The Interrelationship Between Industry/Medical/Patient in the Analysis of Failures in Orthopaedic Implants

摘要

The interdisciplinary involving Biomedical Engineering, especially in orthopaedic devices requires better communication between the related areas. This is an action that is essential for the identification, tracking and improved information management, relating to failures that can affect these devices. This study searched to understand the relationship of the main details in the related axis in this market: industry-medical/health institution-patient, to obtain data capable of guiding the country's situation regarding the development of orthopaedic implants and their surgical practice. Post-installation monitoring was also analyzed to predict the device's performance and impact on patients' quality of life. There was a disagreement of judgment on the nature of failures, and many surgeons said the devices fail because of problems inherent to the patient. Other said that failures occur mainly because of wear. Most patients have argued that the problems are more related to unsuitable surgical procedure. The companies associated the failures with improper surgical procedures, as well as the physician's lack of instruction to the patient about the limitations imposed by the device. The absence of a cooperative relationship between the related axis make it difficult to understand casuistry of failures, as well as obtaining data regarding these occurrences. This fact can reverse both the research advances in Biomedical Engineering and the search for better preventive practices in the development of high performance biomaterials for implants and prosthetic devices.