This case involves a hip implant with package labeling that failed to disclose that it contained a number of cobalt components. The man had undergone surgery to implant the hip, which proceeded without incident. However, shortly after the surgery the patient began to experience a range of unpleasant symptoms associated with the implant, which were eventually determined to be due to the presence of cobalt in the implant. doctors were aware of the fact that the man had a cobalt allergy at the outset of the procedure, but claimed that the packaging for the hip implant used in his surgery did not indicate the presence of the metal.
Question(s) For Expert Witness
- 1. Please describe your experience with material labeling for bio-medical implants.
- 2. What are the labeling standards for medical devices with regards to information on the materials of the device?
- 3. Are there any standards in place indicating a device contains materials known to cause allergic reactions? if so what they might be?
Expert Witness Response E-143022
My background is in materials testing and device testing with class III implant devices. I have recent experience as a lead engineer within R&D for technical content and test strategy for labeling & packaging of class III cardiovascular devices. Labeling and packaging requirements are largely determined by the R&D engineering teams during the risk analysis requirements of the product development life cycle. The risk analysis and R&D evaluations helps determine what are the appropriate requirements and of what must be included in the packaging, labeling, and Instructions For Use (IFUs) portions. In addition the R&D test results for device functionality and shelf life (which includes materials testing in storage, chemicals, leachables from metals and/or polymers over a period of claimed shelf life of the product). Because the FDA cannot possibly know the details of all materials of class III implantable devices; there are guidelines and appropriate ISO standards that must be followed. However, ISO standards are simply guidelines by FDA. The FDA expects the R&D team to determine appropriate risk levels, testing, and labeling based on product bench testing results and results from clinical evaluations.