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CLEANING AND DISINFECTION VALIDATIONS

To address regulatory and liability concerns, manufacturers of medical devices that are intended for reuse and sterilization in health care facilities must provide specific cleaning, disinfection and/or sterilization instructions to their customers. To insure that reliable cleaning, disinfection and/or sterilization will result, the instructions must be validated. For more information, refer to AAMI TIR 12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers.

Pacific BioLabs can simulate most conventional hospital cleaning and sterilization procedures. Fees for the cleaning and sterilization validation studies will vary depending on the validation protocol. Please call us to discuss your requirements. We can perform testing according to our protocol or prepare a protocol in consultation with you.

To learn more about Device Cleaning and Disinfection, please view our detailed posting, "Device Cleaning and Disinfection Validations - A Primer."

Available Validations

• Development of Cleaning, Disinfection, and Sterilization Protocols
• Cleaning Validation Studies
• Disinfection Validation Studies

Types of Cleaning

• Manual Cleaning
  
• Mechanical Cleaning
• Ultrasonic Cleaning

Types of disinfection

• Chemical
• Thermal