Healthcare facilities need to make sure they have enough personnel and equipment that can manage device reprocessing.
The disgraced company founder Holmes and its former President Sunny Balwani have been charged with raising more than $700 million from investors in a massive fraud scheme.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
The 15-mm valve size is small enough to use in newborn patients to treat heart defects.
A $10 million award from the National Science Foundation could help Rice University make this concept a reality.
In many cases, establishments are removed due to a failure to renew annual registration with the agency.
The Banyan Brain Trauma Indicator was authorized through the agency’s Breakthrough Devices Program.
Medical device recalls were at their lowest quarter since Q4 2011, according to Stericycle’s recall index for Q4 2017.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
The addition will further expand IPC’s event capabilities.