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FDA Seeks More Safety Data on Hospital Antiseptics, Proposes Rule
HealthLeaders Media

The U.S. Food and Drug Administration Thursday issued a proposed rule that would downgrade the safety status of virtually all antiseptic products used by healthcare workers, such as hand-sanitizing gels and surgical scrubs. It says more evidence is needed to prove they aren’t unsafe.

There is concern about the safety of alcohol, iodine, and other ingredients used to make hand washes, rubs, surgical scrubs, and patient preoperative skin preparations, including pre-injection preparations used in hospitals and other clinical settings. Antibacterial soaps and hand sanitizer rubs sold as consumer products are not part of the proposed rule.