1. 425Biomedical Instrumentation & Technology November/December 2014
Features
Ebola Virus
Poses New Challenge
To Healthcare Community
Elizabeth Hollis
About the Author
Elizabeth Hollis
is the news and
social media
editor at AAMI.
E-mail: ehollis@
aami.org
This fall, several U.S. hospitals found
themselves grappling with a handful of cases
of the Ebola virus. Although facilities
expected to be prepared—particularly since
they treat other easily transmittable dis-
eases—Ebola has proven trickier.
Ebola “has really driven home having
security of public health,” said Barbara Knust,
an epidemiologist and veterinarian in CDC’s
Viral Special Pathogens Branch. She spoke at
the Interscience Conference on Antimicro-
bial Agents and Chemotherapy, held in
Washington, DC, in September.
“Weak public health infrastructure in one
place—in a little corner of the world—can
have ripple effects throughout the world,” she
said in a presentation during the conference.1
She was confident in the preparedness of
U.S. hospitals, but there are still a lot of
unknowns about the virus, causing anxiety
among healthcare workers—especially after
two Dallas nurses were infected after treating
the first Ebola patient in the United Sates.
The patient, Thomas Duncan died, but the
two nurses have successfully been treated for
the virus. “It is obvious that after the incident
in Texas, everyone is worried about Ebola
transmission in the healthcare setting,” said
Genti Koci, a sterile processing professional
formerly with Mount Carmel Health System
in Columbus, OH. “We don’t know much
about the disease, and there is a fear factor
that has spread among us through the media.”
With the situation changing almost daily,
the CDC has issued frequent updates, and
healthcare facilities are doing their best to
keep their employees safe. “We are following
CDC Guidelines and making sure all patient
care equipment is cleaned and disinfected
per the [instructions for use] (IFUs). How-
ever, we are reinforcing the correct
application and removal of personal protec-
tive equipment (PPE), which seems to be a
weak spot in this,” said Nancy Chobin, a
consultant and educator with the Saint
Barnabas Health Care System.
As Jesse Goodman, MD, attending physi-
cian at the Washington DC Veterans Affairs
Medical Center and MedStar Georgetown
University Hospital, noted during an Ebola
town hall meeting on Washington D.C.-area
radio station WTOP, facilities should be
“overclear, overtrained, and overcautious.”2
That recommendation seems to have
resonated with the healthcare community.
Donna Swenson, president of Sterile Process-
ing Quality Services, Inc, in Berwyn, IL, has
advice to keep facilities prepared. “Both when
performing surgery and after the procedure
when cleaning the instrumentation, it is
necessary for healthcare workers to ensure
that they take adequate precautions to protect
themselves from blood and body fluid
exposure,” she said.
That protection includes gowns and
drapes. Swenson is co-chair of the committee
that developed ANSI/AAMI PB70:2012,
Liquid barrier performance and classification of
Key facts from WHO
The World Health
Organization estimates
that the average Ebola
virus disease fatality
rate is roughly 50%.
Case fatality rates
range from 25% to
90%. Although
largely occurring in
remote villages in
Central Africa, this one
has targeted both urban
and rural regions.
Source: Ebola Virus Disease Fact
Sheet, www.who.int/
mediacentre/factsheets/fs103/en/
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2. 426 Biomedical Instrumentation & Technology November/December 2014
Features
protective apparel and drapes intended for use in
health care facilities which provides informa-
tion on the appropriate attire for those
attending to patients with communicable
diseases. (See sidebar on opposite page.)
The standard spells out different types, or
levels, of surgical gowns, and those levels are
included in a new protocol for operations
involving suspected or confirmed Ebola
patients. That protocol, developed by the
American College of Surgeons, calls for all
operating room personnel to wear AAMI
Level 4 impervious surgical gowns. The
protocol also advises that healthcare workers
who transport such patients wear AAMI
Level 3 fluid-resistant gowns.
Swenson noted that sterilization profession-
als also need a high level of protection, based
on the expected level of liquid contamination.
“If surgical instruments are being processed,
then the level of exposure is expected to be
high, and a Level 4 gown is needed,” she said.
“When hand washing even lightly soiled
instruments, it is necessary to use a gown with
a high level of protection,” Swenson added. “If
one is wiping down patient care equipment,
e.g., an IV pump or pole, then the level of
protection needed is not as high. In this case, a
Level 1 or 2 gown may be appropriate.”
CDC, WHO Step Up
The CDC has posted infection control
recommendations for patients who are
known or are suspected of having Ebola. The
guidance recommends situating the person
in a single-patient room and maintaining a
log of all who enter and leave. Dedicated
medical equipment—preferably disposable—
should be used when caring for the patient.
