The U.S. FDA announces that it has taken new steps to handle how voluntary recalls are managed across many industries, including the medical device sector. In the FDA’s new draft guidance, the agency makes recommendations for recalls in three key areas: training, record-keeping, and procedures.
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With 10,000 baby boomers reaching retirement age every day and an increasing demographic shift from mechanical and hands-on professions, many healthcare organizations are finding it increasingly difficult to staff their biomed departments. Here, three HTM leaders share how they’re helping to find the next generation of talent.
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Despite the number of accolades following his name, Binseng Wang, ScD, CCE, fAIMBE, fACCE, doesn’t consider himself an industry hero. In fact, he’s downright uncomfortable with the thought. But when you get to know a little about Wang, you realize why he deserves the title he is so quick to shy away from.
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According to FDA officials, the agency will be more closely evaluating the potential for certain materials to cause immune/inflammatory reactions in a small number of patients to improve understanding of materials, help uncover ways to identify patients predisposed to these reactions, and improve the overall safety and performance of medical devices.
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How do you measure the expected life of a medical device? Even if the device is working properly—in addition to being well maintained and inspected, an adverse event following its so-called “expiration date” can raise both usability and liability challenges. HTM expert William Hyman explores the issue here.
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