SP 104: Device Inspection Standards & Best Practices
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Visual inspection is a critical component of medical device reprocessing and an essential element of a comprehensive quality management system. However, determining whether a device is clean, intact, and functional may require more than inspection with the unaided eye.
This session will define visual inspection and examine applicable standards, guidelines, and manufacturer Instructions for Use (IFUs) that support visual and enhanced visual inspection of medical devices. Participants will explore the use of adequate lighting, magnification, borescopes, and other inspection technologies to identify residual soil, damage, deterioration, and other conditions that may affect device safety and performance.
The session will also review practical techniques for incorporating visual inspection into a quality management system, including standardized inspection processes, staff competency, documentation of findings, trending, corrective action, and escalation. Real-world examples will demonstrate how a structured approach to inspection can strengthen reprocessing practices, identify potential failures before devices reach the patient, and support patient safety and continuous quality improvement.
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LockedJahan Azizi
Special Projects Manager
Healthmark, a Getinge company
Jahan Azizi, BS, CBET has spent 30 years in healthcare settings investigating and reporting problems with medical devices, his focus has always been on fixing and correcting, then moving on to the next. Jahan has several years with device manufacturing and at the Food and Drug Administration (FDA) as well. Jahan has written numerous safety reports, internal reports, presentations, and hospital policies. He has published the findings from his work, better to reach those in industries and in regulatory agencies that can effect positive changes in medical device design, maintenance, and control. Jahan has spent several years on the issue of validating and optimizing surgical instrument reprocessing methods, which has provided him with a unique skill set and knowledge. Jahan was invited to make presentations at the FDA and industry professionals at symposia of the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Testing of Materials (ASTM), the FDA's MedSun, HSPA (IAHCSMM), local societies, and Jahan is Primary Voter at several AAMI and ASTM Standard Committee(s).
