Federal Agencies Issue Notice About Using Cleaners and Disinfectants on Electronic Medical Equipment

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), and the Occupational Safety and Health Administration (OSHA) have collaborated on a notification that describes the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment.

Background

A broad perspective on contamination drives current infection control strategies that focus on cleaning and disinfecting frequently touched surfaces that contribute to cross-transmission of infections. Contaminated surfaces can include:

-- Surfaces and equipment with blood or other potentially infectious material

-- Surfaces touched by gloved hands after glove contact with patients

-- Surfaces touched by patients, and surfaces contacted by or in the vicinity of aerosols and spatter

-- Surfaces about whose state of cleanliness the healthcare professional is uncertain

Contaminating substances can include:

blood

semen

vaginal secretions

respiratory secretions

fecal material

cerebrospinal fluid

synovial fluid

pleural fluid

pericardial fluid

peritoneal fluid

amniotic fluid

saliva in dental procedures

body fluids that might harbor potential pathogens

any body fluid that is visibly contaminated with blood

all body fluids in situations where it is difficult or impossible to differentiate between body fluids

Over the past two years the relevant federal agencies have learned about and collaborated to address problems associated with inappropriate use of liquids on electronic medical equipment. The problems included equipment fires and other damage, equipment malfunctions, and healthcare worker burns. These problems involved infusion pumps, ventilators, patient-controlled analgesia pumps, sequential compression device pumps, telemetry physiological signal receivers and transmitters, infusion fluid warmers, and infant anti-abduction sensors. This notification, however, is not limited to these equipment types and may be relevant to any equipment that has unsealed electronic circuitry or components, such as computer workstations, handheld devices and other monitoring equipment. 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.

The root cause of the problems mentioned above was likely corrosion of electronic circuitry by disinfecting or cleaning solutions that penetrated the equipment housings. Healthcare workers routinely sprayed the housings with disinfectants or wrapped the housings with disinfectant-soaked towels. These practices are generally not consistent with the equipment manufacturers directions for use, which typically recommend wiping the housing with a soft cloth dampened with a mild detergent and water.

Recommendations

To avoid the aforementioned hazards, review your facility policies on equipment management and assignment of responsibility for key tasks associated with said management. The federal agencies recommend the following in conjunction with your facilitys equipment management policies:

-- Identify the equipment for which this notification applies

-- Obtain the manufacturers labeling which may include information attached to the equipment, instructions accompanying the equipment (such as the user manual), and information on the manufacturers Web site.

-- 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 manufacturers cleaning and maintenance instructions and ensure all staff are trained and will follow these instructions.

-- Protect equipment from contamination whenever possible.

-- Use engineering controls and careful work practices to avoid contaminating the equipment. Such work practices generally include:

Avoid unnecessary touching of the equipment during care delivery, especially with contaminated hands or gloves.

Position equipment to avoid contact with anticipated spatter.

Avoid laying contaminated items on unprotected equipment surfaces.

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:

-- Clean equipment surfaces in accordance with instructions from both the equipment manufacturer and the chemical manufacturer.

-- 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 manufacturers warnings, precautions and cautions, and carefully follow all directions for use. (See Appendix III for OSHA definitions.)

The manufacturers 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.

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).

It is a violation of federal law [ Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA 7 USC § 136 et seq.)] 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.

Follow the equipment manufacturers 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 .

Additional Information

In addition to the cleaning instructions, some equipment manufacturers' labels list disinfectants that the equipment housing can tolerate and refer the user to the disinfectants label for use on the equipment. FDA allows this type of labeling for equipment that it regulates because it would be overly burdensome for every regulated device to provide specific, current instructions for the use of all compatible disinfectants. Interpreting such labeling as well as interpreting the Federal regulations and guidances relevant to disinfection of equipment, requires the user to understand infection control principles and to use sound judgment. The language of relevant labeling and regulations is purposefully non-specific to accommodate the users individual circumstances. The relevant Federal agencies do not intend this notification to modify current regulatory authority. Instead, this notification is intended to clarify current federal regulations and guidances previously issued by these agencies.

The best strategy to avoid damaging equipment is to avoid equipment contamination to minimize the need for disinfectants. Using work practice controls and barriers on equipment can prevent equipment contamination. The use of barriers in healthcare facilities is recognized by OSHA regulation as a contamination control measure and is supported by the CDC in its environmental infection control guidance. Use of work practice controls and barriers on equipment in the patient care environment minimizes contamination with all microorganisms, including drug-resistant microorganisms such as vancomycin-resistant Enterococcus (VRE).

OSHAs Bloodborne Pathogens Standard (29 CFR 1910.1030) requires use of an appropriate chemical disinfectant on contaminated equipment. OSHA considers an item or surface contaminated if it has blood or OPIM on it, or  is reasonably anticipated to be contaminated with blood or OPIM during a procedure that involves blood or OPIM contact.

All disinfectants that meet OSHAs definition of appropriate include directions to keep the item or surface wet for a specified contact time. Equipment that cannot tolerate this exposure to liquids may require special handling if the equipment becomes contaminated and the equipment may need to be removed from use. To avoid wetting the circuitry, the contaminated equipment housing may need to be disassembled, washed, and soaked in the liquid disinfectant. Disassembly of electronic medical equipment may require the services of trained technical staff and/or servicing by the equipment manufacturer before the equipment can be returned to use. This may necessitate shipping the affected piece of equipment to another location. Healthcare facilities must comply with OSHA requirements for handling, servicing or shipping contaminated equipment, which include removal of as much soil as possible and labeling the equipment as contaminated. Once cleaning is accomplished, package the equipment for safe movement within the facility for repairs or in preparation for off-site shipping. If the equipment is sent off-site for decontamination and service, label the equipment package to alert those handling the package that it may contain potentially infectious material per all relevant Federal and local regulations. Send the package per the manufacturers recommendations for service. These recommendations will indicate whether the equipment should be sent directly to the manufacturer or can be sent to an authorized repair service. Please note that some service facilities may require users to provide instructions for decontamination and processing after the equipment is disassembled.

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.

Source: FDA