What about non-certified equipment

What about non-certified equipment

Q. Why are leakage current tests performed and how often are they performed?

A. We perform electrical safety inspections (ESIs) routinely as part of an Equipment Management Program. Whether it is on a scheduled device, loaner, rental, patient- or physician-owned, or post-repair, it is common that our technicians perform this test daily, along with other tests. Each day, equipment fails these tests.

Q. What kind of test failures do biomedical technicians see, and what are the causes?

A. There are a variety of reasons for the excessive leakage current: Degradation of components, which over time one can demonstrate the relation of leakage to wear as the power supply or other components age or stress; damage abuse where a variety of neglect or accidents including missing or broken ground pins, spillage from fluids that egress and evaporate leaving excessive current leakage, and defective power cords; instances where beds or other equipment may have damaged the conductors and cords. We see good systems connected by bad or inappropriate power strips, and we see inappropriate equipment for the patient care setting. All too often IT equipment intended for office or business finds its way into the clinical areas. These conditions can only be avoided by regular testing and inspection.

Q. Do hospital IT departments bring in equipment not suitable for patient areas?

A. Unfortunately it is a common practice for doctors, purchasing agents, equipment representatives and IT departments to try to bring ordinary computer equipment into healthcare facilities and patient areas. Sometimes it’s merely due to lack of knowledge of codes and standards. Sometimes the equipment brought in is certified but not certified for patient area use—there is a big difference between medical devices and all other equipment. Since some of this non-certified and inappropriate equipment makes it into these facilities, we get a chance to inspect this equipment. What are the differences? Only an expert with the right background and tools can answer that question. OSHA and many states realize this and this is why codes and laws are in place.

Q. What about non-certified equipment?

A. The situation is the same with non-certified equipment. Most hospital administration departments and purchasing agents don’t know the inherent dangers associated with unknown and untested devices. The types of equipment vary from EEG devices to neuro-stimulation devices, computers, printers—the list is extensive. Many of these companies know better and continue to sell uncertified equipment. I can tell you that most of the non-certified equipment I’ve seen required modification to be made safe. Grounding is a big problem in non-certified equipment, and grounding problems lead to leakage current exposure.

Q. What is the perception of product safety in the healthcare environment?

A. I live and work in Florida where state code requires NRTL certification to the appropriate intended use. When we point this out, there are a variety of responses. The responses I receive vary from concern for patients and staff to denial. Some worry about the legal aspects, others are genuinely concerned about the compliance to state codes, but many others see no problems and will address problems IF they occur. I hear a lot of comments such as, “Everybody else uses it,” or “We had one at the last hospital I worked at and our biomed there never said anything.” Of course, there are also many who will have any non-certified device inspected and tested; and although this can be a challenge, it is a wise and prudent choice and the only way to really protect patients and healthcare staff.

Many deaths due to electrical shock and current have occurred since the widespread use of electricity. In the 1960s, the issue of leakage current came to the forefront, resulting in the increased level of safety we now have in place. Many articles were written on the subject.11 There are many ways electrical shock can occur in a healthcare facility; for example, humidity in the plugs of blood and fluid heaters causing device failure,12 accidental toppling of a fluid container causing spillage onto a blood pressure monitor,13 electric shocks to anaesthetists after touching a faulty device and the chassis of another device simultaneously,14 an anaesthetised patient was connected to an ECG device that had been wired wrongly with the earth and neutral connections transposed. 15

How widespread are cases of death by exposure to leakage current? This information is difficult to obtain due to several factors. Patients simply die of “heart failure” with no further detail provided. Many of these patients are high-risk, and are exposed to electrical equipment in regions of the country where hospitals may not have biomedical engineering departments and equipment. Many deaths go unreported or are incorrectly reported, but may actually be caused by leakage current.

U.S. safety NRTL system and the CE mark and SDoC threats. A U.S. nationally recognized testing laboratory is a third party agency that ensures the highest level of safety and security needed for electrical products. Conversely, SDoC and CE mark are not product safety programs. A current issue of serious consequence for healthcare facilities (and also consumers) is the repeated attempts by special interest domestic and foreign computer manufacturing groups to gain acceptance of supplier declaration of conformity (SDoC). This special interest group is again pressuring OSHA to allow these products to be sold on the market as equivalent of a U.S. listed product (UL or equivalent). SDoC is a self-declaration program similar to the CE mark self-declaration.

