INDA government affairs staff attended a hearing convened by the U.S. Food and Drug Administration (FDA) on December 12 to examine concerns about microbial contamination of antiseptic patient preoperative skin preparation products including things like single-use pads, wipes and swabs. These products, which are used in hospital and clinical settings, as well as sold over the counter, are designed to prevent pathogens from entering the body but can become contaminated with the same infection-causing microbes they are designed to protect against. FDA said it decided to examine contamination issues following a number of recalls and reports of infection outbreaks to the Centers for Disease Control and Prevention (CDC).
At the hearing, FDA said it was interested in better understanding how bacteria can contaminate preoperative skin preparations during manufacturing (intrinsic contamination) and during product use (extrinsic contamination) as well as recommendations to minimize these instances including whether sterile manufacturing should be required. Currently antiseptic products are not required to be sterile but must be produced using current good manufacturing practices (CGMP). The regulations dictating that CGMP be followed were developed in the 1970s when it was assumed unwanted pathogens would be killed by the antiseptic in the product. However, low levels of microbial contaminants may not be detected even if CGMP are followed, the FDA hearing notice points out, and current tests do not screen for intrinsically antiseptic-resistant organisms like Burkholderia cepacia and Bacillus cereus.
The FDA used the hearing as an opportunity to receive input on actual and potential risks from a variety of stakeholders, including industry, healthcare providers, academics and patient advocates. Officials from the FDA and CDC questioned presenters but did not make presentations.
Three manufacturers offered the industry point of view: Sage Products, Professional
Disposable, Inc. (PDI) and 3M Company. Sage urged the FDA to base any decision on evidence and a risk analysis and noted the challenges in obtaining data of both types of contamination. As far as addressing intrinsic contamination, the industry representatives were unanimous in their conclusion that the products do not need to be sterile. They reasoned that the products are not used in a sterile environment or manner and sterile manufacturing would not eliminate extrinsic contamination. Sage and 3M were particularly concerned that the obstacles to sterile manufacturing could prove insurmountable. Sage and 3M asserted that common sterile manufacturing procedures are not practical because their products degraded with steam and irradiation, could not be filtered, and reacted negatively with ethylene oxide. The products also vary in their composition, so one solution may not fit all products. Sage said that aseptic manufacturing would require a complete redesign of their facilities and HVAC systems, which may prove cost prohibitive.
The industry stakeholders concluded that intrinsic contamination most often occurs when CGMP are not followed and urged the FDA to provide more guidance. 3M recommended forming an FDA/Industry Working Group to study the problem and cautioned against additional sterilization requirements without good science and research. All warned that a greater risk of infection would result from a lack of access to the products due to shortages and high prices. They stressed there was not sufficient evidence of harm to justify such a drastic change in manufacturing requirements.
As for how to address extrinsic contamination, all agreed that better education of proper use by consumers and healthcare providers, more single use products, checklists and expiration dates on multi-use products could lead to fewer incidents of contamination.
The other participants included: Dr. John Thomas, a Professor of Microbiology at West Virginia University; Dr. Jennifer Yttri, a research fellow from the National
Research Center for Women and Families, and Dr. Aaron Johnson, an orthopedic surgeon from Sinai Hospital of Baltimore. Dr. Thomas argued that not every preoperative product needs to be sterile, explaining that not all “bugs” are pathogens and that quite often microbe combinations do not produce negative outcomes.
Dr. Yttri, a patient advocate, argued for greater monitoring of the manufacturing process, better labeling, more single use products and sterile manufacturing when possible. Dr. Johnson vouched for the effectiveness of using chlorhexidine gluconate
(CHG) wipes pre-surgery and said he did not believe there was a need for sterile manufacturing. In answer to a panelist’s question, he stated that he would not use the products any differently if they were sterile.
