Amended Economic Impact Analysis of Final Rule Requiring Use of Labeling on Natural Rubber Containing Devices

SUMMARY: The Food and Drug Administration (FDA) is issuing an amended

economic analysis statement relating to a final rule that published in

the Federal Register of September 30, 1997 (62 FR 51021), requiring

labeling statements concerning the presence of natural rubber latex in

medical devices. This rule was issued in response to numerous reports

of severe allergic reactions and deaths related to a wide range of

medical devices containing natural rubber. The final rule becomes

effective on September 30, 1998. In order to allow further comment on

the economic impact of the September 30, 1997, final rule, FDA

published in the Federal Register of June 1, 1998, an amended economic

impact statement, including an amended initial regulatory flexibility

analysis (IRFA) that it prepared under the Regulatory Flexibility Act

(RFA), as amended by the Small Business Regulatory Enforcement and

Fairness Act (SBREFA). After considering comments submitted in response

to the June 1, 1998, amended economic analysis statement, FDA is

issuing the amended final economic impact statement, including an

amended final regulatory flexibility analysis.

DATES: The September 30, 1997, final rule is effective on September 30,

1998, except for products that contain natural rubber latex solely in

cold-seal type packaging. The rule will not apply to these products for

an additional 270 days from the September 30, 1998, effective date of

the final rule. Elsewhere in this issue of the Federal Register, FDA is

announcing a stay of the effective date of the September 30, 1997,

final rule for these products.\1\

\1\ Note: The stay of effective date referenced in this document

was published at 63 FR 46174 on August 31, 1998.

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ADDRESSES: References are available in the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices

and Radiological Health (HFZ-100), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20850, 301-827-4777, FAX 301-827-4787.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September 30, 1997 (62 FR 51021), FDA

published a final rule (to be codified at 21 CFR 801.437), under its

authority in section 505(a) and (f) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 352(a) and (f)), requiring certain

labeling statements on medical devices that contain or have packaging

that contains natural rubber. This rule becomes effective on September

30, 1998. The agency issued this rule because medical devices composed

of natural rubber may pose a significant health risk to some consumers

and health care providers who are sensitized to natural latex proteins.

FDA has received numerous reports about adverse effects related to

reactions to natural latex proteins contained in medical devices,

including 16 deaths following barium enemas. These deaths were

associated with anaphylactic reactions to the natural rubber latex cuff

on the tip of barium enema catheters. Scientific studies and case

reports have documented sensitivity to natural latex proteins found in

a wide range of medical devices. It is estimated that 5 to 17 percent

of health care workers are sensitive to latex proteins (Refs. 1 through

5.)

The September 30, 1997, final rule (hereinafter referred to as the

final rule) specifically requires that devices that contain natural

rubber that is intended to contact or is likely to contact the health

care worker or patient bear one or more of four labeling statements,

depending on the type of natural rubber in the device and depending on

whether the natural rubber is in the device itself or in its packaging.

These statements are as follows: ``This Product Contains Dry Natural

Rubber.''; ``Caution: This Product Contains Natural Rubber Latex Which

May Cause Allergic Reactions.''; ``The Packaging of This Product

Contains Dry Natural Rubber.''; and ``The Packaging of This Product

Contains Natural Rubber Latex Which May Cause Allergic Reactions.'' The

final rule also prohibits the use of the word ``hypoallergenic'' on

devices that contain natural rubber latex.

In the June 24, 1996, proposed rule (61 FR 32618), FDA stated that

it did not believe that the proposed rule would be a significant

regulatory action as defined by Executive Order 12866, and certified

under the Regulatory Flexibility Act (5 U.S.C. 601-602) that the rule

would not have a significant economic impact on a substantial number of

small entities. FDA stated that it believed the rule's proposed

effective date 180 days after publication would allow manufacturers to

exhaust their existing labeling supplies.

FDA received comments concerning the economic impact of the

proposed rule stating that the requirement would have a major impact on

multinational companies, costing at least $15,000 per device for

labeling. Another comment stated that the agency underestimated the

impact of the rule, as each manufacturer will need to draft, review,

and relabel primary and secondary packages of hundreds, if not

thousands of devices.