This means that a company from anywhere in the world can simply declare their product meets the international electrical safety standards. In the testing laboratory business, we see these self-declared products come in for evaluation and certification for North America on a regular basis. Some of these products are so far away from being compliant that they represent an immediate hazard, especially for fire and electric shock. Recently, the EU has considered an additional product safety mark because of faulty, counterfeit and misrepresented products coming in from Asia. For the U.S., this SDoC program would mean that these cheaply made, non-tested products like computers will end up in our homes and in our healthcare facilities.16

Fortunately, we still have the OSHA federal law for the workplace, 29CFR1910.303 and related sections which requires all electrical equipment in the workplace to be certified by a nationally recognized testing laboratory.17 In addition to reputable and knowledgeable manufacturers, biomedical departments and firms, our NRTL engineers and inspectors are daily maintaining and improving the levels of safety with their work in the testing laboratory, and in the workplace with onsite testing and labeling.

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.

Politics + Electricity = Death

Politics + Electricity = Death

The laws of physics cannot be changed to suit a particular purpose. Lives saved by accomplishments of product safety and hospital biomedical professionals are in the tens of thousands and possibly more. The science behind prevention of death from electricity has guided the requirements of national and international safety standards. The history of electrical safety for medical equipment is the history of U.S. industry, engineering, government and testing laboratory professionals developing consensus safety standards. These requirements cannot be sacrificed to suit the plans of any special interest group. It’s a formula for disaster: Politics + Electricity = Death. Where electrical safety is concerned it’s better to abandon politics and just do the right thing. In the case of medical equipment and electrical safety testing, we need to be allowed and encouraged to keep doing the right thing to protect our families, friends and communities.

References

1 Swerdlow, C.D., and W. H. Olson, M. E. O’Connor, D. M. Gallik, R. A. Malkin, and M. Laks. “Cardiovascular Collapse Caused by Electrocardiographically Silent 60-Hz. Intracardiac Leakage Current: Implications for Electrical Safety.” Journal of the American Heart Association, (1999) 99: 2559–2564.

2 UL 544: Medical and Dental Equipment, 4th ed., (Northbrook, IL, Underwriters Laboratories,1998).

3 Eisner L, R. M. Brown, and D. Modi: “Leakage Current Standards Simplified.” Medical Device & Diagnostic Industry Regulatory Outlook, (2004).

4 ANSI/AAMI ES60601-1:2005, Association for the Advancement of Medical Instrumentation, (2006).

5 UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety. (Northbrook, IL, Underwriters Laboratories, 2003).

6 UL 1950. Safety of information technology equipment, including electrical business equipment, 2nd ed. (Northbrook, IL, Underwriters Laboratories, 1993).

7 American National Standards Institute, ANSI C101-1992: American National Standard for Leakage Current for Appliances. (Northbrook, IL, Underwriters Laboratories, 1992).

8 “The FDA’s Deadly Gamble with the Safety of Medical Devices,” Project on Government Oversight, (February 19, 2009).

9 S-540: Medical Device Safety Act of 2009, (HR 1346), 111th Congress of the United States.
10 Mundy, Alicia. “FDA Chief Eyes Device Group.” The Wall Street Journal, (June 17, 2009).
11 Bruner, J. M. R., MD. “Hazards of Electrical Apparatus.” Anesthesiology 28 (Mar.-Apr. 1967):396–425.

12 Linko, K. “Testing a New In-Line Blood Warmer.” Anesthesiology 52 (1980):445-456.

13 Singleton, R. J., G. L. Ludbrook, R. K.Webb, and M. A. Fox. “Accidental Toppling of a Fluid Container Causing Spillage onto a Blood Pressure Monitor.” Anaesthesia and Intensive Care, (1993).

14 Singleton, R. J., G. L. Ludbrook, R. K. Webb, and M. A. Fox. “Electric Shocks to Anaesthetists after Touching a Faulty Device and the Chassis of Another Device Simultaneously.” Anaesthesia and Intensive Care, (1993).

15 Atkin, D. H. and L. R. Orkin. “An anaesthetised patient was connected to an ECG device that had been wired wrongly with the earth and neutral connections transposed.” Anaesthesiology, (1973).

16 Federal Register (at www.osha.gov). For more information on SDoC, go to www.osha.gov and type “SDoC” into the search box.