Medical device reprocessing – USA
As part of the approvals process, manufacturers of reusable medical devices need to submit proof that the device can be adequately cleaned (and disinfected or sterilized if required), as well as provide clear, validated IFUs (Instructions for Use). TSG understands the challenges associated with medical device reprocessing – from device-design-related cleaning concerns, to human factor issues impacting the effectiveness of reprocessing, to developing comprehensive, easy-to-understand reprocessing instructions.
TSG can help
Reporting all the detail required by the FDA is complex. TSG can provide expert guidance through this process. We can:
- Undertake a reprocessing review per FDA guidance document for industry and FDA staff: ‘Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling’
- Review the low, intermediate and high level disinfections, and terminal sterilization for non-critical, semi-critical and critical medical devices
- Develop protocols and review of cleaning, disinfection, and sterilization method validation data
- Review medical device reprocessing instructions per FDA’s ‘Six criteria for Reprocessing Instructions’
- Determine the overall data requirements for medical device reprocessing
- Device identification for which 510(k) should contain data to validate reprocessing instructions
- Advise on sterilization in healthcare settings for single-use device (SUD) or reusable medical devices
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
Meet our professionals
Our medical device compliance consulting team includes Dr Om Singh, Senior Scientific Consultant at TSG Consulting. He has substantial experience working with companies looking to commercialize medical devices and antimicrobial products such as sterilants, high-level disinfectants, and antiseptics. His previous experience working at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) allows him to better advise companies of anticipated regulatory hurdles when seeking approval and registration for their human health products.