Health care facilities are an
integral part of our lives. We regularly visit them
ourselves and take our loved ones to them for care. We
assume that we are taking them for help and improvement,
and that the technology being used will not cause harm.
We think of electrical power as something that exists
for our benefit, as a convenience or a tool. Electrical
equipment surrounds us and we rarely consider the
potential dangers that lie within. We are focused on the
expected result: That a heart pump will sustain life
during a delicate surgery; that a monitor will display
vital information to nurses and doctors; that an X-ray
image will be transmitted to the film. We feel confident
that the medical and laboratory equipment will be safe
for our family and our healthcare workers. We
unconsciously rationalize that healthcare facilities are
safe havens, places were injuries are treated, not
caused. We suppose that there must be someone who makes
sure the facility will continue to operate properly and
protect us from harm. It would seem reasonable that the
hospital has taken measures to protect our loved ones
and us from improperly built medical equipment. In
reality, how safe are we? Who is responsible for
ensuring that the equipment won’t expose us to
electrical fire and shock hazards?
In the product safety profession, we
get answers to these questions in the course of
performing product inspections and testing. Over the
years we have found that the sense of security that we
feel at healthcare facilities is often false. We have
discovered a good number of healthcare professionals in
many areas of the country are aware of the issues with
electrical safety of equipment. They inspect incoming
equipment, set up regular test programs, and instruct
the staff to ask questions when selecting new or used
products. We have also found that many more healthcare
facilities appear to be doing nothing or very little
with equipment safety. We are finding that many areas of
the U.S. and Canada are disturbingly silent. Entire
states and cities have hospitals and clinics that never
call for a testing laboratory inspection, never inform
their equipment vendors that testing laboratory marks
must be on the equipment they are selling. On a
consistent basis we inspect equipment that is so far out
of compliance it represents an immediate hazard and
could cause injury or death at any moment. What about
your hospital? Your dental office? While you are there
to improve your health, are hazards present that could
cause you worse injury or even to perish before your
time? If you are not sure, are you comfortable with
that? You might say, "Surely somebody is watching
out for us, right?"
Photo 1.
Authority
Having Jurisdiction
In the beginning, there was an authority having
jurisdiction. This was very clear to the architects,
engineers, contractors and property owners: Every major
decision affecting public safety was overseen by
qualified inspectors and plans reviewers. Something
needed improvement; changes had to be made; electrical
products installed required third party certifications.
Delays were necessary while everybody worked hard to
raise the level of safety. Sometimes tempers flared,
especially when time became a factor. Eventually, the
project was complete and the hospital staff started
moving in, the medical and dental offices were ready for
business. Contractors picked up the last of their tools
and materials, and owners breathed a sigh of relief.
After a short period of time, almost nobody thought
about the authority having jurisdiction anymore. Their
work was done. Not much later, more equipment was
bought, new people were coming every day, and the
electrical inspector wasn’t there to watch over the
process. So now who has the authority and
responsibility?
The National Electrical Code,
NFPA 70, defines the responsibility this way,
"Where public safety is primary, the authority
having jurisdiction may be a federal, state, local, or
other regional department or individual such as a fire
chief, fire marshal, chief of a fire prevention bureau,
labor department, or health department; building
official; electrical inspector; or others having
statutory authority." Now, the doors are open, but
who has statutory authority? Who will ensure workplace
safety? Electrical and building inspectors may never
know the specifics of equipment purchased and installed
in a healthcare facility. Sometimes a permit has to be
pulled. In these cases, the inspector may have an
opportunity to get a close look at the equipment. But
what about the rest of the time? After all, the day
after such an installation might be the day a complex
piece of equipment arrives on the dock and needs to be
connected or plugged in. Who is responsible now? Will
someone exercise the authority needed for public and
employee safety?
Photo 2.
Hospital and
Biomedical Engineering, Purchasing
In the hospital, there may be several people with the
authority to carry on the role of the inspector, whether
or not they realize this role. Hospital engineers can
oversee electrical equipment installations, biomedical
engineers test and repair equipment. Purchasing managers
can specify equipment listing and labeling requirements
in purchase orders and contracts. In many hospitals,
purchasing and materials management inspects equipment
before it is delivered to biomedical or hospital
engineering departments. Many hospitals do not. What
about doctor’s offices and clinics?
