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.