FDA officials at the hearing gave no indication of what the agency’s next steps will be or whether there is a timetable for completing consideration of the issue, but the agency is currently accepting public comments until Feb. 12, 2013. INDA will work with its members to evaluate whether to weigh-in and if so, what that input should be. If you are interested in being part of these discussions, please email INDA Director of Government Affairs Jessica Franken at jfranken@inda.org.
For more information, visit: www.federalregister.gov/articles/2012/11/21/2012-28357/antiseptic-patient-preoperative-skinpreparation-products-public-hearing-request-for-comments.
CPSC Issues Representative Samples Rule
The Consumer Product Safety Commission (CPSC) December 5 issued its final rule addressing periodic testing of “representative samples” of children’s products, as required by the Consumer Product Safety Improvement Act of 2008 (CPSIA). The new requirements, which will apply to products manufactured after February 8, 2013, are part of a CPSIA rule issued in early 2012 that requires makers of children’s products to test samples of their products on a periodic basis to ensure compliance with all applicable product safety rules.
Under the rule, manufacturers are required to conduct periodic testing on enough samples to provide a “high degree of assurance” that the tests demonstrate the products’ ability to meet applicable standards. Manufacturers must establish a procedure for selecting representative samples to test and document the basis for inferring that the procedure indicates the compliance of untested products.
A periodic testing plan must outline the tests that will be conducted, testing intervals, and the number of samples tested. The interval selected must be short enough to ensure that products manufactured after initial certification continue to comply with all product safety rules. A manufacturer must retest any time a “material change” occurs, such as changes in the production design, manufacturing process, source of component parts or any change, which could impact the product’s compliance with safety rules.
Manufacturers and importers must maintain records for five years documenting the representative testing, including the number of samples selected and the procedure used to select the samples.
The CPSC released this rule even though it is currently examining ways to reduce the burdens of third party testing requirements. In the meantime, a manufacturer should consider whether it could reduce its testing costs by: (1) qualifying for exemptions as a small-batch manufacturer; (2) re-evaluating whether its products really are “children’s products,” and if they are, whether they are exempt from certain testing requirements; and (3) maximizing “component” testing/certification.
For the Federal Register notice, go to: www.federalregister.gov/articles/2012/12/05/2012-29204/testing-and-labelingpertaining-to-product-certification-regarding-representativesamples-for.
At the hearing, FDA said it was interested in better understanding how bacteria can contaminate preoperative skin preparations during manufacturing (intrinsic contamination) and during product use (extrinsic contamination) as well as recommendations to minimize these instances including whether sterile manufacturing should be required. Currently antiseptic products are not required to be sterile but must be produced using current good manufacturing practices (CGMP). The regulations dictating that CGMP be followed were developed in the 1970s when it was assumed unwanted pathogens would be killed by the antiseptic in the product. However, low levels of microbial contaminants may not be detected even if CGMP are followed, the FDA hearing notice points out, and current tests do not screen for intrinsically antiseptic-resistant organisms like Burkholderia cepacia and Bacillus cereus.
The FDA used the hearing as an opportunity to receive input on actual and potential risks from a variety of stakeholders, including industry, healthcare providers, academics and patient advocates. Officials from the FDA and CDC questioned presenters but did not make presentations.
Three manufacturers offered the industry point of view: Sage Products, Professional
Disposable, Inc. (PDI) and 3M Company. Sage urged the FDA to base any decision on evidence and a risk analysis and noted the challenges in obtaining data of both types of contamination. As far as addressing intrinsic contamination, the industry representatives were unanimous in their conclusion that the products do not need to be sterile. They reasoned that the products are not used in a sterile environment or manner and sterile manufacturing would not eliminate extrinsic contamination. Sage and 3M were particularly concerned that the obstacles to sterile manufacturing could prove insurmountable. Sage and 3M asserted that common sterile manufacturing procedures are not practical because their products degraded with steam and irradiation, could not be filtered, and reacted negatively with ethylene oxide. The products also vary in their composition, so one solution may not fit all products. Sage said that aseptic manufacturing would require a complete redesign of their facilities and HVAC systems, which may prove cost prohibitive.