In addition, healthcare personnel should
limit the use of needles and sharps, if at all
possible these instruments should be
In late October, AAMI reached out to four other healthcare
associations to collaborate on a joint statement about the
handling of biohazardous medical waste contaminated with
the Ebola virus. The other four groups are: the Association of
perioperative Registered Nurses (AORN), the Association for
Professional in Infection Control and Epidemiology (APIC),
the Association of Surgical Technologists (AST), and the
International Association of Healthcare Central Service Mate-
rial Management (IAHCSMM). The joint statement follows:
The recent outbreak of Ebola virus disease has raised
questions about the correct handling of Ebola-contaminated
biohazardous medical waste. This joint advisory statement is
intended to provide guidance to personnel and healthcare
organizations for handling biohazardous medical waste,
including waste contaminated with the Ebola virus.
This statement addresses the use of sterilizers for process-
ing biohazardous waste in the healthcare facility. This
document does not address transportation of biohazardous
waste, or processing of contaminated reusable medical
devices and textiles.
Recognizing that sterilization modalities other than moist
heat may be used for processing biohazardous waste, the
term “sterilizer” is used rather than “autoclave” as used in
other guidelines.
This is an evolving issue and healthcare professionals
should review current research and incorporate new
evidence into practice to mitigate occupational and patient
risk associated with handling biohazardous medical waste.
AAMI, AORN, APIC, AST, IAHCSMM recommend that:
• Healthcare organizations should not circumvent estab-
lished protocols for handling biohazardous medical
waste.
• Biohazardous medical waste should not be brought into
clean areas where processing reusable medical devices is
performed.
• Biohazardous medical waste should not be inactivated
in a sterilizer that is used for processing reusable
medical devices.
• Sterilizers used to inactivate biohazardous medical
waste should be designed and validated for that
particular purpose.
• Organizations should work with infection preventionists
and keep abreast of evolving professional and regulatory
guidelines for handling biohazardous medical waste
JOINT STATEMENT ON PROCESSING BIOHAZARDOUS MEDICAL WASTE
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3. 427Biomedical Instrumentation & Technology November/December 2014
Features
disposable, single-use devices, which should
be handled with care and disposed of in
puncture-proof, sealed containers.
Hand hygiene should be performed often
when dealing with Ebola patients. Healthcare
personnel should wash with soap and water
before and after patient contact or contact
with potentially infectious material, as well as
before putting on and after removing PPE.
Alcohol hand rubs can be used when han-
dling materials that have not been
contaminated with potentially infectious
materials, such as the Ebola virus.
If personnel are exposed to the disease, the
facility should have measures in place to
ensure the safety of all involved. Those who
develop any signs of Ebola should either stop
work immediately or not report to work;
notify their supervisor; seek prompt medical
evaluation; inform state and local health
departments; and comply with work exclu-
sions until they are no longer infectious.
Regarding sterile processing professionals,
“PPE should be applied at all times; there is
no need for panic if an Ebola patient were to
hit our [emergency room] ER doors,” said
Koci. “We as managers should encourage our
technicians to treat every single instrument as
if they had been used to treat a patient with
Ebola, HIV, hepatitis C, or similar condition.
Based on the education that I have had in
microbiology, I always encourage my staff to
be safe; it is our responsibility to protect our
patients and ourselves. Our team is very
confident tackling this issue, as we have a very
strict PPE protocol in place. Furthermore, our
staff always is reminded of the consequences
if a protocol were to be breached.”
Koci expressed confidence should his
facility accept a patient with Ebola. “We have
a multidisciplinary team that has already
prepared a detailed protocol on how to treat a
patient. All of the parties have been educated
on the protocols, while the CDC website is
monitored daily for updates.”
Transportation of Waste
Members of Congress have had many
questions about the CDC’s handling of the
Ebola outbreak. During an October hearing
by the House Energy and Commerce’s
Oversight and Investigations Subcommittee,
Rep. Marsha Blackburn, R-TN, asked about
the disposal of waste from Ebola patients.
As with other patient waste, the Ebola waste
will be trucked to central processing
centers—a move that seemed to cause some
concern to Blackburn.
“Waste from Ebola patients can readily be
decontaminated,” CDC Director Tom
Frieden, MD, said in response to Black-
burn’s query about whether the waste is as
infectious as patients themselves. “The
virus itself is not particularly hardy. It’s
killed by bleach, by autoclaving, by a variety
of chemicals.”3
This stance was voiced by Knust in an
August conference call. “In terms of the
virus, it is not that difficult to inactivate, 10%
CLASSIFICATION OF PROTECTIVE
APPAREL AND DRAPES
Level 1—Gowns and drapes: This classification describes
surgical gowns, isolation gowns, other protective apparel,
surgical drapes, and drape accessories that demonstrate the
ability to resist liquid penetration in a laboratory test, AATCC
42 (Water resistance: Impact penetration test).
Level 2—Gowns and drapes: This classification describes
surgical gowns, isolation gowns, other protective apparel,
surgical drapes, and drape accessories that demonstrate the
ability to resist liquid penetration in two laboratory tests,
AATCC 42 (Water resistance: Impact penetration test) and
AATCC 127 (Water resistance: Hydrostatic pressure test).
