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Q: Currently our process for hand-washed items is that once they are placed in the window one of my staff members wipes the item down with alcohol and then will blow it out (if necessary) place it in the dryer or prepare for sterilization. We do not wear gloves during this process. I have reached out to other facilities and they do not either. I have a new employee who is uncomfortable with wiping off items that come through the window without wearing gloves. What is the best practice?

A: Cleaning is the most important part of the disinfection or sterilization process. The critical importance of thorough cleaning has been emphasized by all standard-setting organizations as well as by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Numerous breaches in processing have been reported in the United States. In virtually all cases, improper cleaning is at the root of the problem. It is essential that every step in the device manufacturer’s current instructions for use (IFU) be followed each and every time. If even one step is omitted, the entire disinfection or sterilization process can be ineffective.

On Sept. 11, 2015, the CDC and FDA issued a CDC Health Advisory titled “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices.” The purpose of the communication was to alert “healthcare providers and facilities about the public health need to properly maintain, clean and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.” (CDC, 2015b)

Cleaning is defined as the “removal of contamination from an item to the extent necessary for further processing or for the intended use.” (ANSI/AAMI ST79) As defined by the Occupational Safety and Health Administration (OSHA) in its regulation limiting occupational exposure to bloodborne pathogens (29 CFR 1910.1030), decontamination is “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.” The decontamination process involves two steps. The first and most important step is manual and/or automated, mechanical cleaning. The second step is the application of a thermal or chemical disinfection process. The disinfection process is used when cleaning alone might not be enough to make the item safe for reuse or further handling without transmitting disease. Although the process sounds simple, each step has many components that must be performed correctly in order to ensure the effectiveness of processing and the safety and health of employees, patients, and the community.

When processing reusable medical devices and instrumentation, you must always follow the manufacturer’s written instructions for use. AAMI TIR-12, “Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers," states that “manufacturers of reusable medical devices have the responsibility to support product label claims of reusability by providing complete and comprehensive written instructions for the handling, cleaning, disinfection, testing, packaging, sterilization and, if applicable, aeration of their products. Manufacturers also have the responsibility to conduct and document any testing necessary to validate the suitability of these instructions.” This is because the manufacturer made the device therefore has performed the required testing to ensure the device can be safely and effectively reprocessed.

However, users (people who are processing the device) have the responsibility to replicate (reproduce) the instructions exactly as provided by the manufacturer. Healthcare personnel have the responsibility to obtain and review manufacturers’ data and recommendations and to ensure that they have the necessary resources to follow manufacturers’ instructions thoroughly.

Compliance with manufacturer’s instructions for use (IFU) is a major patient safety issue today.

Manual cleaning might be the only effective method for certain instrumentation, such as devices with lumens, powered equipment that cannot be immersed, and items that are delicate or of complex design. Manual cleaning might also be performed as a preliminary step before mechanical washing to remove stubborn stains and soils. In some facilities, manual cleaning might be the only method available. The sinks used for manual cleaning should be deep enough and large enough to contain items and minimize splashing.

Some personnel feel that manual cleaning is not sufficient to render a product safe to handle. This is why some sterile processing personnel decide to apply a disinfectant to the device to “make it safe.” 

There are several issues with this. First, as stated above, the device manufacturer must provide validated data that their described cleaning process with be effective. Second, the manufacturer must recommend the chemicals (e.g., enzymatic detergents, germicides) that the manufacturer tested for safety and effectiveness on their devices.

Legally, when staff decides to “modify” the manufacturer’s IFUs, they are using the device “off-label.” This means that the facility now bears full responsibility for the safety and efficacy of the device because they modified the IFU.

Many sterile processing staff do not realize the implications of their actions.  They feel that applying alcohol or using a germicidal wipe after manual cleaning is a good thing. However, if the device manufacturer determined that additional treatment with a germicide was required, it would be in the IFU. Furthermore, we have no idea what impact of the use of alcohol can do to devices or any remaining microbes on the device.  In addition, the use of environmental disinfectants, such as germicidal wipes, is generally intended for environmental (non-living) surfaces, not for devices that will be used directly on human tissue. Therefore, unless the device manufacturer’s IFU specifically recommends the use of a germicide after the cleaning process, staff should not amend the IFU. Instead, the use of latex free, non-powdered gloves is appropriate for handling items that are manually cleaned until they are disinfected or packaged and sterilized.