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 short-term solution, and then wait for the manufacturer’s response describing the action needed to actually correct the problem.
The response time from manufacturers in providing guidance to correct the problem can vary from weeks to months. Such lengthy response times do not seem to match up with the level of urgency stated in the original notification. Even though we have taken a temporary action (education to raise awareness of the problem, in most cases), this temporary action is not strong enough to sustain us for weeks or months.
Manufacturers need to work on improving their response times in correcting problems. After they correct the problem, they should send the completion report to us for documentation, with proper reference to the recall/safety correction/advisory addressed.
What bothers me considerably is that sometimes, we see that we have more than one recall on the same model and make of the device, but we continue using the device for which a planned corrective action is forthcoming. When a medical device has yet-to-be-revealed deficiencies, how safe can it be to continue using?
In recent years, we see more software-related recalls and safety advisories that are mostly “invisible” deficiencies of the device and that the manufacturer will correct with a software upgrade. Some are corrected remotely, while others require intervention by the on-site field service technician. How well are these recalls managed by manufacturers and communicated to us?
I encourage the HTM community to share their thoughts on this topic in the comments section below.
Avinash Konkani, PhD, AHFP, is senior clinical engineer at the University of Virginia Health System in Charlottesville, VA, and a member of the BI&T Editorial Board.