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Amend CSSB 1193 (Senate committee printing) by striking all 
below the enacting clause and substituting the following:
	SECTION 1.  Section 431.002(13), 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 a 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)  Section 431.0215(d), Health and Safety Code, as added by 
this Act, takes effect September 1, 2011.