Controversy Swirls Around Recycled Medical Devices

Recycled <"">medical devices are the subject of a heated debate between healthcare providers and the industry.  Hospitals – and the reprocessing companies they pay to recycle single use medical devices – say that the practice saves million in healthcare costs and waste.  But medical device makers, who stand to lose money through the practice, argue that there is no way to be sure that a recycled device is free of dangerous contaminants.

Recycling medical devices involves shipping devices to reprocessing facilities to be cleaned, sterilized and tested for reuse. The practice is legal as long as reprocessors follow all appropriate Food & Drug Administration (FDA) guidelines.  Reprocessing companies, hospital associations and environmental groups counter that the devices they reprocess are as safe as new thanks to modern sterilization methods, cost 40% to 60% less, and can eliminate thousands of tons of waste from landfills.

Of course, the medical device industry is not a fan of recycled medical devices.  According to The Wall Street Journal, the industry is lobbying in several states for legislation that would require health-care providers to obtain “informed consent” from a patient before using a reprocessed device during a procedure. Utah already has approved liability protections for original equipment makers, and other state bills include measures that would free original manufacturers from liability if a reprocessed device fails and causes injury or death.

Medical device makers claim that their devices are not designed to hold up to the harsh chemicals and detergents used in reprocessing.  They also say that many devices have porous surfaces and small crevices where tissue, fluids and pathogens gather that are difficult for even the strongest chemicals to reach.  They site a study of Medtronic heart stabilizers to back these assertions.  According to the Wall Street Journal, the study, conducted by the University of Minnesota, found that while new heart stabilizers showed little or no manufacturing debris, a majority of reprocessed devices had corroded parts and traces of human hair and protein, bringing into question the effectiveness of the reprocessing efforts.  As a result of that finding, the FDA began requiring that reprocessed heart stabilizers undergo more rigorous premarket clearance reviews

Despite that finding, hospitals and reprocessors continue to insist that recycled medical devices do not endanger patients.  They argue that many devices – such as saw saw blades – were historically reused.  But in the 1980s, due to concerns over the spread of AIDS and other infectious diseases, many manufacturers began labeling such devices for single use.  Dan Vukelich, president of the Association of Medical Device Reprocessors, also claimed in The Wall Street Journal article that medical device manufacturers label many products as single-use merely to be able to sell more new devices to hospitals and thwart competition

According to a report released by the Government Accountability Office (GAO), about 100 devices — just 2% of all devices labeled for single use — are now reprocessed. For its report, released in January, the GAO analyzed 8 years of FDA records on reused medical devices, and found no evidence that they are less safe than new devices.  Of 65 events reported to the FDA from October 2003 to July 2006 involving or suspected to involve reprocessed devices, the device was just one of several possible causes of harm, and the adverse events were of the same type reported for new, nonreprocessed devices, the FDA found.

According to The Wall Street Journal, the FDA has stepped up its oversight of reprocessing, including more plant inspections, after new legislation in 2002 began requiring devices to be labeled if they are reprocessed. The FDA says it is working on a new strategy for monitoring and communicating information about reprocessed devices, and conducting research on “acceptable” single-use device-cleaning criteria.

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