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What should you consider when choosing a chemical disinfectant for your reusable device?

Choosing a chemical disinfectant will depend on a combination of considerations with regards to the reprocessing instructions, location of the users, possible adverse effects on biocompatibility/patient safety and device materials.

Reprocessing instructions

A first consideration when selecting the proper disinfectant for your device is that the disinfectant’s IFU must be compatible with the intended disinfection procedure. Like detergents, disinfectants come in many different forms; sprays, pre-wetted wipes, or liquids. Devices that are intended to be low or intermediate-level disinfected will often be disinfected using a wiping or spraying procedure. Therefore, when wiping or spraying is the intended disinfection procedure the disinfectant’s IFU must be consulted to verify that this procedure is compatible with the product’s intended use. By contrast, high-level disinfection will require full submersion of the device and consequently warrant a liquid disinfectant.

In addition to the intended disinfection procedure, it is important to realize that not all disinfectants, especially high-level disinfectants, are compatible with all cleaning agents. Consequently, the IFU of both the intended disinfectant and the intended detergent must be consulted to ensure that they are compatible; or, if compatibility issues exist this must be accounted for in the IFU—for example by adding rigorous rinsing steps after cleaning.

Disinfection level

Disinfectants can be subdivided broadly into high-level disinfectants/liquid chemical sterilants and into everything else that does not fall into this category. Whereas the number of high-level disinfectants is more limited, a wide variety of chemicals do not fall into this category and are intended for low and intermediate-level disinfection. Consequently, the label claim of the chemical disinfectant should always be checked to ensure that it can reach the intended disinfection level.

User location

Different locations may rely on different types of disinfectants for reprocessing medical devices. For example, for high-level disinfection the US will mostly rely on glutaraldehyde solutions whereas these are not commonly used in many EU countries. Instead, peracetic acid or hydrogen peroxide based high-level chemical disinfectants will be used in the EU. Consequently, it is important to assess which disinfectants are available to your users. There are chemicals, such as ortho-phthalaldehyde used in high-level disinfectants, that are commonly used both in the EU and US markets and can therefore be used to cover multiple markets. Other considerations may come into play as well, such as products sold on the EU market requiring a CE mark.

Another very important consideration is the FDA requirements that are placed on chemical disinfectants. For high-level disinfection, FDA maintains a list of FDA-cleared, high-level disinfectants[1] that should be consulted when choosing a high-level disinfectant for the US market. For low or intermediate-level disinfectants, the FDA will often ask for an EPA registration number[2]. Consequently, when a medical device is intended for release on the US market these FDA guidelines must be kept in mind when selecting a disinfectant.

There could be country-specific recommendations as well. German guidance[3], for example, refers to a list of disinfectants for manual reprocessing of the German Association for Applied Hygiene (VAH)[4].

Device materials

Keeping the reprocessing instructions and location of the users in mind, another consideration needs to be whether the device materials can withstand processing with the intended chemical. Functionality of the device should not be affected by repeated processing with the disinfectant.

Patient safety

In addition to functionality, it is also important that repeated processing does not affect the biocompatibility of the device. Patient safety should be considered with any processing with disinfectant , especially if this is the terminal processing step. Over time implications of added disinfectant residuals can adversely affect the patient. This should always be taken into consideration when selecting a disinfectant. Most often, user perspective is overlooked and undermined; however, regulations surrounding the Material Safety Data Sheet (MSDS) should also be considered when selecting a disinfectant for processing.

In conclusion

Selecting the disinfectant depends on the reprocessing instructions, the required disinfection level, the location of your users, and the device materials. The disinfectant’s IFU should always be checked to make sure that it is appropriate for the intended reprocessing instructions and intended disinfection level, and that it’s compatible with your device materials. Lists of FDA cleared, EPA approved, or VAH approved products exist that can be consulted when choosing a suitable disinfectant.

[1] FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices | FDA

[2] https://www.epa.gov/sites/production/files/2018-01/documents/2018.05.01.liste_.pdf

[3] Recommendation from the Commission on Hospital Hygiene and Infection Protection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for the reprocessing of medical devices” 2012

[4] https://vah-online.de/en/vah-list

Alpa Patel

Alpa Patel

B.S., RM (NRCM)
Principal Scientist

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test...

Lise Vanderkelen

Lise Vanderkelen

PhD
Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...