By Robert Kerwin

On April 23, IAMERS celebrated its 33rd birthday with its annual meeting held at the Charleston Place Hotel in Charleston, South Carolina. As usual, the meeting was well attended by senior management from the ISO Community, OEMs and Sellers/Servicers from across the country. IAMERS President Diana Upton gave special recognition in her welcoming remarks to the several founding IAMERS members who were present and have attended each and every meeting for thirty three years. “We are indebted to them for their considerable efforts to advance the industry and for their continued focus on patient safety.”

The Annual Meeting included a keynote presentation from U.S. Nuclear Regulatory Commissioner David Wright, a cancer survivor who offered heartfelt remarks about the importance of the work that IAMERS members (and others that service medical equipment) undertake. Commissioner Wright also shared that his daughter was also a cancer survivor, both of whom know firsthand about the benefits of diagnostic imaging.
U.S. FDA Compliance Analyst Katelyn Bittleman provided an informative update on FDA matters. As Katelyn had in the past, she also took time to explain important concepts such as manufacturer recalls and FDA’s role in monitoring the recalls. Katelyn also fielded questions on the Remanufacturing Guidance and updated members as to QMSR, which has now replaced the longstanding GMP regulation and brought the agency more in line with the internationally recognized standard found in ISO 13485. As Medinnova CEO Hiren Desai observed: “Katelyn explained some pretty complicated regulatory concepts in a way that was straightforward and easier to understand. We appreciate that she took the time from her busy schedule."

Speaking of complicated subjects... Scott Trevino, Trimedx Senior Vice President of Cybersecurity, skillfully tackled in overview ‘Artificial Intelligence in Medicine’. Scott traced the adoption of AI, particularly as to imaging and radiology and offered some thoughts as to the use of data and models to forecast and healthcare decisions. Scott also offered some aspirational ideas about further adoption in the healthcare ecosystem including with respect to remote patching in light of the widely acknowledged device vulnerabilities. While he predicted enhanced BMET productivity and expected further integration of AI into CE workflows, he also acknowledged the bad actors who are also using AI. We would do well to follow Scott’s cautions to learn best practices and stay up to date with the quickly changing technology landscape.

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