Reusable Medical Device Reprocessing

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Reusable medical device reprocessing validation

To comply with the requirements of the Medical Devices Regulation (MDR) 2017/745, re-processable medical device manufacturers must provide reprocessing instructions describing cleaning, disinfection and sterilisation in the forms of Instructions for Use (IFU). IFU must be validated to ensure that the described procedures are adequate for the specified medical devices. Medical device manufacturers must also demonstrate the safety of the product after reprocessing and over the entire product life cycle.

Test Labs IFU validation method is based on ISO 17664-1 and ISO 17664-2. Service offer includes the evaluation of the effectiveness of your manual or automated cleaning, disinfecting and sterilisation instructions; selection of the most appropriate test soil or organism to simulate relevant clinical use and identification of inoculation sites on your instruments. We will support you in the optimisation of your Instruction for Use. Test methods include:

Automated Cleaning: Washer Disinfector

1 Automated cleaning of reusable medical devices will involve the use of a Washer Disinfector (WD). The validation process will follow the guidelines of the BS EN ISO 15883 series. In the specific the automated cleaning validation follows the BS EN ISO 15883-5 standard. To validated the automated cleaning cycle, the medical 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 mixture of proteins, haemoglobin, and carbohydrates. The medical device will then be exposed to the automated cleaning cycle as per the manufacturer’ IFU. At the end of the cycle the medical device is processed and the residual protein content alongside another analyte (e.g., ATP) are analysed to prove effectiveness of the cycle.

Automated Thermal Disinfection

2 The automated thermal disinfection validation is performed following the requirements expressed in the BS EN ISO 15883-2 standard. The purpose of the test is to prove the during the medical device can reach the required minimum holding time and temperature for thermal disinfection (e.g., 90 C° for 1 minute) during the cycle, as described in the manufacturer’ IFU. Thermocouples are attached to various location within the WD and onto the medical device. A full report showing thermometric analysis of the cycle will be issued, proving the required temperature and time are maintained on the medical device.

Sterilisation Process

3 Reusable medical device sterilisation validations, such as steam sterilisation validations are performed using calibrated autoclave equipment and using validated sterilisation cycles. A steam sterilisation cycle is normally validated following the requirements of the BS EN ISO 17665-1 standard. At Test Labs the overkill method, following the partial-cycle approach, is performed on the medical device to prove the correct Sterility Assurance Level (SAL) is achieved during the cycle. This involves inoculation of the medical device with G. stearothermophilus to prove a minimum 106 log reduction during the partial cycle (i.e., half the cycle time). This will ensure that the cycle is capable of achieving the required SAL on the medical device, as described by the manufacturer’ IFU.

Compatibility Assessment

4 We developed a series of in-house tests methods based on industry standards (such as ISO 21530, ISO 11664 to properly analyse test item materials at both sample and product level during the Initial and Final Assessments. This will ensure that the reprocessing cycle is compatible with the medical device. This can also be used to demonstrate how many reprocessing cycles the medical device will withstand before affecting either the safety or the intended use.

The classification of medical devices is governed by the intended purpose of the device and their inherent risks linked to duration, part of the body, whether it is active or not and whether it is invasive or non-invasive. Based on the classification rules outlined in Annex VII, manufacturers should determine which class their medical device falls under; Class I, Class IIa, Class IIb, or Class III. If more than one rule applies, then the highest classification should apply.

Under the MDR some Class I medical devices have now been reclassified, and the classification has been broken down into include Class Im, Class Is and Class Ir meaning present guidelines cannot be applied to devices now in a higher risk class. Manufacturers with devices which are intended to be used in a sterile condition (Class Is), with a measuring function (Class Im) or are reusable surgical instruments (Class Ir), must now apply the procedures set out in Annex IX and have involvement from a notified body. Learn more

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Clinical Evaluation

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Microbiology Laboratory

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Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

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Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials development.

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Insight September 29th 2022

Reusable Medical Device Reprocessing