Regulatory Focus™ > News Articles > After Failings, FDA Prepares to Reassess Regulation of Preoperative Skin Preparations

After Failings, FDA Prepares to Reassess Regulation of Preoperative Skin Preparations

Posted 20 November 2012 | By Alexander Gaffney, RAC 

Regulators with the US Food and Drug Administration (FDA) are preparing to conduct a meeting on preoperative skin preparations, a type of over-the-counter (OTC) product now used to reduce the number of bacteria on a patient's skin before surgery or injections in the hope of reducing infections.

The products are more commonly seen as wipes or swabs containing alcohol, iodine or chlorhexide gluconate (CHG). Though the products are widely used and available, their antimicrobial properties don't always protect the products from contamination, and the products are not-contrary to popular belief-always sterile.

FDA regulators have been blasted in recent years for failing to prevent the distribution of contaminated wipes manufactured by several companies, including one in New York thought to have distributed hundreds of millions of alcohol pads now linked to a number of deaths and serious adverse events.

FDA has taken note of these contamination episodes before in public forums, noting that the contamination usually occurs on the user end when doctors or other users dilute a bulk solution using unsterilized water or contaminated storage containers. It's similarly difficult to figure out when contamination has occurred. FDA has explained that the patient groups, context of use, myriad of personnel, various physical settings and numerous infection control measures make pinpointing the source of contamination difficult, if not impossible in some cases. This latter form of contamination is known as extrinsic contamination.

It is the other type of contamination, intrinsic contamination, which FDA said it is most worried about, as it has the potential to adversely impact many more people. Such contaminants get into products through sloppy application of current good manufacturing practices (CGMP). "Bacterial contaminants have been isolated from pharmaceutical water supplies and non-sterile antiseptic manufacturing environments," FDA explained.

CGMP standards require companies to have in place methods of detecting and preventing the growth of microbial contaminants in supposedly sterile drug products, but FDA explained that the current standards may not be sufficient to account for some types of contamination.

"The microbial limits test (United States Pharmacopeia Chapter 1111 (Ref. 2)) currently in use by many manufacturers may not detect very low levels of microbial contamination and does not screen for the types of intrinsically antiseptic-resistant organisms frequently identified as contaminants in patient preoperative skin preparations, such as Burkholderia cepacia and Bacillus cereus," it wrote.

Therefore, even supposedly safe products that meet all CGMP requirements could still potentially be of significant risk to patients. As a consequence of both the theoretical and actual risks to patients, FDA said it has decided to hold a public hearing on ways to address the sterility issues of preoperative skin preparations.

A number of issues are set to be discussed, and while drug manufacturers will likely focus much of their attention on intrinsic contaminations, FDA's explanation of the issues to be raised regarding extrinsic contamination have much to do with FDA's regulatory processes as well.

For instance, FDA wishes to know if, given the risks of extrinsic contamination, products should be packaged in single-use containers, with clearer labeling conventions, in safer packaging, or with Risk Evaluation and Mitigation Strategy-like requirements for training.

Intrinsic contamination will be subject to similar questions and considerations, including new methods of validation for sterilization and aseptic manufacturing, manufacturing challenges, and the possibility of requiring all preoperative skin preparations to be manufactured sterile.

The two-day meeting will be held between 12 and 13 December 2012 in Silver Spring, MD.


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