03-13ICT-Antiseptic-Sterility-Report

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Sterility of Antiseptic Products: FDA Investigates, Deliberates on Potential Recommendations

In light of a number of high-profile recalls of contaminated alcohol prep products in the last several years, the Food and Drug Administration (FDA) is currently weighing whether or not to require sterility of patient skin prep products, specifically items such as alcohol prep pads used for injections, but it is not ruling out other surgical prep products.

This report examines key issues relating to the FDA's scrutiny of antiseptic products and includes perspectives from clinicians, manufacturers and medical associations and societies.

  • Explore the current state of manufacturing patient skin prep products
  • Examine the FDA's investigation into intrinsic and extrinsic contamination
  • Review perspectives from prep product users and manufacturers