NMT Approval Process Policy

  1. All applications and supporting documentation for approval of New Medical Technology shall be submitted to the Corporate Materials Management on the Request Form within 2 weeks prior to the next scheduled meeting of the MDMC. Practitioners shall submit their applications on complete and accurate forms, accompanied by relevant and well-recognized scientific information and literature. The material should include a summary of analyses regarding the NMT’s safety, effectiveness and effect on health outcomes in sufficient detail and volume, to allow the CSC to conduct a clinical assessment of the NMT in accordance with the criteria outlined in Item 5 below. If the FDA deems the NMT a Substantially Equivalent Device, the CSC shall defer review and recommendations for approval or rejection of such device to the MDMC.
  2. Corporate Materials Management shall distribute copies of the request supporting documentation as applicable for applications requesting approval of new medical devices and/or medical equipment. 
  3. The CSC and MDMC shall review the application at the next scheduled meeting of each such Committee. 
  4. The MDMC shall perform its review of the application for approval of new medical devices and/or medical equipment in accordance with the policy and procedures set forth in the Medical Device Management Committee Policy and shall report its findings and present its recommendations to the CSC. 
  5. The CSC shall review the NMT in accordance with the following assessment criteria:

    a. The NMT must have final approval from the appropriate government regulatory bodies. This criterion applies to biological products, devices and diagnostics; 
    b. The scientific evidence submitted with the application should permit conclusions concerning the effect of the NMT on patient health outcomes. Such evidence should:
     
    i. consist of well-designed and conducted investigations published in peer-reviewed journals. Scientific evidence and expert opinion provide the basis for assessing the potential net patient health outcome. 
    ii. demonstrate that the NMT can measure or alter the physiological changes related to a disease, injury, illness or condition. There should be evidence that such measurement or alteration positively affects patient health outcomes. 
    iii. include opinions and evaluations by national medical associations, consensus panels or other technology evaluation bodies.
     
    c. The NMT must improve the net health outcome—the NMT should outweigh any harmful effects on health outcomes; 
    d. The NMT must be as beneficial as any established alternatives; 
    e. The improvement must be attainable outside the investigational settings; 
    f. The NMT should not negatively impact the management of available resources disproportionately to the net health outcome gained by the introduction of the NMT. The findings and recommendations from the MDMC regarding capital requirements, reimbursement approval from third party payors and hospital staff training requirements shall be considered in such assessment.
     
  6. All applicants must be available to present the NMT before the CSC and when requested, before the Medical Executive Committee. Other non-members may be invited by the CSC to the assessment meeting for advisory purposes. 
  7. CSC shall recommend to the Medical Executive Committee to either approve or reject the NMT. If the NMT is rejected by the Medical Executive Committee the applicant may appeal such decision to the Medical Executive Committee. 
  8. NMT that requires physician privileging will require notification to the Credentials Committee. 
  9. The CSC reserves the right to recommend provisional approval for certain NMT based upon facts and circumstances that would warrant a second review and approval of the NMT following a conditional period of use. 
  10. All approvals for NMT are subject to approval by the governing body in accordance with established Hospital policy and practice.
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