints, within the meaning of

section 201(h) of the act (21 U.S.C. 321(h)), are medical devices

because they are intended for use in the cure, mitigation, treatment,

or prevention of disease. Therefore, on or after the effective date of

this final rule, any manufacturer distributing a restraint device not

meeting the provisions of this final rule would violate the act by

distributing devices that are: (1) Misbranded, in that no premarket

notification submission has been filed pursuant to section 510(k) of

the act (21 U.S.C. 360(k)); and (2) adulterated, if CGMP requirements

are not met under section 520(f) of the act (21 U.S.C. 360j(f)). FDA

strongly discourages any noncompliance with this regulation and is

prepared to take enforcement actions against persons who violate this

regulation. Such actions may include seizure, injunction, civil

penalties, and criminal prosecution.

Furthermore, FDA disagrees that a substantial economic impact would

result from these regulations. The comment estimated that the company

would incur costs of $200,000 for 100 510(k) applications and as much

as $500,000 to attain compliance with CGMP's, which could force the

company out of business. The comment did not present any data to

support claims of substantially higher costs for complying with CGMP's.

FDA has reconsidered its economic analysis and believes that the

costs of premarket notification submissions and compliance with CGMP's

are considerably lower than suggested in this comment. Also, FDA

expects to allow some grouping by product category in a 510(k)

submission as discussed in comment 10 of this document, which should

limit the number of 510(k)'s that have to be submitted by any

particular manufacturer.

5. One comment questioned the benefit of simply revoking the

exemptions, but believed that the revocations were necessary as an

interim measure while reclassification of the devices to a more

stringent regulatory category is considered. Three comments believed

the proposed revocations to be a totally inadequate response to

problems with restraints and inconsistent with requirements issued by

HCFA. These comments stated that FDA should convene a device

classification panel to determine whether restraint devices should be

reclassified to class II or III.

FDA is continuing to evaluate the need for reclassification of

these devices. However, FDA believes that revocation of the premarket

notification exemption will facilitate more immediate improvements in

the labeling of restraint devices that quickly will provide increased

safety and effectiveness in the use of restraints, and that revocation

of CGMP exemptions will facilitate improvements in the manufacture of

restraint devices. FDA believes that these measures will greatly reduce

the risk associated with use of protective restraints. FDA retains the

option to reclassify the devices at a later time, if such additional

action is believed necessary to protect the public health.

FDA disagrees that its actions are inconsistent with those of HCFA.

As stated in the preamble to FDA's June 19, 1992, proposed rule, the

intent of HCFA's requirements on use of restraints in nursing homes is

to protect nursing home residents from use of restraints for purposes

of convenience or discipline. FDA's actions complement these

requirements by ensuring that for those instances where

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restraints are clinically indicated, the labeling and instructions for

use of the restraints will facilitate correct application by health

care providers.

6. One comment requested immediate recall action on restraints that

have a higher association with death and serious injury than others.

The comment believed that criss-crossed vests were the most dangerous,

although the comment acknowledged that the higher number of death

reports associated with vest restraints may be due to more frequent use

of those devices.

FDA does not believe that the criteria for requiring the recall of

any particular protective restraint have been met. Under section 518(e)

of the act (21 U.S.C. 360h(e)), FDA may order a recall of a device only

after finding that the device would cause serious adverse health

consequences or death. FDA does not have information that any type of

restraint, including criss-crossed vests if used properly, would cause

serious adverse health consequences or death. Furthermore, restraints

can provide benefits that outweigh the risks for some patients, for

example, by preventing patients with medically related cognitive

deficits from involuntarily discontinuing life-support or other needed

medical interventions, by temporarily reducing the mobility of agitated

patients who may otherwise hurt themselves or others, or by helping

patients feel safer in a bed or wheelchair. FDA does not believe that

recalling these restraints where the benefits outweigh the risks would

be in the best interest of the public health. Furthermore, FDA believes

that the risks associated with restraints will be further reduced by

the measures taken in this regulation. FDA, however, will certainly

initiate 518(e) recall action in the future if the agency determines

that individual circumstances warrant such action.

7. Four comments requested that FDA resume plans to conduct

clinical and human factors engineering tests on restraining devices to

assess their safety and effectiveness. Several comments stated that FDA

should gather and study information from other sources besides DEN,

including the Consumer Product Safety Commission, HCFA, State and local

agencies that regulate nursing homes, the courts, review of patient

records, review of the literature, and consultation with experts in the

field.

