Danny Hutson is director of sterility assurance/biocompatibility for CareFusion.
Q: What are the most critical changes AAMI has recently made to its recommendations and requirements for surgical instrument processing?
Danny Hutson: From CareFusion's perspective, the applicable current AAMI-related medical device reprocessing standards do not entail what are considered new requirements. Historical (i.e., past several years) AAMI-related medical device reprocessing standards entail critical device reprocessing requirements that are equivalent to those that exist today. Although recent versions of the applicable AAMI standards entail improved consistency and clarification of applicable requirements (e.g. development of flowcharts, additional definitions, etc.), the more applicable new critical changes pertain to FDA requirements regarding reusable device-related cleaning and sterilization qualifications associated with 510(k) submissions. As an example, device manufacturers must qualify and implement, with respect to the customer related IFU (i.e., information for use), the sterilization cycles (i.e., defined as non-extended cycles) that are specified within the FDA's new draft guidance "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (pdf).
Q: Why do you think these changes were made?
DH: Based upon the draft FDA guidance, the FDA does not consider extended cycles (i.e., sterilization cycles entailing parameters that are outside of the defined FDA guidance cycle parameters) to be technically feasible regarding healthcare facilities/users. In other words, the FDA does not consider hospital-/user-related sterilization equipment and applicable sterilization accessories (e.g., sterilization wraps, sterilization containers, biological and chemical indicators, etc.) to be properly qualified and FDA cleared for sterilization parameters pertaining to extended sterilization cycles.
Q: What challenges do these changes present to organizations?
DH: Moving forward, in order to obtain FDA-related 510(k) clearance, reusable device manufacturers must design and qualify an applicable device to be properly sterilized via the FDA-approved non-extended sterilization cycles. If a device cannot be qualified utilizing an FDA-approved non-extended cycle, the manufacturer must demonstrate acceptable qualification/FDA clearance-for-use data as it pertains to the sterilization qualification equipment and all applicable sterilization-related qualification accessories that were utilized to qualify the extended cycle(s).
Q: In what way can you see organizations struggling to meet these changes?
DH: When compared to historical devices, new devices may entail a more complex design which is required for device functionality in order to improve patient procedure related safety and outcome. Unfortunately, the more complex design may increase the device-related cleaning and sterilization challenge. As a result, device manufacturers may require additional design features, which enable effective sterilization to be qualified in compliance with the FDA-approved non-extended sterilization cycles. The additional design features, which may be required solely to support sterilization qualification pertaining to non-extended sterilization cycles, may add cost to device qualifications, but more importantly may delay the time in which the device is qualified and ultimately approved for use by the customer.
Q: What steps would you advise organizations take to overcome these challenges and meet requirements?
DH: Reusable device manufacturers should ensure that the applicable FDA-related requirement above is taken into consideration during the initial stages of device design. Also, manufacturers should ensure that the FDA approved non-extended sterilization cycles are ultimately qualified, otherwise the applicable 510(k) will likely be rejected by the FDA.
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