Many states and jurisdictions have
lists of acceptable third party testing agencies
qualified to list, label, and field evaluate
non-certified equipment. Most of our inspectors are
familiar with these lists, and many reference the OSHA
Nationally Recognized Testing Laboratory (NFTL) list www.osha.gov/dts/otpca/nrtl/index.-html.
This list can be accessed on the www.osha.gov website, by selecting "n" on the alphabetical
index, then scrolling down to the Nationally Recognized
Testing Laboratory link. This site also shows examples
of certification marks:
Do all purchasing departments inspect
incoming equipment for these marks? Do all biomedical
technicians look for these marks before testing and
applying an "approved" label?
Photo 3, Photo
4, and Photo 5. Used
equipment for sale: Where’s the label? This equipment
was found for sale on the internet, using the search
phrase "Used medical equipment."
John Palmer, clinical engineering
manager for Carolinas HealthCare System in Charlotte,
NC, explains how their system works: "We have an
understanding with the Materials Management department
that all purchases for medical equipment must be
approved by the director of corporate clinical
engineering. This opportunity allows us to ensure all
the proper certifications are in place before the
equipment arrives at the hospital. Additionally,
Clinical Engineering checks in all medical equipment
upon arrival whether it is a new purchase,
demonstration, loaner or evaluation to ensure the proper
requirements are met."
As John and his staff know, most
certification marks will be placed on the product near
the electrical ratings label. If a product does not have
a certification mark or an electrical rating label, it
is most likely not certified. If the product markings or
ratings are questionable, or appear incomplete, the
testing laboratory can verify the status of the product
manufacturer, model and serial number. Then, if it is
determined that the equipment is not certified, a
decision can be made. The healthcare facility can ask
the manufacturer or distributor to have the equipment
field evaluated, or decide to look for an alternate
source. In some cases, the hospital might elect to pay
for the evaluation, or share the cost with the
manufacturer.
The Tests
So, what do these certification marks mean? There are
some common misconceptions regarding the differences
between tests that biomedical engineers perform and the
product certification evaluation and testing undertaken
by a testing laboratory. Preventive maintenance and
periodic safety tests are not safety certification.
While it is true that these tests are very important,
and have prevented many potential disasters, they are
not safety certification. To further confuse the issue,
the "CE" label appears everywhere, and is
represented as an assurance of electrical safety.
Unfortunately, a "CE" mark, by itself, means
nothing in comparison to the North American conformance
assessment processes. "CE" stands for
"conformity European" and that means the
product meets the Europeon directives. This is a summary
of the differences:
As this table illustrates, there are critical differences. Very often
listing certification testing is potentially destructive in nature, or required to be intentionally destructive. For example, abnormal condition testing for
temperature may include blocking the vents on a product.
Other tests may also be required, such as: short circuit
tests, hazardous energy tests, flammability of plastic
enclosures, over-voltage tests, leakage current and
dielectric strength after humidity conditioning,
stability and impact, grounding system impedance, and
many more. All these tests are related to undesirable
consequences in product failure, resulting in shock or
electrocution, combustion, fires and explosions, even
chemical and radiation injuries and deaths. Testing
laboratory project engineers use current product
standards and receive intensive training to select these
tests and make sure they can be repeated with the same
results. Some of these tests rely on special circuits
specified by the product standards. Without a test
program indicated by the product safety standard, all
the passing and failing results might never be seen.
Column 3, preventive maintenance,
shows which of these tests are performed by biomedical
or clinical engineering staff in a hospital or clinic.
These tests are critical, even for a testing laboratory
certified product. All the pieces of medical equipment
represent an enormous investment to a healthcare
facility, and when a regular testing program is
established, a higher level of safety is achieved. In
this way, testing laboratory and biomedical engineers
work together to ensure a "healthy" lifetime
for the equipment. Still, these tests represent only a
small number of the tests required by the testing
laboratory. Without a certified product, these
preventive maintenance tests may only protect us for a
short period of time.
As column 4 shows, products marked
only with "CE" represent even more unknowns.
