The Center for Biofilm Engineering has launched a new regulatory science program with the intent to promote innovation by creating a culture that bridges a regulatory science mission and novel technology solutions to real world problems. The goal is for the CBE to be at the nexus of innovation and regulatory science with regards to the fate and transport of biofilm in the body, environment and engineered systems. The regulatory science program is built upon the pillars of education, research, and technology transfer with standard methods serving as the key communication and decision making tool. In this presentation, a method to assess antimicrobial catheters will illustrate how standard methods are foundational to the regulatory science process.
Urinary catheters are a critical medical device in modern medicine, used in almost every healthcare setting worldwide. Catheter associated urinary tract infections (CAUTIs) account for 37% of all healthcare associated infections. Many surface modifications, such as antimicrobial coatings, have been proposed but none have resulted in a significant decrease in CAUTI. The Intraluminal Catheter Model (ICM) was developed to evaluate the efficacy of surface modifications to inhibit biofilm growth on the catheter lumen. The ICM was subjected to a rigorous statistical evaluation of its ruggedness, responsiveness, and repeatability. The ruggedness test results were incorporated into a proposed Standard Test Method titled ‘Intraluminal Catheter Model used to Evaluate Antimicrobial Urinary Catheters for Prevention of Escherichia coli Biofilm Growth’ that was submitted to ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents. Committee E35 approved the method in October 2021. The development and validation of a standardized in vitro method which reflects the physiological conditions of CAUTI will help FDA regulators more accurately screen potential devices prior to a clinical trial.
Dr. Darla Goeres has over twenty-five years of experience researching biofilm bacteria in a range of industrial and engineered systems including biofilms found in beer draught lines, Danish district heating distribution pipes, anaerobic biofilms in soured oil fields, and biofilms in recreational water systems. She has evaluated a multitude of treatment strategies for killing, removing and/or preventing biofilm formation. In 1996, Dr. Goeres was visiting researcher at the Danish Technological Institute in Aarhus Denmark, and in 2014 she was a Fulbright scholar at Åbo Akademi University, Turku, Finland.
Dr. Goeres leads the Standardized Biofilm Methods Laboratory (SBML) team at the Center for Biofilm Engineering, whose mission is the development and validation of quantitative standard methods for growing, treating, sampling and analyzing biofilm bacteria. A leader in developing biofilm standard methods, Dr. Goeres is a long time member of the American Society for Testing and Materials (ASTM) subcommittee E35.15 and facilitated the acceptance of the first approved standard methods for biofilm bacteria. This work continues with the approval of ASTM Method E3321 titled “Standard Test Method for an Intraluminal Catheter Model used to Evaluate Antimicrobial Urinary Catheters for Prevention of Escherichia coli Biofilm Growth.” In October 2021, Dr. Goeres was awarded “ASTM Professor of the Year.”
In March 2020, Dr. Goeres was appointed Research Professor of Regulatory Science. In her new role, she will develop a regulatory science program at the CBE with a goal of engaging regulatory and industrial decision makers in the development of tools that enable innovation in biofilm science and technology.