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Notice to Readers: Medical Equipment Malfunctions Associated
with Inappropriate Use of Cleaning and Disinfecting Liquids --- United
States, 2007
On October 31, 2007, the Food and Drug Administration (FDA), in collaboration with CDC, the
Environmental Protection Agency, and the Occupational Safety and Health Administration, issued a public health notification
alerting health-care providers and the public about medical device malfunctions caused by improper use of cleaning
and disinfecting liquids.* Inappropriate use of cleaning and disinfecting liquids on certain electronic medical equipment
can cause equipment damage and malfunctions, which might have serious, even life-threatening consequences.
Under the Safe Medical Device Act, health-care facilities are required to report to FDA any medical device malfunctions that
cause or could cause death or serious injury. This notice provides recommendations to help prevent medical
device malfunctions attributed to improper cleaning and disinfection.
Cleaning and disinfection are important practices to
ensure that medical equipment surfaces do not serve as
reservoirs for infectious pathogens. Cleaning is designed to remove infectious pathogens from inanimate objects,
whereas disinfection is the process by which remaining pathogens are inactivated. Each of these two distinct processes
usually involves the use of liquids (i.e., water and detergents for cleaning and chemical disinfectants for
microbial inactivation). Because many types of equipment used in health-care settings have mated surfaces, moving parts, gaps, joints,
and unsealed housings, improper cleaning and disinfection can create opportunities for fluids to enter the internal surface
of medical equipment, resulting in damage that can cause or contribute to equipment
malfunctions.
Health-care facilities, public health officials, and device manufacturers can take several measures to help improve
device cleaning and disinfection and to prevent equipment malfunctions in the future. Facility staff should review
equipment currently in use to determine which pieces of equipment have manufacturer instructions for cleaning but not
for disinfection. Equipment that cannot be disinfected should be used in a way that minimizes the risk for
contamination, for example, by positioning it far from contaminated areas or by covering it with a barrier that can be easily cleaned
or
replaced. If this is not possible, the facility should contact the manufacturer to discuss options for safe and
effective disinfection. If the equipment is fluid-tight, and both cleaning and disinfection instructions are provided by
the equipment manufacturer, the recommended cleaning agents and chemical disinfectants should be used and
the conditions for their use followed. Finally, personnel responsible for cleaning and disinfection must be given
appropriate training.
Reports of medical equipment malfunctions that cause or could cause death or serious injury should be made by
using FDA's MedWatch 3500A form, available at
https://www.fda.gov/medwatch/getforms.htm. Health-care facilities also
are encouraged to report medical devices malfunctions that do not meet the mandatory reporting to MedWatch
by telephone (1-800-332-1088); by fax (1-800-332-0178); by mail (MedWatch, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20852-9787); or online (https://www.fda.gov/medwatch/report.htm).
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.
References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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Users should not rely on this HTML document, but are referred to the electronic PDF version and/or
the original MMWR paper copy for the official text, figures, and tables.
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**Questions or messages regarding errors in formatting should be addressed to
mmwrq@cdc.gov.
