By Jason Pope, B.S., ASQ CQA
Published: Medical Design & Outsourcing
Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential.
Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the microbiocidal process that’s validated for a reusable medical device is a set of sterilization instructions.
Acquisition creates the leading global extractables and leachables lab testing platform to serve the pharmaceutical and medical device industries CLEVELAND, OH. – Oct. 31, 2017—Sterigenics International LLC announced today that it has acquired Toxikon Europe N.V., the European division of Toxikon Corporation, a Bedford, Mass.-based preclinical contract research organization. Terms of the deal were not […]
There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode. Alpa Patel, Senior Scientist at Nelson Laboratories and member of AAMI, ASTM, and AATB, will share her expertise in this presentation and discuss the key factors that determine a successful reusable medical device cleaning validation. Participants who attend the presentation will learn:
The key factors that determine a successful cleaning validation
The current thinking of FDA regarding cleaning validations
The main documents relevant to cleaning validations
The stages cleaning validations should be considered when designing a reusable medical device