Longtime Clinical Engineer Makes Case for Evidence-Based Maintenance

Posted June 11, 2017

Rather than getting bogged down in the debate over who is best qualified to service medical devices, one leader in the healthcare technology management (HTM) community says the field should focus on the overall approach to and rationale for maintenance.

With that, Binseng Wang, director of quality and regulatory affairs at WRP32 Management, Inc. and Greenwood Marketing LLC, made a case for evidence-based maintenance (EBM) during a presentation Sunday at the AAMI 2017 Conference & Expo. EBM, said Wang, is the most useful and direct method for ensuring the safety and effectiveness of medical devices.

EBM holds that outcome data should be used to evaluate a program's safety and effectiveness and, if needed, prompt necessary improvements. Wang strongly recommended the use of failure cause codes (FCCs), emphasizing that codes related to service-induced failures (SIFs), hidden failures (HFs), potential failures (PFs), and preventable and predictable failures (PPFs) are of greatest value when devising effective EBM strategies. But, he noted, therein lies the rub: Accurate and reliable EBM data are needed to prove that HTM is maintaining equipment safely and reliably, but these data are difficult to collect.

To emphasize this point, and to underline the value of collecting the FCC data needed for strong EBM strategies, Wang cited a 1962 quote by President John F. Kennedy on the decision to go to the Moon: “We choose to go to the Moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills.”

Wang illustrated EBM using an example from a three-hospital system. After performing an FCC analysis on three years of data for an inventory of approximately 7,900 pieces of equipment, the system found few SIFs, HFs, PFs, and PPFs. However, one equipment group (an oxygen concentrator) was responsible for several HFs (on nine of 65 units)—premature component wear was revealed to be occurring every five or six years, whereas the original equipment manufacturer (OEM) recommended replacing the component every 10 years.

Therefore, Wang said, this example highlights that the underlying issue is not related to whether service is conducted via the OEM or an alternative equipment maintenance strategy, but rather that EBM strategies, collected via FCC analysis, should be used to determine the effectiveness of a maintenance plan. Analysis of the underlying data is what's crucial.

Wang concluded by saying "start now," as it takes time to collect and analyze these data. Safety and effectiveness evaluations (SEEs) are required by the Centers for Medicare & Medicaid Services, and sooner or later, facilities will be asked to produce them. SEEs, he added, are not only required for compliance but also could help prove to the Food and Drug Administration that “third parties” are doing at least as well as OEMs in servicing equipment.