The Sterility and Infection Control Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to safe and effective medical devices that are free of microbial and biochemical contamination. The program consists of two sub-program areas: Alternatives to Ethylene Oxide Sterilization and Device Related Infections. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Sterility and Infection Control
Alternatives to Ethylene Oxide Sterilization
Selection of sterilization modality for a medical device is an important element in the development of medical devices. Choosing a nonoptimal sterilization modality can lead to several problems, including failure to ensure adequate sterilization and proper device functionality. Currently, it is estimated that about 50% of single-use medical device are terminally sterilized by ethylene oxide (EtO). Additionally, changes in sterilization modality currently require significant revalidation testing including biocompatibility, chemical characterization, and material/device performance testing. Objectives of the sub-program are to provide regulatory science tools to support the transition from EtO to alternative modalities for medical device sterilization.
Device Related Infections
Healthcare-associated infections (HCAIs) attributable to medical devices not only threaten the patients' health and life but also bring additional economic burden to the patients and healthcare system. Infections can occur through multiple situations including inadequate cleaning, disinfection and sterilization of reusable medical devices, bacteria adhesion to devices during implantation, or breaches in the skin with external communicating devices. Sub-program objectives include developing consistent approaches to reprocessing reusable devices and standardized clinically relevant preclinical models to manufacturers evaluating device technologies to reduce device associated infections.
Regulatory Science Gaps and Challenges
The major regulatory science gaps and challenges that drive the Sterility and Infection Control Program are:
- Potential device shortages, such as the sterilization facilities shut down in 2019 (see Statement on concerns with medical device availability due to certain sterilization facility closures)
- Health care associated infections linked to inadequate reprocessing of medical devices, including soils being left behind after cleaning of the device, insufficient disinfection or microbial resistance to used disinfectants, biofilm-related contamination, and incomplete drying. These can lead to microbial proliferation on and biofouling of reusable medical devices, increasing the potential for patient infection.
- Current antimicrobial technologies available may no longer be effective due to multi-drug resistant bacteria and the propensity of biofilm formation on medical devices, making infections more difficult to prevent, detect, and treat.
The Sterility and Infection Control Program is intended to address these challenges and fill these knowledge gaps by fostering the development of Regulatory Science Tools (RST) to reduce device-associated infections and improve the development and assessment of emerging medical technologies.
Sterility and Infection Control Program Activities
The Sterility and Infection Control Program focuses on regulatory science research in these areas:
- Alternatives to Ethylene Oxide Sterilization - To help alleviate the issue, the FDA issued two innovation challenges, calling for alternatives to ethylene oxide (FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies) and reducing ethylene oxide emissions (FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions) to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process. The FDA plans to aid stakeholders in their pursuit of both finding alternatives to and reducing the reliance on EtO by establishing regulatory science tools that can be used to ease impediments to this transition.
- Device Related Infections: Reprocessing of Reusable Medical Devices - The FDA plans to address these issues by providing stakeholders with guidance establishing validation criteria for determining cleaning and drying efficacy.
- Device Related Infections: Advancing Antimicrobial Technologies - To assist stakeholders in evaluating safety and effectiveness of technologies to reduce health care related infections, our focus will be on standardizing methodologies to evaluate the safety and effectiveness of antimicrobial technologies and to detect biofilm formation on devices.
For more information, email OSEL_sterilityandinfectioncontrol@fda.hhs.gov.