Understanding the importance of using certified electrical equipment can support cost savings and protect lives
By Greg Smith, NCE
The health care environment contains a multitude of electrical equipment used to diagnose and treat various medical conditions. Despite the number of devices categorized as electrical equipment, such as patient beds, blood pumps, and x-ray equipment, many health care facilities still have no real process for identifying electrical equipment lacking a safety certification for North America. This may surprise some people, but after 20 years of inspecting noncertified products in the workplace, the numbers are astounding. Not only are facility owners largely unaware of the risks and requirements, but also manufacturers and distributors. Noncertified medical equipment is especially troubling because of its complexity and because of its potential risk of shock and fire—affecting both patients and medical staff.
What are the Federal Requirements for Electrical Safety in the Workplace?
United States federal law (the US Department of Labor, Occupational Safety & Health Administration, or OSHA) requires that all electrical equipment in the workplace be listed or labeled by a Nationally Recognized Testing Laboratory (NRTL), with very few exceptions. The NRTL program is part of OSHA’s Directorate of Technical Support and Emergency Management. You will find links to the regulations, definitions, and OSHA interpretation letters in the sidebar (page 21).
In addition to these requirements, there are also several state, county, city, and other municipality regulations for certification of electrical equipment. In addition, insurance companies and company attorneys often recommend electrical safety certification to protect their customers and limit monetary damages and human casualties. Health care purchasing departments can be a great help by including specific language in contracts and purchase orders. For example, contracts may contain the following: “This equipment will only be approved for purchase and use if it is listed or labeled by a Nationally Recognized Testing Laboratory.” This simple statement has saved a great deal of money and headaches, and in many cases has made it easier for the buyer to insist that the manufacturer or distributor pay the cost of on-site inspection and labeling.
Defining and Comparing
What are the definitions of field evaluation and labeling? How does labeling compare to listing? If a product can be determined to have a valid US product safety certification, it is considered to be listed. The term “listed” has been around for many years, and it simply indicates that a product is on a list of certified products by an NRTL. This process allows a manufacturer to label the equipment before it leaves the factory. It also includes surveillance audits, or unannounced factory inspections. These surveillance audits are required as part of the NRTL accreditation, and if a manufacturer fails these audits it can be prohibited from continuing to use the MET label on its products. In some cases, the authority to use the label is suspended until deficiencies are corrected. The MET label refers to MET Laboratories, an independent electrical testing and certification lab that is qualified to NRTL certify products for compliance to electrical safety standards.
Field evaluation, also referred to as field labeling, is the evaluation and limited nondestructive testing of equipment that has not been through the certification process by the manufacturer. Large and permanently connected equipment is almost always inspected on-site, but many times smaller cord-connected equipment can be shipped to the testing laboratory for inspection and testing. Why has this equipment never been certified? There are a variety of reasons. Some products are specialty, new, or custom made. Other equipment is from outside of North America, and these manufacturers have limited knowledge of US requirements. Very often, manufacturers of medical equipment simply delay going through the process until it becomes too big a burden or hassle for the buyer. Laboratory equipment is even worse in this regard.
How to Recognize a Noncertified Product
If a manufacturer has been through the certification process, there will be an actual mark somewhere on the equipment, usually near the electrical nameplate. Although there are many third-party agencies that can evaluate electrical equipment, only a handful are qualified to test and label medical equipment. The OSHA website lists NRTLs that are accredited to certify medical equipment. Under the link for each of the labs, you can view the standards for which they hold accreditation. Several of these organizations also provide field evaluation and labeling of medical equipment. A report accompanies the label when field evaluation labels are applied. If there is any question about the validity of the label, you can ask for the report—the equipment owner needs to keep these reports available. Most testing laboratories also have an area on their websites where any potential problems or irregularities can be reported. The bottom line is this: If a product does not have a valid and recognizable label on it from an NRTL accredited for certification of medical products, it is most likely noncertified equipment and should be rejected, either in purchasing or during incoming inspection by the health care facility.
What is a CE Marking?
This is another issue that is not well understood, and is often misrepresented by manufacturers and distributors. CE stands for Conformity Europe and is a self-declaration for most categories. Medical is somewhat different, because the Medical Device Directive—intended to harmonize the laws relating to medical devices within the European Union—requires these manufacturers to undergo a quality systems assessment, similar to ISO 9000, and there are more detailed requirements for initial product testing and reporting. Still, unlike the US and Canada, there are no requirements for surveillance of the actual products manufactured. Therefore, products can be altered and modified without oversight or factory inspections of products and test records. European law places the responsibility on the manufacturer, and a manufacturer that is found to have incorrectly or inadequately evaluated and tested a CE-marked product can be sued in international court, even resulting in potential fines and imprisonment.
In the US, the responsibility is on the owner of the workplace, such as the hospital, clinic, etc. In North American testing laboratories, product safety engineers find major and minor deficiencies with CE-labeled equipment every day. So, if a manufacturer or distributor says, “You can accept this; it is CE certified,” that is absolutely incorrect. CE is not a valid or legal process for equipment in the US workplace. To illustrate this, just ask a manufacturer for the phone number and address of the office that controls CE markings—it does not exist.
Deficiencies of Noncertified Products
An electrical fire hazard is primarily the result of improper fusing. Incorrect fusing or inadequate overcurrent protection negates the safety functions of protective devices, and in a fault (or failure) condition it can cause wiring, circuits, or electrical components to heat up to the point of combustion. The fire may then consume the equipment and spread to other pieces of equipment and/or the facility.
