Medical devices that remain contaminated after reprocessing, are a major public health concern, and any associated infections are preventable. To conform to MDR (Medical Device Regulation (EU) 2017/745), reusable medical devices require IFU (instructions for use) which detail a validated method for effectively reprocessing and safely reusing the device. There must be data available to prove the efficacy of cleaning, disinfection and sterilisation, of the methods detailed in the IFU, without affecting the safety or performance of the medical device.
Residual organic matter on medical devices can inhibit the disinfection or sterilisation process; oxidation of the organic compounds by bacterial enzymes, releases energy and carbon which microorganisms need to live. Therefore, it is essential, both microbiocidal activity of the process and the effective cleaning of the process is determined and validated for the IFU.
Guidance on test methods are routinely updated or documents archived and changed, 20/30 Labs have extensive experience in medical device decontamination and consultancy, to assist in navigating the standards and regulations for IFU validation.
Whilst a manufacturer can validate a reprocessing method and detail this in an IFU against legislature described in ISO 15883 / AAMI, process qualifications can be just as important for more complicated devices. As such IFU validations cannot take into consideration the effectiveness of the manual cleaning, potential contaminants from the reprocessing environment, water quality, and proper operation of the washer disinfector, in a clinical setting.
Reprocessing Qualifications Stages:
Stage 1 : Protocol
We work with the client to create a justification of the validation plan, which looks at the medical device classification and medical device family to determine the worst-case clinical scenario. The protocol describes the cleaning steps as per the IFU, which can include manual cleaning / automated cleaning / sterilisation, and be validated separately or as a whole. The protocol identifies and accounts for worst-case processing conditions i.e., shortest contact time, weakest dilution of disinfectant and lowest temperature.
Stage 2 : Soil
Items are soiled and contaminated using clinically relevant markers (i.e., a combination of blood-based and mucus-based for duodenoscopes) as per T/S ISO 15883-5: 2021 or ST98*, which includes a drying phase to simulate delayed processing times. Test articles must be in ‘used’ condition. For sterility assurance testing, biological indicators are placed in worst-case locations, at a dose high enough to prove SAL 10-6. *AAMI TIR30 has been replaced by ANSI/AAMI ST98.
Stage 3 : Wash
Soiled devices are put through wash cycles or sterilisation cycles, in triplicate, as per the IFU from the manufacturer. Ensuring they are suitable placed in loading trays, or disassembled or suitably pre-cleaned if required.
Stage 4 : Analysis
We use UKAS accredited methods that are quantifiable and with predetermined limits, and provide results per whole device, for the following analytes: protein, haemoglobin, endotoxin, total organic carbon and bioburden. We have suitable device controls at each point and obtain extraction efficacy using the exhaustive method.
Stage 5 : Report
We have had a UKAS auditor review our test reports against the ISO 15883 and ISO 17665 documents, to ensure they are complaint.
of validations passed within the first run, on worse case scenarios.
pass marks on external qualification assessments on our processes
business increase in this area since 2020
20/30 Labs testing complies with ISO 15883 series, ISO 17664, AAMI TIR12, AAMI ST98, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling.” We a capable of performing manual clean validations, fully automated clean/disinfect processes, and sterilisation (steam: gravity and prevacuum, ETO and VH2O2).
- Food and Drug Administration Reprocessing Medical Devices in Health Care Settings Validation Methods and Labeling. www.fda.gov/media/80265/download
- ANSI/ASMI ST79, ANSI/AAMI ST77 and AAMI TIR12 are guidelines for testing reusable medical devices.
- AAMI TIR12
- AAMI ST98*
- ISO 17664
- ISO 15883 series
- ASTM 2314