FDA notes that in developing its course of action regarding

protective restraints, the agency gathered considerable information

from many other sources besides DEN, including literature reviews,

interviews with health care professionals and professional

organizations, visits to user facilities, and discussions with

manufacturers of restraints. It is the manufacturers' responsibility to

conduct testing to assess safety and effectiveness. FDA, however, would

welcome any additional research information regarding restraint use

from health and consumer groups and encourages research by such groups

that would promote safer use of restraints. By revoking the premarket

notification and CGMP exemptions, FDA will gain further information

that will enable the agency to ensure safe use of these devices. FDA

will continue to evaluate information received from other available

sources.

8. One comment stated that FDA has ``exhibited confusion'' about

the appropriate circumstances for use of restraints. The comment noted

that the proposed rule states that restraints may be needed to keep

agitated patients from hurting themselves, but an FDA Medical Alert

warned that restraints may only add to this agitation and confusion and

therefore may place the patient in jeopardy.

Whether restraints should be used may vary depending on the

circumstances presented by the individual patient. While FDA realizes

that restraints can adversely affect a patient by increasing agitation,

they may sometimes be necessary under certain circumstances to restrain

agitated patients from harming themselves. The determination of whether

restraint use is appropriate should be made by clinicians for each

patient individually, after assessing the risks and benefits of

restraint use.

9. Several comments that supported the revocations suggested that

manufacturers who fail to submit a 510(k) or fail to adhere to CGMP's

should not only be prohibited from future sales of restraints, but

should be compelled to remove from use (at the manufacturers' expense)

all previously sold restraint products.

FDA disagrees that recalling devices is necessarily an appropriate

remedy for failure to comply with CGMP or premarket notification

requirements. As explained in comment 6 of this document, FDA will

initiate recalls only if the statutory criteria under section 518(e) of

the act are met, and will decide whether those criteria are met on a

case-by-case basis. As stated in FDA's response to comment 4 of this

document, manufacturers who fail to comply with CGMP and premarket

notification requirements are subject to various enforcement actions by

FDA.

10. Five comments requested that manufacturers be allowed to submit

510(k)'s by product category (e.g., vests, limb holders etc.), rather

than for each individual product, because some products differ only in

minor design aspects, while their function, application, and use is

identical.

FDA agrees that grouping of similar devices in a 510(k) submission

would be acceptable to a limited extent. For example, vests of similar

design but composed of different fabrics might be grouped into one

510(k). However, submissions for devices differing substantially in

design (and therefore risk) should not be grouped in a single 510(k).

FDA will review this issue on a case-by-case basis.

11. One comment expressed concern regarding what criteria FDA is

using to determine safety and effectiveness, and whether manufacturers

could be assured that 510(k)'s will not be delayed on the basis of

individual reviewers' perceptions of what constitutes safe and

effective.

FDA advises that there will be uniformity in the criteria that

reviewers consider to determine the safety and effectiveness of these

devices. Section 513(i) of the act (21 U.S.C. 360c(i)) and its

implementing regulations in part 807 (21 CFR part 807) describe the

criteria used by FDA to determine substantial equivalence. FDA provided

guidance that described labeling for restraints at an October 1991

meeting with a medical device trade organization. This guidance has

been incorporated into a draft 510(k) submission guidance that will be

used by FDA reviewers to assist in evaluating 510(k) submissions.

Additional general labeling guidance is available in the Human Health

Services (HHS) publication ``Labeling: Regulatory Requirements for

Medical Devices'' (Ref. 3), the Office of Device Evaluation's labeling

guidance document (Ref. 4), and the publication ``Write It Right,'' a

guidance on labeling for home use products (Ref. 5). The draft 510(k)

submission guidance recommends that manufacturers' 510(k) submissions

for restraints address the following: (1) Specific intended use of the

device; (2) ease of release of the device in the event of emergencies;

(3) tear strength of the materials; (4) potential for injury (e.g.,

whether there are abrasive materials, such as metal fasteners, that

would come in contact with the patient's skin, and similar

considerations); (5) ease of identification of size; (6) completeness,

conspicuousness, and simplicity of directions and labeling; (7) care/

cleaning instructions; (8) whether the material is biocompatible; and

(9) any safety testing data available for the device, including an

analysis of bench simulation testing data; and for certain

circumstances, (10) patient testing data.

