Guiding and Guarding Medical Device Reprocessing

It is tough to believe that medical devices marked single-use by the manufacturer can be safely reprocessed after use, and then used on another patient. Consumer products – sure. But medical devices that are used inside a patient’s body? And what if that patient is your grandma? It’s a tough idea to swallow. And yet, over the past decades, single-use device reprocessing has become standard in hospitals across the country.

It is tough to believe that medical devices marked single-use by the manufacturer can be safely reprocessed after use, and then used on another patient. Consumer products – sure. But medical devices that are used inside a patient’s body? And what if that patient is your grandma? It’s a tough idea to swallow. And yet, over the past decades, single-use device reprocessing has become standard in hospitals across the country.

How did this happen? How was it possible to convince lawmakers, regulatory agencies, the legal system, physicians, hospitals and the U.S. population that it can be safe to re-use single-use medical devices? There are three pieces to this answer:

Firstly, following an outcry by the original manufacturers that hospitals were reusing single-use devices, FDA decided around 2000 to regulate the practice (rather than shutting it down). Given the vast financial impact to hospitals of single-use device re-use, this was a sensible decision. FDA erected substantial barriers around the reprocessing of single-use devices, barriers that effectively stopped hospitals from reprocessing and left the practice with an increasingly sophisticated device reprocessing industry that now had to follow strict procedures, resembling those demanded from an original manufacturer, to obtain an FDA clearance to reprocess and sell single-use devices. FDA has since followed up with additional regulation that has put such demanding standards in place that reprocessed devices have been proven to function similar to new devices and represent no added patient risk. It is thanks to FDA regulation (and oversight) that hospitals and doctors have been able to trust the use of reprocessed devices. And it is thanks to FDA that reprocessors that obtain clearances are among the most sophisticated medical technology companies with safety standards and complaint records that are arguably better than those of manufacturers of new devices.

...reprocessors that obtain clearances are among the most sophisticated medical technology companies...

Secondly, the reprocessing industry came together in the years before 2000 and formed an industry association – the Association of Medical Device Reprocessors (AMDR). AMDR was instrumental initially in eliminating legal challenges to the practice, and later in maintaining high standards for its members and promoting the industry practice of reprocessing. Not everybody becomes a member of AMDR. Bylaws and code of conduct maintain a very high bar for inclusion in the industry and participation in industry activities. It is possible to be a reprocessor without an AMDR membership card, but the association has managed to convince hospitals that such membership means a higher level of integrity, sophistication and performance. AMDR has become the guardian of the founding principles of reprocessing – and, because of this, has contributed in an important way to the development that today makes reprocessing a standard practice across U.S. hospitals.

Thirdly, the conduct of individual reprocessors, their high standards, their transparency, and their commitment to the founding principles behind reprocessing - have enabled the broad acceptance of reprocessing. Regulation is never enough. A commitment to patient safety, to the integrity of the process, and to careful interpretation of regulation characterize reprocessing companies in the United States. It is their belief in founding principles and their self-governance within the guardrails put in place by FDA and guarded by AMDR that continue to make reprocessing a safe, accepted practice.

Yet, medical device reprocessing is still a fragile proposition: If FDA takes the eye off the ball, if AMDR slackens its principles for industry acceptance, or if individual members stray from the founding principles of reprocessing, then the acceptance of single-use device reprocessing can crumble, and hospitals lose access to hundreds of millions of dollars a year. Let me illustrate: If a physician, who has been used to using reprocessed devices, suddenly sees that the devices are inappropriately marked so it is unclear who has reprocessed the devices, or he experiences devices starting to fail in his hands, he will stop trusting that reprocessing works and stop using the devices. If this happens across physicians and hospitals, single-use reprocessing will cease to exist.

This is why Innovative Health celebrates the challenges we encounter when submitting to FDA for clearances. Stricter rules mean higher standards. Higher standards mean increased trust in reprocessing. This is also why Innovative Health stands by AMDR’s code of conduct and continues to insist on their enforcement. We can count on FDA and AMDR.

...Innovative Health stands by AMDR’s code of conduct and continues to insist on their enforcement.