Based on FDA's information, the agency responded that it did not

agree that the regulation would require the relabeling of hundreds or

thousands of devices, and that agency estimates of relabeling costs

were between $1,000 to $2,000 for each type of device. The agency also

noted that the extended 1 year effective date should allow most

manufacturers to exhaust their current labeling stock prior to the

effective date of the regulation. On this basis, the agency stated that

the final rule was not a significant regulatory action under the

Executive Order, and certified that although a substantial number of

small entities would be affected by the rule, the estimated $1,000 to

$2,000 cost of implementing the final rule would not have a significant

economic impact on those entities (62 FR 51021 at 51029).

On October 7, 1997, the Office of the Chief Counsel for Advocacy

of the U.S. Small Business Administration submitted a comment stating

that the agency had not supplied data in the preamble to the final rule

to support its cost estimates. The agency also received information

from industry, subsequent to the issuance of the final rule,

identifying additional products that would be subject to the final

rule. On the basis of this information, FDA issued an amended economic

impact analysis, including an IRFA, and offered opportunity for further

comment before the implementation of the rule (63 FR

[[Page 50661]]

29552). FDA stated that after consideration of these comments, FDA will

decide whether to issue the rule on its current effective date, to stay

the effective date of the final rule, and/or repropose the rule.

II. Comments to the Amended Economic Impact Analysis Statement

FDA received three comments to the amended economic analysis. Two

comments were from the Health Industry Manufacturers Association

(HIMA), and the other comment was from an in vitro diagnostic

manufacturer.

The in vitro diagnostic manufacturer stated that health care

professionals using in vitro products are trained in and expected to

follow universal precautions for handling potential biohazards by

wearing protective gloves. Accordingly, the comment maintained that

health care professionals would not come into contact with latex in in

vitro diagnostic products.

FDA believes that training in universal precautions will not

prevent contact with the latex in in vitro diagnostic products for

several reasons. Contact may occur under a variety of situations

including failure to follow universal precautions, the absence of

wearing protective gloves during the set up phase of testing, the

retrieval of the products from storage or packing, or the disposal of

products. While FDA does not believe that in vitro diagnostic products

may be categorically excluded from the scope of this rule because of

the universal precautions that may be undertaken, FDA believes that

given the variety of product designs, there may be certain in vitro

diagnostic products that may contain latex that are designed in such a

manner as to preclude contact with the user. Currently, FDA is unaware

of any products that are designed in such manner. If, however, there

are such products, these products would not be subject to the final

rule.

The in vitro diagnostic manufacturer and HIMA also commented that

if in vitro diagnostic devices fell within the scope of the rule, they

had not been included in the amended economic impact analysis. This

omission was an oversight. FDA referred this comment and others

described below to Eastern Research Group (ERG), Lexington, MA for

analysis. ERG, after considering comments to the June 1, 1998, amended

economic impact analysis, has issued an amended economic impact

analysis which includes in vitro diagnostic products. The substantive

parts of this analysis are reproduced in their entirety in Appendix 1

of this document.

HIMA submitted two comments. One comment requested an extension of

the comment period to the economic impact analysis until July 31, 1998.

Subsequently, HIMA submitted timely preliminary substantive comments.

FDA denied the request for an extension to the comment period. The

public has now had two separate opportunities to comment on the

economic impact of this rule. Interested persons had 90 days to respond

to the economic impact statement in the proposed rule (61 FR 32618).

FDA received only two comments related to the economic impact of the

proposed rule. The amended economic impact analysis provided an

additional opportunity for comment on the economic impact. FDA believes

that 30 days is an adequate time to respond to the comments,

particularly given the fact that this is the second opportunity for

comment.

Moreover, FDA needed to notify the public whether the comments

related to the costs of the rule would result in a stay of the rule, a

reproposal of the rule, or whether FDA would retain the September 30,

1998, effective date. FDA needed sufficient time to analyze the

comments and publish in the Federal Register a document notifying the

public of its course of action before the September 30, 1998, effective

date. FDA believes that allowing until July 31, 1998, for the

submission of the second round of comments would not have allowed the

agency adequate time to analyze comments and publish in the Federal

Register a document in sufficient time before the September 30, 1998,

effective date of the rule.

While HIMA's request for an extension was pending, HIMA submitted

timely comments to FDA from several of its members. The fact that many

HIMA members submitted responses within the comment period further

demonstrates that the period of time was adequate for the submission of

comments.

