Association for the Advancement of Medical Instrumentation/International Organization for Standards: key to perfusion quality management and safety one patient at a time.

The Association for the Advancement of Medical Instrumentation (AAMI), a not-for-profit organization, writes standards for medical devices and is a country member of the International Organization for Standards (ISO). AAMI standards are reference guidelines for the United States Food and Drug Administration (FDA) and medical device manufacturers for the performance of all perfusion products’ submission for FDA approval for product sales. Depending on the sophistication of the product, steps may involve in vitro bench testing (with fluid and/or animal blood), in vivo animal testing, approval for clinical testing pre-market approval (PMA), and final approval for general market release. Historically, the FDA had virtually a non-participant role, but used AAMI standards as the paradigm for approval of products, which allowed manufacturers, clinicians, and independent experts to produce the details of the standards. Currently, however, there has been a major shift in the FDA philosophy. They have moved from a virtual non-involvement role to extensive participation. For example, one of their initiatives is that the bubble detector is a mandated part of a heart-lung machine and no longer is considered an accessory or can be sold separately. This shift in philosophy can be positive if it is balanced with active participation by clinicians and users. The FDA lacks the expertise to fully understand perfusion practice, but is taking aggressive stands in initiating standards that affect perfusion practice. They also have changed their focus on how the devices should perform to how the performer should perform. Recently, the FDA initiated the adoption of a checklist for extracorporeal circulation. As a member of the Blood/Gas Exchangers Working Group, the American Society of ExtraCorporeal Technology liaison accepted the task of producing the checklist document and co-authored the technical document. It is the first technical document ever with an itemized rationale for each checklist item allowing many clinicians and experts in the professional and standards organizations around the world to efficiently process the document. The delicate balance between the FDA and the clinicians was preserved in this case. The FDA’s role remained the same with manufacturers. However, the recent decline in the number of representatives to the Working Group from manufacturers is a concern. Another effect on perfusion practice is the constant pressure from manufacturers to downgrade a device classification with FDA. The oxygenator, for example, was a Class III device (the most difficult level for the approval process). In the mid-1980s, there was a strong movement initiated by the manufacturers, with reliable academic support, to attempt to downgrade the classification. While working for a manufacturer during that period, I was in a precarious position to petition against that movement. However, I was able to participate, along with an international group of perfusionists, in successfully stopping that movement, and the oxygenator classification remained Class III. I left the standards committees in 1990. Upon my return to the standards committees which included Blood/Gas Exchangers after a hiatus of 13 years in 2003, to my disappointment, the oxygenator had been downgraded to Class II. In the dominant era of bubble oxygenators several decades ago, one of the most successful oxygenator companies experienced a massive number of randomly occurring oxygenator failures. Apparently, defoaming performance break down occurred unpredictably at the onset of cardiopulmonary bypass with their high performance oxygenator without rhyme or reason. The company devoted considerable resources but all the standard quality management Address correspondence to: Richard Chan, Program Director, North Shore University Hospital – Long Island University, Graduate School of Cardiovascular Perfusion, 225 Community Drive, South Entrance, Great Neck, NY 11021. E-mail: [email protected] Richard Chan