Following manufacturers’ cleaning instructions for use – is that enough?

April 20, 2017

Everyone who works in infection control and sterile processing has heard the statement, “If it’s not clean it can’t be disinfected/sterilized.” But what does it take to clean the reusable medical devices that are used in the healthcare facility?

Some people think all that is necessary is to follow the manufacturer’s instructions for cleaning, disinfection and sterilization. After all, the FDA requires the medical device manufacturer to develop and validate procedures that will effectively clean, and if necessary disinfect, and sterilize the reusable devices that the manufacturer produces. From these validated procedures, the medical device manufacturer develops the instructions for use (IFU) that the healthcare facility is supposed to follow to clean, disinfect and sterilize the device.

However, recently it has been reported in the press that even when the employees at the healthcare facility follow the device manufacturer’s IFU the device might not be clean. Ofstead & Associates Inc. conducted a longitudinal study on current techniques used to clean endoscopes for reuse. In this study three assessments were performed on 20 endoscopes over a seven-month period. After each cleaning and disinfection procedure, each endoscope was assessed by visually inspecting with a camera, microbial cultures and biochemical tests.

All of the endoscopes failed at least one criterion in the study. According to the study authors, the manufacturer’s IFU was followed and there were not breaches in technique. The lead study author stated that the findings suggest that something happens during use of the endoscope that changes the device surfaces and causes the reprocessing procedures to fail.

This is very frightening. What can healthcare facilities do if they follow the manufacturer’s IFU and the process still fails?

Testing cleaning quality

There are several things that can be done to ensure that the cleaning, disinfection and sterilization processes work. According to ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, facilities should be conducting product quality assurance (PQA) testing of their sterilization processes. PQA testing enables the healthcare facility to ensure that the manufacturer’s IFU works at their facility with the equipment, cleaning chemicals, disinfection and sterilization processes used by the facility. This has been a requirement in ST79 for over 10 years. Many people think of PQA testing as applying to the sterilization process only, but it is not possible to sterilize a device that has not been cleaned. This means that product quality testing should also be done on the cleaning process.

Basically, PQA testing is the healthcare facility’s validation process and is similar to the testing performed by the device manufacturer. What should be happening is the device manufacturer develops a reusable device and then develops and validates a process for cleaning, disinfecting and sterilization of the device. It is necessary for the healthcare facility to conduct testing that will show that the IFU works at their facility. Process validation is specific to the equipment that is used for processing the device; so it is necessary to conduct testing on each washer and each sterilizer used at the healthcare facility to process medical devices. If this type of testing is not done, then it is impossible to know if the manufacturer’s IFU will work at a specific healthcare facility and produce the same result as was achieved by the medical device manufacturer.

Follow supplier example

PQA testing at a healthcare facility should adhere to the same scientific principles used in industry. This means that it is necessary to conduct three replicate tests and that re-qualification studies need to be conducted annually. All acceptance criteria must be met for the process to be considered acceptable for use.

Once PQA testing has been conducted and one has proved the manufacturer’s IFU is effective at a specific facility it is also necessary to perform ongoing verification testing. Ongoing verification testing involves conducting testing of the cleaning, disinfection and sterilization processes. Routine monitoring (verification testing) has been the standard for many years when it comes to sterilization processes. Healthcare facilities conduct leak tests, Bowie-Dick-type tests, biological and chemical monitoring of sterilization processes. Similar testing can be performed on the cleaning processes used.

Just like with sterilization, testing of cleaning processes can be conducted to ensure that the cleaning equipment is functioning correctly. Testing can also be conducted to ensure that organic debris has been removed from the devices during the cleaning process. Test devices are available which can measure if any protein or hemoglobin remains on a device after completion of the cleaning process. Each healthcare facility needs to develop a comprehensive cleaning verification program. In addition to testing for cleanliness the devices should be visually inspected to ensure that no visible debris remains on the cleaned devices. Visual inspection may require the use of lighted magnifying devices and borescopes to be able to see all surfaces of the devices.

As medical devices have become more complex it has become necessary for healthcare facilities to conduct PQA testing of both cleaning and sterilization processes. Medical device manufacturers at best can only provide guidance on how to effectively clean and sterilize their reusable devices. There are many factors at the healthcare facility that the device manufacturer does not control, e.g., water quality, steam quality, the equipment and chemicals used. Following the manufacturer’s IFU is not enough to ensure that reusable medical devices are effectively cleaned and sterilized; healthcare facilities must also conduct testing to ensure that the device manufacturer’s IFU works.

Original photo courtesy Bayhealth SPD, HPN's 2021 SPD of the Year, with affects added by generative AI.
64770523 © Win Nondakowit | Dreamstime.com
25375493 © Scanrail, 37586544 © Sudok1 | Dreamstime.com
244332651 © Auremar | Dreamstime.com