Binseng Wang

Binseng Wang, ScD, CCE,FAIMBE, FACCE

Many people seem to believe that the preventive maintenance (PM) sticker is a requirement by The Joint Commission (TJC) or another agency. George Mills, director, department of engineering, TJC, dispelled this myth recently and even stated that he is not aware of any other agency that has this requirement.1 Like the proverbial chicken-or-the-egg question, it is not clear who started this misconception. Some claim that a TJC surveyor suggested using stickers so the clinical users can be reassured that the equipment has been checked and is safe to use, while others counter that a surveyor heard this from a biomed and thought this was a great idea and passed it on. Regardless, this has become one of the most enduring urban legends in our profession.

An appropriate analogy would seem to be the inspection sticker that some states require on cars. Those stickers show that the car has been inspected for safety (eg, brakes and lights) and pollution standards. If the medical equipment PM sticker rationale were correct, drivers in those states should check for their car sticker due date every time they go to drive them and stop driving if the sticker is overdue. My guess is that very few people check their car sticker regularly. Even if they did, it would be naïve to believe the car is safe to drive if the sticker is not overdue. Actually, the best way for drivers to know if their cars are safe to drive is to check the dashboard. Nowadays, almost every car manufacturer has built in numerous self-tests and continuous monitoring devices that tell the driver something is out of specification or likely to be unsafe (eg, failing brakes, low tire pressure, etc). Obviously, all these alarms and monitoring devices are not just marketing gimmicks or pure benevolent actions by the manufacturers. Many of these innovations have been introduced to protect the automakers from liability claims from people involved in accidents.

Likewise, most medical equipment manufacturers have built into their products many self-tests, alarms, and other safety features that tell the users whether it is safe and suitable for use. Like their counterparts in the automobile industry, medical device manufacturers are known to be extremely conscious of their liability exposure and would gladly add memory and other tools to defend themselves in lawsuits.

Considering the technological advances and the increased awareness of patient safety, it is time for us to debunk once and for all the PM sticker myth. First, most of the PMs are no longer activities designed to prevent failure, as modern electronic failures cannot be predicted and, thus, prevented. Only mechanical and pneumatic devices have known useful lives and, thus, can benefit from preventive measures. Most of the so-called PMs are actually “safety and performance inspections” (SPI) designed to find hidden or potential (in progress) failures that could put a patient in jeopardy. Recent analyses of failure patterns and causes in tens of thousands of service records2-5 have shown that these failures are rare. Furthermore, their occurrence is unpredictable, which means that if a particular device is inspected today, there is no assurance whatsoever that it will not fail the next hour, day, week, or month. In fact, an annual SPI is nothing more than a sampling of 0.05% of the annual available hours for use.6 Similar questions about the effectiveness of vehicle inspections have been raised. According to a 2008 report produced by the North Carolina General Assembly’s Program Evaluation Division,7 “nearly three decades of research has failed to conclusively show that mechanical defects are a significant cause of motor vehicle accidents or that safety inspections significantly reduce accident rates.” It also reported only 19 states have safety inspections (16 others have emissions-only inspections).

Therefore, it is misleading to tell a clinical user that a piece of equipment is safe to use if it has been inspected and not overdue for the next inspection. It would be much better (and safer) for us to train the user to look at the equipment’s display to ensure that it passes the self-test before it is used on a patient, and monitor it for alarms and other warning messages afterward.

Yes, this is another old habit that is hard to break. However, we should be honest and teach users when they can depend truly on their “tools” to provide safe and proper care for their patients. Instead of training them to rely on PM stickers when responding to surveyors, we should teach them to say, “Just like the car I drive, I look at the equipment’s panel and see if it passes the self-test and whether there are any alarms or cautions before I put it on a patient.” I do not believe it will be difficult at all, as our clinical colleagues are very smart and probably know this answer well before we suggest it. After all, they have been driving cars for a long time without looking at the inspection stickers too!

Binseng Wang, ScD, CCE, FAIMBE, FACCE, is vice president, quality and regulatory compliance, Aramark Healthcare Technologies, Charlotte, NC. For more information, contact .

References
  1. Ask George. BI&T. 2011;45:267.
  2. Ridgway M, Atles LR, Subhan A. Reducing equipment downtime: A new line of attack. J Clin Eng. 2009;34:200-204.
  3. Wang B, Fedele J, Pridgen B, et al. Evidence-based maintenance: Part I – Measuring maintenance effectiveness with failure codes, J Clin Eng. 2010;35:132-144.
  4. Wang B, Fedele J, Pridgen B, et al. Evidence-based maintenance: Part II – Comparing maintenance strategies using failure codes. J Clin Eng. 2010;35:223-230.
  5. Wang B, Fedele J, Pridgen B, et al. Evidence-based maintenance: Part III, Enhancing patient safety using failure code analysis. J Clin Eng. 2011;36:72-84.
  6. Assuming that the SPI takes an hour and the equipment is available for use 8 hours/day for 250 workdays/year.
  7. Doubtful return on the public’s $141 million investment in poorly managed vehicle inspection programs. Report Nbr 2008-12-06; December 16, 2008. Program Evaluation Division, North Carolina General Assembly. www.ncleg.net/PED/Reports/documents/VSI/VSI_Report.pdf. Accessed April 16, 2012.

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