House Bill 0849c1

    Florida House of Representatives - 2000              CS/HB 849

        By the Committee on Health Care Licensing & Regulation and
    Representatives Argenio, Henriquez, Byrd, Fasano and Peaden





  1                      A bill to be entitled

  2         An act relating to reprocessed medical devices;

  3         authorizing use of certain reprocessed medical

  4         devices in the state; requiring compliance with

  5         certain reprocessing requirements; providing an

  6         effective date.

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  8         WHEREAS, medical device manufacturers have designated

  9  certain medical devices as "single-use only," and

10         WHEREAS, a significant body of peer-reviewed scientific

11  research demonstrates that some medical devices labeled as

12  "single-use only" can be properly reprocessed and reused, with

13  no added risk to patient safety, and

14         WHEREAS, the unnecessary disposal of certain medical

15  devices labeled as "single-use only" exacerbates Florida's

16  growing environmental waste problem and leads to increased

17  medical care costs, and

18         WHEREAS, proper reprocessing of certain medical devices

19  labeled as "single-use only" is a patient-safe practice that

20  enables Florida hospitals to achieve significant cost savings,

21  NOW, THEREFORE,

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23  Be It Enacted by the Legislature of the State of Florida:

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25         Section 1.  The use of reprocessed medical devices,

26  originally labeled as "single-use only," is permitted in the

27  state, provided that the reprocessing of such devices is

28  performed in compliance with the applicable requirements

29  enforced by the United States Food and Drug Administration or,

30  in the case of hemodialyzers, provided that such reprocessing

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CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 2000              CS/HB 849

    601-174-00






  1  is performed in compliance with the guidelines adopted by the

  2  Association for the Advancement of Medical Instrumentation.

  3         Section 2.  This act shall take effect upon becoming a

  4  law.

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