Validating Cleanliness Taking Human Factors Into Effect

Patient safety has always been the number-one priority in healthcare facilities with regard to reusable medical devices. Because the instructions for use (IFUs) are not always clear and concise, steps could be overlooked or not understood fully by healthcare workers. Therefore, variance to the IFUs also should be considered during the device validation. This proposed concept of validation accounts for human factors that may have a detrimental effect on cleanliness. As a result, Nelson Laboratories recommends validating IFUs with a conservative approach to ensure a safety buffer is built in, to account for human factors.
 
Human factors often come into play in the high-pressure, fast-paced reprocessing areas of healthcare facilities. These human factors can include cleaning errors at the point of use, cleaning errors in the reprocessing area, interpreting cleaning instructions differently, and not having the correct supplies/accessories that are specified in the IFU.
 
The U.S. Food and Drug Administration’s (FDA) draft guidance, “Processing/Reprocessing Medical Devices in Health Care Settings: Validations and Labeling,” states there are two important components to establishing safe and effective reprocessing instructions:
 
• Developing the cleaning process and disinfection or sterilization method; and
• Validating the cleaning process, disinfection or sterilization method, and the reprocessing instructions to demonstrate that they are complete and understandable to allow for the reuse of the device.
 
Though this is currently draft guidance, FDA reviewers may hold medical device manufacturers to these validation requirements.
 
The cleaning validation of reprocessed and reusable medical devices needs to include a safety range in the IFUs to account for human factors that may occur during the cleaning process. For example, if the instructions recommend soaking a medical device for two minutes in a concentration of a quarter to half ounce of detergent per gallon of water, the soaking time could be reduced to one minute with a lower concentration (e.g., a quarter of an ounce per gallon) of detergent solution for the validation.This safety factor validates the cleanliness and safety of a reusable medical device with human factors considered.
 
In many instances, human factors in the cleaning process can be as simple as someone brushing a device slowly for the specified time instead of vigorously, or scrubbing up and down instead of in a rotating manner. Some healthcare facilities design their own cleaning processes, even though the medical device manufacturer has provided specific, validated cleaning instructions through the IFU; often causing major issues that need to be addressed to ensure the device is properly reprocessed.
 
Medical device manufacturers are expected to provide clearly understandable IFUs with their medical devices. However, they also should build into those IFUs a safety margin to account for the human factors that may be out of their control in actual healthcare facility use—thus ensuring the devices remain safe for patient use.
 
About the Authors
• Emily Mitzel, M.S., B.S., is a laboratory manager at Nelson Laboratories in Salt Lake City, Utah. She is an expert in reusable device reprocessing validations, pharmaceutical testing and microbiology testing. She is a committee member with AAMI, ASTM and serves as co-chair for Working Group 95.
• Alpa Patel, B.S., R.M. (NRCM), is a certified microbiologist and a senior scientist at Nelson Laboratories. She specializes in cleaning/disinfection and sterilization of reusable medical devices. She is responsible for writing protocols for special projects.
• Nick Workman, CQPA (ASQ), is a study director III at Nelson and specializes in cleaning/disinfection and sterilization of reusable medical devices. He consults and guides clients through the FDA 510(k) submission process for reusable medical devices.