HIMA raised several substantive comments in its July 1, 1998,

submission. These comments stated that HIMA was uncertain if the June

1, 1998, estimate included costs related to the following items or

factors: New plates and film for each new label, purchasing or

manufacturing new relabeled boxes and cartons, slow moving inventory or

sterile products that cannot be repackaged, ``specialty'' products that

are manufactured on an intermittent basis and kept in inventory for 2

to 3 years, and inability to place sticker labels on existing inventory

for products that are sterile or carry several layers of packaging.

HIMA also stated that one member had estimated the total cost per SKU

to be $28,000.

These cost factors stated by HIMA were considered by ERG and FDA.

Moreover, the figure reported to HIMA by one member for total cost per

SKU does not affect the conclusions of FDA and ERG about the economic

impact of this rule. The final ERG report, which is reproduced in

Appendix 1, addresses these comments in further detail.

HIMA also stated that the agency did not comply with the Regulatory

Flexibility Act in that it did not publish the initial regulatory

flexibility analysis at the time of the publication of the proposed

rulemaking. FDA does not agree. Regulatory flexibility analyses are

only required if there is a significant impact on a substantial number

of small entities. If an agency certifies there is no significant

impact on a substantial number of small entities, the agency is not

required to perform an initial or final regulatory flexibility analysis

(5 U.S.C. 605(b)).

In both the proposed and final rules, FDA certified that under 5

U.S.C. 605(b) no such analysis was required (61 FR 32618, June 24,

1996; 62 FR 51021 at 51029, September 30, 1997). The first ERG

analysis, as described in the Federal Register of June 1, 1998, and the

subsequent ERG analysis, as described below, that responds to industry

comments, supports FDA's conclusion that no regulatory flexibility

analysis under 5 U.S.C. 603 and 604 is required. Even if such an

analysis is required, FDA believes that the agency can satisfy the

requirements under 5 U.S.C. 603 and 604 by issuing amended initial and

final analyses after a proposed rule is issued.

III. Analysis of Impacts

During the course of reexamining the appropriateness of its

certification that no regulatory flexibility analysis was required, FDA

has already gathered sufficient information to perform a regulatory

flexibility analysis. Accordingly, although FDA believes no regulatory

flexibility analysis is required because there is no significant impact

on a substantial number of small entities, FDA is providing a final

regulatory flexibility analysis, as described below, in this amended

economic impact analysis statement.

FDA has examined the impacts of the final rule under Executive

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

Unfunded Mandates Reform Act (2 U.S.C 1501 et seq.). Executive Order

12866 directs agencies to assess all costs and benefits of available

regulatory alternatives and, when regulation is necessary, to select

[[Page 50662]]

regulatory approaches that maximize net benefits (including potential

economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). Under the Regulatory

Flexibility Act, if a rule has a significant impact on a substantial

number of small entities, an agency must analyze regulatory options

that would minimize any significant impact of the rule on small

entities. Title II of the Unfunded Mandates Reform Act (21 U.S.C. 1532)

requires that agencies prepare a written assessment of anticipated

costs and benefits before proposing any rule that may result in an

expenditure in any 1 year by State, local, and tribal governments, in

the aggregate, or by the private sector of $100 million (adjusted

annually for inflation).

The agency believes that this rule is consistent with the

regulatory philosophy and principles identified in Executive Order

12866 and in these two statutes. The purpose of this rule is to add

labeling statements that will help ensure the safe and effective use by

health care workers and patients of natural rubber devices. Potential

benefits include early recognition of symptoms that could develop into

severe latex allergies, and the prevention of severe allergic reactions

and death that may occur if persons who are allergic to natural rubber

inadvertently use natural rubber devices.

Based on other information referenced in this document, and on the

analysis performed by the ERG, FDA is issuing this amended economic

analysis statement. Since the rule does not impose any mandates on

State, local or tribal governments, or the private sector that will

result in an expenditure in any 1 year of $100 million or more, FDA is

not required to perform a cost-benefit analysis according to the

Unfunded Mandates Reform Act. The rule is not a significant regulatory

action as defined by the Executive Order.

ERG amended its report based on comments received to the June 1,

1998, amended economic analysis statement. The final ERG analysis

estimated that this rule will affect approximately 2,340 small

businesses. Total annualized compliance costs for small businesses are

estimated at $4.1 million, which represent 0.05 percent of revenues for

small medical device manufacturers. This economic analysis indicates

that this rule will not have a significant economic impact on a

substantial number of small entities.

