Reprocessing medical devices originally labeled for single use saved hospitals and surgery centers nearly $500 million in 2018, according to survey findings released by an industry trade group Monday.
For hospitals, reprocessing a device after patient use typically involves sending it to a third-party reprocessor, which cleans, sterilizes and repackages the device. Hospitals reprocess a range of single-use devices, ranging from non-invasive items like blood pressure cuffs to invasive surgical instruments.
While some clinicians initially expressed concerns over the safety implications of reusing devices, these largely have been assuaged in the wake of FDA oversight and lack of evidence pointing to any such health risks.
"In the early days we were focused on proving, 'How do you know it's safe? How do you know it's clean?' " said Dan Vukelich, president of the Association of Medical Device Reprocessors, the group that released the survey findings. The AMDR represents seven reprocessing companies, including Medline ReNewal, ReNu Medical and Stryker's Sustainability Solutions.
But that has changed. Last year, an estimated 8,885 hospitals and surgical centers across the U.S., Canada and Europe used reprocessed devices.
Mayo Clinic said it rolled out a program dedicated to purchasing reprocessed devices in 2015 as a sustainability initiative.
The program, which is managed by Mayo Clinic's supply chain division, collects and purchases devices for reprocessing across multiple product categories, said Terri Nelson, director of value analysis at the Mayo Clinic. While the majority of these devices are in the catheterization laboratory, there are also medical-surgical products like stethoscopes and blood pressure cuffs.
Mayo Clinic collects between 4,000 to 6,000 devices for reprocessing each month.
That provides both cost savings and "green" savings, according to Barb Braun Zinser, clinical quality value analyst at Mayo Clinic. "Even if Mayo does not specifically buy back those devices, there are other healthcare systems that have the opportunity to purchase those back based on our collections," she explained. That helps to eliminate medical waste that may have otherwise been disposed of in landfills.
Nelson declined to share which reprocessing companies the Mayo Clinic works with or specifics on cost savings that the Mayo Clinic has experienced using reprocessed devices, but said the Mayo Clinic's savings have been consistent with published studies that found using reprocessed devices reduces costs by 30% to 40%.
In aggregate, healthcare organizations across the U.S., Canada and Europe saved $471 million and diverted 15 million pounds of medical waste by using reprocessed devices, according to the AMDR survey.
The AMDR in part linked recent growth in device reprocessing to regulatory oversight from the Food and Drug Administration. Since 2000, the FDA has taken steps to strengthen its pre-market review and post-market oversight of reprocessed single-use devices, including inspecting reprocessing companies and requiring reprocessed devices to receive 510(k) clearance.
"FDA's regulations have been legitimizing," Vukelich said. "We've turned a corner."