ECRI Unveils Top 10 Device-Related Hazards
February 1, 2009
NEWS TRENDS
The ECRI Institute has released its second annual report on the top hazards caused by medical devices in the hospital setting.
Half of the list mirrors hazards from the previous year. The other half introduces a new crop of problems—patients suffering from air embolisms caused by contrast-media injectors, for example.
Other problems, such as programming errors on infusion pumps and misconnections on blood pressure monitors to IV lines, failed to make the list this year. Missing the top 10 doesn't mean that these problems have been resolved, however.
Dan Alt, a senior project engineer at ECRI, says that medical device OEMs can help alleviate some of the problems. When devices are incorrectly used in the clinical setting, some OEMs will simply point to the instruction manual. Alt says that manufacturers should design for “the hurried user,” who may not have access to a user manual. In addition, designers should consider that if many people with strong educational backgrounds are not using the device correctly, perhaps the design isn't intuitive enough.
In other cases, potential device problems may be lost in the communication channels. For example, a hospital worker might tell a sales representative from a device company that a device is malfunctioning. The rep may provide a loaner device, which addresses the worker's immediate concern, but the problem may not ever be relayed to the OEM.
ECRI's list is based on the group's medical device problem-reporting database and other problem-reporting databases, as well as from experience in investigating and consulting on device-related incidents.
“We didn't want to put things on the list that tell of Armageddon and [say] that these problems are inevitable,” Alt says. “Each item on the list is preventable to an extent.”
Copyright ©2009 Medical Device & Diagnostic Industry
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