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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