Binseng Wang

Binseng Wang

In a presentation at the North Carolina Biomedical Association on September 4, Binseng Wang of Aramark showed evidence that “in the vast majority of cases,” there is little difference in outcome between following manufacturer’s recommendations for scheduled maintenance and using alternative approaches.

Wang, vice president, quality and regulatory compliance, ARAMARK Healthcare Technologies, Charlotte, NC, shared the podium with his Aramark colleague Salir Balar. Balar began the presentation by recapping the history of the changes in maintenance policies instigated in recent years by the Centers for Medicare & Medicaid Services (CMS). The agency first issued a highly restrictive policy in December 2011 that severely restricted variations from manufacturers’ recommendations for maintenance schedules and procedures. A revision issued in December 2013 somewhat relaxed the policy, but left hospitals with significant burdens to prove the efficacy of alternate equipment management (AEM) programs.

According to Wang, adverse incidents involving medical devices are rarely attributable to maintenance errors, accounting for just 1% to 2%. Evidence from Aramark bears this out. From an average of about 1 million devices for which the company was responsible each year over a 10-year period, he said, 518 incidents involving the devices were reported to Aramark. Of those incidents, 476 were investigated, 202 were found to be related to equipment or accessory failures, and six were found to be potentially related to maintenance errors.

Wang then offered detailed results from a comprehensive study Aramark has performed on the safety and effectiveness of both OEM and AEM practices in the facilities the company services. After examining device failures in relation to the type of maintenance procedure used (OEM or AEM), Wang classified the results into three classes: no difference, AEM potentially better, and OEM potentially better. In theory, he said, whichever method is better would have fewer failures due to maintenance.

The results showed little difference in the huge majority of cases. Among what Wang termed “conclusive categories” of analyzed devices, Aramark found that in 4% of cases the AEM approach proved better, while OEM approaches were superior in 3% of cases.

Wang added that when looking at the results, “there is no clear easy conclusion except that the vast majority [of cases] don’t show any difference in maintenance approaches.” He stressed that while the analysis “is consistent with scientific method, a very large amount of data or a long time is needed to gather evidence.” For hospitals wanting to use AEM programs, he said this poses a difficult dilemma: “How do we convince surveyors in the meantime that we are indeed following the CMS mandate and not just cutting corners?”

John Bethune is editorial director of 24×7. He can be reached at [email protected].