Download CDC Recommendations

11/3/2010
Discussions and Activity at the Federal Level
Regarding Management of Electronic Medical
Equipment
Lynne Sehulster, PhD, M(ASCP)
Health Scientist
Best Practices in Medical Device Cleaning and Disinfection
November 4, 2010
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
Disclaimer / Disclosure
The findings and conclusions in this presentation are
those of the author and her information resources and
do not necessarily represent any determination or
policy of the Centers for Disease Control and
Prevention (CDC).
The author is an employee of the Federal government
(DHHS) and has no commercial affiliations or conflicts
of interest to disclose.
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11/3/2010
FDA Takes Note of Medical Equipment-Associated
Adverse Events
Equipment / device adverse events from 2005 – 2007
were reviewed
Common observation: inappropriate use of liquids on electronic
medical equipment
Problems reported:
•
•
•
•
Equipment fires and other damage
Equipment malfunction
Healthcare worker injuries (i.e., burns)
Potential for adverse effects on patients
o Possible adverse events could include over-infusion of
medications, loss of life-supporting drug therapy, and loss of
patient ventilation
* FDA MedWatch Reporting
FDA Takes Note of Medical Equipment-Associated
Adverse Events
Equipment / device adverse events from 2005 – 2007
were reviewed
Wide variety of equipment involved (including but not limited to):
• Infusion pumps, ventilators, patient-controlled analgesia pumps,
sequential compression device pumps, telemetry devices, infusion
fluid warmers, infant anti-abduction sensors
Potential problem of equipment damage could also become
associated with any equipment with unsealed electronic circuitry
or components
• Computer keyboards, hand-held devices, monitoring devices.
FDA MedWatch Reporting
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11/3/2010
FDA Takes Note of Medical Equipment-Associated
Adverse Events
FDA conducts interviews with healthcare workers and
observes equipment management practices
Healthcare workers routinely sprayed the equipment housings
with disinfectants or wrapped the housings with disinfectantsoaked towels
Equipment instructions were often not available, and/or the
instructions did not provide adequate information about the daily
maintenance of the equipment
When manufacturers’ instructions were available and
reviewed, many would recommend wiping the housing
with a soft cloth dampened with a mild detergent and
water
FDA MedWatch Reporting
Link: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062052
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11/3/2010
CDC Recommendations
E. Recommendations—Environmental Services
I. Cleaning and Disinfecting Strategies for Environmental Surfaces in
Patient-Care Areas
A. Select EPA-registered disinfectants, if available, and use them in
accordance with the manufacturer’s instructions.2, 974, 983 Category IB,
IC (EPA: 7 United States Code [USC] § 136 et seq)
B. Do not use high-level disinfectants/liquid chemical sterilants for
disinfection of either noncritical instrument/devices or any environmental
surfaces; such use is counter to label instructions for these toxic
chemicals.951, 952, 961–964 Category IB, IC (FDA: 21 CFR 801.5, 807.87.e)
CDC / HICPAC Guidelines for Environmental Infection Control in Health-Care Facilities. Available at:
http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf
CDC Recommendations (continued)
C. Follow manufacturers’ instructions for cleaning and maintaining noncritical medical
equipment. Category II
D. In the absence of a manufacturer’s cleaning instructions, follow certain
procedures.
