Reusable Device 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 ensure 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.

Currently, the US FDA requires only a validated manual procedure for cleaning and disinfection. Medical device companies wishing to market their products in Europe, however, are required to validate an automated cleaning and disinfection method as well. This necessitates the use of an automated washer/disinfector, and Pacific BioLabs can perform both manual and automated validations.

PBL’s Reusable Medical Device Cleaning and Disinfection Validations

Pacific BioLabs’ microbiology lab has extensive experience is designing and conducting reusable device cleaning, disinfection, and sterilization validation studies on devices ranging from basic surgical tools to complex robotic instruments, and we 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.

Types of Cleaning Processes Available

  • Manual Cleaning
  • Automated Cleaning (Getinge Automated Washer/Disinfector)
  • Mechanical Cleaning
  • Ultrasonic Cleaning

Types of Disinfection Processes Available

  • Chemical
  • Thermal
  • Automated Disinfection (Getinge Automated Washer/Disinfector)

Cleaning and Disinfection Services

  • Development of Cleaning, Disinfection, and Sterilization Protocols
  • Cleaning Validation Studies
  • Disinfection Validation Studies
  • Life Time Reuse Studies
  • R&D Pilot Studies

Read More About Cleaning and Disinfection Validations

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