Effectiveness, Safety of Healthcare Antiseptics under Scanner
Published By : 30 Apr 2015 | Published By : QYRESEARCH
Antiseptic healthcare products that are used by clinicians over 100 times a day will need to prove themselves to be both effective and safe, especially in the long run, in order to continue being in the market. This is in keeping with the proposed regulations that were announced by the US Food and Drug Administration (FDA) on Thursday.
The healthcare antiseptic products under fire are found in nursing homes, hospitals, clinics, physician offices, and several other outpatient settings. The manufacturers of these antiseptics will have to produce safety and efficacy information on 29 active ingredients, including iodine, alcohol, hexachlorophene, and phenol.
Among other things, the US FDA is seeking information regarding potential hormonal changes, topical absorption, chances of bacterial resistance, and the consequences, if any, on pregnant and/or breast-feeding healthcare workers.
The proposed regulations that were announced on Thursday do not bring in to question consumer antiseptics such as hand sanitizer rubs and antibacterial soaps.
The announcement could possibly lead to cognitive dissonance for nurses, physicians, and other healthcare workers, who are requested to follow extremely strict infection control protocols. These protocols include regular and faithful use of hand rubs and hand washes by everyone including surgeons, and preoperative skin preparations for patients. All of these protocols fall under the US FDA proposal.
At a press conference held on Thursday, an official with the FDA asked clinicians to continue with their infection control rituals and continue to use the healthcare antiseptic products that include the 29 ingredients. Theresa Michele, MD, who is the director of the non-prescription drug department at the Center for Drug Evaluation and Research, FDA, said that the department or the FDA does not believe that those ingredients are unsafe or ineffective. However, there may be need for confirmatory studies to keep up with the changing procedures of infection control.