FDA says more data needed on safety, efficacy of widely-used hospital sanitizers
Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctors' offices and nursing homes to kill germs and prevent infections.
The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin.
Under a proposed rule published Thursday, companies will have until 2018 to submit new data on key safety issues, including possible hormonal effects and contributions to antibiotic-resistant bacteria. Products that are not shown to be safe or effective would have to be reformulated or removed from the market.
For now, the FDA stressed that health care workers should continue using hand washes, sanitizers and surgical scrubs, which are standard tools for preventing health care infections.