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Infusion Errors, Poor Software Management among Top 10 Health Technology Hazards

November 8, 2016
by Heather Landi
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The ECRI Institute rated infusion errors, missed ventilator alarms and poor software management as some of the top health technology safety hazards for 2017.

To help hospitals prioritize technology safety efforts that warrant their attention and to reduce risks to patients, ECRI Institute publishes an annual list of top 10 health technology hazards. Produced each year by ECRI Institute’s Health Devices Group, the list identifies the potential sources of danger that ECRI believes warrant the greatest attention for the coming year.

"Technology safety can often be overlooked when hospital leaders are dealing with so many other issues," David T. Jamison, executive director, health devices group, ECRI Institute, said in a statement. "As an independent medical device testing laboratory and investigator of technology-related incidents, we know what can go wrong and what steps hospitals can take to reduce patient harm related to specific technologies and processes."

The ECRI Institute choose infusion errors as the No. 1 health technology hazard, which specifically addresses the errors that can occur when using large-volume infusion pumps. Although today’s pumps incorporate features that reduce the risks of infusion errors, these safety mechanisms cannot eliminate all potential errors, and the mechanisms themselves have been known to fail.

“ECRI Institute continues to learn about and investigate incidents of infusion errors involving pump or administration set failures, staff unknowingly defeating a safety mechanism, or incorrect infusion programming. Such errors— particularly those that result in the uncontrolled flow of medication to the patient, known as “IV free flow”—can lead to patient harm and even death,” the report authors wrote.

Inadequate cleaning of complex reusable instruments was ranked No. 2 on the list of top health technology hazards, and the report specifically cited outbreaks associated with the use of contaminated duodenoscopes—such as those that caused headlines in recent years—as examples of the severity of the issue. Other complex, reusable instruments, such as endoscopes, cannulated drills and arthroscopic shavers, are of particular concern.

Other topics on the 2017 list include ventilator alarm management, undetected opioid-induced respiratory depression, infection risks with heater-cooler devices, software management oversights, occupational radiation hazards in hybrid ORs and automated dispensing cabinet setup and use errors. The ECRI Institute ranks surgical stapler misuse and malfunctions and device failures caused by cleaning products and practices as the last two safety hazards on the list.

Inadequate medical device software management can delay a facility’s responses to safety alerts, allow cybersecurity vulnerabilities to be exploited, and impact patient safety, according to the ECRI Institute report.

“Maintaining a central repository of up-to-date and easily retrievable information about the software versions used in a healthcare facility’s medical devices is challenging. But failure to do so leaves the facility ill-prepared to effectively manage software updates and alerts,” the report authors wrote.

Mismanagement of software updates and alerts can adversely affect patient care or impact patient and staff safety by, for example, causing downtime or otherwise affecting the performance of medical devices or interconnected systems or delaying identification and implementation of key software updates, including those that address safety concerns.

Further, software management gaps put patient data at risk, allowing cybersecurity vulnerabilities to persist, possibly leading to lost, stolen, or inaccessible data.

“To address the hazard, a healthcare facility should verify that its computerized maintenance management system (CMMS) provides the capabilities needed to effectively track software versions for its medical devices and systems. In addition, the facility should establish practices for keeping the software version information in the CMMS current and complete,” the report authors wrote.


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