0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
From the Centers for Disease Control and Prevention |

Notice to Readers: Medical Equipment Malfunctions Associated With Inappropriate Use of Cleaning and Disinfecting Liquids—United States, 2007 FREE

JAMA. 2008;299(19):2270. doi:10.1001/jama.299.19.2270.
Text Size: A A A
Published online

MMWR. 2008;57:152

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).

Figures

Tables

References

Letters

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles