HBA-DMH H.B. 2535 77(R) BILL ANALYSIS Office of House Bill AnalysisH.B. 2535 By: Maxey Public Health 3/21/2001 Introduced BACKGROUND AND PURPOSE Many medical devices that come in contact with blood or other body fluids are single-use devices, and should be discarded after one use. Instead, these single-use devices are being reprocessed and reused, putting patients at risk without their knowledge. Historically, the United States Food and Drug Administration (FDA) has not considered reprocessing these devices illegal, and with rising medical costs and limited managed care reimbursements this is becoming a more common occurrence. About one million disposable devices are reprocessed every year in the United States. Recently, the FDA increased its regulation of this practice to protect public health. House Bill 2535 prohibits unregulated use of a single-use surgical device and provides criminal penalties. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that rulemaking authority is expressly delegated to the Texas Board of Health in SECTION 1 (Section 431.301, Health and Safety Code) of this bill. ANALYSIS House Bill 2535 amends the Health and Safety Code to establish that a "single-use surgical device" includes any device determined by Texas Board of Health rule to be designed for use in a single surgical procedure to avoid risk of infection from improper sterilization or risk of mechanical failure posed by subsequent use. The bill prohibits a person from knowingly reusing, recycling, refurbishing for reuse, or providing for reuse a single-use surgical device. The bill provides that these provisions do not apply to a person who reuses, recycles, refurbishes for reuse, or provides for reuse a single-use surgical device reprocessed by an entity or person registered with and regulated by the United States Food and Drug Administration. The bill provides that a violation of these provisions is a Class B misdemeanor for a first offense and a Class A misdemeanor for subsequent offenses. EFFECTIVE DATE September 1, 2001.