If you are preparing a 510(k) or PMA for a reusable medical device, one of the most important regulatory questions is how the device must be reprocessed between uses. The U.S. Food and Drug Administration (FDA) requires validated reprocessing instructions that ensure a reusable device can be cleaned, disinfected, or sterilized safely and consistently in clinical settings. The appropriate level of reprocessing depends on the device’s intended use, risk profile, and Spaulding classification. This article summarizes FDA expectations and helps you determine which reprocessing method applies to your device. Book a free 30-minute consultation · Contact page · 1 (910) 812 5188 · info@pulseaxismedicalconsulting.com
1 — Cleaning, disinfection, and sterilization
From FDA’s standpoint, cleaning, disinfection, and sterilization are distinct processes with increasing levels of microbial risk reduction. They are not interchangeable and must be selected and validated based on the level of patient risk.
1.1 Cleaning
Definition: Removal of visible soil (blood, protein, body fluids, debris) using water, detergents, and mechanical action.
FDA view: Cleaning is the first step in any reprocessing workflow and is required for all reusable devices. Residual soil can shield microorganisms and reduce the effectiveness of disinfection or sterilization.
1.2 Disinfection
Definition: Use of chemical or physical agents to eliminate most pathogenic microorganisms, but not necessarily bacterial spores.
FDA view: High-level disinfection (HLD) is typically acceptable for semi-critical devices that contact mucous membranes or non-intact skin. HLD processes must be validated and clearly described in the device labeling.
1.3 Sterilization
Definition: Process that destroys all forms of microbial life, including highly resistant spores.
FDA view: Sterilization is required for critical and implantable devices. FDA expects full validation of the sterilization cycle (for example, per ISO 11135, ISO 11137, or ISO 17665) and sterile barrier packaging validated in accordance with ISO 11607.
2 — Spaulding classification of reusable devices
The Spaulding classification is the framework FDA uses to determine the minimum reprocessing level based on where and how a device is used in the body.
2.1 Critical devices
- Definition: Devices that enter sterile tissue or the vascular system.
- Required processing: Sterilization.
- Examples: Implants, surgical instruments, vascular catheters, bone screws.
2.2 Semi-critical devices
- Definition: Devices that contact mucous membranes or non-intact skin.
- Required processing: At least high-level disinfection (HLD); sterilization preferred when feasible.
- Examples: Flexible endoscopes, bronchoscopes, vaginal specula, dental mirrors.
2.3 Non-critical devices
- Definition: Devices that contact intact skin only.
- Required processing: Cleaning followed by low- or intermediate-level disinfection as appropriate.
- Examples: Reusable blood pressure cuffs, ECG leads, thermometers with probe covers.
3 — Comparison of cleaning, disinfection, and sterilization
3.1 Purpose and level of microbial reduction
- Cleaning: Remove visible soil and organic material.
- Disinfection: Kill most pathogenic microorganisms, but not spores.
- Sterilization: Eliminate all viable microorganisms, including spores.
3.2 Sporicidal activity
- Cleaning: Not sporicidal.
- Disinfection: Not sporicidal (even for HLD).
- Sterilization: Sporicidal.
3.3 Typical use by device category
- Cleaning: All reusable devices; always the first step.
- Disinfection: Semi-critical devices.
- Sterilization: Critical and implantable devices.
3.4 Validation expectations
- Cleaning: Validation to demonstrate effective soil removal using clinically relevant test soils and worst-case conditions.
- High-level disinfection: Validation using appropriate test organisms, exposure times, and process parameters.
- Sterilization: Full cycle validation, biological indicators, and package integrity and shelf-life testing.
3.5 Common methods and examples
- Cleaning methods: Manual brushing, flushing, ultrasonic cleaning with enzymatic or alkaline detergents.
- Disinfection methods: High-level disinfectants such as glutaraldehyde, ortho-phthalaldehyde (OPA), hydrogen peroxide, peracetic acid.
- Sterilization methods: Steam (moist heat), ethylene oxide (EtO), low-temperature hydrogen peroxide, radiation.
4 — FDA reprocessing expectations in 510(k) and PMA submissions
For reusable devices, FDA expects reprocessing to be addressed in both the device design and the premarket submission.
- Validated cleaning, disinfection, and/or sterilization data that reflect worst-case soiling and device configuration.
- Clear, usable, and validated instructions for use (IFU) describing each reprocessing step, equipment, and chemicals.
- Risk-based justification for the selected reprocessing method, tied to Spaulding classification and the device risk profile.
- Alignment with FDA guidance on reprocessing medical devices in health care settings and other relevant standards.
5 — How Pulse Axis can support your reusable device
Misclassifying a device or submitting incomplete reprocessing validation can trigger Refuse-to-Accept (RTA) decisions or major deficiencies. Pulse Axis Medical Device Consulting supports manufacturers with:
- Spaulding classification assessments for reusable and reprocessed devices.
- Cleaning and high-level disinfection validation strategies and protocol development.
- Sterilization approach selection, cycle development, and packaging validation planning.
- Reprocessing IFU and labeling review for clarity, usability, and consistency with validation.
- 510(k) and PMA submission readiness for devices that require reprocessing.
Conclusion
Every reusable medical device must have a clearly defined, validated reprocessing strategy that matches its risk category and clinical use. By correctly applying the Spaulding classification and validating cleaning, disinfection, or sterilization steps, manufacturers can demonstrate that their devices remain safe and effective over repeated use. Pulse Axis Medical Device Consulting helps teams translate these FDA expectations into practical validation plans and submission-ready documentation for reusable medical devices.
Keywords: reusable medical devices, FDA reprocessing requirements, Spaulding classification, cleaning validation, high-level disinfection, sterilization validation, ISO 11135, ISO 17665, ISO 14971, FDA 510(k), PMA, Pulse Axis Medical Device Consulting