Some of these products only bear the letters, and
nothing else has been done. Some come with paperwork
from the manufacturer assuring us that the product meets
certain U.S. standards or European directives. In some
cases, actual testing has been done, but in many
instances, the manufacturer does not even have any staff
qualified to perform tests or review the applicable
requirements. Testing laboratory engineers often get to
see if these CE marked products really comply. They
rarely do. Some are so far from safety compliance that
the company has to completely redesign their product.
The
Evaluation
Certified products also undergo rigorous construction
evaluation. Many pieces of non-certified equipment may
pass the basic biomedical engineering tests, but due to
their construction, represent a high degree of risk.
Incorrect construction can result in internal wiring and
component failure. These failures are likely to result
in electrical fire, electrical shock hazard, energy
hazard, chemical hazards, radiation or mechanical
hazards. These hazards directly affect the well being of
the medical staff and patients.
In this table,
you can see that the testing laboratory performs the
only evaluation that will ever be done. Hospital
biomedical engineers or contract biomedical testing
technicians will most likely never be aware of these
evaluation categories. Again, a CE mark gives no
assurance these evaluations have been done. Some
equipment manufacturers mistakenly assume that building
a product from certified or "recognized"
components assure their equipment won’t cause fire or
electrocution. In product evaluation, we see that there
are unlimited ways of combining certified components in
an electrical product. Unfortunately, many of these
construction methods might result in electrical fire or
shock.
Doctor and
Dentist Offices Are Healthcare Facilities
NEC 517.2 defines a healthcare
facility as "Buildings or portions of buildings in
which medical, dental, psychiatric, nursing, obstetrical
or surgical care are provided. Health care facilities
include, but are not limited to, hospitals, nursing
homes, limited care facilities, clinics, medical and
dental offices, and ambulatory care centers, whether
permanent or moveable." For some reason, many
people don’t consider doctor and dentist offices to be
healthcare facilities. Even chiropractors’ offices are
healthcare facilities by this definition, because they
use, for example, electrically operated beds. Next time
you are in your doctor’s office, take a look around.
Is the equipment certified by an approved testing
agency? Are the receptacles in patient areas
"hospital grade"? Is the equipment subject to
preventive maintenance tests and safety testing? Again,
our records and the records of other testing labs show
that many jurisdictions may not be paying particular
attention to these facilities. The jurisdictions that do
scrutinize these facilities are asking questions about
equipment that will be installed and plugged in. Owners
of these facilities are asked to show proof that their
equipment will not be hazardous to their patients before
being granted their certificate of occupancy. The proof
required is a listing certification mark or a field
evaluation label.
Leakage
Current, IT and Television Equipment
Many product standards include requirements for leakage
current testing, but the testing for medical products
has the most stringent and specific of these tests and
acceptable limits. For example, there are different
requirements for patient vicinity, non-patient
vicinity, isolated patient contact, non-isolated
patient contact, and patient applied voltage.
In general, leakage current can be defined as the amount
of current that flows through the grounding conductor,
and would flow through the human body if a piece of
equipment lost its grounding conductor. Only a few years
back, it was discovered that patients were dying on the
operating table from small amounts of current. As it
turns out, the human body is especially susceptible to
electrical shock when the skin is broken or open. It
only takes a small amount of current in direct contact
with the skin to cause cardiac arrest in a healthy
person. With patients in healthcare facilities, the
acceptable limits are very low, measured in
microamperes. Some limits for leakage current are as low
as 10 microamperes.
Medical products are certified with
the end use specified in the manuals. Sometimes
certified products end up in the wrong place. For
example, an ordinary television or office computer may
end up in a patient area or surgery room. These products
would most likely not pass the requirements for medical
equipment. In a situation where a patient was especially
vulnerable, they could cause shock or cardiac arrest.
Keep in mind, healthcare workers are often touching the
equipment and the patient at the same time, increasing
the exposure to hazards from improper equipment.
For the
Benefit of My Patients
The above powerful words of Hippocrates have been sworn
to by medical professionals for centuries. However, in
the 21st century, the implications are new.
The practice of medicine is inextricably tied to the
equipment we use, and the electricity that powers it.
Many doctors, nurses and health clinic employees are
unaware of the requirements for equipment certification.
