Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Double Edged Regulation of Liquid Chemical Germicides Used in Healthcare Settings. The Burden of a Joint Jurisdiction, Demarcation of Categories and Regulatory Requirements in the United States of America ***

Anna Touhidi (Abschlußjahr: 2016)

Summary
Language: English
Healthcare associated infections and nosocomial infections, respectively, bear a serious threat to human health. To prevent these infections, it is a crucial objective to maintain proper hygiene in healthcare settings, whereas the environment and surfaces as well as medical devices should be considered. To comply with state of the art requirements with regard to hygiene standards, amongst other methods, liquid chemical germicides may be used to disinfect and sterilize inanimate surfaces and medical devices.
In the United States of America, liquid chemical germicides used for disinfection and sterilization of surfaces as well as medical devices in healthcare settings are both devices under the Federal Food, Drug and Cosmetic Act and pesticides under the Federal Insecticide, Fungicide and Rodenticide Act. Since the Environmental Protection Agency is responsible for the regulation of pesticides, whereas the Food and Drug Administration is inter alia responsible for the regulation of devices and their accessories, the regulatory handling of liquid chemical germicides is accompanied by a long history of a joint jurisdiction of the Environmental Protection Agency and the Food and Drug Administration. This joint jurisdiction led to a lack of transparency for applicants as well as ineffective and resource demanding procedures for all parties concerned, therefore, in the 1990is it was agreed to clear responsibilities and product categories regulated by each agency. 
For purpose of the demarcation of product categories and responsibilities, it was appointed that the Environmental Protection Agency would be responsible for general purpose disinfectants used to process noncritical devices and surfaces, whereas the Food and Drug Administration would be responsible for liquid chemical sterilants and high level disinfectants for the processing of critical and semicritical devices.
In practice, the Environmental Protection Agency does not use the term general purpose disinfectants, but regulates antimicrobial pesticides, containing the subcategories hospital disinfectants and sterilants. The sterilants regulated with the Environmental Protection Agency must not be used as a terminal step within sterilisation procedures. The Food and Drug Administration classified general purpose disinfectants to be Class I devices with 510(k) exemption and liquid chemical sterilants/ high level disinfectants to be Class II devices requiring 510(k) clearance.
The data requirements for product applications with the Environmental Protection Agency and the Food and Drug Administration noticeable differ with regard to ecotoxicological considerations on the one hand and efficacy data requirements on the other hand, which may be explained by each agencies governmental mandate.
However, both agencies provide sophisticated regulatory procedures for different application approaches, considering products already available on the market, active ingredients already used and known and demand a high standard to be considered and implemented by the applicant. Since even comparisons with procedures and approaches for medicinal products may be drawn, it is conceivable that different product categories may have influenced the other.
Although already important steps have been made to enhance the transparency of the regulatory landscape for liquid chemical germicides, still points for clarification have remained and regulatory approaches should be further developed; this for example refers to the classification of general purpose disinfectants as Class I devices, which although registration takes place with the Environmental Protection Agency still leads to the need for consideration of the Food and Drug Administration’s Quality System Regulations or to the possible case that medical devices may not be properly categorized and as a consequence obsolete regulatory approaches are reawakened.
Pages: 56
Annex: 1, Pages: 8