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Natural Latex Medical Device Regulation

Natural Latex Medical Device Regulation. Mel E. Stratmeyer, Ph.D. Center for Devices and Radiological Health Food and Drug Administration. CDRH MISSSION. Insure Safety Effectiveness. CDRH ACTIONS. Problem Identification Advisory Role Research Regulatory Initiatives.

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Natural Latex Medical Device Regulation

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  1. Natural Latex Medical Device Regulation Mel E. Stratmeyer, Ph.D. Center for Devices and Radiological Health Food and Drug Administration

  2. CDRH MISSSION • Insure • Safety • Effectiveness

  3. CDRH ACTIONS • Problem Identification • Advisory Role • Research • Regulatory Initiatives

  4. PROBLEM IDENTIFICATION • Adverse event reporting system • High-risk groups

  5. HIGH-RISK GROUPS • Pediatric spina bifida population 20%-60% • Healthcare workers 6%-10% • Rubber industry workers 6%

  6. ADVISORY ROLE • Medical Alert • Industry cooperation • International Latex Conference • Standards development

  7. RESEARCH • Allergen identification • Selection of reference allergen • Methods development • Refinement

  8. REGULATORY INITIATIVES • Protein content guidance • Labeling regulation • Glove reclassification regulation

  9. MEDICAL GLOVES : PROPOSED RULE • Reclassify from Class I to Class II • Special Controls • Label caution statements that include recommended limits • Label protein levels on NRL gloves • Label powder levels on all gloves • Expiration labeling

  10. OTHER GOVERNMENT AGENCIES • OSHA Technical Information Bulletin-select “lower protein content”…”powder free…benefit…reducing systemic allergic responses’ • NIOSH Safety Alert-”powder-free with reduced protein content”

  11. GOALS • Prevent • Sensitization • Adverse reactions

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