PMs Are Not Profiteering
I am dismayed by some of what Binseng Wang and Alan Levenson wrote in the January 2004 Soapbox article [“Are You Ready”].

They suggest that equipment failures due to preventive maintenance are rare and that missing a PM for an entire cycle is unlikely to create a serious safety issue. Worse yet, they suggest that manufacturers schedule PMs in part to increase their parts revenue.

I have worked in the highest level of quality assurance relating to life support with the submarine service. Our military standards were in compliance with factory specifications because we knew that since they made the equipment, the manufacturers knew the best preventive maintenance of the equipment. This holds true in the medical equipment arena as well.

I service hundreds of ventilators each year for many hospitals and have had not one biomedical or clinical engineer refuse or not desire compliance with OEM PM procedures. I have seen equipment failure due to not performing PMs regularly. Many ventilators require that an array of filters be changed periodically. If these filters occlude—and they certainly will—the air and 02 inlets to the vents will become restricted, and the potential for debris reaching critical electromechanical components will increase. These situations are avoided by OEM-prescribed PMs, which are in no way designed just to sell parts.

Patient safety is always priority one or at least should be with all biomeds. I respect Wang and Levenson as professionals, but I am not in agreement with what appears to be a dangerous and misguided calculation regarding OEM-recommended PMs.

My 20 years of experience has proven this time and again. Cutting corners is the quickest way I know to a lawsuit. We must ensure that OEM compliance is taken seriously. We owe it to patients whose lives at times depend on equipment.

J.V. Shapona
Senior BMET/Senior Field Service
Universal Hospital Services
Bloomington, Minn

Binseng Wang and Alan Levenson respond
As clearly stated in our article, we did not accuse all manufacturers of exaggerating their PM recommendations to increase their profits. We also did not state that all PMs were recommended only to sell parts. However, we do have inside information that some manufacturers did institute PMs or increase PM frequency to reduce their liability exposure and increase parts and service revenues.

This reality was clearly exposed during the extensive discussions prompted by the 1998 US Food and Drug Administration (FDA) proposal to regulate servicers and remarketers. We believe the FDA has placed its proposal “on the back burner” because the manufacturers were not able to produce many records of patient incidents caused by equipment failures attributable to service, maintenance error, or lack of maintenance.

Like this reader, we also wish we could trust the manufacturers completely, not only for their service but also for their products. Unfortunately, the experience of thousands of failed incoming inspections, product recalls, and patient incident investigations has convinced us (and many colleagues) that manufacturers are imperfect. Furthermore, some companies are driven by executives eager to generate positive results to impress Wall Street analysts and investors.

It appears to us that this reader missed our point: PM should be just that, maintenance that prevents failure. When time and scarce resources are expended performing PM on devices whose history and experience (especially in that particular facility and user department) has proved that such expenditures do not materially add to MTBF, then one must question its wisdom, even if it is coming from manufacturers or JCAHO. It was never our intention to suggest that PM be eliminated on life-support equipment altogether. On the other hand, we hope that no one (including this reader) is still performing periodic hipot testing on medical equipment, even though it is still recommended by certain manufacturers.

In essence, in order to perform well our duty as clinical engineering professionals, we believe we need to challenge every assumption, dogma, or recommendation. Instead of falling for FUD (fear, uncertainty, and doubt) we should find the truth. Only by questioning those “sacred cows” can we find ways to take our profession to a higher level. Since we do not have unlimited time and money, we must choose wisely when and where to spend them to maximize patient safety and avoid wasting them in search for the holy grail of absolute safety.

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