[Federal Register Volume 67, Number 119 (Thursday, June 20, 2002)]
[Proposed Rules]
[Pages 41890-41892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 01P-0120]
RIN 0910-ZA20


Medical Devices; Needle-Bearing Devices; Request for Comments and 
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this 
document to invite interested persons to submit information to assist 
the agency in determining what additional actions, if any, the agency 
should take to protect healthcare workers from needlestick injuries 
from medical devices. FDA is taking this action because it is concerned 
about the significant health risk posed by needlestick and other 
percutaneous injuries. The agency is also responding to a petition.

DATES: Submit written comments or information by September 18, 2002.

ADDRESSES: Submit written comments or information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8879.

SUPPLEMENTARY INFORMATION: Blood and other potentially infectious 
materials have long been recognized as a potential threat to the health 
of employees who are exposed to these materials by percutaneous contact 
(penetration of the skin). Injuries from contaminated needles and other 
sharps have been associated with the increased risk of disease from 
infectious agents. The primary agents of concern are the human 
immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C 
virus (HCV). (Ref. 1)

I. Previous FDA Actions

    FDA has taken several actions to address the risk of sharps 
injuries to healthcare workers and others from devices and continues to 
monitor this issue.
     On April 16, 1992, FDA issued a safety alert warning of 
the risk of needlestick injuries from the use of hypodermic needles as 
a connection between two pieces of intravenous (IV) equipment. The 
safety alert urged that needleless systems or recessed needle systems 
be used in place of hypodermic needles to access IV lines. The agency 
noted that hypodermic needles should only be used in situations where 
there is a need to penetrate the skin. FDA also outlined various device 
characteristics that have the potential to reduce the risk of 
needlestick injuries.
     In March 1995, FDA issued a guidance document entitled 
``Supplementary Guidance on the Content of Premarket Notification 
[510(k)] Submissions for Medical Devices With Sharps Injury Prevention

[[Page 41891]]

Features.'' This guidance was intended to: (1) Make it easier to 
prepare and submit 510(k) applications for devices incorporating a 
sharps injury prevention feature so as to encourage the development of 
more of those types of devices, (2) promote consistency in the content 
of 510(k)s in order to facilitate review by FDA, and (3) guide FDA 
review staff in conducting and documenting the review of 510(k)s for 
devices with sharps injury prevention features.
     On August 9, 1996, FDA issued a guidance document entitled 
``MDR Guidance Documents and Exemption-No. 3-Needlesticks and Blood 
Exposure-E1996003.'' This guidance document outlined FDA's policy for 
determining when an event involving needlesticks and blood exposure is 
reportable as a serious injury and when it is reportable as a 
malfunction.
     On March 2, 2001, FDA issued a guidance document entitled 
``Premarket Approval Applications (PMA) for Sharps Needle 
Destruction.'' This document provides guidance to manufacturers on the 
types of issues and areas of concern that need to be addressed when 
submitting a PMA for sharps needle destruction devices intended for use 
in healthcare facilities.
     FDA has cosponsored several national meetings on 
needlestick prevention issues.
     FDA has worked with consensus standards development groups 
on needleless injectors.
     FDA has cleared several hundred devices with needlestick 
prevention features.
     In February 1999, FDA, in conjunction with the National 
Institute for Occupational Safety and Health (NIOSH), the Centers for 
Disease Control and Prevention (CDC), and the Occupational Safety and 
Health Administration (OSHA), issued a joint safety advisory about 
glass capillary tubes.

II. FDA Cooperation With OSHA

    FDA also has been working together with OSHA to reduce the risk of 
sharps injuries to healthcare workers and others. FDA regulates medical 
devices, including those containing sharps under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) (the act). OSHA 
maintains authority to regulate workplace controls for the protection 
of employees (Refs. 2 and 3).
    In the Federal Register of December 6, 1991 (56 FR 64004), OSHA 
issued its Bloodborne Pathogens (BBP) Standard (29 CFR 1910.1030). The 
standard reflects OSHA's determination that a combination of 
engineering and work practice controls, personal protective equipment, 
training, medical surveillance, hepatitis B vaccination, signs and 
labels, and other requirements would minimize the risk of disease 
transmission. FDA provided extensive input and comment to OSHA during 
the development of the standard.
    On November 6, 2000, President Clinton signed the Needlestick 
Safety and Prevention Act (Public Law 106-430). This statute required 
OSHA to revise several aspects of the BBP standard within 6 months. In 
the Federal Register of January 18, 2001 (66 FR 5318), OSHA published a 
final rule amending the BBP standard. The final rule went into effect 
on April 18, 2001. Again, FDA provided input and comment to OSHA during 
the development of the amended BBP standard.
    The amended BBP standard added new requirements to the annual 
review and update of a covered employer's exposure control plan. 
Specifically, under these new requirements, each covered employer must 
document the extent to which it uses, or has considered using, products 
that will minimize workplace exposure to needlesticks and other 
percutaneous injuries. The annual update and review of each covered 
employer's plan must also reflect changes in technology that eliminate 
or reduce exposure to bloodborne pathogens and document consideration 
and implementation of appropriate commercially available and effective 
safer medical devices designed to eliminate or minimize occupational 
exposure. Each employer subject to the rule is also required to solicit 
input from nonmanagerial employees responsible for direct patient care 
who are potentially exposed to injuries from contaminated sharps in the 
identification, evaluation, and selection of effective engineering and 
work practice controls. The employer must document the solicitation in 
the exposure control plan.

III. HRG/SEIU Petition

    On March 6, 2001, FDA received and then filed a petition that had 
been submitted jointly by Public Citizen's Health Research Group (HRG), 
a consumer advocacy group, and the Service Employees International 
Union (SEIU). The petition requested that FDA take certain actions to 
further reduce the risk of needlestick injuries to healthcare workers. 
On September 5, 2001, FDA issued a response to this petition. In its 
response, FDA stated that it did not have sufficient information to 
take the actions requested by the petitioners, but that FDA would 
publish this advance notice of proposed rulemaking inviting interested 
persons to submit additional data and information to assist FDA in 
determining a proper course of action. The HRG/SEIU petition and FDA's 
response are available from the Dockets Management Branch (see 
ADDRESSES). In requesting the petition and response, refer to docket 
number 01P-0120.
    In the following paragraphs, FDA summarizes the actions requested 
by HRG and SEIU and invites interested persons to submit additional 
data and information to support these actions or any other action that 
the commenter may consider appropriate.

A. Banning

    The HRG/SEIU petition requested that FDA ban the following:
    1. IV catheters, blood collection devices (needles and tube 
holders) and blood collection needle sets (``butterfly syringes'') that 
do not meet the criteria identified in FDA's April 16, 1992, safety 
alert. This safety alert says that needle-bearing devices should have a 
fixed safety feature that meets all of the following criteria:
    (1) It provides a barrier between the hands and needles after use;
    (2) It allows or requires the worker's hands to remain behind the 
needle at all times;
    (3) It is an integral part of the device, and not an accessory; and
    (4) It is in effect before disassembly, if any, and remains in 
effect after disposal.
The safety alert also suggests that the device should be simple and 
easy to use requiring little training.
    2. Glass capillary tubes; and
    3. IV infusion equipment that does not use needleless technology or 
recessed needles.
    The petitioners stated that they identified these particular 
devices as devices that should be banned because they meet at least two 
of the following three criteria:
    (1) Their use creates a high risk of exposure to bloodborne 
pathogens,
    (2) Their use is common in healthcare today, and
    (3) There is currently available FDA-cleared technology to minimize 
exposure.
    The legal standard to be applied by FDA in deciding whether it is 
appropriate to ban a device is set out in section 516 of the act (21 
U.S.C. 360f). In short, this section states that FDA may ban a device 
if it finds that the device presents a ``substantial deception or an 
unreasonable and substantial risk of illness or injury.'' The 
regulations implementing section 516 state that, in determining whether 
the risk of illness

