Hospitals "Recycling" Single-Use Medical Items
September 15, 1999
Nearly half of 132 hospitals surveyed this year admitted to re- using medical devices meant to be discarded after a single use, such as plastic catheters. Legal experts say the practice could expose the hospitals to massive liability suits.
- When hospitals were asked whether they re-used single-use items, 49 percent said they did, according to OR Manager, and critics say they may be underreported.
- The practice involves instruments which may have been opened -- or sometimes used on a patient -- and then sterilized or disinfected to be used again.
- Critics contend that hospitals which ignore manufacturers' instructions and don't tell patients they are being treated with a reused device are inviting lawsuits which they will surely lose.
- Manufacturers also fear they will be held responsible for misuse of their products.
A small industry has grown up in recent years dedicated to reprocessing medical equipment. The Association of Medical Device Reprocessors contends device manufacturers often label instruments for single use -- not for safety, but because they want to sell more of them.
The Food and Drug Administration says that "third-party reprocessing of single-use devices is unlawful unless the companies comply with all regulatory requirements for manufacturers, including prenotification." The agency says it has chosen to use "regulatory discretion" until it adopts a new policy.
The Health Care Financing Administration says that if the FDA rules that reused medical devices are unlawful without prior approval, it will stop paying hospitals for them.
Source: John Berlau, "A Ticking Medical Time Bomb?" Investor's Business Daily, September 15, 1999.
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