ROCKVILLE, Md. — The U.S. Food and Drug Administration has released guidelines for EMS personnel in order to avoid the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment.
The guidelines focus on frequently touched surfaces that have potential of coming in contact with blood, gloved hands, patients and other sources of contamination.
According to the guidelines, some liquid cleaners had corrosive properties that can cause damage and malfunction to certain electronic equipment. Some of the most common equipment malfunctions due to cleaning liquid are: infusion pumps, ventilators, and patient-controlled analgesia pumps, among others.
The FDA, Centers for Disease Control and Prevention, Environmental Protection Agency, and Occupational Safety and Health Administration have issued these recommendations:
- Identify the equipment for which this notification applies
o Obtain the manufacturer’s labeling which may include information attached to the equipment, instructions accompanying the equipment (such as the user manual), and information on the manufacturer’s website.
o Review the labeling for any cautions, precautions, or warnings about wetting, immersing, or soaking the equipment. If you find any of these, then this notification applies to that equipment. - Review the manufacturer’s cleaning and maintenance instructions and ensure all staff are trained and will follow these instructions.
- Protect equipment from contamination whenever possible.
o Use engineering controls and careful work practices to avoid contaminating the equipment.
o Use barriers on equipment surfaces that you expect to touch with contaminated hands or when contact with spatter cannot be avoided. - If there is suspicion of equipment contamination with microorganisms that might pose a transmission risk in healthcare settings (e.g., those requiring contact precautions), do the following:
o Clean equipment surfaces in accordance with instructions from both the equipment manufacturer and the chemical manufacturer.
o If disinfection is necessary, alternative strategies to avoid wetting should be explored in consultation with the equipment manufacturer. - Always adhere strictly to all the chemical manufacturer’s warnings, precautions and cautions, and carefully follow all directions for use.
o The manufacturer’s directions for use are the primary source for information on disinfectants. All relevant Federal regulations, recommendations, and guidelines support and promulgate this position. This includes information on how to apply disinfectants to the equipment and the time required to achieve disinfection.
o All manufacturers of regulated medical equipment and disinfectants are required to include adequate directions for use of their products. If directions for use are not included with the equipment or disinfectant, obtain the directions from the manufacturer(s).
o It is a violation of Federal law to use a disinfectant in a manner inconsistent with its labeling. Furthermore, if a disinfectant labeled for immersion is applied by wiping or spraying, then disinfection may not result, especially if the recommended conditions for use (such as remaining wet for the required contact time) are not met. - If equipment is contaminated with blood or other potentially infectious material (OPIM), the equipment must be decontaminated per OSHA regulations.
o Follow the equipment manufacturer’s directions for cleaning to remove as much soil as possible.
o It may be necessary to remove the equipment from service for thorough cleaning and disinfection.
For the full report, visit the FDA Web site at www.fda.gov/cdrh/safety/103107-cleaners.html.