[[Page 41892]]

or injury is substantial, FDA will need to consider whether the risk 
posed by continuing marketing of the device is important, material, or 
significant in relation to the benefit to the public health from 
continued marketing (21 CFR 895.21(a)(1)).
    In its petition response, FDA stated that it did not have 
sufficient information to conclude that there is a legal basis for 
banning the devices identified in the petition. In support of their 
petition, the petitioners refer to occupational exposure data obtained 
from the Epinet database coordinated by the University of Virginia 
(Ref. 1). The Epinet data show that 52 hospitals with a total average 
daily census of 9,681 patients reported 3,180 sharp object injuries in 
1998. Syringes accounted for 33 percent of these injuries; needles on 
IV lines, 2 percent; butterfly needles, 8 percent; vacuum tube blood 
collection needles, 6 percent; IV catheter stylets and glass capillary 
tubes, less than 1 percent.
    The petition also cited similar data from the Centers for Disease 
Control and Prevention (CDC). The CDC reported that, for the period 
from June 1995 to July 1999, there were 4,951 sharp object injuries 
reported to its surveillance system. Of these reported injuries, 29 
percent involved hypodermic needles, 13 percent butterfly needles, 6 
percent IV catheter stylets, and 4 percent blood drawing needles. The 
petition also stated that 8 percent of exposures with hollow bore 
needles were categorized as IV line-related.
    Although the petition addressed the number of injuries related to 
generic types of devices, it did not show: (1) Which specific devices 
were used; (2) how many devices of that type were used during the 
relevant time period; (3) what the design characteristics of those 
devices were or (4) whether the devices met any or all of the design 
criteria listed. In the absence of such information about specific 
devices, FDA was unable to conclude that any particular device 
presented a ``substantial deception or an unreasonable and substantial 
risk of illness or injury.'' FDA invites interested persons to submit 
data and information that would provide insight on the basis for 
banning one or more of these devices.

B. Performance Standard

    The petition requested that FDA issue performance standards based 
on the five design criteria identified in the FDA safety alert (listed 
in section III.A of this document) following the procedures set forth 
in 21 CFR part 861. The petition listed the criteria but did not 
discuss how FDA could apply these criteria to specific devices in the 
context of a mandatory performance standard; or how such a standard 
would provide reasonable assurance of the safety and effectiveness of 
these devices.
    In its response, FDA stated that it did not have sufficient 
information to develop a standard to address the risk of needlestick 
injury. FDA believes that these criteria are a good starting point to 
develop a standard, but FDA needs additional information to determine 
how best to apply these criteria to specific devices in the context of 
a standard.
    FDA invites interested persons to submit any information or data 
addressing the appropriateness of developing a performance standard, 
based on these criteria or others. FDA is also prepared to enter into 
discussions with any organization that wishes to develop a voluntary 
consensus standard for one or more of these devices that FDA may adopt 
or recognize in some form.

C. Labeling

    Finally, the petition requested that FDA require that the labeling 
for ``conventional syringes'' state: ``TO PREVENT POSSIBLE EXPOSURE TO 
HIV AND HEPATITIS, DO NOT USE FOR STANDARD BLOOD DRAWS.'' The 
petitioners stated that current labeling for syringes does not contain 
adequate warning of the hazards that the device presents.
    In its response, FDA stated that the information in this statement 
is well known to healthcare professionals who use these types of 
devices and, therefore, under 21 CFR 801.109(c), FDA would not 
ordinarily require such a statement in the labeling. FDA invites 
interested persons to comment on whether the proposed labeling 
statement or any other labeling requirement is necessary to provide 
reasonable assurance of the safety and effectiveness of these devices.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on this document by September 
19, 2002. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
name of the device and the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Public Citizen, Health Research Group and the 
Service Employees International Union (Docket No. 01P-0120) and FDA's 
response dated September 5, 2001.
    2. Letter from Dr. Michael A. Friedman, Deputy Commissioner for 
Operations, Food and Drug Administration, to Charles N. Jeffress, 
Assistant Secretary of Labor for Occupational Safety and Health, dated 
December 18, 1998.
    3. Letter from Charles N. Jeffress, Assistant Secretary of Labor 
for Occupational Safety and Health, to Dr. Michael A. Friedman, Deputy 
Commissioner for Operations, Food and Drug Administration, dated 
February 8, 1999.

    Dated: January 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15493 Filed 6-19-02; 8:45 am]
BILLING CODE 4160-01-S