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PurposeThis paper aims to present a systematic literature review (SLR) to investigate how supply chain risk management (SCRM) is applied to the healthcare supply chains and which improvement opportunities are being missed in this segment.Design/methodology/approachThis SLR used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method to answer three research questions: (1) Which are the main gaps concerning healthcare supply chain risk management (HCSCRM)? (2) What is the definition of HCSCRM? and (3) What are the risk management techniques and approaches used in healthcare supply chains?FindingsThe authors present a complete summary of the HCSCRM body of research, investigating research strings like clinical engineering and high reliability organizations (HROs) and its relations with HCSCRM; (1) This research revealed the five pillars of HCSCRM; (2) The authors proposed a formal definition for HCSCRM considering all the literature blocks explored and (3) The authors generated a list of risks present in healthcare supply chains resulting from extensive article research.Research limitations/implicationsThe authors only reviewed international journal articles (published in the English language), excluding conference papers, dissertations and theses, textbooks, book chapters, unpublished articles and notes. In addition, the study did not thoroughly investigate specific countries' particularities concerning how the healthcare providers are organized.Originality/valueThe contribution of this article is threefold: (1) To the best of authors knowledge, there is no other SLR about HCSCRM published in the scientific literature by the time of realization of authors’ work, suggesting that is the first effort to fulfill this research gap; (2) Following the previous contribution, in this work the authors propose a first formal definition for HCSCRM and (3) The authors analyzed concepts such as clinical engineering and HROs to establish the building blocks of HCSCRM.
PurposeThis paper aims to present a systematic literature review (SLR) to investigate how supply chain risk management (SCRM) is applied to the healthcare supply chains and which improvement opportunities are being missed in this segment.Design/methodology/approachThis SLR used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method to answer three research questions: (1) Which are the main gaps concerning healthcare supply chain risk management (HCSCRM)? (2) What is the definition of HCSCRM? and (3) What are the risk management techniques and approaches used in healthcare supply chains?FindingsThe authors present a complete summary of the HCSCRM body of research, investigating research strings like clinical engineering and high reliability organizations (HROs) and its relations with HCSCRM; (1) This research revealed the five pillars of HCSCRM; (2) The authors proposed a formal definition for HCSCRM considering all the literature blocks explored and (3) The authors generated a list of risks present in healthcare supply chains resulting from extensive article research.Research limitations/implicationsThe authors only reviewed international journal articles (published in the English language), excluding conference papers, dissertations and theses, textbooks, book chapters, unpublished articles and notes. In addition, the study did not thoroughly investigate specific countries' particularities concerning how the healthcare providers are organized.Originality/valueThe contribution of this article is threefold: (1) To the best of authors knowledge, there is no other SLR about HCSCRM published in the scientific literature by the time of realization of authors’ work, suggesting that is the first effort to fulfill this research gap; (2) Following the previous contribution, in this work the authors propose a first formal definition for HCSCRM and (3) The authors analyzed concepts such as clinical engineering and HROs to establish the building blocks of HCSCRM.
Background: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. Methods: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. Results: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. Conclusion: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007–17).
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