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

Recalls of home-based aesculapian devices and defective single-use devices are the apical 2 concerns connected the Pennsylvania-based non-profit's apical 10 exertion hazards for 2023.

The increasing popularity of astute location exertion and home-based healthcare, including distant diligent monitoring programs, means determination are much aesculapian devices successful the location to oversee, either by the attraction squad oregon the patent. That could pb to problems if the devices aren't working.

The situation of identifying recalls for at-home aesculapian devices tops the Top 10 Technology Hazards for 2023, an yearly study issued by ECRI, a Pennsylvania-based non-profit focused connected safety, quality, and cost-effectiveness successful healthcare. Now successful its 16^th year, the study highlights the problems associated with healthcare technology, and spots trends successful attraction transportation that mightiness beryllium catching some providers and patients by surprise.

With at-home aesculapian devices, ECRI notes that patients utilizing those devices astatine location mightiness beryllium the past to perceive of a recall, and they mightiness not recognize what the callback means oregon however the code one.

"Device manufacturers seldom person nonstop connection with location attraction patients; and healthcare providers whitethorn not proactively interaction patients astir recalls," the study notes. "As a result, patients who usage aesculapian devices successful the location whitethorn larn astir a recall—and the steps needed to guarantee harmless usage of the device—long aft it was issued, and perchance from an unreliable source, specified arsenic a tv commercialized for a class-action suit oregon done societal media."

In addition, the callback announcement mightiness beryllium filled with method connection that patients wouldn't recognize clearly. They mightiness not recognize the risks progressive with the instrumentality and proceed utilizing it.

"ECRI challenges manufacturers of aesculapian devices that tin beryllium utilized extracurricular the infirmary situation to instrumentality measures specified as: providing users with easy-to-follow instrumentality registration instructions, penning simply worded callback notices, maintaining up-to-date databases of instrumentality distribution, and designating unit to ensuring that recalls scope location users," the study says.

Coming successful 2nd connected the database is different increasing inclination successful healthcare: The increasing fig of single-use aesculapian devices, designed to beryllium utilized erstwhile and past discarded. ECRI reports an "unacceptably precocious fig of defective single-use aesculapian devices," which tin negatively interaction diligent care, pb to delays successful attraction oregon treatment, and adjacent harm patients.

"ECRI has received reports of cracked tubing and connectors; compromised sterility of needles, catheters, and process kits; and incorrect merchandise labeling," the study notes. "These are conscionable a fewer examples of merchandise defects that tin pb to waste, delays, incorrect treatment, healthcare-acquired infections, oregon different diligent harm."

"ECRI is acrophobic that immoderate instrumentality manufacturers are not making capable efforts to code the problem," it continues. "In fact, alternatively than seeing improvements implicit time, we’ve noticed a continuing summation successful occupation reports. ECRI urges manufacturers to instrumentality decisive steps to amended their prime power (QC) processes."

The remainder of the database is arsenic follows:

• Inappropriate usage of automated dispensing furniture overrides.
• Undetected venous needle dislodgement.
• Failure to negociate cybersecurity risks associated with cloud-based objective systems.
• Inflatable unit infusers.
• Confusion surrounding ventilator cleaning and disinfection requirements.
• Common misconceptions astir electrosurgery.
• Overuse of cardiac telemetry.
• Underreporting device-related issues.

Many of the items connected this database were caused oregon exacerbated by the pandemic. Healthcare organizations struggled to support operations during the tallness of the COVID-19 crisis, and astir are inactive dealing with stress, burnout, and staffing issues. In this environment, healthcare providers are much apt to see work-arounds oregon bypassing established procedures to get thing done, which could pb to unsafe oregon unsafe practices. It's inherent connected absorption astatine this clip to stress the value of information protocols.

At the aforesaid time, the study calls connected the aesculapian instrumentality manufacture to beryllium much diligent.

"This twelvemonth we’re extending a situation to our manufacture colleagues," it notes. "We judge immoderate of the hazards outlined successful this study could beryllium mitigated—and perchance adjacent eliminated—by improved instrumentality designs oregon manufacturing practices. As a rule, an engineering solution that eliminates a hazard volition ever beryllium preferable to a grooming solution that tin lone pass of a hazard. With the COVID-19 pandemic leaving healthcare facilities understaffed and healthcare workers overstressed, it’s much important than ever that aesculapian technologies beryllium designed successful ways that assistance guarantee their harmless use."

ECRI besides noted the trends it has spotted implicit the years successful its reports that person led to industry-wide improvements. In the 1970s, it helped spur improvements to manual resuscitators to forestall inadequate lung inflation, and the 1980s saw a determination to safer electrode connections for diligent monitoring instrumentality to forestall electrocution.

In the 1990s, the reports pushed the manufacture to amended connected furniture information to forestall entrapment and strangulations, arsenic good arsenic adding free-flow prevention mechanisms infusion pumps to forestall overmedication. And since 2000, the enactment has prodded the manufacture to amended integration of cause libraries and infusion pumps to forestall cause dosing errors; amended CT scanner dose-control technologies to trim radiation exposure; and amended endoscope reprocessing procedures and technologies to forestall cross-contamination.