Volume 12, No. 2 • Summer 1997

Debate on Reuse of "Disposable" Medical Equipment Fueled by FDA

Nola K. Gibson, Ph.D.

A preliminary Food and Drug Administration study has uncovered reports of infection, chemical injuries, and mechanical failures associated with reusing equipment designed to be used just once.

Reported by the Associated Press, the investigation revealed that device manufacturers had photographs showing equipment tainted with residual tissue, including arthroscopic blades at a hospital officials refused to identify. So far, anesthesia equipment has not been a major focus of the investigation, but questions about reuse of supposedly single-use endotracheal tubes and other airway-related equipment have been raised in the past.

Arthroscopic blades, dialysis filters, endoscopic surgery cannulation tubes, and angioplasty balloons, for example, were meant to be used just once and then discarded. Instead, in many U.S. hospitals, these items and others are being resterilized to be used again, despite secretions or undetected pieces of a previous patientÕs tissue still stuck inside.

Besides infection risks, these devices often are made of thin plastic and were not designed to withstand sterilizing over and over. Proponents defend this practice by saying that resterilization is safe and necessary to bring down health care costs.

Medical device manufacturers, worried about liability and sales losses due to resterilization, were instrumental in bringing contaminated devices to the attention of the FDA and in urging a crackdown. In Europe and Canada, resterilization has been common, but France and Quebec have now prohibited reuse. Companies that sell the resterilization equipment overseas wonÕt sell domestically because they say clinical trials necessary for FDA approval cost too much. FDA scientists have now been meeting with experts from the Centers for

Disease Control and Prevention and the Health Care Financing Administration to compare injury reports and determine whether government intervention is needed.

The first recycled devices in the United States were dialysis filters that individual patients used repeatedly. The practice was considered safe because patients only used their own dialyzers. However, studies in the early 1990s found that clinics that reused dialyzers had more deaths. Early studies determined that the danger was in the resterilization method. The government has found that the method has now been improved, just as hospitals have begun to reuse dozens of other devices.

The FDA studied injuries among a sample of 3,000 reports to its medical device database since 1991. Approximately 600 injuries were reported for reused dialyzers, although some occurred before clinics adopted safer sterilization methods. Some 60-100 problemsÐÐinfection, injuries from sterilizing chemicals, and mechanical failureÐÐwere reported from other devices.

“We don’t think we have an epidemic of injuries,”emphasized Dr. Susan Alpert, FDA chief of device evaluation, but “I don’t mean to say there isn’t a problem with refurbished devices.”

Many U.S. physicians are awaiting a report soon to be issued by the independent health research firm ECRI. The report promises to help hospitals determine how to reuse devices safely, if at all. A company vice president has stated that it could be accomplished safely but it will depend on the device and skill or competency of the hospital or resterilizing company.

The subject warrants further study of safety and cost factors, after which the APSF and other physician organizations will likely adopt recommendations regarding the safe reuse of disposable products.

Dr. Gibson of Jackson, MS, is the APSF NewsletterEditorial Assistant.