Cleaning is a critical step in medical device reprocessing to ensure disinfection and sterilization effectiveness.Inadequate cleaning can result in 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. SteriLab provides services in establishing appropriate cleaning methods and products based on the design and characteristics of reusable medical devices. SteriLab also offers services in developing a multi-step cleaning process including selecting the appropriate detergent which best remove soils and is compatible with the device material, choosing the optimal cleaning parameters including the temperature andlength of cleaning cycle among others.
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.
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 the 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.
Complete validated sterilization cycle must be developed for medical devices intended to be used sterile. Manufacturer of the 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.
For the medical device sterilization validation testing, medical devices are inoculated with a known population of commonly used microbiological challenge. The medical devices are then sterilized and tested for sterility and material 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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