The final natural rubber latex labeling rule would require certain

labeling statements on products that contain natural rubber latex. This

rule would not invoke new recordkeeping and reporting requirements.

Manufacturers of several types of products may include natural rubber

latex and therefore be subject to this rule. Manufacturers of the

products listed in Table 1-1 of the final ERG report will be subject to

the final rule (63 FR 29552 at 29560).

Manufacturers of natural rubber latex devices need to employ

certain professional skills to implement the new labeling requirements.

Regulatory affairs staff will need to identify the need for a revised

label, and coordinate the labeling review and revision processes with

other departments such as marketing, medical and legal departments, and

prepare the new labeling language. Graphic artists and label layout

specialists will prepare the revised labels. Art work might be prepared

by in-house or external staff. Once prepared, the revised label is

normally sent to outside vendors who prepare new printing plates and

perform final printing. The manufacturing personnel receive and review

the final revised labeling, replace and discard old inventory,

incorporate the new labels into the material control and inventory

systems, and modify labeling and packaging equipment as necessary to

accommodate new labels.

IV. Steps Taken To Minimize the Economic Impact on Small Entities

and Regulatory Alternatives Examined

FDA has analyzed several alternatives and taken several steps to

minimize the economic impact of this final rule on small entities. FDA

did not receive any comments regarding proposed regulatory alternatives

in response to the June 1, 1998, amended economic analysis statement.

As discussed previously, FDA received a comment asking for

clarification regarding the applicability of the final rule to in vitro

diagnostic products, a request for an extension of the comment period,

and several questions from HIMA relating to costs analysis issues.

FDA's response to those comments is discussed in section II of this

document.

A. Application of the Rule to Combination Products and Packaging

Although FDA did not receive any comments to the June 1, 1998,

amended economic analysis statement proposing any regulatory

alternatives, FDA did receive requests from industry, since publication

of the final rule, for alternative approaches regarding the

applicability of the rule. FDA considered both these alternatives, and

modified the application of the rule under these requests in a manner

that reduces the economic impact of the rule on industry, including

small entities.

First, FDA received comments from industry requesting that the rule

does not apply to combination products containing device components

that had previously been regulated solely as drugs or biologics. In the

Federal Register of May 6, 1998 (63 FR 24934), FDA issued a document

stating that upon consideration of these comments and the need to

provide a uniform labeling approach for all drug and biological

products, including combination products, the agency did not intend to

apply the final rule to combination products currently regulated as

drugs or biologics, and instead intends to initiate a separate

proceeding to propose rulemaking requirements for labeling statements

on natural rubber-containing products regulated as drugs and biologics,

including combination products, currently regulated under drug or

biologic authorities.

Second, on June 5, 1998, HIMA submitted a citizen petition

requesting a stay of the implementation of the final rule as it

pertains to packaging (Ref. 6). As a basis for the stay, HIMA cited

several grounds, including assertions that many manufacturers were

confused as to the applicability of the rule to cold seal packaging,

and, therefore, needed additional time to come into compliance with the

new labeling requirements.

On June 19, 1998, FDA responded to this petition by stating it

would stay the effective date of the latex labeling statements required

by the final rule for cold-seal packaging for an additional 270 days

from the September 30, 1998, effective date of the final rule. The stay

of the effective date for the provisions of the September 30, 1997,

final rule as they relate to cold-seal packaging is published elsewhere

in this issue of the Federal Register.\2\ FDA is not granting a stay of

the effective date for all packaging because of the evidence of serious

risks latex poses for certain individuals and the need to inform those

individuals of the presence of natural rubber latex in devices (Ref.

7).

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\2\ Note: The stay of effective date referenced in this document

was published at 63 FR 46174 on August 31, 1998.

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B. Voluntary Compliance

FDA could have issued guidance stating FDA considered statements

about the presence of natural rubber necessary to comply with existing

general statutory and regulatory prohibitions against false and

misleading labeling (section 505(a) of the act), and failure to provide

adequate

[[Page 50663]]

directions for use (section 505(f)). Given the significant health risks

associated with natural rubber products, FDA does not believe that

existing general statutory labeling authority and regulations provide

adequate protection to ensure that health care workers and patients are

warned about the risks associated with natural rubber.

