In attempts to save costs and stem a rising tide of medical waste, hospitals are recycling a growing number of medical devices labeled as single-use, from scissors and scrubs to the sharp blades surgeons use, according to the Wall Street Journal (WSJ).
The WSJ reported that recycling medical devices labeled for single use is legal as long as certain FDA guidelines are followed, but the practice, which involves shipping devices to reprocessing facilities to be cleaned, sterilized and tested for reuse, has raised concerns about safety.
Medical device manufactures have said that their single-use products are designated for such uses, and pose a higher risk of failure and harm when recycled, the WSJ reported. Hospital associations, reprocessing companies and environmental groups counter that the reprocessed devices are as safe as new due to modern sterilization methods, cost 40 percent to 60 percent 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) released a report, stating that there is no evidence that reprocessed single-use devices create an elevated health risk for patients. About 100 devices— just 2 percent of all devices labeled for single use—are now reprocessed, according to the WSJ.
The WSJ said that while the GAO report strongly supports reprocessing and opens the door to more widespread use, device makers still oppose the evidence, and are lobbying in several states for legislation that would require healthcare 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.
“Single-use devices present an increased safety risk to patients because they are designed for optimal performance and safety in a single patient,” Tara Federici, vice president of technology and regulatory affairs at AdvaMed, told the WSJ.
For example, heart stabilizers have hollow tubes and other parts that device makers say could harbor blood and tissue and become weakened during reprocessing in ways that might not be evident during inspection, according to the WSJ.
Last year, the FDA began requiring that reprocessed heart stabilizers undergo more rigorous premarket clearance reviews, and a Medtronic spokesman told the WSJ that the company plans to conduct tests to see if the more stringent requirements improve performance. Until then, the spokesman said that the company stands by its position that the devices can not safely be reprocessed.
About $31.5 billion of single-use medical devices are sold annually in U.S. hospitals and surgery centers, of which around $150 million are recycled, according to Ascent Healthcare Solutions, a reprocessing company. John Grotting, Ascent's CEO, estimated that approximately $3.6 billion of single-use devices are safe for reprocessing, which could save the healthcare industry about $1.8 billion a year. Ascent reported that its hospital customers eliminated about 1,684 tons of waste from their local landfills last year, a 31 percent increase over 2006, by using reprocessed devices.
The FDA has strengthened its reprocessing oversight, including more plant inspections, after new legislation in 2002 began requiring devices to be labeled if they are reprocessed. The FDA said 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, according to the WSJ.