House Bill 0013

    Florida House of Representatives - 2000                  HB 13

        By Representative Henriquez






  1                      A bill to be entitled

  2         An act relating to surgical devices; providing

  3         legislative findings and purpose relating to

  4         single-use surgical devices; providing a

  5         definition; prohibiting knowingly reusing,

  6         recycling, or refurbishing for reuse, or

  7         providing for the reuse of, a single-use

  8         surgical device; providing rulemaking authority

  9         to the Department of Health; providing a

10         penalty; providing an effective date.

11

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

13

14         Section 1.  Single-use surgical devices.--

15         (1)  The Legislature finds that certain surgical

16  devices are designed to be used for only one surgical

17  procedure. Further, the reuse, recycling, and refurbishing of

18  surgical devices intended for single use have been linked to

19  cases of patient infection, chemical injury, and mechanical

20  failure. It is therefore the purpose of this section to

21  protect the public health and safety by prohibiting the

22  unregulated reuse, recycling, and refurbishing of single-use

23  surgical devices.

24         (2)  For purposes of this section, "single-use surgical

25  device" means any device marketed or sold as a disposable or

26  single-use device for use in a single surgical procedure to

27  avoid risk of infection from improper sterilization or risk of

28  mechanical failure posed by subsequent use. Single-use

29  surgical devices shall include, but shall not be limited to,

30  cardiac catheters, angioplasty balloon catheters, arthroscopic

31  knee surgery blades, and other single-use surgical devices as

                                  1

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






    Florida House of Representatives - 2000                  HB 13

    716-108A-00






  1  determined by rule of the Department of Health. The department

  2  is authorized to adopt rules to implement this subsection.

  3         (3)  No person shall knowingly reuse, recycle, or

  4  refurbish for reuse, or provide for the reuse of, a single-use

  5  surgical device. A person convicted of violating this section

  6  is guilty of a misdemeanor of the second degree, punishable as

  7  provided in s. 775.082 or s. 775.083.

  8         Section 2.  This act shall take effect January 1, 2001.

  9

10            *****************************************

11                          HOUSE SUMMARY

12
      Defines "single-use surgical device," and provides a
13    second degree misdemeanor penalty for knowingly reusing,
      recycling, or refurbishing for reuse, or providing for
14    the reuse of, such a device.

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

                                  2