Without the final regulation, manufacturers may not provide any

information at all. The ERG report and FDA's own experience indicate

that some manufacturers never voluntarily revise their labeling. Even

if it could be assumed that all manufacturers would voluntarily provide

some labeling information about the presence of natural rubber, such

information is likely to be presented in a variety of ways that may

confuse consumers and limit the effectiveness of the natural rubber

statement. FDA believes that the provision of consistent, accurate

information to consumers is critical. FDA believes that this

regulation, which provides accurate, consistent information in a

standardized manner, will assure that the safety information is

communicated effectively to the public.

C. Implementation Periods

FDA considered various implementation periods for the effective

date after the issuance of the final rule. The June 24, 1996, proposed

rule proposed an effective date 6 months after the publication of the

final rule. The final rule has reduced the impact on small businesses

by extending the effective date to 1 year after issuance of the final

rule for all products, except those containing natural rubber latex

solely in cold-seal type packaging. For those products the agency is

providing, for the reasons stated previously, an additional 270 days to

comply with the rule.

Based on the ERG report figures, the total industry cost of

compliance for this rule with a 1-year implementation period is $64.1

million. This figure may be somewhat higher than actual costs because

of the extension for compliance granted to cold seal packaged products,

however FDA did not reduce cost estimates related to this variable. The

total annualized costs are calculated at $9.1 million per year. The

costs for a 6-month effective date are 26 percent greater than a 1-year

effective date. Allowing a 24-month implementation date would reduce

costs by 40 percent.

FDA rejected the 6-month implementation period and extended the

implementation period to 1 year to allow manufacturers of products

containing natural rubber latex, including small businesses, to reduce

costs by depleting existing inventories and coordinating this labeling

change with other planned labeling changes. Although costs could

further be reduced by allowing a 24-month implementation period, FDA

believes that the public need for this information about devices that

pose serious risks justifies rejecting this alternative.

D. Exempting Small Businesses

FDA has considered the option of exempting small businesses from

the final regulation. The ERG report estimates that approximately 83

percent of the manufacturers of natural rubber latex products are small

businesses. FDA believes that given that the large majority of

manufacturers of products containing natural rubber latex are small

businesses, and given the risks associated with these devices,

exempting small businesses from this regulation would result in a

significant decrease of consumer protection. Accordingly, FDA does not

believe that small businesses should be exempt from this regulation.

E. Allowance of Supplementary Labeling

FDA could have chosen a regulatory alternative that would require

that all labeling be directly printed on the existing packaging and

labeling. Such a regulatory provision would decrease the possibility

that the required statement would become dislodged during distribution.

Instead, the final rule allows the use of supplementary labeling

(stickers) to provide the required labeling information. As noted in

the ERG report, this will allow a number of firms, including small

businesses, to reduce costs by avoiding extensive repackaging of

existing product inventory that will not be sold prior to the end of

the regulatory implementation period. FDA decided to include this

option in the final rule.

F. Requiring a Labeling Statement on Only One Level of Labeling

Under the provisions of the final rule, FDA estimates that most

devices covered under the final rule will bear the required natural

rubber statement on two or three levels of labeling. FDA considered

requiring labeling statements on only one level of labeling. This

alternative was rejected because of the importance of the information

contained in the required labeling statements. Users may not have the

necessary opportunity to read the statement if it is included only on

some levels of labeling. For some products, especially those with

multiple users, some labeling may be discarded prior to use by

subsequent consumers. The inclusion of the statement on each level of

labeling increases the likelihood that consumers will be aware of the

risks posed by the natural rubber in the product.

V. References

The following references have been placed on display in the

Dockets Management Branch (address above) and may be seen by interested

persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Kibby, T., and M. Akl, ``Prevalence of Latex Sensitization in

a Hospital Employee Population,'' Annals of Allergy, Asthma and

Immunology, 78:41-44, 1997.

2. Kaczmarek, R. G., B. G. Silverman, T. P. Gross, et al.,

``Prevalence of Latex-specific IgE Antibodies in Hospital

Personnel,'' Annals of Allergy, Asthma and Immunology, 76:51-56,

1996.

3. Arellano, R., J. Bradley, and G. Sussman, ``Prevalence of

Latex Sensitization Among Hospital Employees Occupationally Exposed

to Latex Gloves,'' Anesthesiology, 77:905-908, 1992.

