Use of Reprocessed Devices Grows

According to an article in the March 19 edition of the Wall Street Journal, hospitals are recycling a growing number of medical devices labeled as single-use devices to help save costs and reduce medical waste. Recycling medical devices labeled for single use is legal as long as certain FDA guidelines are followed. But manufacturers and patients have raised questions about the practice, which often involves shipping devices to third-party reprocessing facilities to be cleaned, sterilized and tested for reuse.   
Medical device makers say their single-use products are just that, and pose a higher risk of failure and harm when recycled. Reprocessing companies, hospital associations and environmental groups claim 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.

In January, after reviewing eight years of FDA data, the Government Accountability Office (GAO) weighed in with a report concluding there is no evidence that reprocessed single-use devices create an elevated health risk for patients. About 100 devices (just 2% of all devices labeled for single use) are now reprocessed. Despite the GAO report’s findings, device manufacturers are seeking legislation that would require healthcare providers to obtain informed consent from patients before using a reprocessed device during a procedure. Utah already has approved liability protections for OEMs and other state bills include measures that would free original manufacturers from liability if a reprocessed device fails and causes injury or death.

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