SureTek Medical specializes in the reprocessing of ENT and Orthopedic surgical devices. We work with Ambulatory Surgery Centers and Hospitals to reduce procedural costs via SUD reprocessing of devices such as ENT coblation wands, ENT shavers and Orthopedic electrodes. Company resources are allocated at the highest priority to qualified personnel, equipment and processes that directly impact the quality of our products and services. By eliminating the traditional 40% of cost of goods due to sales and distribution fees, SureTek is able to return greater cost savings as compared with competing reprocessors. Our 5-7 day turnaround time provides material managers with effective means to control inventory levels and acquisition costs of single-use devices.
Company and Facility
SureTek is headquartered in Greenville, SC. Our facility is ideally located to provide customers with the industry’s fastest turnaround time for the eastern US, midwest and southern states. Our quick, dependable and reliable turn-around times allow materials managers to effectively plan and control inventory levels and acquisition costs of single-use devices.
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.
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.