Are You Ready?

Most of you probably know that the Joint Commission on Accreditation of Healthcare Organizaions (JCAHO) has completely rewritten its standards for 2004. There are numerous improvements but also some “surprises" in the Environment of Care (EC) chapter. For example, standard EC.6.20 introduces segregation of equipment into two categories with corresponding Elements of Performance (EPs): life support (EP3) and non-life support (EP4).

At first glance, both EPs look very innocent, as they only require documenting maintenance “consistent with maintenance strategies to minimize clinical and physical risks identified in the equipment management plan." A closer look at EP4, however, reveals it has been classified as category C for scoring purposes, which means that you would fail if you missed inspection on three or more pieces of non-life support equipment!

Although EP3 will not be scored per instance of noncompliance, it presents a major challenge, as hundreds—perhaps thousands—of pieces of additional equipment will now have to be managed, depending on one’s definition of “life support." Such a definition could include simple items such as mechanical resuscitators, infusion pumps, suction pumps, oxygen pressure regulators, and oxygen flow meters, which are often excluded from the medical equipment management plan.

When these concerns were brought to the attention of JCAHO, its officials stated emphatically that there was no intention to catch the clinical engineering (CE) community by surprise, increase their work load, or roll back the concept of encouraging each organization to analyze its actual maintenance needs and determine the best strategy for addressing those needs.

Instead of faulting JCAHO for prescribing such a detailed requirement, we believe the CE community itself should take responsibility for keeping alive the long-held misconception that equipment will fail and create serious consequences if maintenance is not performed on schedule. Actually, medical equipment nowadays employs components that have become increasingly more reliable. Moreover, electronic components fail in a random manner, and their failure cannot be predicted by inspections or measurements. Replacement can only be planned for certain mechanical parts as a function of wear. Studies of the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) data and ECRI’s user experience reports (during the debate prompted by the 1998 FDA proposal to regulate servicers and remarketers) showed that the number of equipment failures attributable to service or maintenance error is, indeed, insignificant. The rarity of PM-related failures is hardly surprising since manufacturers typically recommend inspections and PM with a large margin of safety (to reduce their liability risks and perhaps increase their service and parts revenues). Missing a PM, even for an entire cycle, is unlikely to create a serious safety issue.

Life-support equipment also has additional automated failure detection measures that provide alarms and, often, a safe backup operating mode in case a catastrophic failure is detected. These added protections, combined with clinical protocols that require the user to perform a preuse check and employ independent monitoring tools, have made equipment-induced patient incidents extremely rare. Studies have found most incidents are caused by inadequate user training or attention.

Therefore, it would be a disgrace, if not downright dangerous, if the new JCAHO standards misdirected the CE attention from user training to equipment maintenance. Instead of spending more time on inspections, we should focus our attention on training users and providing feedback to manufacturers. This is what will effectively support our organizations’ and JCAHO’s goal of reducing medical errors.

Next month, we will explore alternative ways to comply with the new standards, as it is unclear whether JCAHO is willing—or able—to remove or revise these EPs before the surveyors show up for an unannounced visit.

Binseng Wang is vice president of quality assurance and regulatory affairs at MEDIQ.

Alan Levenson is senior equipment planning consultant currently at New York Presbyterian Hospital.