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Manufacturers may contact the reviewing division to discuss the

appropriate content of their submissions on a case-by-case basis. FDA,

elsewhere in this issue of the Federal Register, is publishing a notice

of availability of this draft guidance and requesting comments on it.

12. Five comments stated that to ensure that protective restraints

continue to be available for medical use, manufacturers need to be able

to continue to market their products during the interim period between

the effective date of the final rule revoking the 510(k) exemptions and

the date that products are cleared by FDA. The comments also stated

that manufacturers need to be given a reasonable amount of time (at

least 6 months) after their final labeling is approved to exhaust the

remaining existing supplies of their products and phase in products

with the new labeling. Additionally, three comments stated that

manufacturers need to be given a reasonable amount of time (for

example, 2 years) to attain compliance with CGMP's.

FDA realizes that there will be a time period between the filing of

a 510(k) submission required by this regulation, and FDA's

determination, based on that submission, of whether the device has

marketing clearance. During the time period between the filing of a

510(k) and the FDA's substantial equivalence decision, FDA, in

exercising its enforcement discretion, does not intend to initiate

enforcement action relating to the distribution of protective restraint

devices that are adulterated under 21 U.S.C. 351(f)(1)(B) because they

fail to have FDA marketing clearance if: (1) The devices were initially

introduced into interstate commerce prior to September 3, 1996; and (2)

the sponsor has filed a 510(k) submission as of September 3, 1996.

FDA, however, intends to exercise its enforcement discretion to

initiate regulatory action against protective restraint devices that

have not received marketing clearance after June 4, 1997 if FDA has

been unable to reach a decision determining substantial equivalence

because the 510(k) submission fails to contain sufficient information.

FDA will notify the sponsor if such additional information is

necessary.

FDA has extended the effective date of the final rule requiring

submission of 510(k)s and compliance with CGMP's from 90 days to 180

days. FDA believes this time period is appropriate.

FDA first informed restraint manufacturers about FDA's planned

actions regarding 510(k) and CGMP requirements at a meeting with a

medical device trade organization in October 1991. FDA again notified

manufacturers in FDA's June 19, 1992, proposed rule, that the agency

intended to revoke these exemptions. Given the fact that industry has

been on notice since 1991 of FDA's plans to revoke these exemptions,

FDA does not believe manufacturers need an additional 2 years to comply

with CGMP's or 6 months after their labeling is approved to exhaust

supplies of labeling.

B. Restraint Identification

13. Two comments agreed with FDA's identification of a protective

restraint as it was published in the proposed rule. Several comments

stated that the identification of restraint used in the proposed rule

is too narrow, leaving major gaps in the coverage of a growing list of

potentially dangerous devices that are routinely used to restrain

patients or residents and that are ``falsely marketed'' as alternatives

to restraints. To alleviate these concerns, several comments suggested

using the broader definition of restraint proposed by HCFA in order to

include the concept of a method of restriction of movement.

FDA disagrees that the identification of protective restraints is

too narrow and leaves major gaps that do not cover devices that are

``falsely marketed'' as alternatives to restraints. Although the

identification gives examples of protective restraints, such as

wristlets, vests, and straps, the identification of protective

restraints is not limited to those examples. The identification is

based on the product's intended use. Under Sec. 801.4, evidence of a

device's intended use is not limited to labeling claims or to verbal

representations. It may be shown by the circumstances that the device

is offered and used for a purpose for which it is neither labeled nor

advertised. FDA considers any actions that otherwise represent a

device's intended use, as well as labeling, to determine a device's

intended use. Therefore, even devices that are ``falsely marketed'' as

alternatives to restraints will fall under the identification of

protective restraint if their intended use is to function as a

protective restraint. If a manufacturer intends a device to be used as

a restraint or is aware that the device is used as a restraint, that

manufacturer must comply with requirements for protective restraints.

FDA encourages consumers or health care workers to report instances

where manufacturers of such products are not complying with the

requirements for protective restraints.

Other comments suggested that the identification should state that

a restraint is any device which a resident cannot remove easily and

which restricts freedom of movement or easy access to their body. FDA

does not agree that the protective restraint identification should be

this broad. FDA may only regulate as devices products that fall within

the definition under section 201(h) of the act. Many products that

restrict freedom of movement or easy access to the body do not fall

under FDA's jurisdiction (e.g., safety belts, car seats). Also, even if

products that restrict freedom or access are medical devices (e.g.,

geriatric chairs), FDA believes it is inappropriate to identify all

such devices as protective restraints where that is not the intended

use of such devices.

