Medical devices and biomaterials pathology. Primary data for health care technology assessment.
Through the postmortem examination, pathologists offer the ultimate clinico-pathologic assessment of the efficacy of medical care. Similarly, pathologists can offer a clinico-pathologic assessment of the efficacy of health care technology. Assessment by pathologists has diagnostic authority because it draws on the resources of the laboratories of surgical and necropsy pathology. In this essay we argue for enhancing the accuracy of medical device and biomaterials technology assessment by systematically collecting pathology-oriented data. We recommend the establishment of a pathology-based medical device registry to assess implantable medical device technology by accumulating reports routinely issued by pathology departments throughout the country. We further suggest that establishment of a university-based, industry-supported Medical Device and Biomaterials Pathology Institute to operate the registry, collect recovered, used health care devices, and generate definitive, pathology-based, primary data for health care technology assessment.
D001344:Autopsy; D003625:Data Collection; D004868:Equipment Failure; D010336:Pathology; D011358:Product Surveillance, Postmarketing; D012042:Registries; D013673:Technology Assessment, Biomedical / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration