Global medical technology company Gambro has had imports of its kidney dialysis monitors into the US blocked by the US Food and Drug Administration (FDA) after a failed plant inspection in September.
The ban relates to Gambro's renal monitor products - Prisma, Prismaflex and Phoenix.
The >FDA sent the company a warning letter last week reflecting it's continued concerns about the adequacy and effectiveness of >Gambro's quality systems, in particular its complaint handling and other reporting systems, at its manufacturing facility in Medolla, Italy.
No further details on the specific manufacturing concerns were made available by the company or the FDA at this stage.
In addition to the issues with the manufacturing facility, the FDA has also raised particular concerns about the safety of the Prisma System, or the safety of the way in which it is currently being used by medical staff.
The Prisma system is a kidney haemodialysis system specially designed to perform the complete range of continuous renal replacement therapy (CRRT) for critically ill patients in the intensive care unit.
Because it is used in an intensive care setting, the warning alarms on the machine must have an override feature. However, there have been numerous incidences occurring where the overriding of a particular alarm on the Prisma System has led to serious injury or death of patients, Gambro spokeswoman Paula Treutiger told www.In-PharmaTechnologist.com.
"There are no faults with the machines themselves and the devices remain appropriate for use when directions are followed. The FDA has concerns about the security of the system, and we are now making sure that it is used correctly," she said.
Treutiger said that the company was aware of the issues surrounding the alarm and had already begun to address the FDA's concerns prior to the inspection by the agency of the Italian plant in September.
In August 2005, Gambro issued a Safety Alert and a Field Corrective Action related to Prisma that included an addendum to the operator's manual, warning label for the machine, and additional training and training materials for customers and intensive care nurses working with the device to ensure proper use of this life-saving treatment, said a company statement.
However, since the US import ban and the issuing of the warning letter this week, the company now plans to run additional training programmes throughout the US for staff who use the Prisma system, beginning at the end of January.
Although the Prisma system is sold globally, the company has no plans to run these additional training programmes outside the US, said Treutiger.
The company has 15 days to develop an action program and respond to the warning letter, issued last Monday, however, it does not know how long it will take to resolve the FDA's concerns and resume importation of the products into the US.
"Gambro takes the FDA's concerns very seriously," said Jon Risfelt, president Gambro Renal Products.
"Our first priority is patient health and safety, and we will continue to cooperate with the FDA to fully and promptly address all issues and ensure that critically ill patients continue to receive the life-saving treatments they depend on," he said.