ECRI Highlights Communication Gaps in Medical Device Recalls

In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to patient safety. This commentary was a part of the organization’s Top 10 Health Technology Hazards report.

According to the ECRI, recalls on home-use products often go unnoticed, as many users are unaware that the recall even happened. While the FDA and manufacturers typically distribute a statement when a recall is made, reaching consumers is another story. Often, patients are not monitoring the FDA and other regulatory websites. Instead, they rely on pharmacists and other providers to notify them of a recall.

Even in cases where patients are notified of the recall, there is often confusion around the reason or extent of the recall. Many manufacturers and organizations use jargon that is easily understood by medical professionals but inaccessible to the public. Recalls usually include long lists of device types, names, and lot numbers, confusing patients as they attempt to determine whether their device is affected.

As a result, many patients may mistakenly continue to use a faulty medical device, increasing their risk. Conversely, a lack of understanding of recall classes may result in the cessation of device use in cases where it is still necessary. These challenges show that there needs to be additional thought put into recall notices, catering to all patients in addition to providers and medical professionals.

In its report, the ECRI states, “ECRI challenges manufacturers of medical devices that can be used outside the hospital environment to implement measures such as providing users with easy-to-follow device registration instructions, writing simply worded recall notices, maintaining up-to-date databases of device distribution, and designating staff to ensure that recalls reach home users.”

Additional items on the hazard list include the following:

• an increase in defective single-use medical devices
• automated dispensing cabinet overrides
• undetected venous needle dislodgement
• poorly managed cybersecurity risks associated with Cloud-based clinical systems
• inflatable pressure infusers
• inadequate ventilator cleaning and disinfection
• misconceptions about electrosurgery
• cardiac telemetry overuse
• under-reported medical device issues