Rob Schluth, ECRI Principal Project Officer 1—Product Development, Device Evaluation

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Advancing Patient Safety Through Better Designs or Processes: Top 10 Health Tech Hazards Part 2

This is part two of a two-part blog.

A nurse's aide, when transferring a mother in labor to the delivery room, turned off the infusion pump delivering Pitocin, a drug administered intravenously to accelerate contractions. The aide removed the infusion set from the pump without first closing the manual clamp on the line. A free-flow infusion occurred, and the mother received nearly 35 times the prescribed amount of drug. The infant suffered organ damage and pneumonia and died four days later.

This incident happened in 1991.

A decade earlier, ECRI had warned about the dangers of IV free flow in a 1982 evaluation of infusion controllers. Free-flow, or unrestricted gravity flow, refers to the uncontrolled delivery of an infusion to a patient when a controlled or metered delivery was intended. Depending on the drug being administered, IV free flow can lead to death or serious patient harm. That's why the test criteria for our 1982 evaluation specified that infusion devices should provide safeguards to prevent uncontrolled flow.

Fast-forward to the decade after that incident. By the early 2000s, many infusion pumps included an effective free-flow protection mechanism to guard against this hazard. Today, such mechanisms are a standard safety feature.

But how many patients suffered harm in the meantime?

It's with that question in mind that we issued a challenge to industry within the pages of our Hazards report. The report identifies 10 health technology hazards that ECRI's experts believe warrant priority attention. In ECRI's view, several of the hazards listed could be mitigated—and possibly eliminated—by improved device designs or manufacturing quality processes. We encourage industry to rise to that challenge.

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Topics: Patient Safety

Top 10 Health Tech Hazards for 2023: A Tool to Reduce Preventable Harm

This is part one of a two-part blog.

Reducing preventable harm is at the core of ECRI’s mission, and has been for more than 50 years. Since the publication of the first issue of the Health Devices journal in 1971, ECRI has served as an information clearinghouse for hazards and deficiencies in medical devices. We collect and analyze reports of device-related problems, identify root causes, and develop practical recommendations to prevent future occurrences and prevent harm.

ECRI’s annual Top 10 Health Technology Hazards report is one tool we develop to help members of the healthcare community participate in that mission. The report informs frontline healthcare workers, administrators, clinical engineers, IT professionals, medical device manufacturers, patients, regulatory bodies, and others about device-related hazards, and it empowers them to address those issues to make healthcare safer.

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Topics: Patient Safety

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