Recalls of home medical equipment and defective single-use devices are two of the most worrisome issues on the Pennsylvania nonprofit’s top 10 technology hazards for 2023.
The growing popularity of smart home technology and home healthcare, including remote patient monitoring programs, means more medical devices in the home need to be overseen by a care team or patentee. This can cause problems if the device is not working.
The annual report published by ECRI states that the challenge of identifying home medical device recalls tops the top ten technological hazards for 2023. ECRI is a Pennsylvania-based nonprofit organization focused on safety, quality and cost-effectiveness in healthcare. now at its 16day This year, the report highlights issues related to healthcare technology and identifies care delivery trends that may surprise both providers and patients.
For home medical devices, ECRI noted that patients who use the devices at home may be the last to hear about the recall and may not understand what the recall is or how it is being recalled.
“Device manufacturers rarely communicate directly with home care patients; healthcare providers may not reach out to patients about recalls,” the report states. “As a result, patients with medical devices at home may learn about recalls and the steps needed to ensure safe use of the devices long after the devices are released, and may come from unreliable sources such as television ad class actions or via social media .”
Additionally, recall notices can be filled with technical language that patients cannot understand. They may not understand the risks involved with the device and continue to use it.
“ECRI requires manufacturers of medical devices intended for use outside of a hospital setting to take steps such as: providing users with easy-to-follow device registration instructions, writing simply worded recall notices, maintaining an up-to-date device distribution database, and designating staff Make sure the recall reaches home users,” the report said.
In second place is another growing trend in healthcare: the increasing number of single-use medical devices, which are designed to be used once and then discarded. ECRI reports “an unacceptably high number of defective single-use medical devices” that can negatively impact patient care, cause delays in care or treatment, and even harm patients.
“ECRI has received reports of ruptured tubing and connectors; compromised sterility of needles, catheters, and surgical kits; and incorrect product labeling,” the report states. “These are just a few examples of product defects that can lead to waste, delays, incorrect treatment, healthcare-acquired infections, or other patient harm.”
“ECRI is concerned that some equipment manufacturers are not doing enough to address this issue,” it continued. “In fact, instead of seeing an improvement over time, we have noticed a continued increase in problem reports. ECRI urges manufacturers to take decisive steps to improve their quality control (QC) processes.”
The rest of the list is as follows:
- Improper use of automated dispensing cabinet overrides.
- No dislocation of the venous needle was detected.
- Failure to manage cybersecurity risks associated with cloud-based clinical systems.
- Inflatable pressure infusion set.
- Confusing ventilator cleaning and disinfection requirements.
- Common misconceptions about electrosurgery.
- Overuse of cardiac telemetry.
- Underreporting device-related issues.
Many of the items on this list were caused or exacerbated by the pandemic. Healthcare organizations struggled to stay afloat at the height of the COVID-19 crisis, and most were still dealing with stress, burnout, and staffing issues. In this environment, healthcare providers are more likely to consider workarounds or bypass established procedures to get a job done, which can lead to unsafe or dangerous practices. Emphasizing the importance of security protocols at this point is inherent in management.
At the same time, the report calls on the medical device industry to be more diligent.
“This year we challenged our industry colleagues,” it noted. “We believe that some of the hazards outlined in this report could be mitigated—and possibly eliminated—through improved equipment design or manufacturing practices. Often, an engineering solution that eliminates a hazard is always better than merely warning of a hazard. With the COVID-19 pandemic Leading to understaffed and overstressed healthcare providers, it is more important than ever to design medical technology in a way that helps ensure its safe use.”
ECRI also points to trends identified in its reports over the years that have led to improvements across the industry. In the 1970s, it helped drive improvements in manual resuscitators to prevent underinflation of the lungs, and in the 1980s there was a shift to safer electrode connections for patient monitoring equipment to prevent electrocution.
In the 1990s, these reports pushed the industry to increase bed safety to prevent entrapment and strangulation, and to add free-flow prevention mechanisms to infusion pumps to prevent overdose. Since 2000, the organization has urged the industry to improve the integration of drug banks and infusion pumps to prevent drug dosing errors; improve CT scanner dose control techniques to reduce radiation exposure; improve endoscope reprocessing procedures and techniques to prevent crossover pollute.
Eric Wicklund is Innovation and Technology Editor at HealthLeaders.
