INDUSTRY INSIGHTS
news & notes
FDA Clears Vistaseal Open, Laparoscopic Dual Applicator Devices Johnson & Johnson Medical Devices Companies announced that Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vistaseal Open And Laparoscopic Dual Applicators (35 cm and 45 cm), three next generation airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding. These biosurgery products are the first to emerge from a recently forged long-term strategic partnership between the global device maker and Grifols, a world leader in the
production of plasma-derived medicines. Grifols developed the Vistaseal Fibrin Sealant (Human), and Ethicon’s devices are designed to deliver the two biological components of the product. Beyond Vistaseal, the partnership with Grifols will provide a supply of thrombin for Ethicon’s current products. In the future, it will mean even more advances in the field of adjunctive hemostats with the goal of reducing complications and improving the standard of care. •
Compliance Platform Launches New Database for Tissues/Implants oneSOURCE has launched its new tissues/implants database for use in health care facilities across the country. This expansion arms sterile processing and operating teams with an efficient way to manage manufacturer IFUs for implantable materials and devices. “We couldn’t be more excited to tap into this new vertical,” said Jack Speer, co-founder and president of oneSOURCE. “More than 80 percent of the health care facilities in the U.S. subscribe to our database for manufacturers’ IFUs for surgical and equipment and we aim to accomplish that type of adoption for this new initiative. We continue to keep patient safety as our top priority and are confident that this highly anticipated launch will enable health care professionals to be equipped with the most reliable and readily accessible documents they need to successfully do their job while also adhering to standards set by regulatory organizations such as The Joint Commission and AAMI.” By including exact and most recent versions of manufacturers’ IFUs for Implantable Tissues and Devices, oneSOURCE is empowering health care facilities with the tools they need to stay compliant in the most efficient and accessible way possible. Based on the recommendations of
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database users, new features such as a customizable option, where users can create lists of frequently used IFUs, have also been added. The diverse range of implants and devices that this database will serve as a resource for includes human tissue allografts, cardiac pacemakers, stents, vascular grafts, repair meshes and slings, devices, orthopedic joints, among more. • For more information, visit onesourcedocs.com.
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