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.