Association of Medical Device Reprocessors

Letter to the Editor, Academic Medicine, An Ethical Imperative to Use Reprocessed Medical Equipment:

By using safe, reprocessed equipment, there will be less need for single-use devices, which are relatively new on the scene and were adopted for convenience, not safety. To promote health and fulfill the ethical imperative discussed above, the medical profession must replace single-use devices with safe, reprocessed ones whenever possible.

Cheryl Macpherson, PhD

Professor and chair, Bioethics Department, St. George’s University School of Medicine, St. George’s, Grenada; ccox@sgu.edu.

EP Lab Digest: Ascent Leads Industry Commitment to Quality Healthcare as a First-Mover on GLN Readiness (08/24/10):

As hospitals and providers work to adopt GS1 global supply chain standards into their operations, Ascent is now ready to work with customers using Global Location Numbers (GLNs). These are standardized identification numbers that give medical locations unique numbers, and will improve the safety and efficiency of healthcare with more effective traceability and improved order, invoice and inventory management capabilities. As the leading re-manufacturer of single use devices (SUDs) and one of the first suppliers to announce GS1 readiness – well before 2010 GLN Sunrise date of December 31 – Ascent demonstrates its leadership and commitment to improving and evolving the healthcare industry.

Healthcare Purchasing News Q&A on Reprocessed single use devices, by Ray Taurasi (August 2010):

Q We have been utilizing an outside third party source to reprocess some of our single use devices (SUDs).While I have been keeping a log of all devices that we send out for reprocessing to date we have not been notifying our patients that a single use medical device may be used on them. Should patients be informed when a SUD is used on them? Doesn’t using a new device on some patients and a reprocessed SUD on another constitute a double standard of care?

A The reprocessing of single use devices is classified as a manufacturing activity and the process is regulated by the US Food and Drug Administration (FDA). Any source that reprocesses SUDs in the eyes of the legal system is deemed to be the manufacturer of that device. Manufacturers of medical devices including “third party reprocessors” or hospitals that choose to do this practice must comply with very rigid FDA manufacturing standards and regulations. To be certain that the SUDs you are having reprocessed meet the FDA’s strict requirements it is critical that you contract with a reprocessing company that is registered and regulated by the FDA with the appropriate clearances to reprocess the devices you are sending to them.

Assuming that you are indeed utilizing the services of a reprocessing company regulated by FDA and the devices being reprocessed have been cleared by FDA there is no need to inform patients that reprocessed devices are being used on them, nor is it considered a dual standard of care to use a new device versus an FDA cleared reprocessed device on patients. To obtain FDA clearance the reprocessor must demonstrate and prove that the reprocessed device is equivalent in performance, safety and quality as it was when originally manufactured by the OEM (original equipment manufacturer). The reprocessor must validate amongst other things the device’s effective functionality, cleaning, and sterilization. Once the FDA has cleared a reprocessed SUD it means that the device has proven to be equivalent in all regards to the original or new device. In such, there is no considerable difference between the two products and thus no dual standard exists.

Treehugger.com: U.S. Health Care Industry Makes a Dent in Massive Medical Waste (07/17/10):

If you’ve ever sat in the dentist’s chair wondering where all those shiny, silver teeth-cleaning tools might end up one day, or perhaps contemplated the future of the bio-hazardous waste bin in your doctor’s office–you, like me, probably assumed the “invisible” landfill as its next destination.

What is barely ever spoken of, nor seen, is just how many mountains of medical waste exists and what’s being done to prevent it. This recent New York Times piece dishes on the industry’s dubious amounts of disposable and recyclable devices, supplies, and equipment….

Orthopreneur: Single-Use Device Reprocessing to Gain Traction Under Reform, July/August 2010:

The recent healthcare legislation has already created some urgency in identifying ways to improve operational efficiency and drive out procedure costs. . . .And according to the Association of Medical Device. Reprocesors (AMDR), reprocessed medical devices provide a 50 percent cost savings when compared to new …

HealthLeaders: Single-Use Device Reprocessing: Balancing Cost Savings, Patient Safety (07/13/10):

Michele De Meo, sterile processing manager at Memorial Hospital in York, PA, says her facility has reprocessed external compression sleeves for the past three years. Starting with low-risk devices also allows your facility to test out a vendor to ensure that you are satisfied with the quality and the relationship. ?I believe that if a company has gone through the process required to get their 510(k) and the devices are deemed safe, and the company doesn?t have any quality issues that have been noted, I think for cost savings and for the environment it?s prudent for us to explore those options as long as the quality is the same as a new device,? De Meo says.

Health Point Capital: Medical Device Reprocessing Gaining Traction in Hospitals Nationwide (07/13/10):

Notably, the U.S. Government Accountability Office (GAO) released a comprehensive report in 2008 detailing the FDA’s supervision of the practice and outlining requirements for reporting any adverse effects. The report concluded that despite the limitations of current FDA data, the agency’s analysis “of reported device-related adverse events does not show that reprocessed SUDs present an elevated
health risk.”

Stemming from the GAO’s findings, as well as their own experiences in the OR, surgeons at Johns Hopkins School of Medicine published commentary in Academic Medicine in March calling for more hospitals to begin recycling disposable SUDs. Their report observes that the U.S. healthcare industry is the second-largest contributor to landfills after the food industry, with medical centers discarding over four billion pounds of waste annually each year.

The Herald Tribune: In a World of Throwaways, Making a Dent in Medical Waste (07/06/10):

In a commentary published in March in Academic Medicine, Dr. Martin A. Makary, a gastrointestinal surgeon, and colleagues at Johns Hopkins School of Medicine called for more medical centers to “go green” by recycling disposable single-use medical devices. Several reprocessing companies take certain disposables — like orthopedic drill bits and heart-monitoring catheters — and clean, recalibrate, repackage and resterilize them, then sell them back to hospitals and medical suppliers for 40 to 60 percent of the price of new ones.

 The commentary stemmed in part from a frustrating moment two years ago when Dr. Makary stared into a trash bin in the operating room after performing routine laparoscopic “keyhole” surgery. As is typical in most hospitals, the wastebasket was full of “perfectly good equipment, much of which was either barely used or never used,” he recalled. The unused devices came from sterilized surgical kits that were opened for the operation; no longer sterile, they got tossed.