About five years ago, it came to the attention of the Centers for Medicare & Medicaid Services (CMS), that The Joint Commission (TJC), which is the largest provider of hospital accreditation surveys dealing with CMS requirements, was not enforcing a longstanding requirement. Specifically, the requirement—found in in the interpretive guidelines of Medicare’s Conditions of Participation—calls for medical equipment to be maintained “according to the manufacturer’s guidelines.”
When this was revealed, representatives of TJC were initially successful in persuading CMS that this very strict requirement was unnecessarily burdensome. They showed that documented patient injury statistics seemed to confirm that the more cost-effective alternative maintenance programs that have been in widespread use throughout the nation for many, many years were clearly adequate and acceptably safe.
As a result of this discovery and its subsequent discussions with TJC and other stakeholders, CMS issued a series of “clarification” memos, the first of which (in December 2011) relaxed the original requirement and permitted the use of alternate maintenance methods for all medical equipment, except for:
- New devices for which there is still insufficient data on its safety, and
- Other devices that are deemed “critical to the health and safety of patients and staff by a risk-based assessment performed by qualified personnel.”
However, at the urging of some of the equipment manufacturers’ lobbyists, a subsequent revision of the CMS requirement (in December 2014) has reintroduced significant restrictions for a few major device types. And clearly, without a more robust justification for TJC’s original contention that no patients are being put at risk by the traditional maintenance practices, the door remains open for the manufacturers to prevail upon CMS to extend these same restrictions to an even broader list of devices—again, presumably, only by virtue of their political clout and with no substantial technical justification.
The rebuttal from the healthcare technology management (HTM) community to this unnerving series of fundamental missteps backwards has, so far, been weak and ineffective, with no apparent prospect of convincing the CMS staff that preventive maintenance-related patient safety during these many, many years of conventional maintenance practices has been completely acceptable. This is particularly disappointing, but the challenge created by CMS’ discovery of this long-time non-conformance still provides an enormous opportunity for the collective HTM community to showcase its professional credentials and capabilities.
We need to come together to ensure that everyone at CMS and TJC understands the right way to perform a true, evidence-driven, risk-based assessment—and proceed from that point by initiating and overseeing the completion of just such an assessment. We concur completely that, as the nation’s watchdog on the effectiveness of services provided to Medicare patients, CMS has every right to ask for reassurance that those responsible for maintaining the nation’s medical equipment know what they are doing—and are able to prove beyond a reasonable doubt that the maintenance programs provided by independent (other than manufacturer) service providers are safe and effective.
Ladies and gentlemen, if we are really the managers of healthcare technology, we need to manage one healthcare technology issue that’s the size of an elephant in the room. Let’s get on with it and take care of our business!
Malcolm Ridgway is a retired clinical engineer who has been a leader in several initiatives aimed at elevating the HTM field and advancing the works of its professionals.