Medical Device Cleaning Validation

Yes. If your device is reprocessed for reuse, manufacturers must provide validated processing instructions (cleaning, and where applicable disinfection/sterilisation) in the IFU. This is required under ISO 17664‑1/‑2 and reinforced by the FDA’s 2015 Reprocessing Guidance.

For critical and semi‑critical devices, ANSI/AAMI ST98 expects visual inspection plus at least two quantitative, clinically relevant analytes (commonly protein plus one of haemoglobin, total organic carbon (TOC), carbohydrate, or ATP), with example acceptance limits provided in the standard’s guidance. Protein is routinely used because it is a dominant component of clinical soils; the second marker is selected to match expected soil (e.g., haemoglobin for blood‑contacting devices, TOC for mixed organics). The FDA also expects analytes that represent clinically relevant soil components.

Under standard guidance, cleaning validations use simulated‑use testing with a minimum of six (6) reprocessing cycles per test/control device, include positive and negative device controls, and require a justified sample size. Industrial expectation is to have a validated extraction method with ≥70% recovery recommended (via spike‑recovery or exhaustive extraction approach), and at least three data points per endpoint test within acceptance criteria.

For automated cleaning, we apply ISO 15883‑5 performance methods (washer‑disinfectors) to demonstrate cleaning efficacy. In the UK, hospitals and suppliers often reference HTM 01‑01 (Part D: Washer‑disinfectors) alongside ISO 15883. In Germany/DACH, the DGSV/AKI Guideline (5th ed., 2017) details validation and routine monitoring of automated cleaning and thermal disinfection, mapping to EN ISO 15883 and local regulatory expectations. For US submissions, ST98 frames the validation requirements.

You receive an audit‑ready cleaning validation package, including protocol, raw data, recovery validation, acceptance criteria, and a final report aligned to ISO 17664, AAMI ST98, and FDA reprocessing guidance. What sets us apart is our consultative, no‑fee support: we work with you before, during, and after the study helping shape IFU drafts, align endpoints, and support technical‑file updates long after the report is issued, recognising that submissions often evolve over multiple years (this is especially helpful under region‑specific expectations like HTM 01‑01 or DGSV/AKI 2017).

Depending on your medical device application, alternative test soils can be selected:

• Coagulating blood test soil – for use with instruments used in general surgery, orthopaedic, vascular and other procedures where blood exposure is expected to coagulate before cleaning.
• Defibrinated (non‑coagulating) blood soil – for use with instruments that contact blood in environments with anticoagulants or heavy irrigation where coagulation is not expected.
• Mucus‑type (British‑standard style) soil – for use with instruments used in upper respiratory/ENT and gastrointestinal endoscopy where mucus is the predominant soil.
• Blood + mucus mixed soil – for use with flexible endoscopes (e.g., GI scopes with biopsy) that encounter both mucus and episodic bleeding; mix soils to mirror clinical soiling.
• Non‑patient–derived soils (e.g., bone cement/PMMA, lubricants, dyes) – for use with instruments that contact these materials during procedures (e.g., orthopaedic saws/burrs), either alone or combined with patient‑derived soils.
• Artificial Test Soil (F3208‑aligned composite) – for use with instruments used in gastrointestinal or other mixed‑soil scenarios when a standardised, protein‑rich challenge is desired and scientifically justified.