FDA seeks proper documentation surrounding Siemens molecular imaging scanners
FDA documents state that during an inspection by FDA investigators of a Siemens facility in Knoxville, Tenn., from July 16, 2007 through Aug. 7, 2007, it was discovered that certain molecular imaging diagnostic equipment device(s) were “adulterated within the meaning of Section 501(h).”
“After the inspection, the FDA suggested areas for improvement, including better documentation for product software design validation, an optimized process to investigate returned parts, or an improved handling process for customer complaints,” Siemens’ representative Tom Schaffner told Health Imaging News.
In response to the agency’s concerns, Ron Nolte, vice president of regulatory affairs and quality assurance, sent a letter to the FDA that the agency deemed “inadequate.”
The FDA addressed Nolte’s response in a Jan. 28 warning letter, stating:
1. Your firm failed to establish and maintain adequate procedures to control design validation, including software validation and risk analysis, where appropriate.
a. The agency said that “because you failed to follow your procedure, the acceptance criteria were not complete prior to the performance of validation activities. Specifically, for ECAT scanners introduced an error in the scan start time used in the decay correction algorithm. This error was most pronounced in the TTTT/EEEE mode.”
b. The “risk analysis is incomplete …for the hazard of linking PET/CT scans to the incorrect patient was performed after a June 2006 incident.”
2. Failure to establish and maintain adequate complaint procedures for receiving, reviewing and evaluating complaints.The company received at least four complaints concerning PET and CT scans linked to the wrong patient, according to the FDA letter.
Shaffner said that “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.”
The agency requested that Siemens respond with specific steps that the company will take to correct the violations, including a plan to prevent future violations, with a timetable for implementation of the corrections, within 15 working days of receiving the letter. Siemens said it received the letter on Jan. 29.
“Siemens is handling the situation with the highest priority and is cooperating fully to provide the FDA with any additional or supporting documentation that is needed. All customers have been continuously informed about any actions which have been taken by Siemens,” according to Shaffner.
This warning letter is the second the company has received in as many months. In December 2007, the company’s ultrasound division received a letter which questioned whether the marketing for several products went beyond the scope of their cleared indications.
The complete letter is posted at the FDA site: http://www.fda.gov/foi/warning_letters/s6655c.pdf