14. One comment objected to the use of ``or others'' after

``protection of the patient'' at the end of Sec. 880.6760 (21 CFR

880.6760) because it is an established rule that restraints may only be

used to ``ensure the physical safety of the resident or other

residents'' (Social Security Act, section 1919 (42 U.S.C. 1396q)). The

comment also objected to the use of the term ``patients'' in the

restraint identification, because it is not appropriate in many non-

hospital settings. The term ``patients or other residents'' was

suggested as a substitute.

FDA disagrees with the comments. Restraints are sometimes used in

situations to protect individuals other than the person in restraints.

For example, hospitals may use restraints in emergency rooms to protect

staff, or other patients/residents from harm (e.g., due to patient drug

abuse or comparable circumstances). With regard to the objection to the

term ``patients'' in the context of non-hospital settings, FDA believes

that since restraints are medical devices, any resident who is

restrained constitutes a patient within the broad meaning of the term

in this section while wearing the restraint. Therefore, FDA rejects

these comments.

15. One comment stated that FDA should define bedrails and

geriatric chairs as restraints.

FDA notes that bedrails and geriatric chairs are currently

classified under Secs. 880.5100, 880.5110, 880.5120, and 880.5140

(bedrails); and Secs. 890.3100 and 890.3110 (21 CFR 890.3100 and

890.3110) (geriatric chairs). For the reasons stated in response to

comment 13 of this document, FDA believes that the current definition

of restraints is appropriate.

16. One comment requested that FDA modify the restraint

identification to exclude from the regulation those restraints that are

used with radiotherapy linear accelerators and simulators, because of

the controlled

[[Page 8436]]

conditions under which such restraints are used and the benefit they

provide. The comment requested that the identification of a restraint

be modified as follows:

A protective restraint is a device * * * that is intended for

medical purposes and that limits the patient's movements to the

extent necessary for treatment, examination, or protection of the

patient or others, excluding restraints which are used for a short

duration under the continual supervision of qualified personnel.

FDA does not believe that it would be appropriate to modify the

restraint identification to exclude restraints which are used for a

short duration under continual supervision from 510(k) and CGMP

requirements. These requirements are necessary for restraints that are

intended to be used for short periods of time under supervision because

such restraints may pose risks to patients if they are not used in the

manner the manufacturer intended. FDA advises that ``restraints'' for

use with radiation therapy systems are included under the

classification regulations for radiation therapy systems in

Secs. 892.5050 and 892.5300 (21 CFR 892.5050 and 892.5300). Under those

classification regulations, such restraints are already subject to

510(k) and CGMP requirements. Manufacturers of restraints that are

accessories to other devices should submit their 510(k) submissions to

the appropriate reviewing division for the primary device.

C. Wheelchair Accessories

17. Two comments supported the proposal to revise the

classification regulation for wheelchair accessories labeled or

otherwise represented as restraints. One comment, however, stated that

restraints should not be classified as wheelchair accessories because

this minimizes the importance of decisions regarding whether a

restraint should be used at all and the selection of the appropriate

type of restraint.

FDA disagrees that the chosen classification of wheelchair

accessories intended for use as restraints diminishes the importance of

decisions regarding use of those devices. FDA specifically emphasized

in the proposed rule and in the July 1992 FDA Safety Alert that the

same safety considerations, including proper selection and labeling,

are equally important for wheelchair accessories that are used as

protective restraints.

18. Two comments recommended that FDA adopt an identification of

wheelchair accessories intended for use as restraints that includes all

accessories and all wheelchair components that are manufactured and

marketed with the intent of restricting the patients' movement,

regardless of whether the devices are labeled or represented as

restraints.

FDA agrees with these comments. As discussed in paragraph 13 of

this document, the definition of protective restraint includes any

device that ``is intended for medical purposes and that limits the

patient's movements to the extent necessary for treatment, examination,

or protection of the patient or others.'' In stating in FDA's June 19,

1992, proposed regulation that FDA was exempting wheelchair accessories

from CGMP and premarket notification requirements that were not

``labeled or otherwise represented'' as a protective restraint, FDA did

not mean to imply that it was exempting those wheelchair accessories

that are not labeled or represented as restraints if they are intended

for use as restraints. To clarify that all wheelchair accessories which

are intended to be used as protective restraints must comply with

premarket notification and CGMP requirements, FDA is replacing the

words ``labeled or otherwise represented'' with ``intended for use'' in

the final regulation.

