AAMI recently appointed Scott Trevino, vice president of quality assurance/regulatory affairs and medical technology at TriMedx, to co-chair a committee formed to update the American National Standard on ANSI/AAMI EQ56:2013: recommended practice for medical equipment management program. Clinical engineering teams around the globe use this standard to help guide them in how they run their medical equipment management programs.
Moreover, the standard provides recommended practices to minimize certain risks associated with equipment that is used during the routine care of patients in a healthcare organization. It also addresses the structure of the program, documentation requirements, staffing, and resources allocated to those responsible for maintaining medical equipment.
Trevino will lead the committee as they convene and collaborate to revise this standard to include quality management principles and systems, aligned with a recent FDA recommendation. The revised standard will also address six critical gaps that were identified by the EQ Committee including the management of quality, service levels, capacity, information security, service continuity, and availability. It is expected to be released in the next year.
In representing TriMedx in the Alliance for Quality Medical Device Servicing, Trevino provides a voice for TriMedx healthcare clients and the industry as a whole. The Alliance is comprised of TriMedx, Sodexo, Crothall, ABM, and The InterMed Group—all third-party medical device service providers.
Trevino was recently invited to speak on a panel at the AAMI/BSI/FDA International Conference on Medical Device Standards and Regulations, held April 24-25, in Reston, Va. During the panel discussion, “Challenges—Servicing versus Remanufacturing—Common Standards for Post-Market Servicing, Repair, and Refurbishment,” Trevino spoke to developments in standards and regulations in the healthcare technology service space.