From: Le Web Inc. [coffeemill@earthlink.net]
Sent: Wednesday, September 18, 2002 11:34 AM
To: fdadockets@oc.fda.gov
Cc: jaugust@afscme.org
Subject: Docket No. 01P-0120

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD  20852

September 18, 2002

 

Re: Advance notice of proposed rulemaking (ANPR) - Docket  No. 01P-0120

 

            The American Federation of State, County and Municipal Employees (AFSCME) urges the Food and Drug Administration (FDA) to take action to protect health care and other workers from needlesticks and other percutaneous injuries.  FDA action to prohibit and/or restrict the use of certain types of medical devices would complement other federal efforts, particularly that of the Occupational Safety and Health Administration (OSHA), to lessen the risks of occupational exposure to bloodborne pathogens such as HIV/AIDS and hepatitis. 

 

            AFSCME represents over 300,000 health care workers across the nation encompassing a wide range of occupations.  The risks of needlesticks and sharps injuries are not limited to nurses or other health care workers who use needles and other devices to provide patient care and other duties.  Laundry, housekeeping and other staff can also be injured by exposed needles and other contaminated medical devices that do not have engineered sharps protections. 

 

            In September 1986, AFSCME was the first organization to petition OSHA to issue a standard to protect workers from bloodborne and other infectious diseases.  Although OSHA denied AFSCMEs call for an emergency temporary standard, the Agency did initiate rulemaking and issued its Bloodborne Pathogens (BBP) final rule in 1991.  In many respects, the OSHA standard has been extremely effective with respect to accomplishing its intended purpose.  Since the standard became effective there have been major advances in terms of compliance with the use of universal (standard) precautions in handling blood and other potentially infectious materials (OPIM), sharps containers, training, hepatitis B vaccination, and other critical measures.  The standard also required the use engineering controls to prevent needlesticks and other percutaneous exposures to blood and OPIM.  

 

            The epidemic of needlesticks and other sharps injuries continued after OSHA issued the BBP Standard, and further action was required to protect workers.  As a result, a coalition of unions led a successful effort to secure passage of the Needlestick Safety and Prevention Act in 2000.  This law directed OSHA to amend the Bloodborne Pathogens standard to require that employers use needles and other medical devices that are equipped with engineered sharps protections.  In addition, employers must solicit input from non-managerial health care workers who provide patient care in evaluating and selecting the needles and other sharps that are to be used.

 

            A growing number of our members have reported an increase in the use of needles and other sharps that have some type of safety feature, as well as the establishment of evaluation committees. Although the amendments to the Bloodborne Pathogens Standard only recently took effect, one lesson has already become clear.  There is a wide range of effectiveness among devices that have been designed to prevent injuries.  Evaluation committees could be more efficient and effective in conducting their critical functions if they were able to focus their attention on only those products that met or exceeded recognized standards for safety. FDA action to establish such criteria and to prohibit and/or restrict the use of products that do not meet these criteria would be of tremendous assistance to those responsible for evaluating and selecting devices, and thereby substantially contribute to the goal of preventing needlesticks and other sharps injuries.

 

 

Sincerely,

 

James August, Assistant Director for Health and Safety

Department of Research and 

Collective Bargaining Services