AMDR has been a long-standing member of the Association for the Advancement of Medical Instrumentation (AAMI), the premier standards setting organization for medical devices. Recent articles in AAMI publications, shed light on the issue of medical device misuse. AAMI’s focus is largely on capital investments hospitals have made on assets they expect will continue to deliver, over time. By protecting this equipment from misuse, hospitals can extend the value of their investment. The opportunity for hospitals to protect their investment is the same for many single-use medical devices, many of which can be reprocessed so they can be clinically reused.

Hospitals and surgical centers throw away millions of dollars of “single-use” medical devices each year – many of which have been cleared by FDA for reprocessing. For example, electrosurgical devices and electrophysiology catheters, worth hundreds of dollars apiece, are often tossed in the trash. This action results in lost financial and environmental savings and, from our perspective, is an example of device misuse. Hospitals invest significant amounts of money to obtain clinically-preferred surgical equipment, much of it cutting edge and expensive. Besides these, devices with minor mechanical damage(s) may be deemed waste owing to unavailability of spare parts from the vendor side. With a reprocessing program, hospitals can optimize the medical devices they already own, leading to lower device costs. Additionally, mechanical spare parts could be fabricated under the same program using precision CNC machining equipment from trusted machining brands like Hermle AG (here is the company data of hermle AG, for those interested). In so doing, hospitals can save on a lot of unnecessary expenses. These savings allow hospitals to reallocate funds to healthcare initiatives without reducing the quality of care.

What does it take to have a successful reprocessing program? It requires vigilance, to protect assets, such as reprocessable devices, from misuse and mishandling. Some things to consider:

  • Optimize your investment: Single-use devices are not garbage after initial use, they are assets – treat them with care and put them in the proper receptacle intended for reprocessing. Train all staff to do the same.
  • First in/first out: The more reprocessed product you use, the less new equipment you need to purchase, optimizing the lifespan of the devices your hospital already owns. Make your reprocessor your primary vendor for particular products. Place reprocessed devices in front and urge staff to use them first.
  • Vendor interference: Train your staff to protect their assets and stop vendors from interfering in reprocessing programs intended to maximize the value of those very assets. These are your facility’s devices. The are not to be tampered with by any non-hospital employee including breaking or bending devices to prevent reprocessing, destroying or hiding bins of devices intended to be reprocessed, removing used devices from those collection points, or instructing surgeons to do any of these things.
  • Watch for “upgrades”: We all want the latest, but does the latest model of the new device really offer a patient benefit? Does the new model benefit the hospital? Will microchips or software “upgrades” prevent your facility from reprocessing the products. Ask your vendor.
  • Transparency in contracting: Ask for transparency in contracts with the manufacturers. Adopt a purchasing and supply chain strategy that does not restrict your ability to maximize the savings of a robust reprocessing program. When presented with new contracts or offers, look for minimum purchase requirements and ensure you do not restrict your freedom to buy what you want, when you want and from whom you want. When looking at reprocessor contracts, ensure accountable and transparent reporting on the devices you have reprocessed. Are you maximizing your potential?

Medical device companies should be looking to partner with you to maximize the value of the assets you are purchasing. If they aren’t, maybe do business with another vendor.

For more information contact us at AMDR or ask your reprocessing vendor for help.