Since the Joint Commission's 2004 changes to standard EC.6.20, hospitals have been directed to group medical equipment into “life support” and “non-life support” categories. While the standard offers several examples of life support equipment (specifically citing ventilators, anesthesia machines, and heart-lung bypass machines), it does not provide a comprehensive list of devices, leaving this determination up to the facilities themselves. This directive has understandably stirred considerable debate about which equipment belongs in which group.
The Joint Commission defines life support equipment as being “those devices intended to sustain life and whose failure to perform its primary function, when used according to manufacturer's instructions and clinical protocol, is expected to result in imminent death in the absence of immediate intervention.” What equipment do hospitals place within this definition? How do they make these determinations, and what should other facilities keep in mind when making up their own lists?
Open to Interpretation
In a recent discussion about this topic on AAMI's Joint Commission listserv, biomeds unanimously include the Joint Commission's three examples in their own lists of life support equipment. Some prefer to use only these three—for both simplicity's sake and to keep preventive maintenance (PM) costs lower. The reasoning behind defining these three devices as life support is relatively clear cut, as the failure of any of these devices would result in patient death.
The inclusion of other devices, however, is not so black and white. For example, some may find it surprising that most respondents included external pacemakers on their lists. Brad Motes, CBET, biomedical services manager for Longmont United Hospital in Longmont, CO, says that while his facility does list external pacemakers as life-support devices, he feels it is debatable, as there is no true PM to perform. “Modern units are small, dependable, and perform their own electronic self checks,” he says.
Defining life support equipment goes beyond medical equipment management and needs to be a team effort. When developing or revising your list, include representatives from the following departments:
✓ Clinical engineering
✓ Risk management
✓ Relevant clinical departments (cardiology, respiratory care, etc.)
Paul Kelley, CBET, manager of biomedical engineering at Washington Hospital in Fremont, CA, says his facility initially included external pacemaker generators as being life support. After posting a request for ideas on how to improve compliance for the devices, however, he was questioned as to why they were included at all. “I submitted the justification to the key stakeholders and they agreed that these generators did not fit our definition,” he says. “We removed them.” Bi-level positive airway pressure (BiPAP) machines, however, were added to the list when the hospital's respiratory care department insisted they were periodically used in life support conditions for some patients.
Defibrillators are another example of devices that some facilities include while others do not. Although most interviewed said they would include defibrillators as life support devices, some mentioned including only those with pacing capabilities. George Mills, senior engineer for the Standards Interpretation Group at The Joint Commission, cites defibrillators as an example of determining what is life support equipment by considering the repercussions of improper maintenance of a defibrillator and, ultimately, that device's failure.
“Assume a defibrillator was determined to not be life support equipment, and therefore not maintained,” he says. “Later, a patient goes into cardiac arrest, the clinician goes to the crash cart and plans to use the defibrillator only to discover the batteries are depleted and the paddles are for a pediatric patient and the adult paddles are not on the crash cart. What were the repercussions of incorrectly identifying this device as not being life support?”
Building a List
Hospitals have different ways of arriving at what devices make the list. Kelley says his hospital developed a definition of life support devices through its Medical Equipment Committee. It was then approved by the Safety Committee and key staff members, including directors of the Operating Room, Critical Care, and Risk Management departments. “Once we had the definition,” he says, “we went through our inventory and selected devices. This list was then circulated among some of the key stakeholders, and then went back to the committees.”
“I determine the risk factors of the devices during incoming inspection,” says David Stiles, biomedical engineering manager for Long Beach Memorial Medical Center in Long Beach, CA. “I use the basic formula of the equipment function, risk, and maintenance needs matrix that is supplied with my CMMS [Computerized Maintenance Management System] program.”
William Patrylo, CBET, director of biomedical services at Cambridge Health Alliance in Massachusetts, says his facility designates anesthesia machines, ventilators, pacers (external), and defibrillators with pacers as life support equipment. All devices are “risk ranked” (location, use, PM requirements, etc.) for inclusion into the Medical Equipment Management Plan. “These are high-risk devices that need PMs and/or output checks,” he says, “since failure or removal of these devices could result in the death of the patient.”
Massachusetts General Hospital uses a classification rating to make these determinations. “The life support equipment classification is based on a score (ranging from three to 20) and it is the essential part of our equipment management program,” says Asadullah Khan, clinical engineer, noting that devices scoring between 16 and 20 are classified as life support. Michael Shepherd, a preventive maintenance technician at Grande Ronde Hospital in La Grande, OR, says his facility primarily uses the Joint Commission standards, but has expanded upon them based on organizational experience. A numerical system is broken down into four priorities, with Priority 1 being “medical equipment that requires the highest-level quality assurance as determined by patient injury potential, clinical necessity, and experience.” This first priority includes two groups: life support (anesthesia machines, ventilators, and pacemakers) and critical equipment, meaning equipment that, if it fails to operate, could cause significant harm to a patient (defibrillators, assist ventilators, electro-surgical units, and blood warmers.)
While a complete listing of life support equipment devices mandated by the Joint Commission would be welcome by some hospitals, others feel the open-ended wording of the standard works by entrusting facilities to make decisions based on their unique needs and their own judgment. The consensus among those interviewed suggests that, however a hospital chooses to create its own list, decisions should undoubtedly be made with extreme care and accuracy, and the reasoning behind them should be carefully documented to demonstrate that critical equipment is clearly receiving priority attention.
Cathy Cruise is a freelance writer based in Fairfax, VA.