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The Ropes of Regulation are Tightening

As it has been said, beware of the “Ides of March”, in 2017 those “Ides” may have skipped to the month of April as U.S Representative Ryan Costello (R-PA) introduced H.R. 2188 Medical Device Servicing Safety and Accountability Act to the 115th Congress. This formally proposed legislation sets the stage for a new era of regulation that will impact Independent Service Organizations (ISOs) and Original Equipment Manufacturers (OEMs) alike. The “Ides” of April 2017 could parallel those of the old Roman calendar in which it marked the transition from one historical period to another – this new era of ISO regulation and its subsequent impact in relationship with OEMs is now upon the health care industry.

This proposed legislation should not be a surprise to anyone in the medical imaging service industry considering that during the previous 20 months or so the ground work has been laid through stated positions from the Centers for Medicare and Medicaid (CMS) regarding imaging equipment service compliancy with OEM standards for ionizing radiation and ultrasonic equipment as well as a flurry of several “town hall” meeting activities led by the U.S. Food and Drug Administration (FDA).

Right, wrong or in-different the era of what the proposed Medical Device Servicing Safety and Accountability Act will bring in change undoubtedly will shape a new ISO and OEM landscape serving the medical imaging community. The ISOs that have already begun the steps in preparation to thrive in this new era of regulation are smart. Those that choose to ignore the impending changes will find it difficult to exist and most will fade away. The business benefits for the prepared ISOs will be many. Supporting resources will become more abundant and, yes, one of the most significant breakthroughs finally will bring true ISO service provider market accessibility to all required OEM service documentation, passwords and service keys that ISO service vendors have struggled to obtain through the current “weak” pathway of 21CFR. Who will the winners be in this new era of imaging equipment regulation? The answer is a simple one – the valued patients that both the ISOs and OEMs ultimately serve through their skilled efforts in maintaining medical imaging equipment!


Alan has been in the Clinical Engineering industry for 29+ years having served directly in the academic, governmental and community hospital settings. Alan’s career has spanned from imaging/ biomedical engineer to Director of Clinical Engineering. Alan currently serves today at the Vice President and Senior Advisor level with a leading medical equipment consultative and asset management firm.



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