Reprocessing Validation For Class 1r Medical Devices

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.

Our Accreditations

Reprocessing refers to a process carried out on a used device in order to allow its safe reuse. It includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.

At Test Labs, we offer testing services to ensure the reprocessing instructions outlined in your Instructions for Use (IFU) are fully validated. Validation of reprocessing follows the principles and guidelines described in BS EN ISO 17664-1 (critical and semi-critical MD) and BS EN ISO 17664-2 (non-critical MD).

Stage 1: Sample Selection

Medical devices representative of a group instruments with similar reprocessing instructions (for example, forceps) are selected for reprocessing validation. The chosen devices should represent the worst-case clinical conditions, based on device complexity and cleaning challenge.

Stage 2: Soil Selection

A test soil is chosen according to HTM 01-01 “Decontamination of surgical instruments`` and validated according to ISO 15883-5:2021. The test soil is intended to mimic a representative level of soiling that the device would likely be exposed to during clinical use (e.g., Edinburgh soil).

Stage 3: Simulated Use Testing

The representative medical devices are then put through simulated use testing. The efficacy of the IFU is assessed after repeated use of the medical device and possible soil accumulation in order to prove that the IFU will reprocess the medical device to a satisfactory standard even after multiple reuses.

Stage 4:Cleaning Validation ISO 15883-5

Automated
For automated cleaning cycle, the soiled Medical Devices are processed as per IFU, using a Washer Disinfector (WD). Visual inspection if carried out as well as testing for residual level of protein using a Modified OPA method. A second residual analyte, such as ATP, is also tested to ensure the correct level of cleanliness is achieved. Test Labs proudly offers this test under the 17025 UKAS accreditation scope.
Manual
For automated cleaning cycle, the soiled Medical Devices are cleaned manually as per IFU using the pre- determined cleaning agents or methods. Visual inspection and residual analytes are performed as per the automated cycle to validate the cleaning process.

Stage 5: Thermometric Disinfection Validation (Automated) ISO 15883-2

During disinfection validation, the medical device is disinfected using WD with the specified time and temperature as outlined in the IFU using UKAS validated thermocouples. The disinfection procedure of the IFU is considered validated if the temperature of the medical device stays within disinfection range for a specified duration. Test Labs proudly offers this test under the 17025 UKAS accreditation scope.

Stage 6: Sterilisation Validation (Moist Heat) ISO 17665-1

The representative medical devices are inoculated with a biological indicator. Using an overkill method, the medical device is exposed to a partial-cycle (half of the full sterilisation cycle) to ensure the required sterility assurance level (SAL) can be achieved. Test Labs proudly offers this test under the 17025 UKAS accreditation scope.

Reprocessing Validation FDA Standards

The above methods would also suffice the requirements set by the FDA for reprocessing medical devices. The following standards will be used for clients intending to submit their claims with FDA.
AAMI TIR30 -- A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
ANSI/AAMI ST98:2022 -- Cleaning Validation of Health Care Products - Requirements For Development And Validation Of A Cleaning Process For Medical Devices.

Sterilisation will also follow ISO 17665-1.

The introduction of new requirements from the MDR for Class Ir Medical Devices has added an extra level of complexity for manufacturers to comply with the regulations. Self-certification will not the allowed for Class Ir, and therefore a Notified Body will be required to review the technical file. Specific attention will be given to the performance requirements of specific intended use, in this case reprocessing. Full validation of the reprocessing cycles included in the IFU needs to be included.

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