Communication gaps with recalls of home-use medical devices tops the list of healthcare hazards in 2023, according to the latest report from ECRI, the nation’s largest non-profit patient safety organization. Other hazards that made ECRI’s top 10 list of healthcare hazards in 2023 include: failure to manage cybersecurity risks in cloud-based clinical systems, defective single-use medical devices, and inappropriate use of automated dispensing cabinet overrides.
Home healthcare is a growing trend and the experts at ECRI are concerned that patients are not receiving safety notices, warnings, and recalls for the devices they are using. Since devices are sold and distributed to patients through intermediaries (like hospitals, pharmacies, retailers, payers, employers, etc.), device manufacturers do not have direct lines of communications with their end-users. Unlike cars, there is no central database that ties the current owner with a specific vehicle. As a result, patients may not learn of safety issues or recalls until months later.
In addition, the language of the notifications can be confusing. One example, cited by ECRI, was the recall of continuous positive airway pressure (CPAP) devices. The recall was initiated in June 2021 and affected 5.5 million devices. It took months for some patients to become aware of the recall and the notice was unclear whether it was safe for patients to continue using the device or what actions they needed to take.
In a press release, Marcus Schabacker, MD, PhD, president and CEO of ECRI had this to say about the communication gap: “Even if patients do receive notifications, 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. Without clear, understandable information about a product recall, patients cannot accurately assess the health risks and may harm themselves by continuing to use an unsafe device, or by inappropriately stopping use of a device.”
Top 10 Hazards
For 16 years, ECRI has published its annual report that identifies health technology concerns that warrant attention by patients, healthcare leaders, and the industry as a whole. ECRI’s team of biomedical engineers, clinicians, and healthcare management experts follows a rigorous review process to select topics for the annual list, drawing insight from incident investigations, reporting databases, and independent medical device testing.
According to ECRI, the top 10 healthcare hazards for 2023 are:
- Gaps in Recalls for At-Home Medical Devices cause patient confusion and harm
- 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
An executive brief version is available for complimentary download at www.ecri.org/2023hazards.