1. Clean noncritical medical equipment surfaces with a detergent/disinfectant. This
may be followed with an application of an EPA-registered hospital disinfectant with
or without a tuberculocidal claim (depending on the nature of the surface and the
degree of contamination), in accordance with disinfectant label instructions.952
Category II
2. Do not use alcohol to disinfect large environmental surfaces.951 Category II
3. Use barrier protective coverings as appropriate for noncritical equipment
surfaces that are
1) touched frequently with gloved hands during the delivery of patient care; 2)
likely to become contaminated with blood or body substances; or 3) difficult to clean
(e.g., computer keyboards).936 Category II
CDC / HICPAC Guidelines for Environmental Infection Control in Health-Care Facilities. Available at:
http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf
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11/3/2010
Interagency Recommendations from the Public
Health Advisory
Identify the equipment for which the notification
applies
Obtain equipment manufacturer’s labeling / instructions
• Instructions attached / affixed to the equipment
• User guide or manual
• Information from the manufacturer website
Look for cautions, precautions, or warnings about wetting,
immersing, or soaking the equipment
If these cautionary statements are found, the recommendations of
the Public Health Advisory apply
Interagency Recommendations from the Public
Health Advisory
Review the equipment manufacturer’s cleaning and
maintenance instructions
First consideration
Look for the recommended cleaning process
Look for manufacturer-recommended cleaning and if needed,
disinfection active ingredients
Ensure all staff assigned to managing the medical
equipment are trained and will follow the instructions
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11/3/2010
Interagency Recommendations from the Public
Health Advisory
Protect equipment from contamination whenever
possible
Engineering controls:
• Barriers on the equipment or surfaces
Careful work practices to avoid contaminating the equipment
• Avoid unnecessary touching of the equipment during care delivery,
especially with contaminated hand or gloves
• Position the equipment to avoid contact with anticipated spatter
• Avoid laying contaminated items on unprotected equipment surfaces
From Point A to Point B
Medical/Dental Instruments
and Accessories
Patient A
Physicians,
Nurses, and
Assistants
Patient B
Medical Equipment,
Environmental Surfaces,
Frequently Touched Surfaces
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11/3/2010
The Inanimate Environment Can
Facilitate Transmission
X represents VRE culture positive sites
~ Contaminated surfaces increase cross-transmission ~
Abstract: The Risk of Hand and Glove Contamination after Contact with a
VRE (+) Patient Environment. Hayden M, ICAAC, 2001, Chicago, IL.
Minimize Glove “Misuse”
• Failure to remove or change contaminated gloves
• 18.3% (4/22) samples showed potential transferral of
microorganisms [a = from patient, b = from gloves]
Source: Girou E, Chai SHT, Oppein F, et al. J Hosp Infect 2004; 57: 162-9
Glove Cultures
Environmental Cultures
# of Contacts
Prior to
Sampling
Bacterial
Counts
(CFU)
Pathogenic
Bacteria
Sampled
Surfaces
Bacterial
Counts
(CFU)
Pathogenic
Bacteria
6
4,500
P. aeruginosa (a),
Serratia
marcescens (a)
Bed barrier
(rail)
85
P. aeruginosa,
Serratia
marcescens (a, b)
10
>30,000
P. aeruginosa
Bedside
table
2
P. aeruginosa
10
>30,000
P. aeruginosa
Bedside
table
>300
P. Aeruginosa (a)
17
>30,000
P. aeruginosa
Weighing
machine
169
P. aeruginosa (b)
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11/3/2010
Interagency Recommendations from the Public
Health Advisory
If there is suspicion of equipment contamination with
microorganisms that might pose a transmission risk in
healthcare settings (e.g., Contact precautions), do the
following:
Clean the equipment surfaces in accordance with instructions
from both the equipment manufacturer and the cleaning /
disinfection chemical manufacturer(s)
If disinfection is necessary, alternative strategies to avoid wetting
should be explored with the equipment manufacturer
Note: Use these opportunities to encourage equipment
manufacturers to provide alternative instructions,
redesign their equipment to protect the electronics
Interagency Recommendations from the Public
Health Advisory
Always adhere strictly to all the chemical
manufacturer’s warnings, precautions and cautions
Carefully follow all directions for chemical usage:
Is a precleaning step indicated?
Concentration or dilution vs. ready to use
Method of application
Contact time (time necessary to achieve disinfection)
• Reapplication of the product may be necessary
• Question for EPA: Define “wet, or wetness”
Detergent / disinfectants (i.e., combination products, “one-step
products”)
• Usually two sets of instructions, one for use of the product as a cleaner,
the other for using the product to disinfect
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11/3/2010
Interagency Recommendations from the Public
Health Advisory
If the equipment is contaminated with blood or other
potentially infectious material (OPIM), the equipment
must be decontaminated per OSHA regulations
Follow the equipment manufacturer’s directions for cleaning to
remove as much soil as possible
It may be necessary to remove the equipment from service for
thorough cleaning and disinfection.
Points for Discussion and Debate
Consider this statement from the Additional
Information section of the Public Health Advisory:
“Be advised that not all equipment handling or patient
contact results in the need for disinfection. None of the
documents from the relevant Federal agencies is
intended to require disinfection of equipment that has
not become contaminated.”
Issues concerning acceptance of barrier coverings
What about surface contamination via aerosols?
What about a “clean hands” assistant?
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11/3/2010
Thank You!
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: [email protected]
Web: www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
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