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U.S. Department of Health and Human Services

Medical Devices

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Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment

Issued : October 31, 2007

Dear Colleagues:

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.

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 hazards described above, review your facility policies on equipment management and assignment of responsibility for key tasks associated with said management. The relevant Federal agencies recommend the following in conjunction with your facility’s equipment management policies:

  • Identify the equipment for which this notification applies
    • 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.
    • 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.
    • 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 manufacturer’s warnings, precautions and cautions, and carefully follow all directions for use. (See Appendix III for OSHA definitions.)
    • 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.
    • 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 [see Appendix III for the OSHA definition of “contaminated.”]
    • Follow the equipment manufacturer’s 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 (See Additional Information).
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 disinfectant’s 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).

OSHA’s Bloodborne Pathogens Standard (29 CFR 1910.1030) requires use of an appropriate chemical disinfectant (see Appendix III ) on contaminated equipment. OSHA considers an item or surface contaminated if it:

  • has blood or OPIM on it (see Appendix III for OSHA’s definition of OPIM), or
  • is reasonably anticipated to be contaminated with blood or OPIM during a procedure that involves blood or OPIM contact.

All disinfectants that meet OSHA’s 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 manufacturer’s 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 (see Appendices at the end of this notification) is intended to require disinfection of equipment that has not become contaminated.

Getting More Information

 

 

FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.

FDA medical device Public Health Notifications are available on the Internet. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.

OSHA - The OSHA Bloodborne Pathogens standard, letters of interpretation and compliance directive are publicly available on OSHA’s Bloodborne Pathogens and Needlestick Prevention webpage at http://www.osha.gov/SLTC/bloodbornepathogens/index.html.

The following link provides an example of a letter of interpretation on the subject: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=24017

CDC - CDC infection control guidelines are available on the Internet at http://www.cdc.gov/ncidod/dhqp/. Guidelines that address this topic include the “CDC/HICPAC ( Hospital Infection Control Practices Advisory Committee) Guidelines for Environmental Infection Control in Health-Care Facilities,” available at http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html and the HICPAC “Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006,” available at http://www.cdc.gov/ncidod/dhqp/

EPA - General regulatory information on hospital disinfectants is available from the EPA Internet sites at http://www.epa.gov/pesticides/factsheets/antimic.htm . EPA also groups the antimicrobial pesticides into Lists A – H according to the intended use of the chemical or the target pathogen for inactivation: http://www.epa.gov/oppad001/chemregindex.htm

Reporting Adverse Events

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices, including electronic medical equipment.  If you suspect that a reportable adverse event was related to the use of a medical device, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.

Additionally, OSHA requires that within eight (8) hours after the death of any employee or the in-patient hospitalization of three or more employees from a work-related incident, you must orally report the fatality/multiple hospitalization by telephone or in person to the Area Office of the Occupational Safety and Health Administration (OSHA), U.S. Department of Labor, that is nearest to the site of the incident. You may also use the OSHA toll-free central telephone number, 1-800-321-OSHA (1-800-321-6742).

Sincerely yours,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Rima Khabbaz, MD
Director
National Center for Preparedness, Detection and Control of Infectious Diseases
Centers for Disease Control and Prevention

Frank Sanders, Director
Antimicrobials Division
Office of Pesticide Programs
Environmental Protection Agency

Richard E. Fairfax, MS, CIH
Director
Directorate of Enforcement Programs
Occupational Safety and Health Administration

 * The content of this notification reflects the products that are currently available, current versions of any relevant regulations and regulatory directives, and current infection control statements from Federal agency guidance. With respect to electronic medical equipment, this notification is limited to that which is regulated by the Food and Drug Administration (FDA) as medical devices. Barrier products that might be marketed to protect this equipment from contamination also are regulated by FDA as medical devices. Hospital disinfectants that might be used on electronic medical equipment are regulated primarily by the U.S. Environmental Protection Agency (EPA) as pesticides, and secondarily by FDA as medical devices. The Occupational Safety and Health Administration (OSHA) regulates occupational exposure of employees to blood or other potentially infectious materials (OPIM) which may occur during the handling of contaminated medical equipment. Other OSHA regulations (e.g., Hazard Communication; Use of [Electrical] Equipment) may also be applicable. Recommendations for general infection control strategies, including cleaning and disinfecting electronic medical equipment are published in guidelines from the Centers for Disease Control and Prevention (CDC), a non-regulatory agency.

