Reusable Surgical Instrument Validation
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.
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).
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.
Frequently Asked Questions
What does “automated cleaning validation” include and why do you measure protein and another analyte?
In an automated cycle, we soil the device, run the washer‑disinfector (WD) exactly per the IFU, then verify cleanliness by visual inspection and quantitative analytes typically protein (via an established o‑phthalaldehyde (OPA) assay) plus a second marker such as haemoglobin. This aligns with AAMI ST98, which expects visual inspection and at least two clinically relevant analytes (e.g., protein + TOC/haemoglobin/carbohydrate) with stated acceptance criteria for critical/semi‑critical devices.
Do manual cleaning validations use the same endpoints as automated cycles?
Yes. For manual cleaning we follow the IFU (tools, detergents, times) and then apply the same pass/fail logic visual inspection plus ≥2 quantitative analytes (often protein + TOC/Hb) with validated extraction efficiency (≥70% recommended) per AAMI ST98.
How do you validate the disinfection step in a washer‑disinfector (thermometric disinfection)?
We confirm that the device achieves the time–temperature lethality defined in the IFU using instrumented thermocouples and the ISO 15883 framework (Part 1 general requirements; Part 2 for WDs employing thermal disinfection). Practically, we verify the device stays within the specified disinfection temperature range for the specified hold time (often expressed as an A₀ value e.g., A₀ = 600 or 3000 depending on policy/clinical need).
What does your moist‑heat (steam) sterilisation validation look like?
For representative devices inoculated with biological indicators, we commonly use the overkill/half cycle approach (a partial exposure) to demonstrate the cycle can deliver the required Sterility Assurance Level (SAL ≤ 10⁻⁶) when operated at the full parameters. This approach and SAL concept are standard practice in moist heat validation and are reflected in current guidance and literature.
What does UKAS (ISO 17025) / GLP accreditation add to these studies?
Accreditations demonstrate our technical competence for defined methods, equipment, staff, and data controls so your results are traceable, reproducible, and internationally accepted under most regulatory frameworks. In short, it’s independent assurance that the tests we perform (cleaning endpoints, thermometric disinfection, sterilisation studies) are valid and defensible.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.
