Not Suitable For Medical Use - Electrical Safety Testing Under Attack

You"re on the operating table, the surgery is almost over. The procedure has gone well. The doctors and nurses are walking in liquid on the floor covered with antiseptic, your blood, and other fluids. As your doctor is making the final repairs, a nurse is at the computer typing in some data; then she turns to assist the doctor, steadying herself with one hand on the computer monitor. As she touches the doctor, the faulty PC sends its stray current through both of them and directly into your heart. They feel almost nothing, but you are especially vulnerable and in a few seconds, it"s too late, the damage has been done.

How could this happen? Let"s examine the situation more closely and try to determine what might have gone wrong. In this unfortunate scenario, a number of things happened because of what people and organizations did and did not do. A special interest group of foreign computer manufacturers brought great pressure to bear on OSHA and bullied them into accepting only a "manufacturer"s declaration," as evidence of product safety. (For those of you who don"t know, this is equivalent to the CE mark). A national healthcare organization worked hard to have leakage current requirements stripped from NFPA 99. An IT department put a regular computer in a patient area and the cord became pinched, causing the ground wire to contact a metal frame. It"s possible there were people on consensus document committees who allowed this happen for "political" or other unknown reasons. Some other people in healthcare safety knew what was going on, but were afraid to act against these organizations. So now, the biomedical engineers were not allowed to test the computer. The hospital administration and the IT department forced purchasing to order regular consumer-type computers for the operating rooms. The doctors and nurses did not even think to consider whether they might not be safe to use in the OR environment. You checked into the hospital not worrying about electrical safety of the equipment. In this story, you are now a victim of negligence and careless tampering with safety requirements. Too late.

Maybe it"s not too late. Maybe we can influence people and organizations; maybe we can have an effect on the outcome. It will take perseverance and patience, and it will not be easy. Electricity is invisible, which makes attacks on electrical safety so prevalent. In the beginning of the modern use of electricity, many buildings and houses burned, and many basic improvements were made to prevent fires. At that point in time, people were very much aware of the hazards of electricity. It was feared and respected. In the twenty-first century, we have three decades of improved levels of safety and three decades of safety professionals who have helped to protect people from these hazards. These days, many people only think about electricity when the power goes out. Periodically, we need to re-educate the public and professions so that people in the workplace don"t become complacent.

Can computer and non-certified equipment in hospitals kill patients? Product safety and biomedical engineering experts know the answer is "yes," so do designers and manufacturers of safety-certified medical equipment. Why then would an organization like ASHE (American Society for Healthcare Engineering) attempt to potentially cripple U. S. safety standards and pressure The Joint Commission (TJC) to have this testing stopped? At the same time, when it comes to the subject of inspection of equipment for U. S. certification and enforcement of existing laws, ASHE is silent. Why are ASHE and The Joint Commission not aggressively encouraging the proper testing and deployment of computer equipment in hospitals under existing regulations and safety standards?

The following is a quote from a letter written in February 2009 by ASHE to The Joint Commission: "This is a rather timely subject as ASHE is working hard to debunk a lot of legend behind leakage current and with it remove it from NFPA 99". Our proposal has passed the public comment stage and has been accepted by the technical committee. So we anticipate a significant reduction in requirements for the 2010 NFPA 99 and hope for elimination in the 2013 edition." Clearly, this shows ASHE"s intention to reduce the present level of safety currently in place. It"s important to consider that ASHE likely has no electrical product safety professionals in their "working groups."

The Joint Commission, formerly The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), has also never taken a firm position on certification and testing of medical equipment; instead, relying on each organization to police itself and attempt to identify and maintain safety-certified equipment. A search of the JCAHO website (www.jointcommission.org) reveals that there are no references to safety of electrical equipment, UL Standards, certification of listed equipment, or leakage current. Also, there is no mention of 29CFR 1910 Subpart S, which requires all equipment in the workplace to be listed or labeled by a nationally recognized testing laboratory (NRTL). The term listed equipment means that equipment is certified by a U. S. NRTL, including the use of applicable standards, in this case UL 60601.

What is leakage current and how does it directly affect the human body? If a piece of equipment is designed with improper grounding or the grounding is compromised, this will result in direct or indirect harm to high risk and other patients. Normal use of portable, cord-connected equipment can lead to the risk of leakage current due to wear and tear on cords and plugs. Also, if a connection plug is incorrectly re-attached, exposure to leakage current will result. These anticipated conditions and the resulting leakage current can cause cardiac arrest.

