Pre-filed December 13, 1999, and 1000 copies ordered printed.
ANNE C. WALKER, Chief Clerk
AN ACT
To amend chapter 191, RSMo, relating to health and welfare by adding thereto one new section relating to single use medical devices, with a penalty provision.
Section A. Chapter 191, RSMo, is amended by adding thereto one new section, to be known as section 191.925, to read as follows:
191.925. 1. The general assembly finds and declares that certain medical devices are designed and intended to be used in a single procedure on only one patient. Such devices are labeled "single use" or "disposable" and are categorized as critical by the center for disease control and prevention. The reuse of such devices on multiple patients increases the risk of infection, cross contamination, chemical injury and device failure. Therefore, the purpose of this section is to protect the public by prohibiting the reuse of such devices.
2. For purposes of this section, the term "critical medical device" means any patient care device that is introduced into the body and comes in direct contact with the bloodstream or other portions of the body normally considered sterile.
3. No person shall knowingly use a critical medical device beyond its intended use in a single procedure for only one patient if any of the following apply:
(1) The device was previously used on another patient;
(2) The federal Food and Drug Administration has not cleared or approved the device for use on more than one person;
(3) The device manufacturer warns against the use of the device on more than one person due to safety concerns;
(4) The use of the device on multiple patients may increase the risk of infection, cross contamination and device failure; or
(5) The use of the device is considered illegal by the federal Food and Drug Administration.
4. Any person who violates the provisions of this section is guilty of a misdemeanor and shall be fined not more
than five thousand dollars for the first offense and not more than ten thousand dollars for the second or
subsequent offenses.
Missouri House of Representatives