By Raymond Baker, Vicki Macks, RN, BSN, and Patricia I. Hilliard, RN, BSN
In 2009, healthcare leaders and experts began to focus more intensely on the risks associated with the improper processing (cleaning, disinfection and/or sterilization) of reusable medical devices and equipment. Within the U.S. Department of Veterans Affairs (VA) hospital system, the Memphis VA Medical Center (MVAMC) and other facilities initiated corrective actions to fine tune reprocessing policies, particularly those related to critical and semi-critical devices, to ensure compliance with manufacturers’ instructions for use. Since then, ensuring adequate device reprocessing has continued to be a concern for regulators, providers and medical device manufacturers. Ongoing discussions have led to direction such as an FDA draft guidance document for device manufacturers (FDA, 2011), and a report from the medical device reprocessing summit hosted jointly by AAMI and FDA (AAMI, 2011).
In April 2012, the MVAMC decided to expand the scope of reprocessing improvements by focusing on its disinfection methods for noncritical equipment. Noncritical items are defined in the Spaulding Classification System as those that come in contact with intact skin but not mucous membranes. They include such items as bed rails, patient furniture, blood pressure cuffs, crutches and wheelchairs (Rutala, 2008).
Why focus on noncritical equipment?
The effective disinfection of noncritical equipment and environmental surfaces is an important element in breaking the chain of healthcare-associated infections. This equipment can serve as a mode of disease transmission as hospital personnel routinely touch noncritical equipment and then proceed to interact with and care for patients without necessarily changing gloves or washing their hands. This presents a significant opportunity for cross-contamination and potential infection. Furthermore, many patients who acquire an infection during their hospital stay continue to come into contact with other noncritical equipment that may carry a significant bacterial or viral load, which can add to their risk. All of this contributes to the recorded deaths each year from healthcare-associated infections (Magill et al, 2013).
The first step for MVAMC was to assemble an investigative taskforce. Raymond Baker, chief of sterile processing services, chaired the team, and representatives of all stakeholders including the Infection Control, Patient Safety, Sterile Processing, Environmental Services, Logistics, and Engineering and Biomed departments were members. This cross-functional team began a detailed audit of facility practices related to decontaminating noncritical items. At the MVAMC, these items included, but were not limited to patient-controlled analgesia pumps, crash carts, specialty carts, blood pressure machines, feeding pumps, rental beds, patient beds, wheelchairs, commodes, patient specialty chairs, shower chairs, suction equipment, wound evacuation equipment, televisions, computers on wheels, IV poles, portable intravenous pumps, stretchers and monitors. Over the course of several infection control rounds, the taskforce recorded a number of concerns.
Areas of infection control concern identified by the taskforce
1. Lack of training for disassembly and cleaning of complex equipment
2. Equipment cleaning was often time-consuming and technically challenging
3. Missed surfaces during routine cleaning
4. Insufficient contact time when using surface disinfectants
5. Lack of validation for wipe-down cleaning protocols
6. Inadequate or incorrect cleaning of equipment in hallways and patient areas
7. Cleaning of rolling stock (wheelchairs, IV poles) was not “owned” by any single department. This contributed to some items being neglected or not cleaned.
As part of their investigation, the taskforce also discovered that, although there were well defined guidelines, protocols and procedures for the processing of critical and semi-critical equipment in the hospital, there was no such detailed guidance from authoritative bodies for the routine processing of noncritical equipment (only CDC/HICPAC 2008 guidelines). In addition, many equipment manufacturers provide little, if any, guidance on how to routinely process their equipment. As a result of the taskforce’s finding, MVAMC began to require all manufacturers to provide processing protocols before the center would purchase their equipment.
The taskforce also noted that in addition to a general lack of attention to noncritical equipment, there was often a lack of clarity surrounding who at MVAMC was responsible for cleaning particular pieces of equipment. A pervasive notion also persisted that responsibility for processing lay with the staff using the equipment. This was a concern for the team since this would undoubtedly interfere with the clinicians' primary responsibility for direct patient care. The taskforce recommended that the processing of noncritical equipment be performed by a dedicated staff, and that consistent cleaning/disinfection methods be applied.
Assuring capacity, efficiency and consistency
The taskforce’s next step to improve processes for disinfecting noncritical reusable medical equipment was to dedicate a space in which to do it. A portion of the hospital’s central service department (previously used to reprocess critical surgical devices) was repurposed for processing noncritical equipment, with the goal of developing and implementing uniform decontamination procedures that ensure a consistent outcome. The taskforce agreed that regardless of the procedures and technologies that would eventually be used, the new processing area would need to meet certain criteria. It should:
- Be safe for staff and away from patient-care areas
- Minimize the potential for human error
- Allow the capacity to disinfect without extending the current time required to clean the equipment
- Provide better utilization of the chosen space
- Permit monitoring and validation of the process by the Infection Control Committee
After a thorough review of commercially available options, the taskforce proposed and received approval to integrate a new technology for equipment disinfection: a fully enclosed decontamination room.
The modular construction of the technology allowed the room to be installed within in an existing underutilized area of the central services department. The room is a 12-foot by 16-foot two-door enclosure (allowing for a dirty load and clean unload side). The system vaporizes liquid 35 percent hydrogen peroxide sterilant and disperses this dry vapor throughout the room and its contents in a defined, controlled cycle. The equipment is easy to use, has a one-button start-up, and allows the operator to monitor the progress of the cycle. A typical cycle requires about three hours per load.
