New Risks, Many of the Same Considerations for Medical Equipment Recalls

Chris Clemenson

For the first time last fall, the FDA recalled a medical device because it was found to be vulnerable to cyber threats. While there weren’t any known reports of patient harm – this represented a new day in the management of medical equipment.

Hospital systems can have hundreds of thousands of medical devices across their facilities. Whether a cyber threat or another deficiency in the device, it begs the question – how are these devices being quickly removed from service to protect the safety of patients and staff?

Working with healthcare organizations across the country, we’ve seen clinical engineering departments bogged down with countless safety alerts each week and the heavy groundwork that is needed to identify, locate, repair, remove and replace equipment before health or safety risks are imposed on patients and staff.

From these experiences, we’ve created a brief checklist to help support teams in medical equipment recall management processes:

1. Receive All Recall Notifications

Make sure to subscribe to multiple sources of product recall notifications (FDA, ECRI Institute, manufacturers, distributors, rental companies).

2. Verify the Existence of Recalled Equipment

Generate a list of affected assets in your CMMS system and distribute to affected departments.

3. Locate and Remove Recalled Equipment

This is often the most difficult step. While hospitals have recall management systems in place to comply with Joint Commission standards, taking the step of quickly locating and removing the affected equipment can be a heavy task. Utilizing RTLS location-sensing hardware and InSites Asset Management software, our customers have dramatically cut the amount of time it takes to locate and retrieve affected equipment. It’s incredible to see their reaction when they can easily locate this equipment with a simple click of a button.

We conducted many mock recalls so the staff could demonstrate their abilities. We were able to trace to the granularity of specific manufacturer lot numbers. Finding the exact items went from being nearly impossible to locating these items in seconds with RTLS.”
Network Chief Logistics Officer, VA Medical Centers

4. Safeguard Quarantined Equipment

Store all quarantined equipment in a designated and clearly marked area until it’s addressed according to the recall notice.

5. Evaluate the Recall Management Process

Assess any challenges encountered during the recall process and document ways to improve. How long did it take to complete all equipment recall tasks required for closure? Evaluate, document, share, and train.

Has your organization changed how you manage the recalled equipment process given the potential of new cyber threats?

Cheers,

Chris

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