Cleaning Validation

Cleaning Validation

Cleaning Validations of Reusable Devices

Manufacturers of reusable medical devices must provide written instructions for cleaning of the products between use to ensure that the device can be used safely for the purpose for which it is intended. Manufacturers are obligated under the Food and Drug Administration (FDA) labeling regulations (21 CFR 801) to have the suitability of these processes validated.  

LexaMed is an industry leader in designing and performing medical device cleaning validations.  Every device is different therefore each program begins with generation of a unique protocol by an experienced project manager followed by study execution by trained microbiologists and chemists.  

The validation protocol and testing are developed and conducted in compliance with the following standards:

· AAMI TIR 30 (ST98 draft) A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices,

· ISO 17664 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices,

· FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.


Protocol Development

Working closely with the study sponsor, the LexaMed project manager will attain an understanding of the device and the manufacturer’s cleaning instructions.  Using this information a protocol will be generated that will ensure all elements of the various standards are properly incorporated including things such as description of end-of-life conditioning, appropriate soil choice with justification and acceptance criteria for the chosen soil markers.  The study sponsor will be asked to review and approve the protocol prior to study initiation.

 End-of-life Conditioning

As stated in the guidance documents it is important that devices used for validation testing are reflective of their end of life condition in order to represent worst case conditions for cleaning.  Prior to use for testing, devices should be cycled through the typical number of cleaning and sterilization/disinfection cycles they are expected to be exposed to.  Clients may choose to conduct this activity prior to submitting devices for testing or LexaMed is equipped to help with this.      


Trained analysts inspect each device to determine the most difficult to clean area such as lumens, hinges and matted surfaces.  Devices are then contaminated, focusing on these hard to clean areas, with an organic test soil material that contains clinically relevant components such as hemoglobin, protein, carbohydrates or endotoxin. The device may be soiled by handling with soiled gloved hands and/or complete immersion in the test soil to simulated worst case.  Movable parts are actuated during soiling to simulate clinical use.  The soil remains in place for a sufficient time to simulate time between patient use and cleaning.


Cleaning which is ineffective in removing foreign material from the inside and outside of a device can interfere with efficacy of subsequent disinfection and/or sterilization processes. Contaminated devices are cleaned using either the manufacturer’s recommended cleaning process or a process developed as part of the validation.   Using the manufacturer’s specified detergent, cleaning is performed using a manual process such as wiping, brushing with a soft bristle brush, flushing, soaking or a combination of these methods.  Cleaning may also be conducted using an automated process in a washer-decontaminator.  Following cleaning, the devices are visually inspected for residual soil.

 Recovery Efficiency Studies

Analytical test methods used to determine levels of challenge soils remaining on devices following cleaning cannot always recover 100% of the soils present on a device due to the various materials of construction and configuration.  Prior to extraction a Recovery Efficiency Study is performed for each challenge soil to determine the percentage that can be recovered during extraction.  Using the results of this test, a recovery factor is calculated and then applied to all testing conducted.  Multiple extraction method attempts may be necessary to determine the most efficient method for soil removal.


Cleaned devices, a negative control device which was cleaned without soiling and a positive control which was soiled but not cleaned are extracted using deionized water and the method determined during the recovery efficiency study.  Any residual soil not removed during the cleaning process will be extracted from the device. 


Extracts from the test articles and controls are evaluated to determine if the cleaning process effectively removed the challenge soils to acceptable levels.  Extracts are exposed to a validated quantitative analysis to determine the level of residuals remaining, the previously determined recovery factors are applied to the results.  The final step is an evaluation to determine if the cleaning process effectively removed detergent residuals to a safe non-toxic level.   A cleaned device is subjected to an ISO Cytotoxicity Test to measure the level of any toxic residuals that may be remaining following the cleaning process. 

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