House Bill 0849

    Florida House of Representatives - 2000                 HB 849

        By Representatives Argenio, 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 federal

  5         registration of reprocessors; requiring

  6         compliance with certain reprocessor

  7         requirements; providing an effective date.

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  9         WHEREAS, medical device manufacturers have designated

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

11         WHEREAS, a significant body of peer-reviewed scientific

12  research demonstrates that some medical devices labeled as

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

14  no added risk to patient safety, and

15         WHEREAS, the unnecessary disposal of certain medical

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

17  growing environmental waste problem and leads to increased

18  medical care costs, and

19         WHEREAS, proper reprocessing of certain medical devices

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

21  enables Florida hospitals to achieve significant cost savings,

22  NOW, THEREFORE,

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

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26         Section 1.  The use of reprocessed medical devices,

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

28  state, provided that reprocessors of such devices are

29  registered with the United States Food and Drug Administration

30  and such reprocessing is performed in compliance with the

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






    Florida House of Representatives - 2000                 HB 849

    735-101A-00






  1  reprocessor requirements enforced by the United States Food

  2  and Drug Administration.

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

  4  law.

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  7                          HOUSE SUMMARY

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      Authorizes the use in the state of reprocessed medical
  9    devices originally labeled "single-use only," provided
      the reprocessor is registered with the U.S. Food and Drug
10    Administration and the devices have been reprocessed in
      compliance with requirements of the U.S. Food and Drug
11    Administration.

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