Appendix I
Centers for Disease Control and Prevention

Summary - CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities, 2003 ” (from the full text version available on the Internet at: http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html)

The discussion relevant to the topic of this Public Health Notification is located in the Environmental Services section of this guideline (pages 71-78 of the full text version). Briefly, strategies for routine management of patient-care equipment take into account the potential for this equipment to become contaminated in areas where patient care is provided. Contamination is influenced by a number of factors, including but not limited to the presence of organic matter from worker, patient, or environmental sources and the degree of contaminated hand contact with the item or surface. The recommendations in this guideline support the strategy outlined in this Public Health Notification. CDC encourages manufacturers to provide adequate use and maintenance instructions for equipment and clear indications for use of cleaners and disinfectants. Furthermore, CDC states that users of equipment and disinfectants should follow manufacturer instructions first and foremost when operating or caring for the equipment. Cleaning and disinfection are discussed in this context. If the manufacturer indicates in their maintenance instructions that their equipment cannot withstand liquids, the healthcare worker will need to evaluate his/her work practice controls and/or engineering controls for practical ways to prevent the device from becoming contaminated. Work practice controls and strategies should be developed to minimize contaminated hand or glove contact. The use of barriers is emphasized, especially when the device is difficult to clean or the device must be touched during the delivery of care.

Definitions relevant to this topic from this guideline (pages 202, 203, and 205) are cleaning, disinfection, low-level disinfection, and intermediate-level disinfection.

Summary - HICPAC “Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006” (from the text available on the Internet at http://www.cdc.gov/ncidod/dhqp/ )

The intent of this guidance is to provide strategies to prevent the spread of microorganisms in general, but specifically the multidrug-resistant organisms (MDROs). This summary is derived from the Environmental Management section on page 27 and the corresponding recommendations on pages 40-41. This guidance, as with other CDC guidelines, acknowledges the impact of hand transfer of microorganisms in the spread of surface contamination. Cleaning and disinfection of frequently touched surfaces and equipment are recommended. However, this directive becomes problematic when equipment that can’t be disinfected becomes contaminated. In the event of blood or OPIM contamination, such equipment may need to be taken out of service, dismantled, disinfected, and reassembled every time the equipment becomes contaminated.

This HICPAC guideline does encourage continuing education about strategies to prevent the spread of contamination. When faced with the possibility that a piece of electronic medical equipment cannot be disinfected, healthcare professionals should evaluate their care activities involving this equipment and develop procedures and utilize additional infection control measures designed to prevent contamination from occurring. While this guideline does not mention the use of barriers on equipment in the discussion of environmental management, this omission should not be interpreted as a recommendation against the use of such barriers.

Appendix II

Environmental Protection Agency 

EPA regulates pesticides under the statutory authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Many of the laws, guidance, and policies that govern EPA are contained in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as Amended in 1996, 40 Code of Federal Regulations (CFR) Parts 152, 156, and 158, and the Office of Pesticide Prevention and Toxic Substances (OPPTS) Harmonized Test Guidelines (http://www.epa.gov/oppad001/).

The EPA regulates the registration of disinfectants for use on hard, non-porous surfaces, with classification of disinfectants as limited, general, or hospital as determined by their level of efficacy. Limited disinfectants have demonstrated efficacy against Salmonella enterica (Gram negative) OR Staphylococcus aureus (Gram positive). General disinfectants have demonstrated efficacy against BOTH Salmonella enterica (Gram negative) and Staphylococcus aureus (Gram positive); while Hospital disinfectants have demonstrated efficacy against the two bacteria listed above, in addition to Pseudomonas aeruginosa.

Appendix III

Occupational Safety and Health Administration 

As previously stated, the best strategy to prevent liquids from damaging electronic medical equipment is to avoid equipment contamination minimizing the need for cleaning and for the use of disinfectants. Using work practice controls and barriers on equipment can prevent the equipment from becoming contaminated in the first place. OSHA regulation recognizes the use of barriers in healthcare facilities as a contamination control measure. For the protection of employees, OSHA requires the use of appropriate chemical disinfectants on contaminated medical equipment. Some important definitions and links are provided below.

OSHA Bloodborne Pathogens Standard 29 CFR 1910.1030: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

Definitions: 

Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

Decontamination means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.

Other Potentially Infectious Materials means (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV .

OSHA provides interpretation and clarification of the OSHA regulation and OSHA enforcement policies in theOSHA Compliance Directive, CPL 02-02-069: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=2570.

Appendix IV

Food and Drug Administration 

Barriers, including protective covers, drapes or sheaths, which are intended for use with medical devices to protect them from contamination during use, are regulated by FDA as medical devices. Those covers which are specific to a particular device are regulated as an accessory to that device and regulations for that specific device (as found in 21 CFR) apply to the barrier for that device.

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100