By the time this column appears in print, there may be a resolution to the current disparity between the Dec. 2, 2011 memorandum from the Centers for Medicare & Medicaid Services (CMS) on maintenance requirements, and the medical equipment management standards of The Joint Commission (TJC) and DNV. But I doubt it.
About a year and a half ago, TJC announced that it had gotten official permission from CMS to allow flexibility for setting maintenance frequencies. That is, hospitals could use other than a manufacturer's recommended maintenance frequency if they could show how and why a different frequency was safe and effective. Subsequently, DNV, another accrediting body, pointed out that it had always allowed hospitals to develop maintenance frequencies different from manufacturers' as long as they had a good justification. DNV officials said that CMS was aware of this and did not object.
In fact, both TJC and DNV allow hospitals to establish the maintenance procedures that they use for equipment inspections and maintenance, as well as the frequency of these procedures. Hospitals do have to show that these procedures ensure that equipment is maintained as safe and reliable. When the JC and DNV made their announcements about CMS allowing flexibility with maintenance schedules, neither they nor CMS made any comment about maintenance procedures. Apparently, we all assumed that the flexibility that TJC and DNV had been allowing was still acceptable, despite the statement in CMS's State Operations Manual that there must be a maintenance program that follows the manufacturers' recommendations.
Well, the December CMS memo disabuses us of that assumption (see http://www.aami.org/news/2011/122011.cms.pdf). CMS states specifically that hospitals must follow manufacturers' recommended maintenance procedures; alternatives are not allowed. Not only that, CMS provided further qualifications for adjusting maintenance frequencies. You can't adjust the maintenance frequency of new equipment until you have a maintenance history that supports the adjustment. You can't adjust the maintenance frequency of any equipment critical to patient health and safety. Examples of such equipment are life-support, resuscitation, critical monitoring, and radiologic imaging equipment.
Reactions have been appearing on the Internet ever since the CMS memo. The majority are highly critical of CMS for reverting to the dark ages of inspection programs. However, there are still some folks who think that requiring hospitals to use manufacturers' recommended maintenance procedures, including frequencies, is a great idea. I guess that CMS is not the only group still stuck in the dark ages. So much has been done over the past few decades to advance the principles and practices of inspection and preventive maintenance programs that it cannot be ignored.
So much has been done over the past few decades to advance the principles and practices of inspection and preventive maintenance programs that it cannot be ignored.
What about all of the clinical engineering departments, which for years have been developing and refining their inspection and preventive maintenance programs? As part of this development, they have collected years of evidence of safe and reliable equipment performance, for hundreds of makes and models of equipment, and thousands of pieces of equipment. They have also tailored their staffing to meet the needs of these alternative procedures. These staffing levels might not come close to being adequate if they had to revert to manufacturers' recommended procedures and frequencies. Heck, there might not be enough biomedical equipment technicians (BMETs) in the country to meet the need if manufacturers' procedures were followed for all of the medical equipment in use.
What about all of the generic inspection procedures that the ECRI Institute has been publishing for more than 40 years? There is no organization that has been more involved in developing, training, and implementing inspection and preventive maintenance programs than ECRI. There is also no organization more dedicated to medical equipment safety and reliability, or more objective and dedicated to scientific proof than they are. They have been espousing generic procedures and accurate recordkeeping for far longer than CMS and accreditation agencies have had requirements for medical equipment management. There is no evidence that these procedures have ever come up short in ensuring equipment safety and reliability.
What about issues related to manufacturers' service training and test equipment? In order to perform some of the manufacturers' recommended maintenance procedures, special training and/or test equipment may be required. Putting aside for the moment that there is no evidence that these are any better than generic procedures or test equipment, there would be considerable extra expense for this special training and test equipment. It's quite likely that, for similar medical equipment, each manufacturer might recommend different makes or models of test equipment. Would we be forced to have a fleet of nearly identical test equipment, each of which would have to be used only with specific models of medical equipment? This sounds particularly ridiculous, but well within the bounds of reality, considering CMS' requirement for following manufacturers' recommended procedures. After all, these procedures undoubtedly recommend specific test equipment.
What about all of the articles and book chapters about inspection and preventive maintenance programs? Scores of BMETs and clinical engineers (CEs) have conscientiously tested alternative procedures, documented results, and published recommendations. Presumably all of them have been successful for the people who created them and for the additional people who took their advice. No one has written about using manufacturers' recommended procedures. Thus, there is no published proof that they ensure safe and reliable equipment performance.
I'm at a loss as to what to recommend for clinical engineering departments. I certainly cannot recommend that we continue to use our time-tested, evidence-based, alternative programs. Perhaps we can trust that some organization or coalition, with sufficient credentials to impress CMS leaders, will be able to convince them of the error of their ways. Would the mere fact that there are reams of evidence from successful inspection and preventive programs based on alternatives to manufacturers' recommendations, and no evidence that programs based entirely on manufacturers' recommendations even exist, much less ensure safe and reliable medical equipment, have any impact on CMS?
AAMI and the TJC are collecting anecdotal data on the effects of CMS's pronouncement. Presumably, this will be part of a joint effort to impress CMS. Normally, I'm quite the optimist, and look for ways to turn lemons into lemonade. Right now, however, I'm pretty discouraged by the stance CMS has taken. It is so far off the mark—so illogical—that I don't see how mere logic and proof can change their minds. That should not keep us from trying, however.
What about all of the articles and book chapters about inspection and preventive maintenance programs? Scores of BMETs and clinical engineers (CEs) have conscientiously tested alternative procedures, documented results, and published recommendations.