Shock hazards exist for a number of reasons, including incorrect wire routing, improper grounding, untested (non-suitable) components, and the absence of proper danger/warning markings. As an example of shock hazard, if a fuse holder is wired incorrectly, it may still provide protection to the equipment, but operators and service personnel can be shocked while attempting to replace a fuse. Electrical shock affects anyone coming into contact with the equipment (operator and service personnel), and can result in temporary and permanent injury or death.
Safety markings are for the protection of equipment operators and service and maintenance personnel. For example: If a device cover has accessible sources of electrical power when opened, it needs to be marked, “Warning—Risk of Electric Shock. Disconnect Both Before Servicing.” Without this marking, service personnel might forget that power is still connected and would then be exposed to a shock hazard. Also, lawsuits can be better avoided or awards lessened.
Improper grounding: There are many ways of improperly grounding electrical products, depending on the type of equipment. Many pieces of equipment reviewed have inadequate or no provisions for grounding. If the ground connections are not correct, and there is a wiring breakdown or component malfunction, the electrical path to ground becomes the human body, thereby exposing the individual to the risk of shock. Proper review of the supply ground and other equipment bonding (secondary grounds) in accordance with the applicable standard is the only way to verify the integrity of the overall product grounding. For example, is the ground configured so that the connection is “dedicated”? In other words, if a secondary ground is removed, does it require the main ground to also be disconnected? Is the ground connected to a screw or other part used to mount a component? If a machine screw is used, does it have the minimum number of threads in contact with the enclosure or mounting surface? These requirements come from the product standards and are not common knowledge.
Noncertified components represent another area of deficiency. Many electrical components that make up a piece of equipment have never been tested by an accredited testing agency. This means that the safety and reliability of these parts may have never been tested or verified, and their use could represent the risk of shock injury to the operator, and/or a fire hazard. Often, the solution is extra protection added for the component (eg, a fire screen or a ground fault circuit interrupter—GFCI), or replacement. Some components have the appropriate certifications, but are not marked, and must be checked by referencing tested component directories or information from the manufacturer to determine suitability. Even “certified” components can be used incorrectly and represent fire and shock hazards.
Test failures: Tests performed are the applicable tests from the current product safety, UL, ANSI, or NFPA standard. If any of these tests are failures, this immediately identifies a product that has been damaged, incorrectly manufactured, or improperly installed. When a product passes these tests, this ensures an established level of safety for the actual tests performed in the field.
Product construction issues and failures may include inadequate wire or cord size for the voltage and current, holes in enclosures that require airtight seals for protection from fire, missing or incorrect grounding, untested or custom components, equipment with plastic enclosures using material not tested or rated for flammability, and many others. These issues again represent potential fire and shock hazard to operators and equipment technicians.
NFPA 99 Changes and Product Certification
Recent changes to NFPA 99, specifically the removal of electrical testing requirements, have some important implications for how electrical product safety is handled. Since many facilities may eventually abandon some periodic testing programs, it becomes even more important to screen equipment before purchasing it. When a piece of equipment is purchased that has passed the NRTL requirements, certain things can be assumed: These products have been examined down to the component level and for correct electrical construction, abnormal and fault tests have been completed and successfully passed, the manufacturer is subject to regular unannounced factory inspections to assure the continued correct construction of the product, and production line testing is performed on all units being labeled before they leave the factory. These assurances are important to consider if a decision is made to discontinue any regular electrical safety test program being performed by the health care facility.
Choosing a Testing Laboratory
When you select a third-party testing agency or NRTL, there are several things to consider. It is best to choose an organization that has experience in your category of equipment (eg, medical or laboratory). Also, you may want to select an agency that will be recognized by any local electrical or building inspections department—in case the evaluation is part of a construction project. The price of the project is always a consideration, but so is the ability to get the project done according to a specific time frame.
The electrical product safety system in the US is designed to protect everyone involved. It protects the manufacturer from product liability lawsuits (that can result in bankruptcy), it protects the owner of the workplace from employee injury and death, and it protects the unsuspecting public and patients from hidden electrical dangers. All this protection saves unnecessary cost, but more importantly, it saves lives. 24×7 Feature Story April 2013
Getting to Know OSHA
Below, find links to the regulations, definitions, laboratories, and OSHA interpretation letters regarding its Nationally Recognized Testing Laboratory (NRTL) program:
OSHA’s list of NRTLs: www.osha.gov/dts/otpca/nrtl/index.html
29CFR1910.303a—Subpart S—Electrical: http://www.gpo.gov/fdsys/pkg/CFR-2002-title29-vol5/html/CFR-2002-title29-vol5-sec1910-303.htm
OSHA Interpretation Letter—All Equipment Must be NRTL Approved: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=23890
OSHA Bulletin: Certification of Workplace Products by Nationally Recognized Testing Labs: http://www.osha.gov/dts/shib/shib021610.html
An example of marks NRTLs use to certify products for the purpose of OSHA product-approval requirements: http://www.osha.gov/dts/otpca/nrtl/nrtlmrk.html#1
Greg Smith, NCE, a nationally certified product safety engineer, has inspected thousands of products in the testing laboratory and in the field for 20 years. For more information, contact firstname.lastname@example.org.