As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, […]
This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, […]
Last month, the FDA issued its guidance document Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices and a commentary by Bakul Patel. The essence of the form of interoperability addressed is the transfer […]
A common theme for many years and escalating now is the need for qualified healthcare technology management (HTM) technicians. We have heard you and are working diligently to effectively look “outside the box” to address […]
In April, Rep. Brian Fitzpatrick (R-PA) introduced HR 2163, the Medical Device Guardians Act. This act proposes to add physicians and physician offices to those that must report medical devices misadventures under the FDA’s Medical […]
Hey, biomed! Thanks for waiting for me after the change control board meeting IT just had. I wanted to follow up on our discussion of supplicants for medical device cybersecurity because the best way to […]
Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be. The first one involves a push by medical device […]
