Reprocessing single-use medical devices

AORN Journal, March, 2002 by Barbara D. Cohoon

A perioperative nurse searching the sterile supply shelves for biopsy forceps often has a choice between a reprocessed single-use device (SUD) or a SUD from the original equipment manufacturer (OEM). Which shall he or she choose? This scenario takes place daily in more than one-third of US hospitals. (1) According to some, this is "medicine's dirty little secret," and the reprocessing and reuse of SUDs are "medical experimentation without patient benefit, written consent, or even patient knowledge." (2)

BACKGROUND

The first SUD was developed in 1948. (3) Before that time, medical devices were intended to be reusable. The practice of reusing SUDs initially was thought to be safe; however, in the late 1950s, a New Jersey dentist reused single-use hypodermic needles, which resulted in nine patients dying from hepatitis. (4) In 1970, a facility in the United Kingdom reprocessed single-use oxygenators used in heart bypass surgery. Patients consequently developed fatal immune reactions from pyrogens that had not been removed properly from the oxygenators. (5)

During the 1970s and 1980s, technology resulted in medical device designs that included plastics. Original equipment manufacturers, aware of the potential harm to patients due to improper reuse, began to label more of their devices as single use only. (6) The pressure from the Balanced Budget Act of 1997, the increasing prevalence of health maintenance organizations, and Medicare caused some hospitals to turn to reprocessing SUDs as a way to reduce costs and create savings. (7) This move created an outside market of third-party reprocessors. Third-party reprocessors reprocess more than one million SUDs per year with a profit of nearly $40 million. (8)

HISTORICAL ANALYSIS

In November 1977, the Compliance Policy Guide (CPG) was issued by the US Food and Drug Administration (FDA). The CPG states that

   hospitals that reprocess SUDs assume full liability and responsibility for
   their reprocessing actions and should ensure that the products are
   adequately cleaned and sterilized and that device safety, effectiveness,
   and quality are maintained. (9)

The FDA has not issued regulations that address third-party reprocessors of SUDs.

Under current policy, third-party reprocessors are subject to registration, listing, quality service, labeling, and medical device reports. (10)

The original requirements for labeling medical devices were created in the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. This Act was amended by the passage of HR 3095 and S 2783. (11) The FDA Modernization Act of 1997, signed into law by former President Clinton on Nov 21, 1997, created three medical device classes: Class I, II, and III. (12)

On May 5 and 6, 1999, a conference was held by the FDA and the Association for the Advancement of Medical Instruments (AAMI). This provided an opportunity for the FDA to listen to a wide variety of people and organizations directly involved or affected by the practice of reprocessing and reusing SUDs. The main issues were

* the need for equal regulation of OEMs and third-party reprocessors,

* additional guidance and strict rules regarding the reprocessing process, and

* the collection of scientific research to determine the safety of reprocessing. (13)

Armed with this information, in November 1999, the FDA proposed new draft regulations titled "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme and the Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." (14) These draft regulations outline the FDA's additional categorization of reprocessed devices as high, moderate, or low risk. The FDA will use these new settings to determine remarket requirements. According to the FDA, high risk SUDs may pose a significant risk to a patient's health after being reprocessed, moderate risk SUDs are not in the low or high risk category, and low risk SUDs pose little or no threat to the safety of the patient after being reprocessed.

The proposed guidelines state that the FDA will enforce stringent requirements on reprocessed medical devices that fall into the high risk category, less for those in the moderate risk category, and even less for the low risk category. All items are listed and can be obtained on the FDA's web site at http://www.fda.gov/cdrh/reuse/1029.html. This proposal will be applicable to third-party reprocessors and hospitals that reprocess instruments. Exempt are permanently implantable pacemakers and opened but unused SUDs. Health care facilities that are not hospitals will be investigated at a later time. The FDA will phase in the enforcement of these new guidelines, which will allow reprocessors and hospitals to acclimate and will not strain the FDA's limited resources.

The requirements set forth in the guidance for third-party and hospital reprocessors include

* registration and listing,

* medical device reporting,

* tracking,

* corrections and removals,

* quality system regulation,