Medical Device Bloodborne Pathogen Control

Texas Health and Safety Code (HSC) Chapter 81, Communicable Disease; Public Health Disasters; Public Health Emergencies Act, has been amended. HSC Section 81.307, which contained the language requiring the department to maintain a list of registered needleless systems and sharps with engineered sharps protection was repealed by Senate Bill (SB) 970, passed during the 87th Texas Legislature, Regular Session.  Many of the other parts of HSC Chapter 81, Communicable Disease; Public Health Disasters; Public Health Emergencies Act were not repealed.  The department will no longer accept applications for registration of needleless system devices or a sharps device with engineered sharps injury protection.

Our Drugs and Medical Devices Group keeps a list of registered needleless systems and sharps devices with engineered sharps injury protection to help state and local governments apply bloodborne pathogen control provisions found in 25 Texas Administrative Code, Sections 96.101 - 96.601. 

The devices on the list are widely available and have cleared marketing requirements set by the U.S. Food and Drug Administration. This list only contains devices that have been registered and reviewed by us before being added. Registration of a needleless system or a sharps device with engineered sharps injury protection is voluntary and does not constitute an endorsement or recommendation of such device by us.