The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Reusable medical devices are designed for repeated cleaning and sterilization, but determining when they reach the end of their usable life remains a challenge. In this research Q&A, Patel explains how the 100-cycle testing protocol was developed, what the study...
Ensuring that reusable medical devices can be properly cleaned, disinfected, and/or sterilized is imperative to ensure patient safety and to minimize healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases,...
Choosing a chemical disinfectant will depend on a combination of considerations with regards to the reprocessing instructions, location of the users, possible adverse effects on biocompatibility/patient safety and device materials. Reprocessing instructions A first consideration when selecting the proper disinfectant...
The ISO 17664 series[1][2] as well as the FDA guidance for reprocessing medical devices in health care settings[3] specify that processing instructions should include the required quality of any water that is used for preparing solutions or for rinsing. A...
Initial rinse The first step in the cleaning process is often a rinse with cool utility water to remove any remaining gross (large) debris from the medical devices[1]. This is an important step given that many organic soils, including proteinaceous...
