High- and low-risk devices are all the same to surveyors; New maintenance standards could prove costly for hospitals

Many were shocked by The Joint Commission’s newest standards and elements of performance (EP) on medical device maintenance. The accreditor will no longer distinguish between “high-risk” and “non-high-risk” equipment when surveying maintenance and inspection compliance. Instead, facilities are expected to achieve 100% inspection compliance for both types of devices.

But hold off before panicking over how you’re supposed to track down and inspect 100% of the medical devices in your facility. The new standards have exceptions written into them for items that are in use or have gone missing.

The standards also bring up the question of how to inspect medical devices. Facilities have two options when it comes to inspections and maintenance activities: follow the original equipment manufacturer (OEM) recommendations or create an alternative equipment management (AEM) program. AEMs allow organizations to set their own activities and frequencies related to inspecting, testing, and maintaining equipment.

Is this a big deal?
The short answer is yes, according to Kevin Kiely, CHSP, CHFM, CPSO, HEM, a senior consultant with Compass Clinical Consulting.

“What happened in the past was your biomedical department or vendor would do a risk analysis of that particular device,” he says. “And if it scored a certain number it would go into the high-risk category, and if it scored below that number it would go into the low-risk category. In some cases, they’d just put it out there as being ‘no preventive maintenance (PM) necessary’ and they basically just forget about it.”

Now, all of those low-risk items will have to be found and re-inventoried to comply with CMS and The Joint Commission. This can be tricky, says Kiely, as in many cases there’s no record of where the low-risk items have been put. It will also mean an increase in cost if a hospital has a third-party vendor assigned to its biomedical equipment.

“This has the potential of being a costly venture for hospitals,” he says. “But the biggest concern is going to be the hospitals that have in-house services. Just making sure they stay on top of these changes and are able to document, document, document. That’s the key to the whole, whether it’s third-party or in-house. It’s going to be CMS’ push to be 100% compliant and then documenting your services and making sure that your risk assessment is right on the money.”

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