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Device cleaning: right device, right product, right protocol
PERIOP BRIEFING
SPECIAL REPORT: OR Cleaning
Device cleaning: right device, right product, right protocol Kelly Putnam, Managing Editor
T
he “Top 10 Health Technology Hazards for 2017” from the ECRI Institute include medical device failures caused by incompatible cleaning products and practices that damage surfaces and degrade materials.1 Damage to seals, reduced lubrication, and fluid intrusion from cleaning products can cause electronic equipment, including power supplies and motors, to fail.1 The report cites problems with a range of devices, from infusion pumps to robotic surgical equipment, that were related to cleaning products and practices.1
Understanding manufacturers’ instructions for use In March 2015, the U.S. Food and Drug Administration (FDA) released recommendations for manufacturers to improve their labeling and instructions for use (IFUs) of reusable medical devices, including suggestions for incorporating validated cleaning instructions.2 In the past two years, issues related to manufacturers’ IFUs continue to pose problems for health care workers. “The take-home message is that you should follow the manufacturers’ instructions for use for any piece of equipment, in the OR or otherwise. If you vary from specific IFUs, you may run the risk of damaging that equipment,” said Marsha Barnden, RN, MSN, CIC, corporate director of Infection Prevention & Clinical Standards at Adventist Health, Roseville, Calif. Reliability of IFUs Recommendations from organizations such as AORN, The Joint Commission, and the Royal College of Nursing frequently direct end users to the manufacturers’ IFUs in lieu of providing specific cleaning instructions.3-5 However, Barnden said manufacturers’ IFUs can point users to products that have not been carefully tested for the specific device. In addition to validating a cleaning product’s effectiveness to remove pathogens, manufacturers also need to confirm that the product does not http://dx.doi.org/10.1016/S0001-2092(17)30337-X
P10 | Periop Briefing
impair the integrity of the surfaces and components of a device with repeated cleanings over the long term. This type of exhaustive testing can be cost prohibitive. Adherence to IFUs As manufacturers continue to improve their IFUs in response to the FDA’s recommendations, IFUs remain the best resources for health care personnel developing environmental and device cleaning policies. A review of studies evaluating cleaning practices through covert observation or fluorescent methods across multiple care settings, including ORs, found that only 40 percent of surfaces were cleaned according to hospital policies.6 Time pressures and lack of familiarity with the IFUs may contribute to cleaning and disinfection noncompliance. “It’s problematic because we have a lot of environmental surfaces and equipment that need to be cleaned and disinfected, and various groups of workers—both clinical and nonclinical—who may or may not be informed as to the appropriate cleaning and disinfection process,” said Barnden. For example, some disinfecting products require reapplication over the course of several minutes to keep the surface wet and help ensure maximal pathogen inactivation. Personnel must strictly adhere to this “kill time” (i.e., wet time or dwell time); however, personnel may be unaware of this requirement or feel pressured to turn over the room quickly and compromise this step. To support adherence to specific steps in the disinfection process, personnel should have ready access to the IFUs for equipment in their facility and should be be able to clearly articulate the correct process when asked. Educators should implement programs that help familiarize personnel with the IFUs. Software is available that can store all the IFUs for a facility’s given inventory, increasing the accessibility for all appropriate personnel.
Monitoring cleaning practices Among environmental cleaning and nursing personnel, there may be miscommunication regarding who is responsible for cleaning various surfaces and equipment at different times of the day.7,8 Clear delineations of the responsibilities of each team member during room turnover and terminal cleanings in the OR can help ensure that personnel consistently Cleaning personnel should use compatible cleaning agents follow the IFUs. Some facilities when cleaning and disinfecting reusable medical devices to minimize rely on third-party contractors for damage to the equipment. terminal cleaning after hours, and these personnel should have the same level of competency as facility personnel. 2. Reprocessing medical devices in health care Robust surveillance and monitoring systems can reveal workflow and compliance issues that may prevent personnel from carefully following the IFUs. Barnden said it is vital to routinely conduct rounds on various shifts and watch the process from start to finish—both during room turnovers and terminal cleaning. This observation can reveal opportunities for education to help health care workers improve cleaning and disinfection practices, and it provides an opportunity for observers to offer valuable real-time feedback.
