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Medical Devices and Biomaterials Parhology

Published online by Cambridge University Press:  10 March 2009

Nir Kossovsky  and
Ram Kossowsky
Nir Kossovsky
Affiliation:
UCLA Medical Center
Ram Kossowsky
Affiliation:
Pennsylvania State University
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Abstract

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 the 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 he lth care technology assessment

Type
General Essays
Information
International Journal of Technology Assessment in Health Care , Volume 4 , Issue 2 , April 1988 , pp. 319 - 323
Copyright
Copyright © Cambridge University Press 1988

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References

REFERENCES

Anderson, J. M., Barenberg, S., & Hiltner, A. Prosthetic valve wear products — embolization and systemic presentation. In Weinstein, A., Gibbons, D., Brown, S. & Ruff, W. (eds.), Implant retrievaLS Material and biological analysis, National Bureau of Standards Special Publication 601, Washington, DC: U.S. Government Printing Office, 1981, 283–298.Google Scholar
Benjamin, E., Ahmed, A.Rashid, A. T., & Wright, D. H.Silicone lymphadenopathy: A report of two cases, one with concommitant malignant lymphoma. Diagnostic Histopathology, 1982, 5, 133–141.Google Scholar
Bommer, J., Ritz, E., Waldher, R., & Gastner, M.Silicone gel inclusions causing miltiorgan foreign body reaction in dialyzed patients. Lancel, 1981, 1, 1314.CrossRefGoogle Scholar
Chastre, J., Basset, F., Vlav, F., Cournovo, P., Bouchama, A., Akesbi, A., & Gilbert, C.Acute pneumonitis after subcutaneous injections of silicone in transsexual men. New England Journal of Medicine, 1983, 308, 764–767.CrossRefGoogle ScholarPubMed
Christie, H. A., Weinberger, K. A., & Dietrich, M.Silicone lymphadenopathy and synovitis: Complications of silicone elastomer finger joint prostheses. Journal of the American Medical Association, 1977, 237, 1463–1464.CrossRefGoogle ScholarPubMed
College of American Pathologists Foundation Dearborn II Conference. The practice of pathology into the 21st century: Conference recommendations. Archives of Pathology and Laboratory Medicine, 1986, 110, 304–305.Google Scholar
Corrin, B.Silicone lymphadenopathy. Journal of Clinical Pathology, 1982, 35, 901–902.CrossRefGoogle ScholarPubMed
Darling, J. R., Weiss, N. S., Metch, B. J. et al. , Primary tubal infertility in relation to the use of an intrauterine device. New England Journal of Medicine, 1985, 312, 937–941.CrossRefGoogle Scholar
Digby, J. M.Malignant lymphoma with intranodal silicone rubber particles following metacarpal phalangeal joint replacements. Hand, 1982, 14, 326–328.CrossRefGoogle Scholar
Dujovny, M., Loubeau, J. M., Kossovsky, N., Kossowsky, R., & Dixon, R. R.Brener shunt failure in carotid endarterectomy. Vascular Surgery, 1980, 14, 291–297.CrossRefGoogle Scholar
Fishbein, M. C., Levy, R. J., Ferrans, V. J. et al. , Calcification of cardiac valve bioprostheses: Biomechanical, histologic, and ultrastructural observations in a subcutaneous implantation model system. Journal of Thoracic and Cardiovascular Surgery, 1982, 83, 602–609.CrossRefGoogle Scholar
Goffin, Y. A., Gruys, E., Sorensen, G. D., & Wellens, F.Amyloid deposits in bioprosthetic cardiac valves after long-term implantation in man: A new localization of amyloidosis. American Journal of Pathology, 1984, 114, 431–442.Google Scholar
Goldman, L.Diagnostic advances versus the value of the autopsy: 1912—1980. Archives of Pathology and Laboratory Medicine, 1984, 108, 501–505.Google Scholar
Goldman, L., Sayson, R., Robbins, S., Cohn, L. H., Bettmann, M., & Weisberg, M.The value of the autopsy in three medical eras. New England Journal of Medicine, 1983, 103, 1000–1007.CrossRefGoogle Scholar
