I am Dr. Jennifer Yttri and I am speaking today on behalf of the National Research Center for Women & Families. Our organization does not accept funding from device manufacturers and therefore I have no conflict of interest.
Our nonprofit research center includes scientists and medical and public health experts who analyze and review research on a range of health issues. I have a doctorate in immunology from Washington University in St. Louis. In addition to conducting research and publishing our findings in medical journals, we provide objective and understandable information to patients, health care providers, and policy makers through briefings, CMEs, testimony, and other materials and formats.
We have great respect for the FDA, and that’s why our center’s president is on the Board of Directors of 2 nonprofit organizations focused on providing additional resources to the FDA: the Alliance for a Stronger FDA and the Congressionally mandated Reagan Udall Foundation.
Contamination of antiseptic products is a serious public health issue. High profile cases, such as the Triad Group’s high-risk recall of alcohol prep pads following the death of a child in Texas, serve as warnings for the most severe cases. Even lower risk recalls have the potential to severely harm patients. It is imperative to take measures NOW to prevent future outbreaks.
Antiseptic resistant microbes are not something most consumers think about. Consumers and physicians may not be aware that most antiseptic skin preparation products are not sterile. Even if told, the associated risk might not be understood—if a product is intended to clean skin, as an antiseptic, the logical conclusion is all contaminants are removed. They rely the FDA to make sure those products are safe.
Additionally, there is a large level of variance in the ability to detect or minimize potential contamination at home and outside the hospital. It is challenging to maintain aseptic conditions, sterile water, and containers. Therefore, the FDA should focus on strategies that would improve manufacturing and outreach to prevent future outbreaks caused by the use of antiseptic products.
There are several steps the FDA can take to better ensure the safety of consumers who are exposed to antiseptic preoperative skin preparation products.
First, we support the recommendation of the August 2009 Advisory Committee in ensuring that all antiseptic patient preoperative skin preparation products are held to current good manufacturing practice (GMP) standards. Sterile and non-sterile products have both been part of major recalls. Sterilization alone will give a potentially false sense of security to healthcare professionals and consumers. The FDA has to strengthen monitoring of manufacturing facilities to ensure GMP compliance.
Routine end of manufacturing testing for microbes should be required. The FDA should also update their acceptable non-sterile criteria. More advanced screening processes have been developed that can detect lower bacterial levels than culture techniques. The list of specified microorganisms to test for needs to include any that have been associated with contamination outbreaks. By taking the steps to effectively monitor contamination during the manufacturing process, the number of outbreaks can be significantly reduced.
Second, the FDA should remove ineffective antiseptics from the market. For instance, benzalkonium chloride containing products have been recalled at higher rates than other antiseptics. These products are not approved by the FDA for use as an antiseptic. Benzalkonium chloride seems to be causing more harm than benefit to patients. If it cannot be used appropriately, it should not be used at all.
Third, as extrinsic contamination accounts for the majority of contamination outbreaks, FDA should require product packaging that would reduce extrinsic manipulation. We recommend that all products intended for use at home be made as sterile as possible. These products should be packaged as single-use, and pre-diluted to the correct concentration so as to avoid contamination with water. Methods for maintaining sterility should be as simple as possible. The FDA should also require easy-to-understand instructions on how to use these products, including appropriate storage, dilution or mixing if needed, and application.
Finally, while the majority of outbreaks seem to be related to extrinsic contamination, intrinsic contamination introduced during manufacturing most likely accounts for a greater number of contaminated products. Large scale recalls may sometimes be due to improper storage at hospitals, but hundreds of millions of packages have been recalled in recent years because of poor manufacturing. Many of the antiseptic products being discussed today are cleared through the 510(k) process. Inspections and other monitoring are essential, but unfortunately are rare in the 510(k) process. The FDA should require special controls such as inspection of the manufacturing process prior to market release, submission of premarketing microbial testing, and maintenance of ISO and ASTM standards (if available), regardless of device class. Monitoring of microbial levels should be continued as part of a required post-market surveillance plan rather than passively in response to serious problems.
Patients are relying on YOU, the FDA, as the regulatory agency to protect them from contaminated antiseptic products. Whether entrusting a physician to properly use an antiseptic device or using it themselves at home, most of these patients will not know if they are exposing themselves to potential harm. An improved set of guidelines for manufacturing and monitoring of microbial contamination will help reduce this potentially lethal risk. We urge you to help restore the consumer’s confidence in the FDA and in medical products sold in the U.S. by maintaining higher standards. Special controls are needed to keep patients safe.