The European Union has instituted a proposal to boost cooperation among EU member states for assessing healthcare technologies. After all, EU officials say, more assessments could lead to effective, innovative health tools reaching patients faster.
Read MoreKenneth Monroe, PE, MBA, CHC, PMP, has been appointed to the position of senior associate director in the Standards Interpretation Group’s (SIG) department of engineering at The Joint Commission. Monroe succeeds George Mills, who previously held the position.
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The U.S. FDA and the Department of Defense’s (DoD) Office of Health Affairs announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
Read MoreThe Joint Commission announces the appointment of Edward Pollak, MD, as medical director and patient safety officer, Division of Healthcare Improvement, and Andrew C. Bland, MD, MBA, FAAP, FACP, as medical director, Division of Healthcare Quality Evaluation. Both appointments were effective January 2.
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One of the questions the U.S. FDA asked in its 2016 Request for Comments was: “What information do third-party entities need in order to perform…the safe and effective operation of medical devices?” Not surprisingly, both manufacturers and third-parties organizations cited service manuals—although some manufacturers seem reluctant to release such information. Here, Binseng Wang spells out the reasons some OEMs are giving to defend their actions.
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