The industry stakeholders concluded that intrinsic contamination most often occurs when CGMP are not followed and urged the FDA to provide more guidance. 3M recommended forming an FDA/Industry Working Group to study the problem and cautioned against additional sterilization requirements without good science and research. All warned that a greater risk of infection would result from a lack of access to the products due to shortages and high prices. They stressed there was not sufficient evidence of harm to justify such a drastic change in manufacturing requirements.
As for how to address extrinsic contamination, all agreed that better education of proper use by consumers and healthcare providers, more single use products, checklists and expiration dates on multi-use products could lead to fewer incidents of contamination.
The other participants included: Dr. John Thomas, a Professor of Microbiology at West Virginia University; Dr. Jennifer Yttri, a research fellow from the National
Research Center for Women and Families, and Dr. Aaron Johnson, an orthopedic surgeon from Sinai Hospital of Baltimore. Dr. Thomas argued that not every preoperative product needs to be sterile, explaining that not all “bugs” are pathogens and that quite often microbe combinations do not produce negative outcomes.
Dr. Yttri, a patient advocate, argued for greater monitoring of the manufacturing process, better labeling, more single use products and sterile manufacturing when possible. Dr. Johnson vouched for the effectiveness of using chlorhexidine gluconate
(CHG) wipes pre-surgery and said he did not believe there was a need for sterile manufacturing. In answer to a panelist’s question, he stated that he would not use the products any differently if they were sterile.
FDA officials at the hearing gave no indication of what the agency’s next steps will be or whether there is a timetable for completing consideration of the issue, but the agency is currently accepting public comments until Feb. 12, 2013. INDA will work with its members to evaluate whether to weigh-in and if so, what that input should be. If you are interested in being part of these discussions, please email INDA Director of Government Affairs Jessica Franken at jfranken@inda.org.
For more information, visit: www.federalregister.gov/articles/2012/11/21/2012-28357/antiseptic-patient-preoperative-skinpreparation-products-public-hearing-request-for-comments.
CPSC Issues Representative Samples Rule
The Consumer Product Safety Commission (CPSC) December 5 issued its final rule addressing periodic testing of “representative samples” of children’s products, as required by the Consumer Product Safety Improvement Act of 2008 (CPSIA). The new requirements, which will apply to products manufactured after February 8, 2013, are part of a CPSIA rule issued in early 2012 that requires makers of children’s products to test samples of their products on a periodic basis to ensure compliance with all applicable product safety rules.
Under the rule, manufacturers are required to conduct periodic testing on enough samples to provide a “high degree of assurance” that the tests demonstrate the products’ ability to meet applicable standards. Manufacturers must establish a procedure for selecting representative samples to test and document the basis for inferring that the procedure indicates the compliance of untested products.
A periodic testing plan must outline the tests that will be conducted, testing intervals, and the number of samples tested. The interval selected must be short enough to ensure that products manufactured after initial certification continue to comply with all product safety rules. A manufacturer must retest any time a “material change” occurs, such as changes in the production design, manufacturing process, source of component parts or any change, which could impact the product’s compliance with safety rules.
Manufacturers and importers must maintain records for five years documenting the representative testing, including the number of samples selected and the procedure used to select the samples.
The CPSC released this rule even though it is currently examining ways to reduce the burdens of third party testing requirements. In the meantime, a manufacturer should consider whether it could reduce its testing costs by: (1) qualifying for exemptions as a small-batch manufacturer; (2) re-evaluating whether its products really are “children’s products,” and if they are, whether they are exempt from certain testing requirements; and (3) maximizing “component” testing/certification.
For the Federal Register notice, go to: www.federalregister.gov/articles/2012/12/05/2012-29204/testing-and-labelingpertaining-to-product-certification-regarding-representativesamples-for.
