What Does AMDR Membership Mean?

I have been in the single-use device reprocessing industry for almost two decades, and most of that time, I have also represented the reprocessing company I worked for on the AMDR Board of Directors. I have seen a lot of companies and individuals join AMDR, and I have seen several leave AMDR as well. AMDR turned 25 years this year, and I have previously published about the accomplishments and challenges of AMDR. However, this anniversary year is also a good opportunity to review what AMDR membership means – to the reprocessing company and, more importantly, to the hospitals and surgery centers that need to select a reprocessing partner to reduce costs and environmental harm.

Single-use medical device reprocessing is a highly regulated activity with arguably stricter rules than those that have to be observed by the original manufacturers that design and market the original medical devices. This means that any reprocessing company that follows the law can be assumed to maintain high standards. However, regulations can be interpreted differently, oversight isn’t constant (and partially the responsibility of the reprocessing company itself), and even the strict rules of the regulatory system may not be enough to guard the healthcare facility against utilizing faulty devices or achieving sub-par results from their reprocessing partner.

AMDR as a trade association demands higher standards from its members than those formally imposed on the industry by regulation; and AMDR guides its membership to interpret regulations in a way that ensures the highest quality devices, highest patient safety, and optimal reprocessing program results. From its outset, AMDR understood that only with standards that exceed those that are demanded from a regulatory perspective, can the reprocessing industry retain its role in the market and its position in the medical device industry. This is because medical device re-use, however safe it may be, will always be subject to questions about safety, quality, and functionality. In addition, the involvement of original manufacturers in the reprocessing industry (starting with Stryker’s acquisition of Ascent in 2009) has introduced a risk that reprocessing programs are not designed to produce maximum savings and environmental impact for the hospital – but to drive maximum profitability for the manufacturer. 

AMDR guides its membership to interpret regulations in a way that ensures the highest quality devices, highest patient safety, and optimal reprocessing program results.

AMDR’s bylaws and its code of conduct commits its members to the highest standards of safety, value, and corporate behavior. Members who violate any of these risk their membership in AMDR. Reprocessors outside AMDR might operate with very high standards as well, however, there is great risk that they are not. So, what is at risk when selecting a reprocessing partner that does not have AMDR membership?

1. AMDR members commit to uncompromised product quality and safety, and demands to their quality systems are stringent. No shortcuts are taken in terms of cleaning, inspection, and testing, and the quality control system has redundancies to ensure every single device is safe and functional. AMDR members test and inspect each device as opposed to a sample of devices from each lot. Working with non-AMDR members means risking less quality and safety in the reprocessed devices.
2. AMDR members also commit to strict adherence to FDA clearance guidelines. No shortcuts are taken when it comes to when data needs to be submitted to FDA, and no shortcuts are taken when it comes to the diligent collection of data needed for FDA clearances. The FDA clearance process is the most cumbersome, expensive, and time-consuming pathway to legally market a reprocessed device. There are other pathways, and at times, these are appropriate, but only within the FDA guidelines. Working with non-AMDR members means risking that the reprocessor has a more relaxed view on the need for FDA clearances to market reprocessed devices.
3. AMDR members commit to a singular focus on maximizing the results from the hospital’s reprocessing program. In other words, consideration for overall corporate profit that may suffer from reprocessing have secondary importance versus considerations for maximizing cost savings and environmental impact for the hospital. Original manufacturers that are AMDR members follow this principle. Working with non-AMDR members means risking that the reprocessor restrains its reprocessing activities in order to maximize profits – for example by only offering limited quantities of reprocessed devices or avoiding the use of FDA clearances to bring cost savings to the hospital.
4. AMDR’s code of conduct also demands that AMDR members follow strict rules for corporate ethics, transparency, and accountability. Deceitful communication, lack of transparency about program results, etc. are not permitted for AMDR members. Working with non-AMDR members means risking that the reprocessor has a more relaxed view on corporate ethics and program transparency.

Members of a trade association are usually competitors. However, in the context of the work of the trade association, they become peers who are jointly committed to furthering the reach and results of the entire industry. It follows from the principle of “a rising tide lifts all boats” that a more successful, more ethical, mode results-oriented industry is beneficial for all members of the trade association. Among AMDR members, higher ethics and standards are pursued, and an important aspect of this is the peer monitoring of other AMDR members. As previously mentioned, a great deal of reprocessing oversight isn’t constant, and it is partially the responsibility of the reprocessing company itself. AMDR members watch that all members follow the bylaws and the code of conduct. They understand that the entire industry is damaged if one member fails to abide by bylaws and code of conduct. Non-AMDR members are not subject to this control.  

Among AMDR members, higher ethics and standards are pursued, and an important aspect of this is the peer monitoring of other AMDR members.

More and more reprocessing companies are NOT AMDR members. Not because members are fleeing the trade association, but because as the industry demonstrates success, it attracts more companies; and as the interest in reducing the cost and environmental impact of healthcare becomes more international, reprocessing companies emerge outside of the United States and Europe. As more reprocessing companies emerge, hospitals should be mindful of the risk associated with partnering with a non-AMDR member.