Have no fear! You can access it here in recorded format or as a slide presentation.
To provide more information on reusable device validations, Pacific BioLabs conducted a webinar on reusable devices. The webinar covers an overview of requirements and presents three case studies of validations performed on devices of various complexity.
A great deal of thought goes into the design of any medical device, and engineers should be encouraged to thoroughly examine the ways in which the design of their device can facilitate or hinder reprocessing. The best device design facilitates the use of the device, and also facilitates the reuse of the device. However, some devices, in the initial design, prove so difficult to reprocess that the design must be altered to facilitate cleaning and reuse. By understanding the choices made in creating a reprocessing methodology and how device design and use puts constraints on the reprocessing method, engineers can save significant amounts of time and speed device approval, thereby ensuring that their devices get to market as quickly as possible.
Advancement in diagnostic and therapeutic medicine has led to more sophisticated medical device designs. As these designs become more complex, the process of adequately cleaning and disinfecting and/or sterilizing instruments has become more complex as well. Pacific Biolabs helps manufacturers in the validation of their product claims, and helps ensure patient safety by providing assurance that the product meets FDA requirements. PBL offers a wide range of selections from protocol preparation to validating and performing the routine cleaning and disinfection procedures. PBL will not only validate a given procedure, but will help in designing and creating protocols for a given device.
For a consultation on what is necessary for your device, please visit our website for more information on cleaning and disinfection validation services, and we will also be happy to provide you with a quote on pricing for your specific project.