D. Labeling/Human Factors

19. Six comments requested that the agency consider the wide

variety of protective restraints available and evaluate each device

according to its intended use/size/design, without imposing a

``blanket'' labeling requirement for all restraints. For example,

devices such as vests should be labeled to clearly distinguish the

front and back of the restraint, whereas other restraints which have no

front and back should not be required to have such labeling.

FDA agrees that a ``blanket'' labeling requirement in this sense

should not be imposed and that the risks and benefits of each restraint

device should be reviewed individually in determining appropriate

specific labeling for restraint devices. FDA believes, however, that

similar protective restraints should have similar labeling. FDA also

believes that protective restraints should include step-by-step

instructions on how to apply the device and where to secure the ties,

have securely attached warning labels that clearly identify the front

and back of the restraints, and warn users of the dangers of reversal,

preferably using pictorials. Additional labeling instructions are

listed in the draft guidance document discussed in comment 12 of this

document.

20. Several comments expressed concern that the FDA regulation

implies that the only danger of restraints is in their potential

misapplication and that they are safe when used in accordance with the

manufacturer's instructions, and that HCFA's regulations will be

undermined.

FDA disagrees with these comments. FDA's regulation does not imply

that it alone will ensure safe and effective use of restraints. As

explained more fully in both the preamble to FDA's June 1992 proposed

rule and comment 5 of this final rule, FDA's regulations and HCFA's

regulations complement each other, they do not undermine each other.

HCFA laws and regulations ensure that restraints are only used on

persons who need restraints, and FDA's regulations will help ensure

that if clinically appropriate, such restraints will be applied safely.

21. Several comments requested that FDA require that restraint

labeling contain specific information including information about all

potentially harmful effects from the use of restraints, including

hazards, side effects, warnings/precautions, and contraindications for

their use. The comments also requested requiring clear delineation in

the device labeling as follows: (1) The front and back of the

restraint; (2) top and bottom of the restraint; (3) length of time the

restraint can be applied safely; (4) frequency with which the restraint

should be released; (5) frequency with which the patient should be

monitored; and (6) minimum standards or qualifications of personnel to

administer restraints. Several comments stated that labeling should be

required to be on the inside or underside of the device in as discrete

a manner as possible to convey necessary information and/or

instructions to users, in order to preserve the dignity and self-esteem

of the individual being restrained.

FDA advises that this regulation will allow FDA to review the

labeling for protective restraints, and that all labeling must provide

material information related to its safe use in accordance with section

502(a) of the act (21 U.S.C. 352(a)). In the preamble to the proposed

rule, FDA stated certain labeling practices that FDA believes are

necessary to help ensure the safe use of devices. Also, specific

suggested labeling is stated in the draft guidance document discussed

in comment 11 of this document. After receipt of individual premarket

notifications, FDA will review the labeling on a case-by-case basis.

With regard to placement of labeling, FDA encourages placement of

labeling in a manner that respects the patient's dignity, as long as

the placement does

[[Page 8437]]

not compromise the visibility of the labeling to the person applying

the restraint.

22. Several comments noted support for the utilization in all

product labeling of pictorials, languages other than English, and

textual information written for low language comprehension levels, in

sufficiently large type to clearly express the message. Several

comments suggested that the use of languages other than English is not

feasible and that the manufacturer's obligation should be limited to

adequate step-by-step instructions in English, with translations made

available by individual employers.

FDA agrees that pictorials and text materials written for low

language comprehension levels are important for effective conveyance of

application and hazard information. FDA also encourages manufacturers

that distribute devices for use by populations who do not use English

as a first language to provide instructions in foreign languages to the

extent possible and in accordance with the foreign language

requirements of Sec. 801.15(c). FDA has discussed human factors

considerations related to labeling with manufacturers, including the

selection of legible font types and sizes. Under 21 U.S.C. 352(c)

labeling statements required by or under the authority of the act must

be placed with conspicuousness and in such terms as to render them

likely to be read and understood by the ordinary individual under

customary conditions of purchase and use. See 21 CFR 801.15.

23. Several comments suggested that in addition to improved

labeling, posters should be made available for use and kept in

accessible view, such as in the restrained patient's room, nurses

stations, and physical therapy facilities.