Studies on the effects of leakage current on humans show that leakage current will cause cardiac arreste in certain patients, especially for high-risk patients. However, everyone involved with patients or present in these areas is exposed. For example, if a healthcare worker touches a piece of equipment with higher-than-safe leakage current and also touches the patient, the patient and the healthcare worker will be put at risk. If a piece of equipment is worn or damaged, the likelihood of shock or energy hazard increases. 1

Electrical safety standards are written due to deaths and/or because of obvious, imminent, scientifically verifiable threats to human life and well being. This applies to many aspects of product safety, including grounding, dielectric voltage withstand, leakage current, short circuit, abnormal conditions, single fault/multiple fault temperature/overload, explosion, radiation and chemical hazards, incorrect use of components and more.

For medical equipment, the primary standard for many years was UL 544, Safety of Medical and Dental Equipment.2 This standard also requires that power supplies be certified as protecting any low-voltage circuits, and often sets requirements for medical grade cords, plugs and other components. UL 544 was an Underwriters Laboratories (UL) standard, a consensus product safety standard, and was created with cooperation from product safety engineers, design and manufacturing specialists, medical/biomedical and inspection authorities. Products that met this necessarily strict standard became the best performers in healthcare in the U. S. and international safety agencies. In the last edition of UL 544, leakage current for ground to chassis was 300 microamperes, (300 A). Depending on the specific medical device, leakage current limits are as low as 10 A. For example, a non-patient connected device like a spirometer (connect to the patient by a plastic tube/air only) requires a maximum of 300 A leakage current from chassis to ground. An electrosurgical generator, for example, is in direct patient contact with applied voltage, so the limits are extremely low, in some cases as low as 10 A.3

UL 60601 is the U. S. version of an internationally "harmonized" standard, from the original (International) IEC 601. The U. S. version contains national deviations to account for differing voltages and national requirements for the United States. The leakage current limits and electrical safety requirements are very similar to the UL 544 limits. The AAMI Standard, used by biomedical technicians, is similar to IEC 601, and requires a chassis to ground maximum of 500 A. 4 The advantage of the harmonized standards is the ability of testing laboratories to complete the final items for U. S. certifications. Despite the differences, the requirements for leakage current are now similar worldwide. Another result of this harmonization is that X-ray equipment, including portable X-ray units, are now subject to the 60601 requirements. NFPA99 has similar testing requirements and leakage current limits.5

Why is certain equipment not suitable for medical use? Why does medical equipment undergo different/more rigorous evaluation and testing than other categories of equipment? Why would unsuitable equipment be moved into ORs, ICUs and other patient exam areas?

For medical equipment, added safeguards and testing are required. There are many areas where such medical grade equipment needs to be used: operating rooms, emergency, intensive care units, and all patient care and exam rooms. Listed medical equipment often has special markings, such as "Do not use in the presence of flammable anesthetics," and "Grounding reliability can only be achieved with the use of a hospital grade receptacle." When you see this kind of equipment and hospital grade receptacles in the facility, then you will know that other equipment in these areas must meet the requirements for medical use, such as computers, computer monitors, x-ray film viewers, etc. 6

Many pieces of equipment do not belong in these areas, such as: microscopes or other laboratory equipment, regular "consumer" computers, office furnishings or lights not listed for medical use, and many other products.7 Still, there are many healthcare facilities that have no incoming inspection for equipment, or no one on staff that would recognize a non-certified piece of equipment. Many distributors do not even know the difference; while some do know and try to pass off CE marking as a certification mark. (CE is not a certification mark). Sometimes, physicians request very new or prototype equipment directly from a distributor or manufacturer, thus bypassing any incoming inspection by biomedical engineering or purchasing procedures that might be in place. Much of this new equipment has never been tested for safety, and can put the physician and the healthcare provider in the unfortunate position of potentially harming the patients they are trying to help.

In addition to more rigorous requirements for electrical safety, NRTL-certified devices have to meet requirements for electromagnetic interference and compatibility (EMI/EMC). This means that these devices have to be designed and tested to receive interference from other devices without malfunctioning, and have to function without interfering with other devices. Equipment not certified for medical use does not have to meet these requirements. Also, many devices not certified for medical use do not meet the requirements for enclosure construction, and can be easily damaged from fluids commonly used in healthcare facilities. This compromising of a device with fluid ingress can lead to short circuits and shock, even electrocution.

There are many examples of medical equipment suitable for use in patient areas. Cybernet makes a medical grade computer (www.cybernetman.com). Maxant Technologies manufactures medical display workstations (www.Maxant.com). Both of these companies have their products listed to UL 60601. These manufacturers understand the requirements, and have testing lab certifications specifically for healthcare facilities.

Brud Sturgis is the President of Maxant Technologies. Maxant designs and manufactures equipment especially for healthcare patient and operating room environments. Brud has answers to questions about designing and building medical devices to insure regulatory compliance.