However, reprocessing is a growing industry, and in later years, we have seen the entrance of new companies with less experience in the industry – and less closeness with the founding principles of reprocessing. More reprocessing companies is a GREAT thing that should be celebrated, but it also represents a vulnerability, since the conduct of any reprocessing company could create cracks in the trust in reprocessed products.

So, for the benefit of newcomers to the industry, here is a selection of the principles that have guided – and guarded – the industry over the years:

1. Used devices belong to the hospital: Used devices placed in drawers and other collection containers in the hospital do not belong to you. They belong to the hospital. They only become yours when the hospital has explicitly allowed you to collect them. Don’t collect devices destined for other reprocessors – even devices the hospital has decided to be collected by an original manufacturer. You are at the hospital as a guest. The hospital decides which devices you can collect. If you collect more than you have been explicitly allowed to, you engage in theft.
2. Quality, quality, quality: The most important department in a reprocessing company is not the Sales department or the Engineering department. It is the Quality department. Complaint handling and complaint responses must involve the absolute most conservative principles and follow strict procedures. Handling and responding must be swift. And remember: Complaints are an important source of information that can result in manufacturing improvement, product holds, etc. If something is wrong with a device, stop producing and find the root cause. Internal and external audits are key to the integrity of the quality system. The goal is to have a quality system that exceeds the standards of any reviewer – and a quality system that exceeds the standards of a new device manufacturer.
3. Submissions to and clearances from FDA: The regulatory and engineering process of preparing an FDA submission is time-consuming and expensive. But don’t cut any corners. Once again, your standards should be higher than an original device manufacturer. Consider “the n+1 rule”: If you ask to reprocess a device twice for a total of 3 uses, provide data that shows device integrity after 3 reprocessing cycles (2+1). If devices in transport could be exposed to temperatures of 100 degrees for 24 hours, put them in the oven at 150 degrees for 48 hours, if maximum strength put on a handle in a procedure is 20 pounds, test the device at 40 pounds, etc. In an FDA submission, transparency and data integrity is important. Don’t try to pile more device families into your submission than data supports. Don’t try to cut corners, and don’t try to cheat. If FDA comes back to you with additional testing demands, say “thank you”, and meet them. And when you utilize your clearance, be conservative about what devices you consider to fall under that clearance.
4. Device marking/labeling: Reprocessed devices must be marked so that it is clear that they have been reprocessed and what company has reprocessed them. The reprocessor assumes ownership and liability for the device when it has been reprocessed, so this is important. If the device fails and it is not clearly marked, the hospital cannot determine where to file a complaint or where to look for responsibility. This is a key principle in reprocessing. Different reprocessors use different solutions, including serial stickers, laser etching, QR codes, pad printing, etc. There is no convention in the industry, but each reprocessor must use a clear system for marking the device. And keep in mind that the device is taken out of its packaging before use: You cannot just mark the packaging.
5. Double-reprocessing: A reprocessor cannot reprocess a device previously reprocessed by another reprocessor. There are two reasons for this: 1) When an FDA clearance is granted to a reprocessor, that clearance is granted to reprocess the device a certain number of times. Reprocessing and reusing beyond this is against regulations. Since there is no convention in the industry for how devices are marked, you are only able to “read” your own devices and discover their history in terms of number of uses. It follows that you risk going against regulation if you reprocess another reprocessor’s device. 2) Different reprocessors with clearance to reprocess the same device may use different methods for cleaning devices. For example, different chemicals may be used in the cleaning process. Using different chemicals may result in reactions in the material that make the device unsafe.
6. Transparency in reporting: Hospitals use reprocessing to reduce procedure costs and environmental waste. Because of this, it is important that the hospital sees what cost savings and carbon emission reductions are driven by reprocessing. If this reporting is not transparent or frequent, the motivation for reprocessing goes away. Because environment and costs drive reprocessing behavior, this reporting needs to be done at the level where it can change or validate behaviors – the department must know, the doctor must know.

These are all principles that have guided the reprocessing industry for 25 years. Observing these principles protects the reprocessing industry, because they are what makes hospitals and clinicians trust reprocessing. I would encourage hospitals to demand that these principles are observed, so that they can protect the savings that come from reprocessing.