Central Florida Division and State Chapter Board of Directors

Central Florida Division and State Chapter Board of Directors

Robert Stickels has worked in electrical product safety for 20 years, including as a regulatory design engineer for NCR. He is currently the director of field evaluations for TUV Rheinland, and has personally inspected a great deal of medical equipment at numerous healthcare facilities. Robert is an inspector member of the IAEI, and is on the Central Florida Division and State Chapter Board of Directors.

Q. When you are inspecting a non-certified piece of medical equipment, do you find test failures for leakage current? What kind of failures are you seeing?

A. Yes, I find test failures during leakage measurements. The equipment’s components may or may not be certified. Many times I find components are certified and when combined into the end-use product, the product as a whole does not meet the leakage current requirement set forth in the medical standard. I see many failures between a few μA (microampere) to 4 mA. (milliampere).

Q. What kind of equipment have you found these failures in? Patient area? Operating Room? Emergency?

A. This equipment is found in all areas. Case in point, Heart Cathlab A/V integrated system failed leakage current tests. The problem was with power supplies. The power supplies were not rated for use with medical equipment, instead they were certified/listed to the ITE standard. Due to the current requirement of the monitor, a replacement power supply was not available. To fix the problem, a medical grade isolation transformer was used to reduce the leakage current to acceptable levels. Other systems of concern are patient beds, luminaires, and types of new procedure equipment, and others.

Q. What do the manufacturers of this equipment say about these test failures?

A. Sometimes not much or nothing, often the manufacturer simply states, “We have never run into this before” or “The equipment meets the NRTL requirements for the intended use.” System integrators use what is cost effective and meets the immediate need. Unless designed for medical area use, A/V equipment for use in a medical area typically may not be available; therefore, testing and evaluation is necessary by an NRTL.

Q. What do the owners of the equipment say about the failures? Did they know they were buying non-certified equipment?

A. It is buyer beware. Typically, the hospital and doctors do not have a clue; they only know what the equipment does as far as the procedure it’s intended for. The equipment is tagged for evaluation only when compliance is required by a local AHJ, The Joint Commission, state agency or an internal hospital equipment acceptance procedure. Keep in mind that non-compliant equipment may range from as small as a relocatable power tap to OR equipment to as large as a DI water chiller system used for Dialysis patients.

This fact remains: Equipment that is not suitable for medical use can put patients and healthcare providers at risk for electric shock and death. In the Product Safety Consensus Standards writing process, there are two considerations for writing specific sections and values for exposure to electrical current and voltage. The first is a list with names of people who have died because of this hazard. The second is the scientific proof that without a particular requirement there would be an additional list of people who have died. To suggest that critical testing, such as leakage current, should be stopped is like arguing that since cars have airbags we can save money by removing seat belts. This is why the ASHE position on leakage current testing is especially troubling and dangerous. In their proposal to cut sections of NFPA 99, they state that these requirements are being cut in order to “…manage risks while bringing efficiencies to the regulatory compliance burden faced by healthcare providers.” In other words, this is being done simply to cut costs. Any “re-engineering” of NFPA 99 should absolutely consider the existing U.S. product safety standards, (e.g., UL 60601) and their scientific basis.

When an electrical product or system loses its ground, patients and staff are immediately exposed to leakage current. As research has shown, AC leakage current can cause complete cardiac arrest at low levels. Portable listed medical products employ heavy duty cords and plugs to help avoid the loss of ground; however, this condition is inevitable, especially when a piece of equipment is kept in service for many years. No one questions the physicist coming in to check the viability and correct operation of equipment that uses radiation. Conversely, since our track record with electrical incident and deaths has improved because of the correct application of U.S. standards such as UL 60601 and NFPA 99, electricity has indeed become “invisible” and because of this success the practices of electrical safety are questioned.

With counterfeit products from Asia and special interests pushing things like the SDoC program, now is the time for increased vigilance, not for softening or the elimination of time-tested safety standards and product testing. The ASHE attempt to influence JCHAO and dilute NFPA 99 should be closely scrutinized and their vested interest and motivations identified and monitored.