Against the FDA report's recommendations, the editorial calls on Congress to pass the very controversial Medical Device Servicing Safety and Accountability Act (H.R. 2118). This act would create regulations that would, by design, burden third-party servicers with paperwork and costs without producing any commensurate safety benefit, not to mention duplicating an adverse reporting system already in place. The only real beneficiaries of the act are MITA's members, who stand to gain an additional share of the medical device service market when burdensome regulations force third-party servicers to raise costs.

ACCE supports the FDA report's findings and recommendations because they are based on evidence and not innuendo. We do recognize the growing, critical role that increasingly sophisticated medical technologies play in healthcare. We agree with the FDA report that all elements of the industry involved in the use and technical support of medical devices should look to adopt quality management systems. We also support the FDA's recommendation for the formation of collaborative communities made up of representatives from device manufacturers, users, patients, healthcare professionals, and regulators that would work together to identify challenges and develop solutions. We believe solutions to the healthcare technology challenges of today and tomorrow are more likely to be successfully addressed through the efforts of a collaborative community than through lobbying for burdensome regulation that benefits one segment of industry without improving public safety.


ACCE invites MITA to join us, the FDA and other key industry stakeholders in a collaborative community that will work together to address real challenges.

About the author: Arif Subhan is the president of the American College of Clinical Engineering.

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