Single Use Device (SUD) Reprocessing for Safety and Compliance
Enhance safety and reduce waste with single use device reprocessing solutions. Discover our comprehensive services today.
Life Science Outsourcing provides comprehensive single-use device (SUD) reprocessing services, ensuring safety, compliance, and cost-effectiveness for healthcare facilities and medical device manufacturers.
Single-Use Device ReprocessingReduce Costs, Maintain Compliance,Drive Sustainability
Extending the lifecycle of single-use devices shouldn’t mean compromising on safety or performance. As part of our end-to-end solutions, we deliver precise cleaning, testing, and sterilization to meet the highest regulatory standards—helping you cut costs and reduce waste without risk.
What is Single Use Device Reprocessing?
Single-use device reprocessing involves cleaning, disinfection, testing, and repackaging of disposable medical devices for safe and effective reuse.
- Cost-effective sustainability – Reducing medical waste and lowering costs for healthcare providers.
- Standardized cleaning and sterilization – Ensuring devices meet original performance specifications.
- Regulatory compliance – Adhering to FDA and ISO standards for reprocessed medical devices.
Who Needs Single Use Device Reprocessing?
- Hospitals and surgical centers seeking to extend the lifecycle of disposable devices.
- Medical device manufacturers ensuring compliance with reprocessing regulations.
- Third-party reprocessors managing high-volume device cleaning and sterilization.
How Does Single Use Device Reprocessing Work?
- Device Collection & Inspection – Devices are collected, sorted, and inspected for contamination or damage before reprocessing.
- Cleaning & Decontamination – High-level disinfection removes biological residues using automated cleaning systems and chemical agents.
- Sterilization & Packaging – Devices are terminally sterilized using methods like ethylene oxide (EtO), gamma irradiation, or steam sterilization, then sealed in protective packaging.
- Regulatory Compliance & Documentation – Full traceability is maintained through compliance records, batch testing, and FDA regulatory filings.
What standards apply?
- FDA 21 CFR Part 820 – Quality system regulations for reprocessed medical devices.
- ISO 13485 – Quality management system for medical device reprocessing.
- AAMI ST98 – Standards for reprocessing of single-use medical devices.
Why LSO?
- Proven expertise in SUD reprocessing ensuring compliance and safety.
- Standardized cleaning and sterilization: Ensuring devices are properly cleaned and terminally sterilized to meet performance and safety requirements.
- Cost-effective solutions reducing environmental waste and healthcare costs.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica