Circulation 60,475 • Volume 15, No. 3 • Fall 2000

“Disposables” Re-Use Now Regulated by FDA

In what may be an apparent contradiction in terms with significant patient safety implications, the U.S. Food and Drug Administration (FDA) has officially addressed the apparently common practice of medical institutions and practitioners reusing supposedly “single-use-only” disposable medical devices. An Associated Press report in various newspapers referred to the August 2, 2000, completion of new standards by the FDA “to ensure that disposable medical devices are safely resterilized and rehabilitated before being reused.”

Reference was made to cardiac catheters and angioplasty balloons because of their high cost. Reuse of these “disposable” devices had been previously unregulated. No specific mention was made of anesthesia equipment or devices, such as double-lumen endotracheal tubes for example. Controversial comments have appeared for several years in various presentations and articles about the anesthesia patient safety implications of reusing supposedly single-use-only devices, especially disposable breathing circuit tubing used on several patients over the course of a work day with a change to a new heat/moisture exchanger filter for each patient. Information about whether this practice is addressed in the new FDA standards was not available but this may be unlikely because it is not a classic type of resterilization and reuse.

The FDA was quoted as stating that hospitals and resterilizing companies would be required to meet standards to prove they recycle safely and that the most rigorous standards would apply to “high-risk” devices.

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