By: Wentworth S.B. No. 1193
A BILL TO BE ENTITLED
AN ACT
relating to the maintenance and service of certain medical devices
in health care facilities; providing a criminal penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subdivision (13), Section 431.002, Health and
Safety Code, is amended to read as follows:
(13) "Device," except when used in Sections 431.003,
431.021(l), 431.0215, 431.082(g), 431.112(c), and 431.142(c),
means an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, that is:
(A) recognized in the official United States
Pharmacopoeia National Formulary or any supplement to it;
(B) intended for use in the diagnosis of disease
or other conditions, or in the cure, mitigation, treatment, or
prevention of disease in man or other animals; or
(C) intended to affect the structure or any
function of the body of man or other animals and that does not
achieve any of its principal intended purposes through chemical
action within or on the body of man or other animals and is not
dependent on metabolization for the achievement of any of its
principal intended purposes.
SECTION 2. Subchapter B, Chapter 431, Health and Safety
Code, is amended by adding Section 431.0215 to read as follows:
Sec. 431.0215. ADDITIONAL PROHIBITED ACTS; CRIMINAL
PENALTY. (a) In this section:
(1) "Electronic direct care medical device" means a
device used in the treatment, monitoring, or diagnosis of a
patient.
(2) "Facility" means an ambulatory surgical center,
physician's office, or medical clinic, other than an ambulatory
surgical center, physician's office, or medical clinic owned or
operated by a hospital, that is authorized under the laws of this
state to provide health care in this state.
(b) Except as provided by Subsection (c), a person may not
calibrate, repair, or perform preventive maintenance on or
otherwise service an electronic direct care medical device in a
facility unless the person:
(1) holds at least an associate of applied science
degree issued by an accredited college or university in engineering
as a biomedical equipment technician or medical imaging specialist
or holds a similar degree focused on the service, maintenance, or
service and maintenance of medical devices;
(2) holds satisfactory evidence of completion of a
program of service or maintenance of medical devices issued by the
United States military;
(3) for at least two of the preceding four years has
been actively engaged in and holds documented evidence of
proficient performance of electronic direct care medical device
service or maintenance apprenticeship or training, including
experience under Subdivision (4);
(4) holds at least an associate's degree in an
electronics field or an information management field from an
accredited college, university, or vocational school, or is
actively pursuing such a degree or pursuing an associate's degree
described in Subdivision (1), and is servicing or maintaining
electronic direct care medical devices under the supervision of an
individual who meets the requirements of Subdivision (1) or (2);
(5) holds satisfactory evidence of successful
completion of service or maintenance training from an electronic
direct care medical device manufacturer or designated trainer,
provided the person only provides service or maintenance for
devices made by that manufacturer and specifically covered by the
training; or
(6) holds a certification issued by the International
Certification Commission as a certified biomedical equipment
technician, certified laboratory equipment specialist, or
certified radiology equipment specialist, provided the person only
provides service or maintenance for the type of electronic direct
care medical devices covered by the certification.
(c) Subsection (b) does not apply to:
(1) the calibration, repair, maintenance, or service
of a class II or class III medical device that is used only for
teaching and research purposes;
(2) in-service or software upgrades of a medical
device performed by an employee or authorized sales representative
of a medical device manufacturer; or
(3) routine evaluations specified by the medical
device manufacturer performed by the owner or person designated by
the owner of the medical device.
(d) A person commits an offense if the person violates
Subsection (b). An offense under this subsection is a Class C
misdemeanor.
SECTION 3. (a) Except as provided by Subsection (b) of
this section, this Act takes effect September 1, 2010.
(b) Subsection (d), Section 431.0215, Health and Safety
Code, as added by this Act, takes effect September 1, 2011.