3.
4.
Conclusion There may never be a single cleaning or disinfection product that is effective and easy to use for every medical device and hospital surface. In light of this, health care workers are responsible for knowing which product to use on which device or surface and how to best perform the cleaning and disinfection. Many of the problems associated with medical device cleaning and disinfection are rooted in the manufacturers’ IFUs—either their reliability for repeated, long-term cleaning or personnel’s access and adherence to them—and supervisors should investigate and correct these issues.
5.
6.
7.
References 1. Top 10 Health Technology Hazards for 2017. ECRI Institute. www.ecri.org/2017hazards. Published November 2016. Accessed March 10, 2017.
© AORN, Inc, 2017
8.
settings: validation methods and labeling. U.S. Food and Drug Administration. https:// www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/ guidancedocuments/ucm253010.pdf. Published March 17, 2015. Accessed March 10, 2017. Guideline for environmental cleaning. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2017:7-28. The selection and use of disinfectant wipes: RCN guidance. Royal College of Nursing. https://www2.rcn.org.uk/__data/assets/pdf_ file/0011/382538/003873.pdf. Published June 2011. Accessed March 10, 2017. Waldowski L. Preventing breaches in disinfection. The Joint Commission Healthcare Executive. https:// www.jointcommission.org/assets/1/18/HCExec_ Column.pdf. Published 2015. Accessed March 10, 2017. Carling PC, Bartley JM. Evaluating hygienic cleaning in health care settings: what you do not know can harm your patients. Am J Infect Control. 2010;38(5 Suppl 1):S41–50. Dumigan DG, Boyce JM, Havill NL, Golebiewski M, Balogun O, Rizvani R. Who is really caring for your environment of care? Developing standardized cleaning procedures and effective monitoring techniques. Am J Infect Control. 2010;38(5):387–92. Anderson RE, Young V, Stewart M, Robertson C, Dancer SJ. Cleanliness audit of clinical surfaces and equipment: who cleans what? J Hosp Infect. 2011;78(3):178–81.
May 2017 Vol 105 No 5 • Periop Briefing | P11
PERIOP BRIEFING
SPECIAL REPORT: DEVICE CLEANING
SPECIAL REPORT: OR Cleaning
Device cleaning: right device, right product, right protocol Kelly Putnam, Managing Editor
T
he “Top 10 Health Technology Hazards for 2017” from the ECRI Institute include medical device failures caused by incompatible cleaning products and practices that damage surfaces and degrade materials.1 Damage to seals, reduced lubrication, and fluid intrusion from cleaning products can cause electronic equipment, including power supplies and motors, to fail.1 The report cites problems with a range of devices, from infusion pumps to robotic surgical equipment, that were related to cleaning products and practices.1
Understanding manufacturers’ instructions for use In March 2015, the U.S. Food and Drug Administration (FDA) released recommendations for manufacturers to improve their labeling and instructions for use (IFUs) of reusable medical devices, including suggestions for incorporating validated cleaning instructions.2 In the past two years, issues related to manufacturers’ IFUs continue to pose problems for health care workers. “The take-home message is that you should follow the manufacturers’ instructions for use for any piece of equipment, in the OR or otherwise. If you vary from specific IFUs, you may run the risk of damaging that equipment,” said Marsha Barnden, RN, MSN, CIC, corporate director of Infection Prevention & Clinical Standards at Adventist Health, Roseville, Calif. Reliability of IFUs Recommendations from organizations such as AORN, The Joint Commission, and the Royal College of Nursing frequently direct end users to the manufacturers’ IFUs in lieu of providing specific cleaning instructions.3-5 However, Barnden said manufacturers’ IFUs can point users to products that have not been carefully tested for the specific device. In addition to validating a cleaning product’s effectiveness to remove pathogens, manufacturers also need to confirm that the product does not http://dx.doi.org/10.1016/S0001-2092(17)30337-X
P10 | Periop Briefing
impair the integrity of the surfaces and components of a device with repeated cleanings over the long term. This type of exhaustive testing can be cost prohibitive. Adherence to IFUs As manufacturers continue to improve their IFUs in response to the FDA’s recommendations, IFUs remain the best resources for health care personnel developing environmental and device cleaning policies. A review of studies evaluating cleaning practices through covert observation or fluorescent methods across multiple care settings, including ORs, found that only 40 percent of surfaces were cleaned according to hospital policies.6 Time pressures and lack of familiarity with the IFUs may contribute to cleaning and disinfection noncompliance. “It’s problematic because we have a lot of environmental surfaces and equipment that need to be cleaned and disinfected, and various groups of workers—both clinical and nonclinical—who may or may not be informed as to the appropriate cleaning and disinfection process,” said Barnden. For example, some disinfecting products require reapplication over the course of several minutes to keep the surface wet and help ensure maximal pathogen inactivation. Personnel must strictly adhere to this “kill time” (i.e., wet time or dwell time); however, personnel may be unaware of this requirement or feel pressured to turn over the room quickly and compromise this step. To support adherence to specific steps in the disinfection process, personnel should have ready access to the IFUs for equipment in their facility and should be be able to clearly articulate the correct process when asked. Educators should implement programs that help familiarize personnel with the IFUs. Software is available that can store all the IFUs for a facility’s given inventory, increasing the accessibility for all appropriate personnel.
