By: Wentworth S.B. No. 1193

(In the Senate - Filed February 26, 2009; March 13, 2009, read first time and referred to Committee on Health and Human Services; April 24, 2009, reported adversely, with favorable Committee Substitute by the following vote: Yeas 9, Nays 0; April 24, 2009, sent to printer.)

COMMITTEE SUBSTITUTE FOR S.B. No. 1193 By: Deuell

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. 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, "facility" means a hospital, ambulatory surgical center, physician's office, or medical clinic 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 a device designated by the United States Food and Drug Administration as a class II or class III 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 or 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, maintenance, or service and maintenance of medical devices issued by the United States military;

(3) holds at least an associate degree in an electronics field or an information management field and has been actively engaged in the service, maintenance, or service and maintenance of medical devices for at least two of the preceding four years under the direct supervision of an individual who meets the requirements of Subdivision (1) or (2); or

(4) holds satisfactory evidence of successful completion of service, maintenance, or service and maintenance training from a medical device manufacturer, provided the person only provides service or maintenance for devices made by that manufacturer unless the person otherwise meets the requirements of Subdivision (1), (2), or (3).

(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 2. This Act takes effect September 1, 2009.

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