- The failure to quickly and clearly communicate information about recall notices to patients with home-use medical devices is the top health technology hazard of 2023, according to nonprofit safety body ECRI.
- Citing Philips’ recall of millions of respiratory devices as an example of the problem, ECRI said it takes months for news of safety problems to reach some patients, and when it does the language used can leave them confused about what actions they need to take.
- ECRI is challenging manufacturers to provide easy-to-follow device registration instructions, write simply worded recall notices and maintain up-to-date databases of device distribution.
Philips’ recall of 5.5 million continuous positive airway pressure devices and other respiratory machines in 2021 represented a large undertaking.
The company needed to reach individual users of its devices and communicate what would happen next. ECRI, an independent organization that works to improve the safety, quality, and cost-effectiveness of healthcare and formerly known as the Emergency Care Research Institute, was critical of Philips, claiming “several months elapsed before some patients became aware of the recall” and people were confused about the next steps.
In ECRI’s view, the problems stem from the fact that device manufacturers rarely have direct communication with home-care patients and healthcare providers may fail to proactively contact their patients about recalls.
“The language may be jargon-heavy and perplexing, and patients may have difficulty determining whether their device is affected or what to do about it, ECRI CEO Marcus Schabacker said in the report. Without clear, understandable information about a product recall, patients can’t accurately assess the health risks and may harm themselves by continuing to use an unsafe device, or by inappropriately stopping use of a device.”
In an emailed comment, a Philips spokesman wrote the company “regrets the concern and uncertainty our field action has caused,” referring to the recall. Philips noted that by the end of last year, it had completed “almost 90%” of the replacement devices and repair kits needed for the remediation program.
As well as challenging manufacturers of home-use devices to do better, ECRI shared details of nine other health hazards for 2023. They are:
- The growing number of defective single-use medical devices puts patients at risk
- Inappropriate use of automated dispensing cabinet overrides can result in medication errors
- Undetected venous needle dislodgement or access-bloodline separation during hemodialysis can lead to death
- Failure to manage cybersecurity risks associated with cloud-based clinical systems can result in care disruptions
- Inflatable pressure infusers can deliver fatal air emboli from iv solution bags
- Confusion surrounding ventilator cleaning and disinfection requirements can lead to cross-contamination
- Common misconceptions about electrosurgery can lead to serious burns
- Overuse of cardiac telemetry can lead to clinician cognitive overload and missed critical events
- Underreporting device-related issues may risk recurrence