Staci has worked in both quality and sterility assurance roles, supporting medical device manufacturing, before joining NAMSA as a Validation Scientist. Since joining NAMSA in 2008, her primary focus has been assisting medical device manufacturers in the creation and validation of reprocessing instructions for reusable medical devices.

CORE COMPTENCIES 

• Preparing technical documentation for reusable and single-use medical device process validations and managing validation activities, including laboratory instruction, scheduling and budgeting
• Cleaning validations (manual and automated)
• Disinfection validations (high-, intermediate- and low-level)
• Sterilization (chemical, hydrogen peroxide, steam, ethylene oxide [EO], gamma and e-beam)
• Residual cleaning and disinfecting agent testing
• Preparing Instructions for Use (IFUs) outlining device reprocessing methods with consideration of user needs and practices
• Preparing technical documentation for the grouping of medical devices into product families and selecting master product(s) for use in reprocessing validations
• Preparing technical documentation providing product and/or process adoption rationale for new or modified medical devices
• Preparing technical documentation, including feasibility test protocols, supporting the selection of medical device design features, to help ensure the final product design facilitates effective processing
• Supporting efforts for EU Medical Device Regulation (MDR) compliance for the reprocessing of medical devices
• Expertise in the U.S. Food and Drug Administration (FDA) Guidance Document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
• Providing training on medical device reprocessing requirements for the FDA
• Member of the Association for the Advancement of Medical Instrumentation (AAMI)

RECENT PROJECTS

• Re-validated the IFU for a large medical device manufacturer’s product lines in order to comply with EU MDR
• Created and validated IFUs for a multifaceted medical device system including multiple processes (i.e., cleaning, disinfection, EO hospital sterilization and steam sterilization) and multiple component types (i.e., critical, semi-critical and non-critical)
• Created technical documentation for the grouping of multiple non-critical medical devices resulting in the reduction of cleaning and disinfection validations required for 510(k) submission