Q. What does it take for a manufacturer to excel in designing and building medical devices?

A. We need to employ an educated and highly skilled and trained electrical and mechanical engineering team. They need to understand and apply regulations such as UL 60601, as they relate to the healthcare environment. We design a custom product to meet regulations; we assemble manufacturing talent, procedures and assembly capability to build and deliver the product. This includes developing relationships among component manufacturers and design teams. We also develop the capability for proper testing and verification of each product family and individual unit shipped, and we must be able to build and ship product within very specific price and budget restrictions. As a company, we have to understand the needs, wants and expectations of all providers and users within the healthcare delivery system.

Q. How does your experience and expertise differ from a computer manufacturer?

A. Unlike a computer manufacturer, we work closely with end-users to define use parameters and identify the proper product to meet specific needs. We have to understand the in-depth nature of the healthcare delivery systems and how one modality differs from another. Our quality and design characteristics need to be of a higher standard in order to function in heavy use and lengthy periods of 24/7 use. We need to have the ability to communicate effectively with doctors and skilled IT professionals to identify needs and configure the features of each product built.

Q. Are there companies selling non-medical grade product into this market in competition with you?

A. Yes there are". however most of the major computer manufacturers are issuing disclaimers in their product literature that their product does not and is not intended to meet medical use standards in patient care areas. These disclaimers and warnings are most often ignored when reaching IT and purchasing decisions. Regardless, non-compliant equipment invariably finds its way into patient care areas, thus putting patients at risk.

Q. How do you insure regulatory compliance?

A. We had to develop in-depth knowledge of all possible regulations and requirements, then design and build units which are capable of meeting or exceeding these regulations. Every unit is tested prior to shipment to insure that all rules and regulations are met. For example, the Maxant Mediport is the only high performance all-in-one workstation designed and tested to meet 60601 and NFPA 99 requirements.

Q. How does the added requirement of meeting rules and regulations (60601 and others) translate in costing and pricing decisions?

A. To insure the quagmire of higher standards required in hospital, we work closely with federally approved nationally recognized testing labs, including UL and Met Labs. To meet these requirements, there are considerable added component costs and manufacturing expenses incurred. For example, we are required to acquire and maintain sophisticated testing equipment and procedures to insure each product built meets all appropriate standards. Also, the quality and reliability of costly components must be insured to meet the demands of high-use healthcare environments. All these factors add considerable expense to cost of goods sold while still having to meet severely limited end-user budget requirements.

Federal Law (OSHA) 29CFR1910 requires that all electrical equipment in the workplace be listed or labeled by a nationally recognized testing laboratory. Some will claim that it is OSHA"s responsibility to police safety in the workplace. Electrical safety groups such as American Council on Electrical Safety (ACES) have been working with OSHA to promote training of OSHA inspectors to enforce current laws, but it is an uphill battle for several reasons. Due to budget and personnel limitations, OSHA most often visits a workplace after someone has already died. The fact that OSHA does such a poor job of enforcement leaves the workplace owner with all the liability for injuries and deaths. When there are incidents of this nature, the workplace owner is then forced to bring lawsuits against equipment manufacturers and distributors, and anyone else responsible for bringing or allowing this equipment in the workplace. This can include inspectors, contractors, hospital safety committees, risk management directors and others.

FDA-problems and misconceptions. The US Food and Drug Administration (FDA) is the government agency concerned with many issues and areas, most having no bearing on safety of equipment. Although there are FDA requirements for medical equipment, these requirements are not generally related to electrical safety of this equipment, rather they focus on correct and reliable operation of equipment.

The FDA has an incident reporting database called MAUDE. While this database is interesting, it has no search parameters for electrical injury and death resulting from causes related to product safety. Additionally, this database is a voluntary reporting database for incidents, relying on a variety of different sources. Many of these sources are people who have no training in electrical safety, and are not even minimally qualified to judge the root cause of the incident, much less to determine if an incident was the result of leakage current. In the end, this database is not a reliable source for any scientific analysis of electrical injury or death from equipment.

The FDA also ignores the issue of electrical safety certification to U. S. standards. Many do not understand that because a device functions correctly that does not mean it is electrically safe. Additionally, The Project on Government Oversight reports that decisions by senior FDA officials in 2006 eliminated critical measures that keep manufacturers of medical devices compliant with high quality standards.8 Many other problems with the FDA make it a highly questionable source for research on the subject.

In a recent regulatory bulletin provided by Bureau Veritas, it was revealed that under the provisions of legislation introduced earlier this year in the U.S. House of Representatives, manufacturers may soon face liability for medical devices that harm consumers, even if those devices received pre-market approval from the U.S. Food and Drug Administration (FDA). The proposed H.R. 1346: Medical Device Safety Act of 2009 would amend the Federal Food, Drug and Cosmetic Act to provide legal recourse to patien