Article about the inability or ineptitude of the FDA regarding products that can be lethal to patients. Focusing on feeding and iv tubes that can be misconnected together and two dialysis machines that can kill by removing too much uf, the article condemns byzantine rules and practices at the regulatory agency. It also reports that certain manufacturer groups have been able to game the system and prevent industry-wide specifications from being developed.
http://www.nytimes.com/2010/08/21/health/policy/21tubes.html?pagewanted=1&ref=health&src=meI personally know someone who could have been killed by a Gambro Integra machine when it somehow reset the UF to six litres, from the user programmed two litres or so. The deadly machine in the article is the Prisma which is also made by Gambro.