Executive Summary

Hamilton Health Sciences (Ontario, Canada) was named a finalist for the 3rd Health Devices Achievement Award in September 2008 for developing a more efficient approach to addressing an infusion pump recall.

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​Last year, Hamilton Health Sciences (Ontario, Canada) was faced with a Class I recall affecting about 1,500 infusion pumps within the facility. The mitigation steps proposed by the manufacturer were elaborate and time-consuming, and would have included a comprehensive test followed by an x-ray of each pump. In the face of a potentially overwhelming task, the hospital took another look at the problem and found a better solution.

The problem with the pumps was an occluder spring in the pump assembly that might have been missing from some units, potentially resulting in an overinfusion that could harm patients. The "short-term" solution proposed by the manufacturer was a test that would determine, based on the pump's performance, whether the pump was affected by the problem. But conducting the test on all its pumps would have required around 500 hours of technician time. And the other alternative—a fluoroscopic examination of the pumps—would probably not have been completed for over four months. Both tests, moreover, would have involved taking each pump out of service.

So instead, Hamilton devised its own test procedure. Using a commercial push gauge, technicians developed a test that measured the pressure of the pump's occluder finger and thereby determined whether the occluder spring was present. This "noninvasive" test was able to be carried out on the floor, without taking the pumps off the patients—each pump merely needed to be placed on pause for 10 seconds.

Thanks to this creative but simple approach, more than 1,300 of the pumps were able to be tested in the space of a day and a half, with minimal effort, minimal cost, and virtually no disruption to patient care.

This project earned Hamilton Health Sciences recognition as a finalist for the 3rd Health Devices Achievement Award, issued by ECRI Institute in 2008 to honor excellence in health technology management. Learn about the other submissions that achieved recognition.

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Topics

Biomedical Engineering; Hazard and Recall Management; Infusion Therapy; Service and Maintenance

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Hospital Inpatient; Hospital Outpatient

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Biomedical/Clinical Engineer; Risk Manager

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Guidance

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Product Catalog

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ICD9/ICD10

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Publication History