FDA Proposes Strategy to Address Single-Use Medical Devices

By Claudia Parks-Miller, J.D., LL.M. Candidate

Under pressure to cut costs, hospitals and health care providers are recycling and reusing disposable medical devices such as biopsy forceps, invasive procedure catheters, saw blades and drill bits after patient use. An increasingly common practice, it is estimated that one-third or more of all U.S. hospitals routinely reuse disposable medical devices labeled and approved for one time use. At issue are medical devices and instruments labeled for single use that hospitals and health care professionals deem recyclable. Unbeknownst to patients, hospitals either reprocess the devices themselves and reuse them or they send the instruments out to a third-party for reprocessing. Doctors are not required to inform patients that a recycled medical device will be used on them. There are no standards on the number of times a device can be reprocessed. And patients are usually billed the same amount whether a medical device is new or recycled.

Manufacturers began to sell single use medical devices in the late 1970s in response to the demand for disposable products by hospitals and health care providers. Prior to this time most medical devices were constructed from glass, metal or rubber and required only a simple sterilization process for reuse. Today, with the advancement of medical technology, disposable medical devices are more complex, smaller and constructed from plastic. Consequently, the devices are often more delicate, less durable, and have the increased potential for the transmission of infections. Moreover, the cleaning and sterilizing of disposable instruments is more problematic, requiring sophisticated cleaning and sterilizing methods. There is the potential with complex devices that reliability and physical integrity may be compromised leading to increased risks of patient infections or injury.

In recent months, medical device manufacturers have waged a media campaign to publicize this practice and to pressure the Food and Drug Administration (FDA) into reconsidering current policies that allow hospitals to use reprocessed single use devices. The issue is highly charged on both sides of the debate with high financial stakes. Recycling medical devices is a $20 million a year industry and growing. Hospitals and reprocessors maintain that the process is safe, and the real issue is about economics, not patient safety. They argue that the designation for single use is at the manufacturer's discretion and is intended to increase sales. Medical device manufacturers counter that scientific evidence to support the claim that the process is safe is lacking.

If original equipment manufacturers want to market a single use medical device as reusable, they are required to submit a 510(k) application to the FDA demonstrating that the medical device can be recycled and reused safely. Hospitals that reprocess devices in their own facilities are not similarly regulated. Third-party reprocessors are only required to register with the FDA, follow production guidelines and undergo spot inspections.

The literature contains few independent studies on the safety of reusing single use medical devices. The use of reprocessed medical devices is common in other countries with mixed results. France and Australia recently banned the practice, but Canada recently approved the reuse of medical devices.

The growing controversy over the recycling of single use medical devices led Congress and the FDA to seek federal solutions to the issue. In August 1999, Senator Richard Durbin introduced a bill in the Senate (S. 1542) and in October 1999 a similar measure was introduced in the U.S. House of Representatives (H.R. 3148) by Representatives Anna Eshoo (D-California) and Fred Upton (R-Michigan). The legislative measures will ensure greater FDA oversight of reprocessing, requiring a pre-market review for any medical device intended for reuse demonstrating that the device is safe for patient use after recycling. The measures also require informed consent to be obtained from the patient prior to use of a reprocessed device and the development of a monitoring and reporting system for adverse outcomes. In September 1999, Congress directed the U.S. General Accounting Office to conduct an investigation into the extent of reuse and its effects on patient care.

Meanwhile, on November 1, 1999, the FDA announced a proposed strategy and is seeking public comment on its recommendations for addressing the practice of reuse of single use medical devices. The FDA's recommendations include regulating reprocessors and hospitals that use recycled medical devices in much the same way it regulates original equipment manufacturers. The FDA proposal calls for a three-tiered system of regulation commensurate with the potential risk posed from recycling the medical device. The FDA proposes removing "high risk" single use devices from the market and establishing premarket requirements for "medium risk" devices. "Low risk" medical devices would include products that pose little or no risk to the public and would be exempt from premarket requirements. On December 14, 1999, the FDA held a public meeting to gather comments on its proposed strategy. See http://www.fda.gov/cdrh/reuse.

12/21/99