Gordon, M., & Bullough, P. G.Synovial and osseous inflammation in failed silicone-rubber prostheses. Journal of Bone and Joint Surgery, 1982, 64, 574–580.CrossRefGoogle ScholarPubMed
Hyman, W. A.An evaluation of recent medical device recalls. Medical Device and Diagnostic Industry, 1984, 34.Google Scholar
Kaufman, D. W., Watson, J., Rosenberg, L., Helmrich, S. P., Miller, D. R., Mietinnen, O. S., Stolley, P. D., & Shapiro, S.The effect of different types of intrauterine devices on the risk of pelvic inflammatory disease. Journal of the American Medical Association, 1983, 250, 759–762.CrossRefGoogle ScholarPubMed
Kircher, T.Silicone lymphadenopathy: A complication of silicone elastomer finger joint prostheses. Human Pathology, 1980, 11, 240–244.CrossRefGoogle ScholarPubMed
Kossovsky, N., Dujovny, M., & Kossowsky, R.Reporting the failure of medical devices. New England Journal of Medicine, 1985, 312, 447.Google ScholarPubMed
Kossowsky, R., Dujovny, M., Kossovsky, N., & Keravel, Y.Failure of a Heifetz aneurysm clip. Journal of Neurosurgery, 1982, 57, 233–239.CrossRefGoogle ScholarPubMed
Kossovsky, N., Heggers, J. P., Dujovny, M., Diaz, F., & Ausman, J. I.Ventricular shunt failure: Evidence of immunological sensitization. Surgical Forum, 1983, 34, 527–529.Google Scholar
Kossovsky, N., Heggers, J. P., Parsons, R. W., & Robson, M. C.Analysis of the surface morphology of recovered silicone mammary prostheses. Plastic and Reconstructive Surgery, 1983, 71, 795–802.CrossRefGoogle ScholarPubMed
Kossovsky, N., Kossowsky, R., & Dujovny, M.Artificial hearts, fractured valves, and other problems with medical devices. Journal of the American MedicalAssociation, 1985, 254,3307–3308.CrossRefGoogle ScholarPubMed
Kossowsky, R., Kossovsky, N., & Dujovny, M.Risk management: The role of the medical device autopsy. Medical Device & Diagnostic Industry, 1985, 7, 33–39.Google Scholar
Kossovsky, N., Stelzer, P., & Kossowsky, R.Complications of permanent cardiac pacemakers. New England Journal of Medicine, 1985, 313, 1086.Google Scholar
Leong, A. S. Y., Dioney, A. P. S., Gobe, D. W.Spallation and migration of silicone from blood pumping tubing in patients on hemodialysis. New England Journal of Medicine, 1982,306, 135–140.CrossRefGoogle Scholar
Matos, M. H., Amstutz, H. C., & Machieder, H. I.Ischemia of the lower extremity after total hip replacement: Report of four cases. Journal of Bone and Joint Surgery, 1979, 61-A,24–27.CrossRefGoogle Scholar
Medical Device Bulletin. Center for Devices and Radiological Health, 1986, 4, 2–3.Google Scholar
Mikuz, G., Hoinkes, G., Propst, A., & Wilflingseder, P.Silicone lymphadenopathy following augmentation mammoplasty. Chirurgia Plaslica, 1982, 6, 209–214.CrossRefGoogle Scholar
Morgagni, G. B.Quoted in H. Meessen, Die pathologische anatomie und die biologische zukunft des menschen. Verh. Dtsch. Ges. Pathol., 1970, 54, 28–32.Google Scholar
Moses, L. E.Data acquisition for assessment of medical technology: Methods other than technical trials. International Journal of Technology Assessment in Health Care, 1986, 2,27–38.CrossRefGoogle ScholarPubMed
Parfrey, P. S., O'Driscoll, J. B., & Paradinas, F. J.Refractile material in the liver of hemodialysis patients. Lancet, 1981, 1, 1101–1102.CrossRefGoogle Scholar
Perry, S.Technology assessment: Continuing uncertainty. New England Journal of Medicine, 1986, 314, 240–243.CrossRefGoogle ScholarPubMed
Roberts, W. C., & Morrow, A. G.Causes of death and other anatomic observations after cardiac valve replacement. Advances in Cardiology, 1972, 7, 226–247.CrossRefGoogle Scholar
Travis, W. D., Balogh, K., & Wolf, B. C.Abstract—Silicone related pathology: A review. American Journal of Clinical Pathology, 1984, 81, 806.Google Scholar