Background

The practice of reprocessing single-use devices (SUDs) for reuse began in hospitals in the late 1970’s. Approval of the practice of reusing hemodialyzers in the early 1980s by the US Public Health Service led the way for current activity.

A reprocessed single-use device is an “original device that has previously been used and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.”

Reusable medical devices, those which the original equipment manufacturer (OEM) provides instructions for reuse, are devices that healthcare providers can reprocess and reuse to treat multiple patients. Disposable devices are those labeled by the OEM as single-use only or single-patient use.

Historically, most items in the hospitals were designated as reusable and were reprocessed and reused. The use of disposables became popular because of convenience and reducing the risk of cross contamination. However, as the cost of waste disposal increased, hospitals looked for opportunities to reduce waste. They attempted to return to the use of reusable items and began to reprocess certain items.

A survey of hospitals by the Food and Drug Administration (FDA) in 2002 found that the most commonly reprocessed SUDs and percent of hospitals reprocessing these devices in 2002 were:

  • Sequential compression device (SCD) sleeves (15.8 percent of hospitals)
  • Drill bits, saws, blades, or burrs (7.3 percent)
  • Biopsy forceps, snares (6.2 percent)
  • Endoscopic/laparoscopic scissors, graspers, dissectors, or clamps (6.1 percent)
  • Electrophysiology (EP) diagnostic catheters (3.9 percent)

In-house reprocessing of open but unused SUDs is not currently regulated by the FDA.

GAO report to congress

The US Government Accounting Office (GAO) issued a report to Congress in June 2008 entitled: “Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk.” This report notes that FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks. After reviewing FDA’s processes for monitoring and investigating its adverse event data, [GAO] found no reason to question FDA’s analysis.

The reprocessing of SUDs is legal in the United States under the Federal Drug and Cosmetic (FD&C) Act. Class I and II medical devices have been cleared for reprocessing and, for most devices, manufacturers are required to submit premarket notifications or an application for premarket approval. The FDA has authority to regulate the safety and effectiveness of all medical devices, including reprocessed SUDs.

The FDA policy on instrument reuse from 1987 states that the reuse decision belongs to the hospital and the practitioner. The reuse decision was to be based on whether the instrument could be adequately cleaned and sterilized, whether it would not be adversely affected in terms of quality, and whether it remained safe and effective for its intended use.

Guidance Documents

From 2000 to 2005, the FDA released many guidance documents on reprocessed single use devices (see FDA timeline) addressing concerns such as enforcement priorities, submission of data on adverse outcomes, labeling requirements, and inspection of reprocessing facilities. Guidance documents include:

These publications set forth FDA’s priorities for hospitals and manufacturers who wished to reprocess SUDs. Subsequent documents have been published by the FDA in 2003 and 2005 to provide guidance for the industry and FDA staff to supplement and clarify related guidance and regulations and are available at the FDA Reprocessing of Reusable Medical Devices Web site. As a result of the FDA requirements issued in August, 2000, hospitals have moved their reprocessing of SUDs from “in-house” to third-party reprocessing companies.

All entities that reprocess SUDs are required to obtain approval from FDA (e.g., registration requirements and for each device, submission of either a 510(k) application or PMA [premarket approval]). The specific FDA requirements for the regulation of devices are based on 1) the criticality of the device (critical, semicritical, or noncritical) and 2) the risk category/class of the device according the FDA’s Risk Prioritization Scheme. (See FDA website for further details)

See additional requirements to ensure safety of reprocessing outlined in the Medical Device User Fee and Modernization Act (MDUFMA) of 2002.