If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
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Protecting healthcare systems against cyber threats requires intensive training and education throughout the workforce. Scott Trevino, senior vice president of product management and solutions at TRIMEDX, discusses the steps the clinical asset management company is taking to prepare their associates for the future.
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GE Healthcare has recalled its Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system, which may cause the mechanical ventilation to stop working.
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Stryker is notifying a population of LifePak 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.
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In the works, if certain challenges can be overcome, is a “collaborative community” of medical device servicers. 24×7 Magazine correspondent Chris Hayhurst explores the initiative in this in-depth feature article.
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