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CMS comes clean about its maintenance rule

by Loren Bonner , DOTmed News Online Editor
This first appeared in the May 2014 issue of DOTmed HealthCare Business News

Right before the start of the year, the Centers for Medicare and Medicaid Services spoke out about an issue that had clinical engineers in health care facilities across the country worried for almost two years: Whether they were going to have to revise long-established protocols on how often they perform preventive maintenance for medical devices.

When CMS cleared up the equipment maintenance guidelines on Dec. 23, 2013, the clinical engineering community was mostly relieved. In the updated directive, CMS announced that it will allow health care facilities to follow an alternative equipment maintenance (AEM) program based on accepted standards of practice for maintenance. In other words, clinical engineers can continue doing what they have been doing to maintain medical equipment — a practice that has been endorsed and approved by the Joint Commission for over 10 years — except when it comes to imaging equipment, lasers, and new equipment without a long enough history to establish an adequate risk-based assessment for maintenance. In those cases, facilities will now have to follow what the OEMs recommend.

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“If I’m the clinical engineering director, I’m very happy to receive this memo, I’ve gotten most of my flexibility back, not all of it,” says Jonathan Gaev, business line manager of BioMedicalBenchmark at ECRI Institute.

Overall, Gaev says the memo was wellreceived by the clinical engineering community — but with a little less cheer in those areas where the directive still holds.

Exceptions to the rule
In November 2013 — before CMS had cleared up the directive — Rep. Tim Murphy (R-Pa.) and Rep. Allyson Schwartz (D-NY) sent a letter to CMS voicing their concerns, which were shared by dozens of industry stakeholders, including the Medical Imaging & Technology Alliance (MITA), an industry lobby, that in essence said that weakening the requirement to follow manufacturers’ recommended maintenance standards on imaging equipment is unsafe.

The imaging community said that deviating from the manufacturer’s recommended maintenance standards could threaten safety as well as put the operators in harm’s way, and the outcry from the industry is what likely prompted CMS to include the AEM exception for imaging equipment.

Since 1994, the Joint Commission has consistently allowed for a risk-based process to evaluate an organization’s equipment inventories, preventive maintenance strategies and assignment of preventive maintenance frequencies. Manufacturers’ recommendations have always been the starting point for clinical engineering departments’ maintenance process. But over the years, the Joint Commission — which accredits the majority of U.S. health care facilities — allowed clinical engineers to deviate from the recommendations as the experience of the facility maintaining the equipment warranted.

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