Dated January 29, the letter describes what the agency calls documentation and procedural inaccuracies that were found during a site inspection in Knoxville, TN, in July and August of 2007, particularly for the company's ECAT scanners. The problems introduced an error in the scan start time used in the decay correction algorithm, and was most pronounced in the TTTT/EEEE mode, according to the FDA.
After the inspection, the FDA suggested areas of improvement, to which Malvern, PA-based Siemens responded in written form. But the FDA found the company's response to be inadequate, and the warning letter is the agency's further communication on that score.
The letter states that Siemens failed to establish and maintain adequate procedures to control design validation, including software validation and risk analysis; that the company's risk analysis was incomplete, particularly for the hazard of linking PET/CT scans to the incorrect patient; and that Siemens failed to establish and maintain protocols for correcting the errors and avoiding them in the future.
The FDA asked Siemens to accomplish certain steps to correct the errors, such as creating a plan to prevent future violations and a time frame for making the corrections. The agency expects this response within 15 working days of Siemens' receipt of the letter.
A Siemens spokesperson said the company is working to comply with the requests in the letter.
"Siemens formally responded to the FDA to inform them of corrective actions to address the issues," said Tom Schaffner, Siemens Medical Solutions manager of media relations, in an e-mail to AuntMinnie.com. "Most of these actions have already occurred, and some necessary software updates are currently being tested that will be applied as soon as possible. With its warning letter, the FDA is now requesting detailed documentation of these corrective actions."
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