Monitoring cleaning practices Among environmental cleaning and nursing personnel, there may be miscommunication regarding who is responsible for cleaning various surfaces and equipment at different times of the day.7,8 Clear delineations of the responsibilities of each team member during room turnover and terminal cleanings in the OR can help ensure that personnel consistently Cleaning personnel should use compatible cleaning agents follow the IFUs. Some facilities when cleaning and disinfecting reusable medical devices to minimize rely on third-party contractors for damage to the equipment. terminal cleaning after hours, and these personnel should have the same level of competency as facility personnel. 2. Reprocessing medical devices in health care Robust surveillance and monitoring systems can reveal workflow and compliance issues that may prevent personnel from carefully following the IFUs. Barnden said it is vital to routinely conduct rounds on various shifts and watch the process from start to finish—both during room turnovers and terminal cleaning. This observation can reveal opportunities for education to help health care workers improve cleaning and disinfection practices, and it provides an opportunity for observers to offer valuable real-time feedback.
3.
4.
Conclusion There may never be a single cleaning or disinfection product that is effective and easy to use for every medical device and hospital surface. In light of this, health care workers are responsible for knowing which product to use on which device or surface and how to best perform the cleaning and disinfection. Many of the problems associated with medical device cleaning and disinfection are rooted in the manufacturers’ IFUs—either their reliability for repeated, long-term cleaning or personnel’s access and adherence to them—and supervisors should investigate and correct these issues.
5.
6.
7.
References 1. Top 10 Health Technology Hazards for 2017. ECRI Institute. www.ecri.org/2017hazards. Published November 2016. Accessed March 10, 2017.
© AORN, Inc, 2017
8.
settings: validation methods and labeling. U.S. Food and Drug Administration. https:// www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/ guidancedocuments/ucm253010.pdf. Published March 17, 2015. Accessed March 10, 2017. Guideline for environmental cleaning. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2017:7-28. The selection and use of disinfectant wipes: RCN guidance. Royal College of Nursing. https://www2.rcn.org.uk/__data/assets/pdf_ file/0011/382538/003873.pdf. Published June 2011. Accessed March 10, 2017. Waldowski L. Preventing breaches in disinfection. The Joint Commission Healthcare Executive. https:// www.jointcommission.org/assets/1/18/HCExec_ Column.pdf. Published 2015. Accessed March 10, 2017. Carling PC, Bartley JM. Evaluating hygienic cleaning in health care settings: what you do not know can harm your patients. Am J Infect Control. 2010;38(5 Suppl 1):S41–50. Dumigan DG, Boyce JM, Havill NL, Golebiewski M, Balogun O, Rizvani R. Who is really caring for your environment of care? Developing standardized cleaning procedures and effective monitoring techniques. Am J Infect Control. 2010;38(5):387–92. Anderson RE, Young V, Stewart M, Robertson C, Dancer SJ. Cleanliness audit of clinical surfaces and equipment: who cleans what? J Hosp Infect. 2011;78(3):178–81.
May 2017 Vol 105 No 5 • Periop Briefing | P11
PERIOP BRIEFING
SPECIAL REPORT: DEVICE CLEANING