Medical Device Cleaning And Sterilization Validation

Medical Device Cleaning Procedure

Cleaning is a critical step in medical device reprocessing that affects disinfection and sterilization effectiveness. Inadequate cleaning can result in the retention of blood, tissue, mucous or biological material which can allow micro-organisms to survive the disinfection or sterilization process, thereby resulting in patient infection.

Cleaning methods include manual cleaning, ultrasonic cleaning and automatic washer-disinfectors. SteriLabs provides services in establishing appropriate cleaning methods and products based on the design and characteristics of reusable medical devices. SteriLabs also offers services in developing a multi-step cleaning process including selecting the appropriate detergent which best removes soils and is compatible with the device material, and choosing the optimal cleaning parameters including the temperature and length of cleaning cycle among others.

Medical Device Cleaning Validation

Manufacturers of reusable medical devices and surgical instruments are required to perform cleaning validations. A typical cleaning validation procedure includes contamination with suitable contaminant to simulate clinical use, cleaning, extraction of residual contamination and post-reprocessing effectiveness evaluations. The reprocessing scientists at SteriLabs actively serve on CSA, AAMI, ASTM and ISO committees that develop applicable standard and guidance documents.

Medical Device Disinfection Validation

SteriLabs offers disinfection validation services to support medical device manufacturers in validating disinfection processes for devices that are incompatible with sterilization methods. The reprocessing level of disinfection will depend on the intended use and Spaulding’s classification of the medical device which divides medical devices into 3 categories; critical, semi-critical and non-critical items based on the degree of risk of infection.

Failure to properly disinfect medical devices could potentially lead to infection. SteriLabs trained team can assist with determining the methods and agents employed to disinfect medical devices to achieve appropriate microbicidal effects.

MEDICAL DEVICE STERILIZATION VALIDATION

A complete validated sterilization cycle must be developed for medical devices intended to be used sterile. Manufacturers of medical devices are responsible for ensuring that their products can be sterilized by licensed sterilization equipment and cycles with accessories such as PCDs, packaging materials and monitoring products.

SteriLabs offers medical device sterilization validation services to determine the appropriate sterilization cycle parameters to achieve sterility while preventing undesirable effects on the device and its packaging.

• Moist heat (Steam) sterilization – Gravity or Pre-vacuum
• Hydrogen peroxide sterilization - Plasma or Vaporized 
• Ethylene Oxide sterilization
• Radiation sterilization

For the medical device sterilization validation testing, medical devices are inoculated with a known population of a commonly used microbiological challenge. The medical devices are then sterilized and tested for sterility and materials compatibility. As per current standards, an appropriate sterilization validation method is selected in order to demonstrate a sterility assurance level of 10-6 for the device.

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