All We Do
What do we mean by reprocessing specialist?
SUD Reprocessing is
Our sole business is SUD Reprocessing. Our approach is simple – we partner with your center to implement a focused program designed to safely deliver cost savings and drive down your OEM costs - all while providing the highest quality devices. Safety, efficacy and quality control are paramount to longevity in this business. As we approach two decades of ENT and Orthopedic focused reprocessing for ASC’s, our record is unparalleled for centers looking to reduce costs on high end ENT and Orthopedic devices.
Regulatory Compliance
As a reprocessor of single use devices, SureTek is regulated by the FDA Center for Devices and Radiological Health with requirements to register its facility, list its products, obtain premarket clearances for non-exempt products and maintain an effective quality system in conformance to current Good Manufacturing Practices/Quality System Requirements (cGMP/QSR). Every device is reprocessed under established protocols, including test and inspection by a qualified biomedical engineer or surgical tech with a thorough understanding of the design and intended use of each instrument. SureTek decontamination, refurbishing, packaging and sterilization processes and controls undergo rigorous validation testing in accordance with ISO and ASTM standards and FDA guidelines for product safety and effectiveness.
Cost Savings
SUD Reprocessing is a reliable and proven strategy within the ASC market. Our experienced team implements a targeted device strategy, aimed at reducing procedural costs while maintaining the highest levels of patient care for your center. This focused approach to the reprocessing partnership maximizes surgeon satisfaction and is key to long lasting program. We feel strongly that cost savings are maximized when devices are targeted which yield high surgeon and clinical satisfaction. Many of the below devices will yield in excess of $100/device when reprocessed by SureTek.
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ENT Electrodes/Coblation Devices
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ENT Shavers
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ENT Tubing
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Colorado Needles
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CTR Carpal Tunnel Release Blades
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Orthopedic Electrosurgical Ablation Wands
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Arthroscopic Shavers
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Orthopedic Class I Devices
An ASC averaging 25 sinus or tonsil procedures monthly will typically save in excess of $3000 monthly. Many of our larger customers have been realizing $75k or more in annual savings consistently over the years.
Mike Sammon received his Ph.D. in Biomedical Engineering from Case Western Reserve University with postdoctoral training at Dartmouth School of Medicine. Dr. Sammon was an Assistant Professor at UMass Medical Center, an Adjunct at Worcester Polytechnic Institute and Clark University Graduate School of Management and has published 9 research articles for Journal of Applied Physiology and Annals of Biomedical Engineering. Prior to founding SureTek, Mike was Manager of Clinical Services for CardioCommand and Director for Vanguard Medical Concepts and MediSISS. He is an industry expert in medical device design, process engineering and controls, quality systems, regulatory compliance, clinical sciences and risk management. Dr. Sammon served as industry representative during legislative sessions for the Medical Device User Fee and Modernization Act of 1992 that codified product labeling, premarket requirements and quality system regulations for reprocessors into federal law.