07.01.15
In order to ensure public health, professionals in the health care field must continue to rely on over-the-counter antiseptic healthcare products, according to a leading trade association. The American Cleaning Institute (ACI) issued the following response to proposed rules by the US Food and Drug Administration (FDA) governing over-the-counter antiseptic healthcare products.
“We strongly agree with the Food and Drug Administration’s recommendation that healthcare personnel continue to use antiseptic products as they currently do. These soaps, washes, alcohol rubs, hand scrubs and pre-operative skin preparations are critical to infection control for patients and healthcare workers alike,” said Richard Sedlak, ACI executive vice president, technical and international affairs. “We believe that the FDA already has in its hands a wealth of scientific data that details the safety and effectiveness of these critical antiseptic products.”
According to Sedlack, antiseptic products have been used safely and effectively by healthcare workers for decades.
“While manufacturers have submitted extensive data already, we will continue working with the FDA and provide the necessary information to answer their questions. We need to ensure these products remain available to help save lives in thousands of hospitals and healthcare settings across the United States,” concluded Sedlak.
The statement follows a recent move by FDA requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. FDA stressed that these products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.
“Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”
Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease.
Ultimately, the FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe, said sources at ACI.
FDA noted that since it began reviewing health care antiseptics in the 1970s, many aspects have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body and more.
“We strongly agree with the Food and Drug Administration’s recommendation that healthcare personnel continue to use antiseptic products as they currently do. These soaps, washes, alcohol rubs, hand scrubs and pre-operative skin preparations are critical to infection control for patients and healthcare workers alike,” said Richard Sedlak, ACI executive vice president, technical and international affairs. “We believe that the FDA already has in its hands a wealth of scientific data that details the safety and effectiveness of these critical antiseptic products.”
According to Sedlack, antiseptic products have been used safely and effectively by healthcare workers for decades.
“While manufacturers have submitted extensive data already, we will continue working with the FDA and provide the necessary information to answer their questions. We need to ensure these products remain available to help save lives in thousands of hospitals and healthcare settings across the United States,” concluded Sedlak.
The statement follows a recent move by FDA requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. FDA stressed that these products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.
“Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”
Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease.
Ultimately, the FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe, said sources at ACI.
FDA noted that since it began reviewing health care antiseptics in the 1970s, many aspects have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body and more.