Current Status of Standards and Unmet Needs in Retrieval Analysis

No matter the discipline, detailed analyses of components that functionally or mechanically fail (or both) are invaluable for improving future design iterations. However, for these evaluations to provide useful information to the parties involved, methodologies need to be clearly defined that are standardized and support interlaboratory implementation. In these regards, and with particular focus on implantable medical devices, ASTM F561-13, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids, does offer guidelines for these analyses; however, the level of detail provided for evaluation of the associated tissues and fluids far exceeds that provided for the retrieved medical device(s). To address the latter, this paper proposes the creation of an "Industry Reference Guide" to clearly define the specific damage modes for metals, polymers, and ceramics/glass utilized in medical devices in conjunction with a visual reference for damage scoring, which has been determined as an unmet need. Further, established qualitative and quantitative methodologies that should be considered for inclusion in the next revision of ASTM F561 are presented to address shortcomings of the existing standard. Although the proposals outlined in the following paragraphs may appear onerous, their intent is to promote interlaboratory comparison within the medical device industry through both education and the development of consensus based grading/scoring scales.