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Home Medical Device Safety Tops ECRI's List of Healthcare Technology Hazards

Analysis  |  By Eric Wicklund  
   January 19, 2023

Recalls of home-based medical devices and defective single-use devices are the top two concerns on the Pennsylvania-based non-profit's top 10 technology hazards for 2023.

The growing popularity of smart home technology and home-based healthcare, including remote patient monitoring programs, means there are more medical devices in the home to oversee, either by the care team or the patent. That could lead to problems if the devices aren't working.

The challenge of identifying recalls for at-home medical devices tops the Top 10 Technology Hazards for 2023, an annual report issued by ECRI, a Pennsylvania-based non-profit focused on safety, quality, and cost-effectiveness in healthcare. Now in its 16th year, the report highlights the problems associated with healthcare technology, and spots trends in care delivery that might be catching both providers and patients by surprise.

With at-home medical devices, ECRI notes that patients using those devices at home might be the last to hear of a recall, and they might not understand what the recall means or how the address one.

"Device manufacturers seldom have direct communication with home care patients; and healthcare providers may not proactively contact patients about recalls," the report notes. "As a result, patients who use medical devices in the home may learn about a recall—and the steps needed to ensure safe use of the device—long after it was issued, and potentially from an unreliable source, such as a television commercial for a class-action lawsuit or through social media."

In addition, the recall notice might be filled with technical language that patients wouldn't understand clearly. They might not understand the risks involved with the device and continue using it.

"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 ensuring that recalls reach home users," the report says.

Coming in second on the list is another growing trend in healthcare: The growing number of single-use medical devices, designed to be used once and then discarded. ECRI reports an "unacceptably high number of defective single-use medical devices," which can negatively impact patient care, lead to delays in care or treatment, and even harm patients.

"ECRI has received reports of cracked tubing and connectors; compromised sterility of needles, catheters, and procedure kits; and incorrect product labeling," the report notes. "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 device manufacturers are not making sufficient efforts to address the problem," it continues. "In fact, rather than seeing improvements over time, we’ve noticed a continuing 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:

  • Inappropriate use of automated dispensing cabinet overrides.
  • Undetected venous needle dislodgement.
  • Failure to manage cybersecurity risks associated with cloud-based clinical systems.
  • Inflatable pressure infusers.
  • Confusion surrounding 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 maintain operations during the height of the COVID-19 crisis, and most are still dealing with stress, burnout, and staffing issues. In this environment, healthcare providers are more likely to consider work-arounds or bypassing established procedures to get something done, which could lead to unsafe or dangerous practices. It's inherent on management at this time to emphasize the importance of safety protocols.

At the same time, the report calls on the medical device industry to be more diligent.

"This year we’re extending a challenge to our industry colleagues," it notes. "We believe some of the hazards outlined in this report could be mitigated—and possibly even eliminated—by improved device designs or manufacturing practices. As a rule, an engineering solution that eliminates a hazard will always be preferable to a training solution that can only warn of a hazard. With the COVID-19 pandemic leaving healthcare facilities understaffed and healthcare workers overstressed, it’s more important than ever that medical technologies be designed in ways that help ensure their safe use."

ECRI also noted the trends it has spotted over the years in its reports that have led to industry-wide improvements. In the 1970s, it helped spur improvements to manual resuscitators to prevent inadequate lung inflation, and the 1980s saw a move to safer electrode connections for patient monitoring equipment to prevent electrocution.

In the 1990s, the reports pushed the industry to improve on bed safety to prevent entrapment and strangulations, as well as adding free-flow prevention mechanisms infusion pumps to prevent overmedication. And since 2000, the organization has prodded the industry to improve integration of drug libraries and infusion pumps to prevent drug dosing errors; improve CT scanner dose-control technologies to reduce radiation exposure; and improve endoscope reprocessing procedures and technologies to prevent cross-contamination.  

Eric Wicklund is the Innovation and Technology Editor for HealthLeaders.


KEY TAKEAWAYS

For 16 years, ECRI has listed the top 10 technology hazards in the healthcare space, highlighting issues that can affect care delivery and even harm patients.

This year's list highlights the growth of home-based and patient-centered healthcare, with recalls of home-based devices and a large number of defective single-use products coming in first and second.

The organization is urging healthcare organizations to be diligent in emphasizing safety protocols and asking the medical device to do a better job with device manufacture and safety requirements.


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