RE: Medical Devices; Needle-Bearing Devices; Request for Comments and Information; Advance notice of proposed rulemaking (67 Federal Register 41890) June 20, 2002

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Wednesday, September 18th 2002

Margaret M. Dotzel
Associate Commissioner for Policy
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear Ms. Dotzel:

On behalf of our nearly 5,000 member hospitals, health systems, networks and other providers of care, the American Hospital Association (AHA) welcomes the opportunity to comment on the Food and Drug Administration’s (FDA) advance notice of proposed rulemaking on medical devices and needle-bearing devices.

Hospitals, health systems and the AHA have a long-standing commitment to ensuring the safety of patients and our health care workers.  We applaud the FDA’s ongoing efforts to prevent sharps injuries, including the agency’s safety alerts, numerous guidance documents, national meetings and educational forums and its cooperation with other governmental agencies.  We hope that as the FDA considers this advance notice of proposed rulemaking, the agency will strongly consider the importance of encouraging, not inhibiting, new technologies.  In addition, we urge the FDA to fully examine all the consequences of banning devices.

The AHA has been a proud partner with government agencies, including the FDA, the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control and Prevention, and others, in preventing sharps injuries.  In the 1980s, the AHA was involved in the development of OSHA’s Bloodborne Pathogens Standard – a standard that revolutionized safety for health care workers.  In 1989, we gave OSHA the rights to duplicate our educational video and manual titled, “Working Together: Needlestick Prevention.”  OSHA also used AHA’s educational video about universal precautions to help educate its compliance officers.

Since 1992, the AHA has published two books on sharps injury prevention that have been distributed to all hospitals.  In 1999, we worked with NIOSH in developing its needstick injuries prevention alert.  More recently, the AHA worked with the OSHA in updating its Bloodborne Pathogens Standard compliance directive that was codified into its revised Bloodborne Pathogens Standard in January 2001.  Throughout this period, we have continually communicated with hospitals and health systems, advocating sharps safety and injury prevention through various publications, videos and educational seminars.

Continuing advances have brought increasingly sophisticated technologies to the marketplace, increasing the opportunity to enhance patient and worker safety.  Some of the devices regularly used in hospitals today were unimaginable 10 years ago.  The FDA plays an important role in reviewing emerging technology and bringing to the marketplace new devices that have the potential to prevent sharps injuries.  As such, it is important that the FDA not inhibit new technologies by adopting performance standards that may not be applicable in the development of tomorrow’s “safety” devices.  The FDA should continue to encourage innovation and review devices on a case-by-case basis.  It is possible that tomorrow’s devices are unimaginable today.

FDA-approved medical devices, such as IV catheters, blood collection devices and blood collection needle sets, play a vital role in delivering care to our patients.  In some instances, there are alternative devices available to take the place of conventional ones.  In these instances, hospitals and health systems are required by OSHA’s Bloodborne Pathogens Standard to use alternative devices.  OSHA has consistently required hospitals to use engineering controls, such as “safety” devices, and work practices as the primary means of eliminating or minimizing employee exposure to bloodborne pathogens.  Hospitals are also required to review devices in the marketplace, at least annually, to ensure that they are using the most appropriate and effective devices designed to eliminate or minimize occupational exposure.

There are numerous clinical exceptions to using alternative devices, some which involve our most vulnerable patient populations - premature babies, patients with collapsed veins, or patients with fragile tissue.  When considering a ban on a device, the FDA should analyze the consequences to patient care and weigh the potential benefits to health care workers, including the effect of banning a particular device on other “safety” and conventional devices.  In limited circumstances, banning conventional devices would not allow health care workers to use corresponding “safety” devices.  Additionally, before a ban is considered, sufficient alternative devices should be readily available and appropriate for all patient populations.

Due to sufficient alternatives in the marketplace, hospitals and health systems almost exclusively use non-glass or wrapped glass capillary tubes and needless IV infusion systems.  There was a rapid conversion to these “safety” devices due to their availability and benefit for all patient populations and health care workers.  In this instance, hospital experiences, marketplace changes, guidance documents and OSHA’s Bloodborne Pathogens Standard have, in effect, “banned” the use of glass capillary tubes and conventional IV infusion equipment.

OSHA’s Bloodborne Pathogens Standard also requires hospitals and health systems to provide employee training (at the onset of employment and in annual reviews) in minimizing exposure to bloodborne pathogens.  Training includes information on bloodborne diseases and their transmission, engineering and work practice controls, including the proper use of devices, universal precautions and personal protective equipment.  The AHA agrees with the FDA that the risks associated with conventional syringes are well known and as such, the FDA would not ordinarily require a warning label on these devices.  Hospitals and health systems continually strive to eliminate sharps injuries through education, training, and evaluation and implementation of sharps injury prevention programs, including the adoption of “safety” devices.

The AHA’s efforts to educate the field on the implementation of new, effective technologies to reduce the risk of on-the-job injuries will continue.  We appreciate the opportunity to submit these comments on FDA’s advance notice of proposed rulemaking.  If you have any questions about these comments, please feel free to contact me, or Robyn Cooke, director, state issues forum, at (202) 626-2672.


Rick Pollack
Executive Vice President


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