AAMIBlog

This year, I had the opportunity to attend a conference and take part in panel discussions with the main topic of “the customer comes first.” A number of the questions posed to the panel centered on what service organizations could provide to their customers. This is not a new subject—this has been an area of […]

The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each recall notice. There are six different entries on the menu that use the word software. These are (in the order […]

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, customer advisory) from manufacturers are categorized as “urgent.” We follow up with internal customers about these notifications, undergo the required […]

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, and renewed interest in making data-based decisions. The discussion can get particularly heated when we talk about third-party service providers […]

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 of data from one medical device to another or perhaps from one or more medical devices to a separate processing […]

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 this challenge. A group of us at AAMI and beyond are working on attaining a National Science Foundation planning grant […]

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 Device Reporting (MDR) requirements. The legislation excels in brevity and simplicity by amending the term “covered device user facility” in […]

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 leverage 802.1X is to use digital certificates. Why would we do this? Because we can prepare your equipment for authentication […]

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 manufacturers to get hospital-based and non–manufacturer-based service organizations to follow some of the quality systems requirements that manufacturers currently follow. […]

The latest addition to the long-running battle over adequate access to service manuals for medical devices is The Joint Commission’s (TJC) announcement, via George Mills, at the recent AAMI Annual Conference that starting in January there will be a new element of performance, EC.01.01.01, EP 3, which states: “The organization has a library of information […]