Decontamination Room, STERIS Corp.
Hydrogen peroxide gas has been used for many years as a disinfectant and for sterilization processes (McDonnell & Sheard, 2012). According to the EPA, it “destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses." These gas processes have been used in pharmaceutical and research areas for decades, and in recent years the technology has also been used to remediate contaminated buildings (e.g., buildings contaminated with anthrax spores in 2001) and hospital rooms (e.g., during contagious disease outbreaks). In addition to its antimicrobial activity, the gas is compatible with many component materials. It can be used to disinfect sensitive electronics (e.g. computers on wheels and IV pumps) that might otherwise be subjected to harsh liquid disinfectants such as bleach, which can damage equipment over time. MVAMC has been one of the first to use this technology for routine equipment disinfection in the United States.
New program leads to new reduction benchmarks
The taskforce’s stakeholder departments took on the responsibility of integrating the new technology and procedures into their routine operations. This included developing a detailed implementation plan for installing the decontamination room, identification of equipment to be disinfected, staff responsibilities, written processes for cleaning visibly soiled equipment, use of the decontamination room, a validation plan (including risk analysis), and procedures for routinely monitoring the process. Items specifically identified for routine disinfection included wheelchairs, IV pumps/poles, commodes, stretchers, beds and computers. Everyone involved agrees that the leadership and full support given by various department leaders was critical to the success of this new program.
The decontamination room and new program went into routine operation in August 2013. To date, the facility has not observed any negative effects on the materials and equipment undergoing disinfection. The real benefit, however, has been how this change has impacted the hospital’s ongoing HAI reduction initiatives.
As the program began, MVAMC had already successfully reduced the HAI rates by introducing infection control ‘bundle’ approaches for catheter-associated urinary tract infections (CAUTIs), central line associated bacteremia (CLAB), ventilator-associated pneumonia (VAP) and extended spectrum beta-lactamase (ESBL) Gram-negative bacterial infections in the Spinal Cord Unit. The rate of methicillin-resistant staphylococcus aureus (MRSA) had also fallen.
The rates of infection had been successfully reduced before 2013, but a significant additional reduction in rates was documented after the new noncritical equipment disinfection program began. The new policies, procedures and technology for processing this equipment were the only additional interventions added to these bundles during this time. Equally as important, the program brought greater consistency and repeatability to the routine processing of noncritical items, which has greatly enhanced the hospital’s overall infection prevention efforts.
The importance of champions
Establishing a new department and technology for processing noncritical medical equipment would not have been possible without the support and dedication of the MVAMC leadership. Dr. C. Diane Knight, medical center director, Jimmy McGlawn, associate medical center director, and Karen Gillette, RN, MSN, GNP, associate director for patient care and nurse executive, were all fully behind this initiative. In addition, the support of multiple hospital department leaders has been critical to the success and ongoing results of these new infection prevention protocols. These supportive professionals include: from the Biomed Department, Sheena House; from Engineering, Jon Shaw and his staff; from Logistics, Valerie Calhoun; from Sterile Processing Services, Valerie Kozik, Darren Johnson, and Harriet Jefferies, among others.
Opportunity for improvement and advancement
Today there is a greater awareness that environmental and noncritical device and equipment contamination serves as a source of patient and staff risk. In addition, studies have shown that cleaning and disinfection practices in these cases are often not well controlled. The investiga-tions at the MVAMC have shown that greater attention needs to be paid to infection prevention practices for routine processing of noncritical items in all healthcare facilities. By assessing the status of each hospital’s disinfection practices, investigating evidence-based new technologies that can add consistency and efficiency, and gaining the support of cross-functional champions, each health system has the opportunity to further reduce healthcare-associated infections. In addition, we need to encourage the development of new national and international guidelines and standards that can help address this infection reduction effort.
Raymond Baker is the chief of MVAMC Sterile Processing Services.
Vicki Macks, RN, BSN, is the multidrug-resistant organism prevention coordinator and an infection preventionist at MVAMC.
Patricia Hilliard, RN, BSN, is an infection preventionist at MVAMC.
1. Association for the Advancement of Medical Instrumentation, 2011. A Clean Start Priority Issues from the AAMI/FDA Medical Device Re-processing Summit. Arlington, VA: AAMI. Retrieved from
2. United States Food and Drug Administration. 2011. Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Rockville, MD: FDA. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf
3. McDonnell G, Sheard D, 2012. A Practical Guide to Decontamination in Healthcare. Wiley-Blackwell, West Sussex, UK, pp. 341-348.
4. Rutala WA, Weber DJ and the Healthcare Infection Control Practices Advisory Committee (HICPAC), 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA: CDC. Retrieved from http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
5. Magill S, Edwards JR, Bamberg W, et al. 2014. Multistate Point-Prevalence Survey of Health Care–Associated Infections. N Engl J Med; 370:1198-208.
For more information about the VAPROQUIP™ Decontamination Room from STERIS Corporation, contact Douglas Goldman, senior product manager, at (440) 392-7683 or send an email to [email protected]