Doctor’s offices, urgent care facilities, dentists and
eye doctors do not have engineering departments, and few
have contracted biomedical engineering firms to test
their equipment. Does this mean that doctors might be
unintentionally doing harm to the patients they are
sworn to protect?
The facts are evident when we look at
the results from field evaluations of healthcare
equipment. We knew the numbers were high, just from
remembering how many pieces of medical and laboratory
equipment failed on the first inspection. Still, it is
surprising to see the types and amounts of serious
hazards this non-certified equipment represents. These
days, a good percentage of the new equipment being sold
is safety certified at the factory, but the amount of
used equipment still in use and still being sold is
staggering. From the testing records, we estimate that 8
out of 10 pieces of equipment field-evaluated failed on
the first evaluation. After this initial evaluation,
these healthcare facilities often elect to discontinue
use of some equipment, rather than attempt to get the
manufacturer or distributor to make changes and repairs.
The failures uncovered are critical, including: risk of
fire; risk of electrical shock; incorrect grounding
methods; unknown flammability of plastic enclosures;
non-certified components and test failures.
Knowing this, will you have that
false sense of security the next time you go to the
hospital or doctor’s office? Ask some questions, look
at the equipment being used. If you cannot immediately
determine if a product has been safety certified, ask
your nurse or doctor. If they are unsure, ask if you can
speak to someone in biomedical engineering or hospital
engineering. Ask if they know about the rules for
equipment purchasing, and what kinds of incoming
inspections are performed. If you can’t get any
satisfactory answers, there may be trouble in your
healthcare facility. You may want to make some calls to
some other facilities, check with some safety
organizations. After all, this is where we take our
families, and there may come a day when our citizens are
calling you, asking these questions.
Together, we have the responsibility,
some of us actually have the authority. Consider the
definition of authority having jurisdiction from the
NEC, and the phrase, "statutory authority."
Since statutory is defined as "enacted, regulated,
or authorized by statute." Statutory authority for
healthcare facilities may include a number of local or
state people, but most certainly the electrical
inspector. On hospital construction projects, our AHJs
will most likely be aware that equipment is being
installed that needs to be examined for a testing
laboratory certification or labeling. X-ray and nuclear
medicine, physical plant equipment and HVAC, water
purification equipment will be inspected for the correct
safety certifications. But what about the equipment that
comes later? What about all the cord-connected equipment
that will be brought in? Many inspectors are unaware of
the dangers posed by non-certified equipment that is
cord-connected. In fact, cord-connected equipment is
more likely to lose its ground and expose people to
leakage current and shock. Unfortunately, our inspectors
may never get to see this equipment.
Get more involved with your
electrical safety counterparts in the healthcare
community, especially biomedical engineering and
hospital engineering professionals. City/county
electrical inspectors and testing laboratory inspectors
can benefit from an association with these people and
their organizations. For example, on a national level,
there are ASHE and AAMI. ASHE is the American Society
for Healthcare Engineering; their website is www.ashe.org . AAMI is the Association for the Advancement of Medical
Instrumentation, and can be found at www.aami.org . On your state level, there are also many resources you
can call upon. For example, in North Carolina, there are
the NC Biomedical Association (NCBA), and the NC
Healthcare Engineer Association (NCHEA). In Florida
there is the Florida Healthcare Engineering Association
(FHEA), working with the Agency for Healthcare
Administration (ACHA). These are just some examples of
the organizations available for your interaction.
Consider making arrangements to visit your local
hospitals and clinics. It might be beneficial to attend
their meetings, and invite them to yours. Working
together, we can help to increase the level of safety in
our healthcare facilities.
Equipment that has not been tested by
an accredited testing laboratory represents potential
risks to patients, doctors, and other medical and
service personnel. Healthcare engineering, biomed
departments and contract biomed service companies need
to be aware of these risks, and be vigilant in reporting
any non-certified equipment to their risk management and
facilities engineering departments. But when it doesn’t
get reported, it will still be there: in your
jurisdictions, in our communities.
Greg
Smith is an IAEI inspector member and a project engineer
for MET Laboratories in Morrisville, NC, with over 10
years of product safety evaluation experience. Greg can
be reached at 800-321-4655, by cell phone at
919-524-4555, or by e-mail at gregs@fieldlabeling.com
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