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Applying a quality management system (QMS) to existing policies and procedures in healthcare technology management (HTM) departments can better satisfy the needs and expectations of healthcare providers and improve patient care. This article will explain why adopting QMS principles is important and describe how HTM departments can apply QMS principles to a medical equipment management program (MEMP) using a three-step approach. The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. Manufacturers of medical devices distributed in the United States must comply with the Quality System Regulation (QSR; 21 CFR Part 820). The QSR includes requirements related to the methods used in healthcare facilities, as well as the controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices. In the same manner that the FDA regulates the manufacturers/remanufacturers and distributors of medical devices, federal agencies (e.g., Centers for Medicare & Medicaid Services [CMS]) and state health departments require healthcare organizations to manage medical equipment risks. In addition, accreditation agencies (e.g., The Joint Commission [TJC], DNV GL, Healthcare Facilities Accreditation Program [HFAP]) ensure that healthcare organizations comply with those requirements/ standards. Original equipment manufacturers (OEMs) often blame HTM departments if equipment fails or is involved in a patient incident when it is not maintained by the OEM, despite HTM departments complying with various regulations. In March 2016, the FDA announced that a docket would be established "to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices." Various stakeholders engaged in one or more of these activities have responded to the docket, and based on the comments, the FDA held a two-day public workshop in October 2016. In May 2018, the agency issued a report on the quality, safety, and effectiveness of medical devices with respect to servicing. The report also promotes the adoption of quality management principles by medical device servicers as part of their ongoing activities. The adoption of a QMS is a strategic decision for an organization to improve its overall performance. The potential benefits to an organization of implementing a QMS include: • Organizational credibility. • Development of a common, understood system with consistent and repeatable processes. • Process integration through gained efficiencies by eliminating waste. • Clarity about what to do and how. • Better management control and reporting. • Improved customer satisfaction. • Increased employee satisfaction. Bhaskar Iduri, MS, CCE, CHTM,

Commentary : Applying QMS Principles to a Medical Equipment Management Program