4. Lagier, F., D. Vervloet, I. Lhernet, et al., ``Prevalence of

Latex Allergy in Operating Room Nurses,'' Journal of Allergy and

Clinical Immunology, 90:319-322, 1992.

5. Yassin, M., M. Lierl, T. Fisher, et al., ``Latex Allergy in

Hospital Employees,'' Annals of Allergy, 72:245-249, 1994.

6. June 5, 1998, HIMA citizen petition requesting a stay of the

implementation of the final rule as it pertains to packaging.

7. June 19, 1998, FDA response to HIMA citizen petition

requesting stay of the implementation of the final rule as it

pertains to packaging.

VI. Public Outreach

FDA has conducted extensive public outreach relating to the final

rule to small businesses. Interactions with the public on issues

relating to this rule are discussed in detail in the amended economic

analysis statement published in the Federal Register of June 1, 1998

(63 FR 29552, at 29553 and 29554).

Dated: September 10, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

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Table 1-1.--FDA Estimates of the Medical Device Categories Affected and Device Listings per Category

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

Percent

containing Levels of Number of Number of

Device product code Product natural labeling registrations listings per

rubber [a] per category category [b]

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

BSJ.................... Mask, gas, anesthetic...... 50 1 28 28

BSK.................... Cuff, tracheal tube, 1 3 7 7

inflatable.

BSR.................... Stylet, tracheal tube...... 10 3 13 13

BSY.................... Catheters, suction, 10 1 32 32

tracheobronchial.

BTQ.................... Airway, nasopharyngeal..... 20 2 13 13

BTR.................... Tracheal tube (w/wo 5 2 30 30

connector).

CAT.................... Cannula, nasal, oxygen..... 1 2 30 30

CBH.................... Device, fixation, tracheal 50 2 16 16

tube.

CBI.................... Tracheal/Bronchial tube.... 5 2 5 5

DWL.................... Stocking, medical support.. 5 1 15 15

DZB.................... Headgear, extraoral, 20 2 16 16

orthodontic.

ECI.................... Band, elastic, orthodontic. 10 1 27 27

EMX.................... Balloon, epistaxis......... 50 3 16 16

EXJ.................... Condoms, urosheath type.... 100 3 12 13

EYC.................... Catheter, upper urinary 100 2 1 1

tract.

EYR.................... Tourniquet, gastro-urology. 20 1 1 1

FCD.................... Kit, barium, enema, 40 3 4 4

disposable.

FCE.................... Kit, enema (for cleaning 40 3 19 19

purposes).

FGD.................... Catheter, retention, barium 40 3 2 2

enema with bag.

FMC.................... Gloves..................... 100 3 110 135

FMF.................... Piston syringe............. 95 2 77 77

FPF.................... Bottle, hot/cold, water.... 80 3 12 12

FQM.................... Elastic, bandage........... 10 1 89 89

FXX.................... Face, mask, surgical....... 100 1 56 56

GAX.................... Tourniquet, nonpneumatic... 20 1 26 26

HDW.................... Diaphragm, contraceptive... 80 3 3 3

HIS.................... Condoms.................... 100 3 44 48

HOY.................... Ophthalmic eye shields..... 100 2 44 44

ILG.................... Stocking, elastic.......... 5 1 7 7

INP.................... Tips and pads, cane, 80 1 37 37

crutch, and walker.

JOH.................... Tube, tracheostomy and tube 1 3 9 9

cuff.

JOW.................... Sleeve, limb, compressible. 100 2 26 26

KCY.................... Tourniquet, pneumatic...... 20 1 12 12

KGO.................... Gloves, surgeons........... 100 3 54 66

KME.................... Bedding, disposable, 5 1 38 38

medical.

KMO.................... Binder, elastic............ 5 1 5 5

KNT.................... Tubes, gastrointestinal 5 3 40 40

(and accessories).

KYZ.................... Irrigating syringe......... 90 2 61 61

LCG.................... Intestinal splinting tubes. 50 3 1 1

LLJ.................... Condoms, organ protection.. 100 3 1 1

LTZ.................... Condoms, with nonoxynol-9.. 100 3 19 21

LYY.................... Gloves, latex.............. 100 3 319 392

MBU.................... Condoms, intravaginal pouch 100 3 5 5

In vitro diagnostics....... 15 3 1,529 17,000

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

Total.............. NA NA 2,911 18,499

Average............ 48.59 2.16 32.14 NA

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

Source: FDA, Center for Devices and Radiological Health, 1998, FDA, Division of Clinical Laboratory Devices,

1998, and FDA In-Vitro Diagnostic Device Branch, 1998.