Level 3—Gowns and drapes: This classification describes
surgical gowns, isolation gowns, other protective apparel,
surgical drapes, and drape accessories that demonstrate the
ability to resist liquid penetration in two laboratory tests,
AATCC 42 (Water resistance: Impact penetration test) and
AATCC 127 (Water resistance: Hydrostatic pressure test). For
Level 3, the test criterion for AATCC 127 performance has
been set at a higher value than for Level 2.
Level 4—Gowns: This classification describes surgical
gowns, isolation gowns, and protective apparel that demon-
strate the ability to resist liquid and viral penetration in a
laboratory test, ASTM F1671 (Standard test method for
resistance of materials used in protective clothing).
Source: ANSI/AAMI PB70:2012, Liquid barrier performance and
classification of protective apparel and drapes intended for use in
health care facilities
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4. 428 Biomedical Instrumentation & Technology November/December 2014
Features
bleach, hospital grade phenolics or quater-
nary ammonium solutions are appropriate
disinfection procedures,” she said. “The virus
is liable to desiccation.”
Blackburn then asked about the safety of
transporting these materials. “We work very
closely with both the Department of Trans-
portation, as well as the commercial waste
management companies to ensure that
capability,” Frieden answered.
The Pipeline and Hazardous Materials
Safety Administration, part of the Depart-
ment of Transportation issued guidance for
the transportation of Ebola-contaminated
items, labeling it Category A infectious
substance. A Category A infectious substance
“is a material known or reasonably expected
to contain a pathogen, such as Ebola, that is
in a form capable of causing permanent
disability or life-threatening or fatal disease
in otherwise healthy humans or animals
when exposed to it. An infectious substance
classification is based on the patient or
animal’s known medical history or symp-
toms, endemic local conditions, or
professional judgment concerning the
individual circumstances of the source
human or animal.”4
According to an interim CDC guidance,
examples include medical equipment, sharps,
linens, soiled absorbent pads or dressings,
kidney-shaped emesis pans, portable toilets,
used PPE, or byproducts of cleaning.
As the guidance noted, a Category A infec-
tious substance must be triple packed in a
primary watertight receptacle, watertight
secondary packaging, and rigid outer
packaging. “If available, steam sterilization
(autoclave) or incineration as a waste
treatment process can inactivate the virus
and reduces waste volume,” according to the
CDC. Employees preparing the waste for
transportation must have training that
covers the following: general awareness,
function-specific, safety, security awareness
training, and modal-specific training, e.g.,
driver training and procedures necessary for
the safe operation of a motor vehicle.
The guidance also requires a security plan
that addresses personnel security, unauthor-
ized access, and en route security. n
References
1. Knust B. Ebola Presentations from ICAAC 2014.
Presentation at the 54th Interscience Conference
on Antimicrobial Agents and Chemotherapy;
Sept. 8, 2014; Washington, DC.
2. Fauci A, Goodman J, Sharfstein J. WTOP
Hosts Special Town Hall on Ebola Live From
the Newseum. Available at: www.newseum.
org/2014/10/15/wtop-hosts-special-town-hall-on-
ebola-live-from-the-newseum. Accessed Oct. 20, 2014.
3. House Energy & Commerce Committee.
Examining the U.S. Public Health Response
to the Ebola Outbreak. Available at: http://
energycommerce.house.gov/hearing/examining-
us-public-health-response-ebola-outbreak.
Accessed Oct. 16, 2014.
4. U.S. Department of Transportation’s Pipeline
and Hazardous Materials Safety Administration.
Department of Transportation Guidance for
Transporting Ebola Contaminated Items, a
Category A Infectious Substance. Available at:
http://1.usa.gov/1tYLXvt. Accessed Oct. 17, 2014.
5. The Centers for Disease Control and Prevention.
Interim Guidance for Specimen Collection,
Transport, Testing, and Submission for Persons
Under Investigation for Ebola Virus Disease
in the United States. Available at: http://1.usa.
gov/1oubNiw. Accessed Oct. 19, 2014.
For More Information
AAMI has assembled a number
of news articles, guidance doc-
uments, standards, and other
resources related to the Ebola
outbreak on a special page on
its website: www.aami.org/
hottopics/ebola/index.html.
A Ray of Hope
The federal government is backing efforts to find a vaccine to the
deadly Ebola virus. Working with the financial support of Uncle Sam,
Baltimore, MD-based Profectus BioScience Inc., is trying to develop an
experimental Ebola vaccine. Meanwhile, an arm of the National Insti-
tutes of Health, is backing Phase I clinical trials evaluating a potential
Ebola vaccine from GlaxoSmithKline and an experimental Ebola vaccine
developed by the Public Health Agency of Canada and licensed to
NewLink Genetics Corp. Phase II efficacy trials for these vaccine candi-
dates are expected in 2015.
Source: HHS advances development of Ebola vaccine. HHS press release, Oct.
16, 2014.
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5. 429Biomedical Instrumentation & Technology November/December 2014
Features
There are many steps everyone can take to prevent Ebola transmission.
Symptoms of Ebola
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