Sterilization
To Assess or Determine? Unraveling the D-Value
There is a misconception that U.S. Pharmacopeia (USP) requires the end-users of biological indicators (BIs), except under specific conditions, to perform a D-value determination on incoming lots of BIs prior to acceptance and use. Assessing the D-value is much easier and much less...
BeamOne Expands to Meet Complex Device Demand
BeamOne provides sterilization services to the global medical device market. Pictured is the company’s process conveyor system at a facility in Costa Rica. As medical devices are becoming more complex, sterilization requirements are also becoming more stringent....
Steam: Uses and Challenges for Device Sterilization
STERILIZATION Table I. (Click to See Full Table) A sampling of time-temperature relationships for steam sterilization. The use of steam for sterilization is fairly widespread; however, steam is seldom used as a sterilization method by the medical device industry. Most...
Massachusetts Considers Unprecedented Reprocessing Law
NewsTrends Pamela Furman thinks the bill is industry's way of trying to get rid of economic competition. A bill in Massachusetts could make it the first state to require caregivers to get patient consent before using a reprocessed SUD that would pierce the skin or...
WHO DID WHAT IN 2005
Debate over Reprocessed SUDs Continues Conflicts over reprocessing single-use devices (SUDs) have persisted for many years, and 2005 was no different. From a major merger to a Massachusetts bill that would require informed consent when using reprocessed SUDs on patients, the...
Merger Creates Largest Third-Party Reprocessor
Originally Published MDDI November 2005 Industry News Maria Fontanazza Hospitals reprocess surgical instruments to save money. The merger could save them more than $92 million in supply costs. Third-party device reprocessors Alliance Medical Corporation Inc. and...
Parametric Release for Low-Temperature Gas Plasma Sterilization
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI October 2005 Sterilization With the possibility of parametric release, low-temperature gas plasma sterilization may be a viable alternative to ethylene oxide for processing heat-...
Global Sterilization: Making the Standards Standard
Originally Published MDDI March 2005 Sterilization Global Sterilization: Making the Standards Standard The new harmonized documents may hold the key to sterilization standards, but critical changes are in store for manufacturers. Robert Reich, Philip M. Schneider, and...
Despite Complaints, FDA Shows Progress on SUD Reprocessing
Originally Published MDDI February 2005 NEWSTRENDS Despite Complaints, FDA Shows Progress on SUD Reprocessing Erik Swain and James G. Dickinson Alliance Medical Corp. received FDA clearance for reprocessed diamond-burr drill bits. As expected, there was much sound and...
USP <797>: How It Affects Medical Device Manufacturers
Originally Published MDDI January 2005 Sterile Compounding USP <797>: How It Affects Medical Device Manufacturers Manufacturers of compounded sterile preparations have been faced with proving the compliance of some of their products with USP's new sterile...