FDA agrees that posters could be very helpful in promoting proper

use of restraints and has encouraged manufacturers to develop such

posters. Several manufacturers have already implemented instructions on

posters. Placement of such posters should be done in such a way that

they will be readily accessible to personnel but still comply with

nursing facility requirements for a homelike environment, in accordance

with provisions of 42 CFR 483.15(h)(1).

24. One comment noted that warnings and instructions for restraints

should be conveyed in a form suitable for home use as well as

institutional use.

FDA agrees with the comment and encourages use of FDA's guidance on

developing user instruction manuals for medical devices used in home

health care (Ref. 5). The document, entitled ``Write It Right,'' has

been distributed to all domestic and foreign medical device

manufacturers. Copies may be obtained from the Division of Small

Manufacturers Assistance, Center for Devices and Radiological Health,

800-638-2041.

25. One comment stated that experience demonstrates that product

labels and directions cannot in and of themselves protect patients from

injury or death. The comment stated that while the labeling guidelines

proposed by FDA represent a positive step in recognizing the potential

dangers of inappropriately applied or inappropriately supervised use of

restraints, such guidelines may do more to help shield manufacturers

involved in product liability suits than to protect patients from

avoidable accidents.

FDA agrees that product labeling alone cannot protect patients from

injury or death. However, well-presented labeling that is written in a

salient, informative, and concise manner can motivate the user to read

instructions, which can reinforce demonstration instruction and prevent

misuse of devices. Studies, as early as 1960, illustrate that behavior

can be affected by warnings and safety posters in the workplace (Ref.

6). More recent studies demonstrate that user behavior is clearly

influenced by the presence and location of warnings and adequate

instructions for use (Ref. 7).

FDA agrees that clearer labeling may in some instances help shield

manufacturers from product liability. However, regardless of any effect

on product liability, improved labeling, which may help reduce the

incidence of injury and death is important. To supplement the

beneficial effects of improved labeling, FDA advises that adequate

training and education of health care providers is necessary for safe

and effective use of restraints.

26. One comment stated that knots tied in some restraints are often

difficult to untie in the event of an emergency, and if it were at all

possible, restraints that tie should be replaced by those that release

with a clasp of some kind.

FDA supports the development of safe innovations that would improve

the ease of use of restraint devices.

E. Sizing/Color Coding

27. Several comments stated that a universal color coded sizing

system should be adopted throughout the industry to help facilitate

selection of the appropriate restraint size and reduce incidences of

misapplication of an incorrect size that could lead to deaths or

injuries.

FDA agrees with the comments. FDA also notes the availability of a

voluntary new sizing standard for women over the age of 55, which might

be of use in designing restraints for geriatric patients, who typically

have upper torso dimensions that are substantially different from

younger patients. The standard, entitled ``The Development of Body

Measurement Tables for Women 55 and Older and the Relationship to Ready

to Wear Garment Sizes,'' is available from the American Society for

Testing and Materials, 1916 Race St., Philadelphia, PA 19103.

28. One comment from a manufacturer noted that for 54 years their

company has manufactured restraints in accordance with a particular

color code for size, and that this color code has become the most

commonly used and understood color code by users of restraints. The

comment stated that if FDA decides to adopt a different color standard

than what the comment perceives as the ``prevailing standard,'' it will

create serious confusion among users because of the extensive user

familiarity with that color coding standard. Another comment stated

that color coding sizes for restraints would have a substantial

financial impact on industry.

This regulation is not requiring the adoption of a color-coded

sizing standard. However, FDA encourages manufacturers to develop an

industry-wide voluntary standard.

29. Two comments noted that manufacturers produce a selection of

sizes of certain types of restraints (e.g., vests), but that this does

not ensure that facilities have purchased adequate sizes or the entire

line of vest restraints for utilization in their facility.

FDA advises that selection of the appropriate size and type of

restraint is critical for safe and effective use of the device and that

clinicians and purchasing agents should consult medical practice

guidelines and instructions for use in determining the appropriate

size.

F. Flame Retardancy

30. FDA explicitly solicited comments regarding whether some or all

restraints should be made of flame resistant materials. Several

comments supported a universal requirement for flame resistant

restraints, citing the following reasons:

(1) There have been reports to FDA of at least six patients dying

or being injured as a result of deliberately or accidentally igniting

their restraints;

(2) Clinicians report having seen many restraints with ash and

cigarette burns in them, further indicating a

[[Page 8438]]

safety problem with respect to flammable materials;

(3) Many of the persons who are restrained may retain their right

to smoke in designated areas. These patients may have poor posture

control or hand dexterity, or may be confused, increasing the chances

of an accident. Also, visitors and other residents unaware of a

potential fire hazard may give smoking materials to the resident

without staff knowledge;

(4) Many nursing home residents may use oxygen, or be in close

proximity to other residents who use oxygen, increasing the danger of

fire.

