Product Liability and Innovation Managing Risk in an Uncertain Environment (1994) / Chapter Skim
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Medical Devices, Component Materials, and Product Liability
Medical Devices, Component Materials, and Product Liability
Pages 54-61
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From page 54... ...
These devices significantly complemented the medical armamentarium that was at that time limited to pharmaceutical preparations, surgical intervention largely based on excision of diseased tissue and expendable organs, and perhaps most successful of all, "tincture of time." In the 1950s, medical devices such as large-diameter vascular grafts for the first time permitted surgeons to replace body parts that had become defective. The year 1958 saw the implantation of the first electronic device, the cardiac pacemaker.
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From page 55... ...
It must also withstand the abrasive action of blood and the wiping action of the heart valve through which most leads pass while still serving its primary role as a stable conduit for electrical signals passing to and from the heart. As another illustration, a prosthetic mechanical heart valve is expected to function flawlessly for the patient's lifetime while being subjected to wear forces and large pressure-induced forces as it opens and closes (Figure 2~.
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From page 56... ...
Stimulation pulses move along the lead, through the electrode at its far end to cause the heart to contract. In a similar manner, signals produced by the heart travel through the lead/electrode to appropriately alter the pacemaker's operation.
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From page 57... ...
A rigorous but responsive and responsible regulatory process helps to ensure that new medical technologies represent the state of the art, have the real potential to do good as demonstrated in scientifically grounded studies, and reach patients promptly. IMPORTANCE OF MEDICAL DEVICES The impact of medical devices has been profound and far reaching.
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From page 58... ...
Yet, a key manufacturer of the fibers notified the heart valve industry in 1993 that it will discourage future use of its material in permanently implantable products. The company had concluded that selling raw material could not be justified in light of the business risk of litigation from merely having their raw material in permanent implants.
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From page 59... ...
The medical device industry has seen a growing list of highly reputable material supply companies such as Dow Chemical, Dow-Corning, and DuPont announce their intention to restrict sales to implant manufacturers. These companies have sharply reassessed the extent and manner in which they participate in medical devices.
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From page 60... ...
2. The medical device industry has an obligation to produce high quality products, track their performance, conduct research to expand understanding of underlying mechanisms of action, and invest in initiatives that build on knowledge gained to produce evolutions of improved products.
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From page 61... ...
4. Component and raw material suppliers should be shielded by law from medical device product liability actions for FDA-approved products if readily available "off-the-shelf" materials meeting specifications are incorporated into implantable products that undergo FDA approval.
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