Should the Centers for Medicare & Medicaid Services (CMS) revise its new directive on the preventive maintenance (PM) of medical devices? Presenters at ECRI Institute’s Feb. 15 webinar addressing the matter answered that question with a resounding "Yes"—and 221 members of the audience who voted in a flash poll during the event expressed a majority agreement.

Asked what impact they believe the CMS directive will have on patient care, just 4 percent answered “positive.” Fifty-two percent said the directive would negatively impact patient care, while 42 percent said it would have no impact at all.

Published last December, CMS’s new directive demands that hospitals not veer from manufacturers’ recommendations for inspecting and maintaining many categories of medical equipment. Failure to strictly adhere to the suggestions may jeopardize a hospital’s eligibility for Medicare and Medicaid payments.

The webinar, titled “What Happened to Evidence-based Maintenance?”, sought to rally support for the approach to PM advocated by the Joint Commission and to encourage attendees to let the CMS know about the widely shared concerns of clinical engineers.

The Joint Commission allows hospitals to eschew a policy of inspecting all devices routinely and, instead, prioritize the devices deemed to present a higher risk of failure while “PM-ing” lower-risk devices less frequently. The consensus among presenters and attendees was that, in contrast with PM-based maintenance, evidence-based maintenance improves efficiency, increases time for more pressing technology-management activities and saves hospitals money without compromising patient safety, quality of care or performance of equipment.

“I believe the clinical engineering community’s universal use of the term ‘PM’ has, unfortunately, led the folks at CMS to conclude that manufacturers’ recommendations are for true preventive maintenance activities and that, if not performed, devices will be unreliable and less safe,” said presenter Tim Ritter, a senior project engineer in ECRI’s health devices division. He then laid out a number of “things the CMS doesn’t know or hasn’t considered.” Among these:

• Failures are typically unpredictable and not preventable;
• Many devices have onboard diagnostics;
• Electrical safety has become a nonissue;
• Strictly following manufacturer recommendations will result in the purchase of unnecessary test equipment;
• Recommendations may be for worst-case scenarios; and
• Few devices require true preventive maintenance.

Other presenters included Jonathan Gaev, director of technical programs in ECRI’s health devices division, who spoke on using benchmark data to assess and improve the performance of clinical engineering departments, and Mark Newell, a regional director of clinical engineering for Novi, Mich.-based Trinity Health, who described the results that the 10-state provider institution has realized in its evidence-based maintenance program. Newell said a post-implementation “process validation” produced metrics pointing to reductions in use errors, damage and device incidents.

James P. Keller, Jr., ECRI’s vice president of health technology evaluation and safety, served as moderator. He noted that CMS had been invited to participate in the discussion but did not reply to the invitation.