Inadequate Warnings on Medical Device Packaging Allegedly Lead to Patient Injury

Case Overview

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.

Questions to the Medical Device expert and their responses

Please describe your experience with material labeling for bio-medical implants.

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.

What are the labeling standards for medical devices with regards to information on the materials of the device?

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).

Are there any standards in place indicating a device contains materials known to cause allergic reactions? if so what they might be?

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.

About the expert

This expert has extensive experience in the medical device field, specifically in cardiovascular devicing. She earned her BS, MS and PhD in Materials Science Engineering from the University of Washington and the University of California, San Diego respectively. She went on to work with NASA's JPL Laboratories on electrical thermal point concentrations and has since been published a handful of times. Prior to her current positions, she worked her way up at Medtronic from Junior, Senior and eventually Principle Research and Development Cardiac Rhythm Device Engineer. Currently, she works as a medical device product development engineer for a private engineering company and is an Adjunct Associate Professor of Biomedical Engineering at a university in an Arkansas where she also holds an advisory seat.

E-143022

Specialties:

Medical Device