Alternatively, multiple comments opposed requiring all protective

restraints to be constructed of flame resistant material, citing the

following reasons:

(1) Adequate and appropriate supervision is the best means of

prevention of burn and smoke inhalation injuries to individuals who are

being restrained;

(2) Many other items found on or near the bed are not flame

resistant, such as bed linens, pajamas, clothing, and even the

patient's hair, so having restraints made of flame resistant materials

would not serve a useful purpose. Residents might be better served

through establishment of a smoke-free environment;

(3) Labeling of restraints as flame resistant might actually

encourage smoking in bed by providing a false sense of security to both

residents and health care providers, who might relax smoking policies;

(4) The availability and effectiveness of flame resistant

restraints is limited by current technology. Some device components are

not readily available in flame resistant material, so requiring

restraints with this property might be prohibitively expensive. Also,

textile materials treated with flame resisting chemicals will burn if a

source of ignition is present, and the flame retardancy of some devices

is destroyed after the first laundering of the device. Warnings against

the exposure of protective restraints to ignition sources should

adequately address concerns related to burn injuries;

(5) Flame resistant vests are now marketed with very little success

due to the higher price (approximately 30 percent). This cost outweighs

the negligible benefit that might be derived with a universal

requirement for flame resistant restraints.

Several comments also stated that FDA should study the actual

contribution to patient safety that would be afforded by flame

resistant restraints versus the economic impact of replacing devices

currently in use. One comment suggested that the comfort and care of

the patient should be the primary concern and that secondary issues

should include whether fire resistant materials make the restraint less

flexible or more likely to cause rubbing or irritation; the effect on

safety features of the device; and the extent of protection flame

resistant materials would actually offer in the event of fire.

FDA has carefully considered the comments submitted and concluded

that although there are potential fire hazard concerns for some

patients, adequate and appropriate supervision is the most effective

and useful means of preventing fire-related injuries associated with

restrained patients. Some additional benefit, however, may occur by

using flame-resistant restraint material on patients who smoke.

Although FDA does not believe it is appropriate to require the use of

flame-resistant materials for all restraints, FDA recommends that

health care institutions develop and implement policies for the use of

flame-resistant restraints for patients who smoke while in restraints.

G. Training, Education, and Guidelines for Use

31. Several comments advocated increased training, education, and

FDA development of guidelines for restraint use to promote the safe

application of restraint devices. Several comments suggested that FDA

should publish a consumer (family) guide or brochure on the appropriate

use of restraints, the risks and benefits of restraint prescription and

application, and the potential side effects and hazards of restraint

use.

FDA agrees that adequate training and education for users of

restraints in all care scenarios is critical to the safe and effective

use of restraints and FDA strongly encouraged increased education about

restraint use in its July 1992 Safety Alert issued to health care

professionals. FDA has actively participated with health care

associations in the development of guidelines for use of medical

devices in the past and is willing to participate in such efforts for

protective restraints. FDA advises that in using restraints,

institutions are required to meet all State and local laws and HCFA

requirements, and are encouraged to meet guidelines developed by

professional health care organizations. With regard to publication of a

consumer guide, the FDA 1992 Safety Alert on restraints contains

information about restraint use specifically directed towards patients

and family members. Copies of FDA's Safety Alert are available upon

request from the Office of Surveillance and Biometrics (HFZ-500),

Center for Devices and Radiological Health, 5600 Fishers Lane,

Rockville, MD 20857.

32. One comment stated that because the liability burden for

patient morbidity and mortality caused by restraints is increasingly

shifted to nursing home staff, FDA should consider requiring

manufacturers to offer training and accessible advice to nursing homes

with device questions or problems, as a component of the new premarket

notification and CGMP rules.

Such requirements are beyond the scope of this rulemaking. However,

FDA encourages health care facilities to request training when

purchasing restraints and if such training is not made available, to

reconsider their purchasing policies. Manufacturers have already been

strongly urged by FDA to develop training videos and other materials to

assist health care facilities in training their staff in the proper

application and use of their products.