[a] The numbers in italic are ERG estimates. ERG assumed that 100 percent of products included natural rubber

that would contact humans in the absence of survey information on the product category.

[b] For condom and glove categories, ERG did not have complete listing data from FDA and estimated the number of

listings based on the number of registered establishments.

1-4

[[Page 50675]]

Table 1-2.--ERG Estimates of the Number of Medical Device Models Affected

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

Number of

listings Number of Percent Total

Product per models per containing models to

category listing [b] natural be changed,

[a] rubber [c] by category

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

Mask, gas, anesthetic....................................... 28 5 50 70

Cuff, tracheal tube, inflatable............................. 7 2 1 1

Stylet, tracheal tube....................................... 13 4 10 6

Catheters, suction, tracheobronchial........................ 32 6 10 20

Airway, nasopharyngeal...................................... 13 3 20 8

Tracheal tube (w/wo connector).............................. 30 28 5 42

Cannula, nasal, oxygen...................................... 30 1 1 1

Device, fixation, tracheal tube............................. 16 19 50 152

Tracheal/Bronchial tube..................................... 5 28 5 7

Stocking, medical support................................... 15 14 5 11

Headgear, extraoral, orthodontic............................ 16 14 20 45

Band, elastic, orthodontic.................................. 27 14 10 38

Balloon, epistaxis.......................................... 16 2 50 16

Condoms, urosheath type..................................... 13 14 100 182

Catheter, upper urinary tract............................... 1 52 100 52

Tourniquet, gastro-urology.................................. 1 14 20 3

Kit, barium, enema, disposable.............................. 4 13 40 21

Kit, enema (for cleaning purposes).......................... 19 4 40 31

Catheter, retention, barium enema with bag.................. 2 2 40 2

Gloves...................................................... 135 14 100 1,890

Piston syringe.............................................. 77 14 95 1,025

Bottle, hot/cold, water..................................... 12 14 80 135

Elastic, bandage............................................ 89 14 10 125

Face, mask, surgical........................................ 56 23 100 1,288

Tourniquet, nonpneumatic.................................... 26 14 20 73

Diaphragm, contraceptive.................................... 3 14 80 34

Condoms..................................................... 48 14 100 672

Ophthalmic eye shields...................................... 44 5 100 220

Stocking, elastic........................................... 7 14 5 5

Tips and pads, cane, crutch, and walker..................... 37 14 80 415

Tube, tracheostomy and tube cuff............................ 9 30 1 3

Sleeve, limb, compressible.................................. 26 14 100 364

Tourniquet, pneumatic....................................... 12 14 20 34

Gloves, surgeons............................................ 66 14 100 924

Bedding, disposable, medical................................ 38 14 5 27

Binder, elastic............................................. 5 14 5 4

Tubes, gastrointestinal (and accessories)................... 40 14 5 28

Irrigating syringe.......................................... 61 22 90 1,208

Intestinal splinting tubes.................................. 1 14 50 7

Condoms, organ protection................................... 1 14 100 14

Condoms, with nonoxynol-9................................... 21 14 100 294

Gloves, latex............................................... 392 14 100 5,488

Condoms, intravaginal pouch................................. 5 14 100 70

In vitro diagnostics........................................ 17,000 1 15 2,550

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

Total................................................. 18,499 NA NA 17,605

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

Source: FDA, Center for Devices and Radiological Health, 1998, FDA, Division of Clinical Laboratory Devices,

1998,

In-Vitro Diagnostic Device Branch, 1998, and ERG estimates.

[a] For Condom and glove categories, ERG did not have complete listing data from FDA and estimated the number of

listings based on the number of registered establishments. These estimates are presented in italics.

[b] The numbers in italics are based on the average number of models per listing, as estimated from ERG's review

of medical device product catalogues.

[c] The numbers in italics are ERG estimates. ERG assumed 100% natural rubber content in the absence of survey

information on the product category.

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[FR Doc. 98-24864 Filed 9-21-98; 8:45 am]

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