Journal of long-term effects of medical implants
-
Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U. S. ⋯ In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.
-
There is no doubt about the need for tort reform. The current state of the legal system imposes great costs on the U. S. health care system and society in general-an astounding $865 billion each year. ⋯ Regulation of expert testimony by medical societies would curb false or biased testimony. Other recommendations to improve the tort system include establishing expert health courts similar to those that currently exist for tax and patent law, using mediation, creating patient compensation funds, making acknowledgment of errors inadmissible in court, providing certificates of merit or pretrial screening panels to confirm the validity of lawsuits, and developing treatment contracts. Clearly some action must be taken to amend our current wasteful tort system.
-
J Long Term Eff Med Implants · Jan 2007
ReviewBiomedical engineers and participation in judicial executions: capital punishment as a technical problem.
This paper discusses the topic of judicial execution from the perspective of the intersection of the technological issues and the professional ethics issues. Although physicians are generally ethically forbidden from any involvement in the judicial execution process, this does not appear to be the case for engineering professionals. This creates an interesting but controversial opportunity for the engineering community (especially biomedical engineers) to improve the humaneness and reliability of the judicial execution process.
-
J Long Term Eff Med Implants · Jan 2007
Posterior lumbar interbody fusion versus circumferential fusion using the B-Twin expandable spinal system.
We reviewed the medical files of 32 patients with degenerative disc disease, spinal stenosis, and spondylolisthesis who underwent posterior lumbar interbody fusion using the B-Twin system. In 12 of these patients, posterior lumbar interbody fusion has been supplemented with posterior lumbar-instrumented fusion (circumferential fusion) because of spinal instability. Clinical and functional outcomes were assessed. ⋯ However, in comparing the two groups there was no statistical significant difference. The B-Twin system is safe and effective for the management of degenerative disc disease as a stand-alone device. The combination with posterior lumbar-instrumented fusion systems for circumferential fusion yields statistically significant differences in fusion rate and functional outcome.
-
J Long Term Eff Med Implants · Jan 2007
Randomized Controlled TrialSegmental kinematics and adjacent level degeneration following disc replacement versus fusion: RCT with three years of follow-up.
Prospective, randomized and controlled clinical and radiological study. ⋯ The range of motion of the treated segment with prosthesis remained unchanged 3 years after surgery in comparison to the 1-year result. The prosthesis shows a significant segmental motion in contrast to the fusion group at each RSA examination time (p < 0.05). After both procedures, a significant pain reduction in neck and arm was observed, without significant differences between both groups. During the course of the 3 years follow-up, no patients of the prosthesis group required further surgical intervention.