H. Chemical Restraints

33. Two comments noted that they do not support the use of

pharmaceutical options as chemical restraints in substitute for

physical restraints and stated that FDA is well positioned to address

the issue of the misuse of chemical restraints. The comments

recommended that FDA consider labeling recommendations for

manufacturers of drug products frequently used for chemical restraint.

FDA is advised that guidelines for the use of chemical restraints

in nursing homes are being finalized by HCFA, but such controls are

beyond the scope of this medical device rule. If the comments wish to

express concerns regarding labeling of specific drug products believed

to be misused as chemical restraints, those comments should be referred

to FDA's Center For Drug Evaluation and Research, Division of

Neuropharmacological Drug Products (HFD-120), 5600 Fishers Lane,

Rockville, MD 20857.

III. The Final Rule

Persons required to file premarket notification submissions under

section 510(k) of the act (21 U.S.C. 360(k)) and the procedures in

subpart E of 21 CFR part 807 must file a premarket notification

submission for any protective restraint device already marketed or

intended to be introduced or delivered for introduction into interstate

commerce for commercial distribution on or after September 3, 1996.

[[Page 8439]]

All protective restraints that are introduced or delivered for

introduction into interstate commerce on or after September 3, 1996,

are required to be manufactured in compliance with the CGMP regulations

in 21 CFR part 820.

In a notice published elsewhere in this issue of the Federal

Register, FDA is announcing the availability of a draft guidance

document for the preparation of a premarket notification (510(k))

submission.

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) 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.

V. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

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 final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the final

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because this final rule only removes an exemption

and subjects manufacturers of patient restraints to the same

requirements as manufacturers of other devices, the agency certifies

that the final rule will not have a significant economic impact on a

substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is required.

VI. 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. ``FDA Safety Alert: Potential Hazards with Restraint

Devices,'' Food and Drug Administration, Rockville, MD, July 15,

1992.

2. Johnson, R., FDA, letter to restraint manufacturers,

February, 1992.

3. ``Labeling: Regulatory Requirements for Medical Devices,''

HHS Publication No. FDA 89-4203, Food and Drug Administration,

Rockville, MD, August, 1989.

4. Office of Device Evaluation, ``Device Labeling Guidance,''

No. G91-1, Food and Drug Administration, Rockville, MD, March 8,

1991.

5. ``Write It Right: Recommendations for Developing User

Instruction Manuals for Medical Devices Used in Home Health Care,''

Food and Drug Administration, Rockville, MD, August, 1993.

6. Laner, S., and R. G. Sell, ``An Experiment on the Effect of

Specially Designed Safety Posters,'' Occupational Psychology,

34:153-169, 1960.

7. Wolgalter, M. S. et al., ``Effectiveness of Warnings,'' Human

Factors, 29(5):599-612, 1987.

List of Subjects

21 CFR Parts 880 and 890

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts

880 and 890 are amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

1. The authority citation for 21 CFR part 880 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 880.6760 is revised to read as follows:

Sec. 880.6760 Protective restraint.

(a) Identification. A protective restraint is a device, including

but not limited to a wristlet, anklet, vest, mitt, straight jacket,

body/limb holder, or other type of strap, that is intended for medical

purposes and that limits the patient's movements to the extent

necessary for treatment, examination, or protection of the patient or

others.

(b) Classification. Class I (general controls).

PART 890--PHYSICAL MEDICINE DEVICES

3. The authority citation for 21 CFR part 890 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

4. Section 890.3910 is revised to read as follows:

Sec. 890.3910 Wheelchair accessory.

(a) Identification. A wheelchair accessory is a device intended for

medical purposes that is sold separately from a wheelchair and is

intended to meet the specific needs of a patient who uses a wheelchair.

Examples of wheelchair accessories include but are not limited to the

following: armboard, lapboard, pusher cuff, crutch and cane holder,

overhead suspension sling, head and trunk support, and blanket and leg

rest strap.

(b) Classification. Class I (general controls). If the device is

not intended for use as a protective restraint as defined in

Sec. 880.6760 of this chapter, it is exempt from the premarket

notification procedures in subpart E of part 807 of this chapter, and

is also exempt from current good manufacturing practice regulations in

part 820 of this chapter, with the exception of Sec. 820.180, with

respect to general requirements concerning records, and Sec. 820.198,

with respect to complaint files.

Dated: February 15, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 96-4719 Filed 3-1-96; 8:45 am]

BILLING CODE 4160-01-F