A Medical Device Daily
Senior executives at Gambro (Stockholm, Sweden) said they recently met with the FDA officials to address the agency's concerns about the safety of the company's Prisma System and the adequacy and effectiveness of Gambro Renal Products ' (Lakewood, Colorado) quality program addressed earlier this year in a warning letter.
Gambro Dasco (Medolla, Italy), a production unit within Gambro Renal Products, reported receiving an FDA warning letter concerning the agency's inspection of its Medolla facility that manufactures monitors and indicating concerns about the safety of the Prisma System and the adequacy and effectiveness of Gambro Dasco's quality systems (Medical Device Daily, Jan. 10, 2006).
It said that the FDA also issued an import alert calling for the detention of Gambro's monitor products – Prisma, Prismaflex and Phoenix – shipped into the U.S.
The company said in a statement, however, that the devices can be used “when directions are followed.“
Gambro said that in mid-March it submitted a comprehensive corrective action plan (CAP) to the FDA detailing the steps it will take to resolve the agency's issues “as quickly and thoroughly as possible.“
The company also said it has created an organization and management team to create and implement the CAP and that it has hired outside experts to support the development of the quality systems in order to meet the FDA's requirements.
It said that in a separate meeting, senior Gambro officials and outside experts met with the FDA to discuss a new software version for Prisma under development to address the concerns raised by the FDA and further strengthen Prisma's Fluid Balance management system. The company said that it anticipates that the new Prisma software and associated training module will be released for “a gradual rollout“ this summer.
“The company continues to train and inform customers and intensive care nurses on the proper use of the Prisma System,“ it said in a statement.
It emphasized that caregivers must pay particular attention to the “Incorrect Weight Change Detected“ alarm on the system. This alarm should never be overridden without first identifying and removing the cause of the alarm, it said.
“Our goal is to ensure that Gambro products meet the highest standards for quality, safety and effectiveness,“ says Sören Mellstig, president and CEO of Gambro.
FDA to meet on dental amalgam devices
The FDA said a joint meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research will be held Sept. 6 and 7 from 8 a.m. to 5 p.m. at the Holiday Inn in Gaithersburg, Maryland.
The joint committee will review and discuss peer-reviewed scientific literature on dental amalgam devices and their potential mercury toxicity, specifically as it relates to neurotoxic effects. Dental amalgam, also called “encapsulated amalgam,“ consists of dental mercury and amalgam alloys.
The FDA said certain consumer groups have raised concerns about the effects of using mercury as a component of dental restorative materials.