MedSun Sites Contribute to Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment
MedSun: Newsletter #19, December 2007

This notification describes the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment and recommends ways to avoid these hazards. The Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Environmental Protection Agency (EPA), and Occupational Safety and Health Administration (OSHA) collaborated to develop this notification. Over the past two years these Federal agencies have learned about and worked to address problems associated with inappropriate use of liquids on electronic medical equipment. Several MedSun Representatives and individuals from MedSun facilities were instrumental in helping analysts from FDA and the other Federal agencies to understand the root and scope of the problem.

Essential to the genesis of this document were four MedSun reports received from two MedSun hospitals documenting the degradation of plastic on IV pumps due to the use of certain disinfectants. In addition, there were infusion pump fires associated with fluid ingress entered into the MAUDE database. Based upon these reports and information garnered during follow up with the MedSun site reporters, the CDC was notified and formal interviews were set up with the original MedSun sites that reported the problem, plus three additional MedSun sites. These interviews were arranged with the individuals that were responsible for overseeing the cleaning of infusion pumps at their MedSun institutions and involved persons from Central Supply, Housekeeping and Biomedical Engineering. During these interviews, individuals were asked about their infusion pump reprocessing policies and procedures and if they had observed degradation problems with the pumps’ housing, or malfunctioning of the pumps due to fluid ingress. These interviews revealed the critical nature of the problem and led to the involvement of two other federal agencies, EPA and OSHA. Together in a notable act of collaboration, the 4 Federal agencies, FDA, CDC, EPA and OSHA drafted the Public Health Notification. Individuals from MedSun sites were involved in reviewing and providing feedback on these drafts.

Problems associated with the use of excess cleaning and disinfecting liquids is not limited to IV pumps and may be relevant to any equipment that has unsealed electronic circuitry or components. The equipment malfunctions could result in life-threatening events to patients such as over-infusion of medications, loss of life-supporting drug therapy, and loss of patient ventilation. In this notification, root causes are noted and recommendations to avoid the hazards described above are outlined.

Additional Information:

For the full text of this Public Health Notification go to
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062052.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun