SLS 15RS-3023 ORIGINAL 2015 Regular Session SENATE RESOLUTION NO. 177 BY SENATOR MILLS HEALTH CARE. Create a task force to study and recommend revisions of regulations related to the distribution of medical devices in Louisiana. 1 A RESOLUTION 2 To create and provide for the Task Force on Medical Device Distribution in Louisiana which 3 shall review existing regulations and propose revisions of regulations and the 4 elimination of duplicate regulations related to the distribution of medical devices 5 while remaining focused on the protection of the health and safety of Louisiana 6 citizens. 7 WHEREAS, the manufacture, marketing, and distribution of medical devices is 8 strictly regulated by the federal Food and Drug Administration (FDA); and 9 WHEREAS, medical devices are atypical in the manner in which they are developed, 10 manufactured, and provided to patients by a licensed healthcare provider and require a 11 unique blueprint for regulation; and 12 WHEREAS, presently, the FDA is implementing a Unique Device Identification 13 system and other measures to enhance the safety and performance of medical devices; and 14 WHEREAS, several states, including California, Florida, and Maryland, have 15 recently eliminated state medical device regulations that are duplicative of federal 16 regulations; and 17 WHEREAS, the current budget issues in Louisiana present an opportunity to identify 18 state operations and regulations that would reduce state expenditures, if eliminated; and Page 1 of 3 SR NO. 177 SLS 15RS-3023 ORIGINAL 1 WHEREAS, a task force is needed to review existing regulations and report its 2 findings and make recommendations regarding the balancing of the regulation of medical 3 device distribution with the goal of protecting the health and safety of Louisiana citizens. 4 THEREFORE, BE IT RESOLVED that the Senate of the Legislature of Louisiana 5 does hereby establish the Task Force on Medical Device Distribution in Louisiana to review 6 existing regulations and propose revisions of regulations and the elimination of duplicate 7 regulations while remaining focused on the protection of the health and safety of Louisiana 8 citizens. 9 BE IT FURTHER RESOLVED that the membership of the task force shall consist 10 of the following: 11 (1) The secretary of the Department of Health and Hospitals, or her designee. 12 (2) The president of the Louisiana Senate, or his designee. 13 (3) The speaker of the Louisiana House of Representatives, or his designee. 14 (4) The executive director of the Louisiana Board of Drug and Device Distributors, 15 or his designee. 16 (5) A representative of the Advanced Medical Technological Association. 17 BE IT FURTHER RESOLVED that the executive director of the Louisiana Board 18 of Drug and Device Distributors, or his designee, shall serve as the task force chairperson. 19 BE IT FURTHER RESOLVED that the names of the task force members shall be 20 communicated to the chairperson no later than August 15, 2015. 21 BE IT FURTHER RESOLVED that the task force chairperson shall call the first 22 meeting of the task force no later than September 1, 2015. 23 BE IT FURTHER RESOLVED that the Louisiana Board of Drug and Device 24 Distributors shall keep minutes of the task force meetings and shall provide any 25 organizational and secretarial support necessary to accomplish the work of the task force. 26 BE IT FURTHER RESOLVED that the members of the task force shall serve 27 without pay or per diem. 28 BE IT FURTHER RESOLVED that the task force shall submit a written report of 29 its findings and any recommendations for legislation to the Senate and the House of 30 Representatives no later than December 15, 2015, at which time the task force shall Page 2 of 3 SR NO. 177 SLS 15RS-3023 ORIGINAL 1 terminate. 2 BE IT FURTHER RESOLVED that a copy of this Resolution shall be transmitted 3 to the secretary of the Department of Health and Hospitals, the executive director of the 4 Louisiana Board of Drug and Device Distributors, and the Advanced Medical Technological 5 Association. The original instrument and the following digest, which constitutes no part of the legislative instrument, were prepared by Mary Dozier O'Brien. DIGEST SR 177 Original 2015 Regular Session Mills Creates and provides for a Task Force on Medical Device Distribution in Louisiana which shall review existing regulations and propose revisions of regulations and the elimination of duplicate regulations while remaining focused on the protection of the health and safety of Louisiana citizens. Page 3 of 3