Medical devices contaminated with pathogens may be a source of infection for humans. Therefore, according to the Medical Device Directive, devices must be designed and manufactured in such a way as to eliminate or reduce the risk of infection to the patient, user or third parties as far as possible.
Device Cleaning, Sterilization and Reprocessing
The requirements of device cleaning, reprocessing and sterilization procedures of medical devices can be divided into two product categories:
- Medical device cleaning, sterilization, and delivery in a sterile state
- Cleaning, reprocessing and sterilization of reusable medical devices (ISO 17664)
Both product categories have in common that device cleaning validation testing can only be applied to devices which are clean and disinfected. Cleaning and disinfection are therefore prerequisites for any effective sterilization process. All processes need to be subjected to cleaning validation studies.
Microbiology Device Testing and Status
Medical device manufacturers, in particular if they manufacture sterile devices, must produce their products under adequate and microbiologically monitored conditions involving a clear zone concept. Furthermore, the final products, and if necessary the starting and packaging materials, must be subjected to bioburden determinations in order to support the later sterilization success. For devices with an invasive application endotoxin testing is necessary in order to evaluate the potential risk that the device may cause fever reaction during application.
The microbiological basic validation testing of “UL Medical Device Testing (MDT)” inform the manufacturer about the microbiological status of their products, determine anti-infective properties of materials and disinfectants and help to control manufacturing processes and sterilization procedures.
The cleaning validation testing can be performed in a UL accredited lab and we can work with you on a combination of different testing needed.
- Cleaning and sterilization of medical devices delivered in a sterile state
- Cleaning, reprocessing and sterilization of reusable medical devices
- Validation of sterilization processes
- Bioburden Determinations
- Differentiation and Detection of Pathogenic Microorganisms
- Endotoxin Testing (LAL Test)
- Antimicrobial Activity Testing
- Microbiological Monitoring of Production
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