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January 15, 2021 HURON, SD – Huron Regional Medical Center (HRMC) honored employees for 740 years of combined service in addition to two employees for exceptional customer service skills at the hospital’s Employee Awards Presentation on Friday, January 8, 2021, at the Legacy Plaza Auditorium. During the event, which was hosted at the hospital and online to accommodate social distancing, 38 employees from 19 departments were recognized for sharing their hearts and years of service, ranging from 5 to 40 years, with hospital patients. Employees in attendance enjoyed a meal while reflecting on 2020 and celebrating the care provided by all in attendance. In addition to the service awards, HRMC recognized two employees with special awards. Tom Miner, who has worked as a certified physician assistant (PA-C) in HRMC’s emergency room for more than four years, was selected by the HRMC board of directors to be the 2020 Exceptional Employee of the Year from the 12 monthl ....
. Successful implementation of an effective EU MDR-compliant PMS requires a systems approach which requires appreciation of not only the organizational context within which PMS operates but also the knowledge management as it relates to PMS generated data, information, knowledge, and wisdom. . It not only explores the interfaces between risk management and PMS but also discusses the postmarket aspects of risk surveillance and their accomplishments. Part 4 details an important upcoming topic with relevance going beyond EU MDR. Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. The regulation asks for a methodology to gauge “statistically significant increases” in a certain subset of postmarket incidents. This article details salient features of any such method such that any chosen tool can act as a postmarket ri ....
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management By Jayet Moon, author of the book As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1 . “Investigations” are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. With clarity on this most fundamental unit of PMS, ....