Single-use device reprocessing is governed by FDA regulation – and with high standards for clearance to reprocess single-use devices and for making them available to hospitals for another use, the reprocessing industry has come far in enabling hospitals to reduce costs without compromising quality. The Association of Medical Device Reprocessors (AMDR) has contributed to defining these standards, fought for them on the Hill and in State courts in the 1980s, 1990s and 2000s, and, today, AMDR is taking this voluntary regulatory movement to make savings safe to the next level, admitting more members and setting higher standards. Altogether, AMDR has brought a small revolution to Healthcare, in its 20-year legacy of providing appropriate safety and regulatory standards, and maintaining a high “bar” for admittance into the reprocessing industry.
...AMDR has brought a small revolution to Healthcare, in its 20-year legacy of providing appropriate safety and regulatory standards, and maintaining a high "bar" for admittance into the reprocessing industry.
This opinion piece does not address the off-standards reprocessing activities of manufacturers and reprocessors that do not live up to the high standards and code of conduct of AMDR membership. I would recommend to anybody seeking to save through reprocessing to select a partner who is an AMDR member. Most importantly, beware of reprocessing programs maintained by original device manufacturers, as these are not designed to optimize hospital savings.
...beware of reprocessing programs maintained by original device manufacturers, as these are not designed to optimize hospital savings.
That said, while AMDR sets the standard, each AMDR member determines the level of safety and as FDA standards become tighter, new FDA clearances become more difficult to get. So, I wanted to point out a few areas in which Innovative Health provides more stringent attention to ensure what we call “making savings safe”:
- Innovative Health maintains the highest device rejection standards in the industry. I see this every day when I look at rejection rates and talk to my colleagues in Receiving: Devices that would otherwise be accepted, reprocessed and re-used are rejected at Innovative Health thanks to our team of device inspection experts, who reject devices for even possible physician “look-and-feel” reasons. In fact, devices we reject are sent back into the market and frequently picked up by other reprocessors with lower standards. Make your choice: We don’t put savings over safety.
- We have also decided to not seek FDA clearance for maximum “cycle count”. “Cycle count” is the number of times it is FDA OK’ed to reprocess devices. We go low, because patient safety and physician comfort with devices is more important than using cheaper devices. As a result, for many of our devices, one re-use is all we accept. This is not true for all reprocessors. Ask your current reprocessor about “cycle count”. Making savings safe is what you want.
- Innovative Health FDA clearances are all less than three years old. Many of the most expensive devices we reprocess are also reprocessed by other reprocessors who got their clearance several years ago, when standards for cleaning and inspections were less stringent. Since then, FDA has tightened its expectations about cleaning standards and even added requirements for inspections that did not exist when early clearances were granted. The use of borescopes to inspect the lumen in reprocessed devices is a case in point: This was required for Innovative Health’s recent Agilis clearance – but not in clearances granted for this device in the past.
- As Innovative Health pursues clearances for devices that have not been considered reprocessable in the past, new types of standards are introduced by FDA, including standards and testing methodologies from the pharmaceutical world. While our engineers and regulatory experts develop new protocols and testing practices, we doubt that this level of attention is payed to cleaning and inspection other places; - especially since it seems like new FDA clearances for Cardiology devices are just not coming to our industry partners.
It is safe and responsible to reprocess with any AMDR member. However, “making savings safe” may mean different things to different reprocessing companies. I encourage hospitals to ask into the details of the matter when it comes to cleaning and inspecting some of the more complex devices they re-use.