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. Medical device cleaning validations are critical component to the overall reprocessing validation, it proves that the device can be cleaned following the manufacturer’s instructions for use (IFU). Organic matter left on the device can inhibit the disinfection or sterilization process by protecting microbes from the disinfection or sterilization agents, therefore it is essential that the cleaning process if effective. Likewise, the manufacturer’s instructions for the disinfection or sterilization steps must be validated to show the microbicidal process is effective.
Medical Device Cleaning Validations
A medical device cleaning validation requires that the device is soiled with biological material in a manner that is clinically relevant. The soil will often depend on the type of device being tested, but typically is a mixtures of proteins, hemoglobin, and carbohydrates. Artificial Test Soil (ATS) is the most commonly used soil for medical device cleaning validations. Once soiled, the medical device will be cleaned according to the manufacturer’s instructions and any remaining soil will be extracted from the device. The process is considered validated if a series of at least three cleaning tests show that the markers (typically protein and hemoglobin) are below levels prescribed in AAMI TIR 12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers.
Manual cleaning is the most frequently requested medical device cleaning validation method, but many hospitals and clinics use automated washer disinfectors for reprocessing reusable medical devices. Therefore, ISO standards recommend that at least one automated cleaning method be validated. An automated cleaning validation is performed the same way as a manual cleaning validation except that the actual cleaning steps are performed by an automated washer/disinfector.
Medical Device Disinfection Validations
Medical device disinfection validations are performed differently depending on the level of disinfection required, high level disinfection, intermediate level disinfection or low level disinfection. The level of disinfection is determined by the Spaulding Category of the device, critical, semi-critical or non-critical. Critical medical devices come in contact with the blood stream and sterile parts of the body. These devices must be sterilized. Semi-critical devices come into contact with intact mucous membrane or non-intact skin but do not normally penetrate the blood barrier or sterile area of the patient. Semi-critical devices should be sterilized but if the device can not withstand sterilization, high level disinfection may be used. Non-critical devices only contact intact skin. Non-critical devices can be disinfected using intermediate or low level disinfection.
All disinfection validations require that the device be inoculated with bacteria and then exposed to the disinfectant. Any remaining bacteria is extracted from the device and grown on plates in a manner similar to a bioburden test. High level disinfection requires a six log reduction of Mycobacteria. A three log reduction of Mycobacteria and a six log reduction of four different vegetative organisms are required for intermediate level disinfection. Low level disinfection requires only a six log reduction of four different vegetative organisms.
Medical Device Sterilization Validations
Pacific BioLabs also performs reusable medical device sterilization validations such as steam sterilization validations. For more information on medical device sterilization validation performed by PBL, please visit our Sterilization Validation page.
Reusable Medical Device Cleaning and Disinfection Validation
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 a medical device cleaning validation and sterilization validation will vary depending on the validation protocol. Please call us to discuss your reusable device validation requirements.
Medical Device Cleaning Validation: Processes Available
- Manual Cleaning
- Automated Cleaning (Getinge Automated Washer/Disinfector)
- Mechanical Cleaning
- Ultrasonic Cleaning
Medical Device Disinfection Validation: Processes Available
- Automated Disinfection (Getinge Automated Washer/Disinfector)
Medical Device Cleaning and Disinfection Validation 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 Medical Device Cleaning and Disinfection Validations
- PBL’s Learning Center – Reusable Device Validations
- PBL’s Blog – Device Cleaning and Disinfection Validations – A Primer
- PBL’s Blog – Reusable Device Cleaning Validation – Three Cycles or One Cycle?
- PBL’s Blog – FDA Expectations for Reusable Device Reprocessing Validations
- PBL’s Blog – Webinar on Reusable Device Validations Now Online
PBL’s Reusable Device Validations Booklet
Download the free booklet