[Federal Register Volume 70, Number 173 (Thursday, September 8, 2005)]
[Proposed Rules]
[Pages 53326-53328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17733]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2001P-0120 (Formerly Docket No. 01P-0120)]


Medical Devices; Needle-Bearing Devices; Withdrawal of Advance 
Notice of Proposed Rulemaking

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of an advance notice of proposed rulemaking (ANPRM) 
concerning needle-bearing devices. FDA is concerned about the 
significant health risk posed by needlestick and other percutaneous 
injuries but FDA believes that the actions it has taken and continues 
to take along with the actions taken by the Occupational Safety and 
Health Administration (OSHA) are addressing the issue adequately at 
this time.

DATES: The ANPRM published at 67 FR 41890 (June 20, 2002), is withdrawn 
as of September 7, 2005.

ADDRESSES: Responses to petitions and references may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or on the Internet at 
http://www.fda.gov/ohrms/dockets/default.htm.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Devices and 
Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

    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 ``HRG/SEIU petition''). The HRG/SEIU 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 an ANPRM inviting 
interested persons to submit additional data and information to assist 
FDA in determining a proper course of action.
    In the Federal Register of June 20, 2002 (67 FR 41890), FDA 
published an ANPRM on this topic. FDA invited interested persons to 
submit comments on the HRG/SEIU petition and other matters related to 
needlestick prevention by September 18, 2002. FDA received more than 50 
written and electronic comments from a wide variety of individuals and 
organizations.

II. HRG/SEIU Petition

    The following is a brief summary of the HRG/SEIU petition. The 
petition and FDA's response are available from the Division of Dockets 
Management (see ADDRESSES). In requesting the petition and response, 
refer to docket number 2001P-0120.

A. Banning

    The HRG/SEIU petition requested that FDA ban the following:
    1. Intravenous (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.

B. Performance Standard

    The HRG/SEIU petition requested that FDA issue performance 
standards based on the five design criteria identified in the FDA 
safety alert following the procedures set forth in 21 CFR part 861.

C. Labeling

    Finally, the HRG/SEIU 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.

III. Comments

A. Banning

    A few comments supported the ban proposed in the HRG/SEIU petition. 
One of these comments submitted three studies that showed a significant 
decrease in needlesticks when safety devices were used. In their 
comment, HRG objected to FDA's conclusion in the petition response that 
there was insufficient information to relate injuries to specific 
devices so as to justify banning them. HRG suggested that FDA should 
make a greater effort to extract the data from its own records to 
support a ban. Many comments opposed a ban. Several of these comments 
suggested that the criteria for banning a device under section 516 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360f) 
were not met. Many of the comments suggested that a ban would create a 
critical shortage of necessary devices.
    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. 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 or injury is 
substantial, FDA will need to consider whether the risk posed by 
continued 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 response to the HRG/SEIU petition, 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

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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 HRG/SEIU 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 has not received any information since 
publication of the ANPRM that would lead it to reach a different 
conclusion.

B. Performance Standards

    Many of the comments expressed a willingness to participate in the 
development of a performance standard for needle-bearing devices. Many 
of these same comments and other comments, however, expressed doubt as 
to whether a standard could be developed because of the wide range of 
devices and technologies. No comments proposed any specific parameters 
for such a standard. FDA has consulted with some standard development 
organizations. The representatives of these groups expressed some 
willingness to work with FDA to develop a standard but also 
acknowledged the difficulty of developing a standard to address so many 
different devices. FDA will continue to work with these standard 
development groups to determine if one or more useful standards could 
be developed.

C. Labeling

    Some comments suggested that the labeling statement for 
conventional syringes proposed in the HRG/SEIU petition may be useful. 
Many comments suggested that the labeling statement was unnecessary.
    In its response to the HRG/SEIU petition, FDA stated that the 
information in the proposed 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 has not found anything in the comments to suggest a 
different conclusion.

D. National Association for the Primary Prevention of Sharps Injuries 
List

    The National Association for the Primary Prevention of Sharps 
Injuries (NAPPSI) requested that FDA post on its Web site and 
disseminate NAPPSI's Safety Device List. This list includes sharps 
injury prevention devices. Several comments supported this proposal.
    FDA is in favor of health care professionals having access to 
information that will help them choose safer medical devices. However, 
FDA believes that it would be difficult to ensure that NAPPSI's Safety 
Device List was up to date at all times. FDA, nevertheless, encourages 
health care professionals and others to make use of whatever 
information is available to choose safe devices.

E. The OSHA Bloodborne Pathogens Standard

    Several comments suggested that the OSHA Bloodborne Pathogens (BBP) 
standard, together with the actions that FDA has been taking, provides 
sufficient protection.
    FDA 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.). 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 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 
this 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.

IV. Conclusion

    FDA has cleared several hundred devices with needlestick prevention 
features. FDA continues to work with manufacturers to assist in the 
clearance of devices with needle-free technology or needlestick 
prevention features.
    On November 12, 2002, FDA issued a guidance document entitled 
``Needlesticks Medical Device Reporting Guidance for User Facilities, 
Manufacturers, and Importers.'' This guidance document outlines 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 continues to work with health care professionals 
on educational issues concerning the safe use of needle-bearing 
devices.

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    As noted previously, FDA is working with consensus standards 
development groups to determine whether standards could be developed to 
address the issue of needlesticks related to medical devices.
    FDA believes that these actions, in conjunction with the actions 
taken by OSHA under its BBP standard, are sufficient to address the 
risk of needlestick injuries related to the use of needle-bearing 
medical devices. FDA, therefore, does not intend to take any of the 
specific actions requested in the HRG/SEIU petition at this time and is 
withdrawing the ANPRM published in the Federal Register of June 20, 
2002.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (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. 2001P-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: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17733 Filed 9-7-05; 8:45 am]
BILLING CODE 4160-01-S