RECYCLED EQUIPMENT: A ‘Ticking Medical Time Bomb’
"Risky recycling" is one of several terms used recently to describe the increasingly common hospital practice of reusing single-use medical instruments, a "dirty little secret" of medicine that the FDA is expected to soon weigh in on, according to the U.S. News & World Report. Rising medical costs, coupled with pressure from insurers and federal health care programs, have forced an increasing number of hospitals to refurbish delicate instruments that manufacturers recommend should be used only once, giving rise to a device reprocessing industry that now takes in $20 million annually. Critics argue the trend creates a shaky precedent, opening the door for increased infection and fatal surgical errors with instruments, but proponents contend that reusing instruments is a sound cost-saving measure. Stephen Hammill, director of the electrophysiology lab at the Mayo Clinic in Rochester, MN, reports his lab has used nearly 50,000 catheters "without a single problem," achieving an estimated $9 million in resulting savings over the past 20 years.
More Regs to Come
Opponents to recycling include device makers concerned about liability issues and patient advocates focused on the ethical ramifications of the practice (Hawkins, U.S. News, 9/20 issue). Now the government is jumping into the fray as well. Sen. Richard Durbin (D-IL) has introduced a bill asking the FDA to require hospitals, currently not subject to any such regulation, and "companies that refurbish medical devices to show the government that what they're doing is safe and effective -- before they do the job." The FDA currently uses "regulatory discretion" with reprocessing companies, but is investigating proposals to stepup regulation. For example, a July letter from an FDA official confirmed that third-party reprocessing of single-use devices is lawful only if companies comply with "all regulatory requirements for manufacturers, including pre-market certification" (Berlau, Investor's Business Daily, 9/15). Congress has directed the GAO to "determine the extent of reuse and how it affects patient care," and HCFA weighed in this month, stating that, pending FDA action, it will cease providing funds to hospitals participating in unlawful reuse of medical instruments.
In Their Own Hands
In the interim, some professional health care organizations, such as the Association for Operating Room Nurses (AORN), are developing their own guidelines for reuse of medical devices. Patient advocates, concerned about the ethics of charging patients for new devices when they are receiving recycled ones, are calling for hospitals that recycle instruments to alert patients prior to their use -- something few providers do now (U.S. News & World Report, 9/20).