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A Medical Device Collective Risk Management Model for Health Care Organizations and Postmarket Oversight

Wang, Binseng ScD, CCE

doi: 10.1097/JCE.0000000000000193

Healthcare organizations (HCOs), accreditation organizations (AOs), and national competent authorities (NCAs) have been using risk classification for many years to design and implement management strategies for devices within their inventory or jurisdiction. The initial risk models were focused on severity of harm with little consideration for the probability of failure. The International Organization for Standardization (ISO) standard 14971 gave equal attention to probability and severity and has been effective for manufacturers (original equipment manufacturers [OEMs]) to manage risks associated with the devices they produce and market. However, because of the different scopes from those applicable to OEMs, HCOs, AOs, and NCAs cannot use ISO 14971 without significant adaptations. Furthermore, these organizations also need to use actual postmarket device failure rates and causes collected from their inventory or domain instead of premarket estimates made by OEMs to make their risk assessment pertinent to their reality. To assist HCOs, AOs, and NCAs, a collective risk management model is proposed in this article. First, severity is expanded from individual degree of hazard by combining it with the number of patients potentially affected. Next, the Swiss-cheese model proposed by Reason is used to break up the probability of harm as a combination of probabilities resulting from the postmarket activities of distinct stakeholders (patients, users, healthcare institutions, companies, etc). Finally, failures caused by individuals are segregated from “latent conditions” created by organizational failures. Applying this new model to 24 common device categories found in HCOs shows significantly different results from those obtained from the risk classification methods currently used, as well as from ISO 14971. Thus, it is believed that this collective risk model will allow HCOs, AOs, and NCAs to better determine where they should focus their limited resources to achieve the highest possible degree of safety and best care for their patients.

Corresponding author: Binseng Wang, ScD, CCE, WRP32 Management, Inc, 79 Primrose St, White Plains, NY 10606. He can be reached at

Binseng Wang is director of Quality and Regulatory Affairs with WRP32 Management, Inc. He began his career in Brazil, working in academia, hospitals, and a large public health system. In the United States, he was a visiting scientist at the National Institutes of Health and served as vice president at MEDIQ/PRN, Aramark Healthcare Technologies, and Sundance Enterprises Inc. He earned a doctorate from Massachusetts Institute of Technology and certifications as CCE and ISO 9001 auditor. He has been elected fellow by the American College of Clinical Engineering (ACCE) and American Institute of Medical and Biological Engineering, as well as bestowed the ACCE Lifetime Achievement Award. He has also consulted for numerous foreign countries and international organizations.

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