Difference between revisions of "Resource:E1f32efa-98f0-4036-857b-441c15bb39da"
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{{Resource | {{Resource | ||
|Resource Type=Cases | |Resource Type=Cases | ||
| − | |Title= | + | |Title=Unlicensed usage of medical devices on patients: a case of accusations |
| − | |Is About= | + | |Is About=The case is about a factual controversy that surrounded the experimental usage of a heart valve device called a Myxo ring. A doctor accused the inventor of the device of using the Myxo ring on patients with surgical needs without informing them the device is not licensed. The university refused the accusations arguing that the ring is FDA approved. Some conflict of interests issues are also discussed. |
| − | |Important Because= | + | |Important Because=The development of innovative materials and devices for better treatment and health care are significant goals of medicine. New materials and devices must be tested on patients in a professional infrastructure, in controlled settings while properly following the ethical and legal regulation on clinical trials on medical devices. Informed consent and independent REC approval are necessary conditions. |
| − | |Important For= | + | |Important For=Research Ethics Committees; health care professionals; medical researchers |
}} | }} | ||
{{Link | {{Link | ||
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}} | }} | ||
{{Related To | {{Related To | ||
| − | |Related To Theme=Theme:D44fd22a-ed5d-4120-a78b-8881747131fd | + | |Related To Theme=Theme:D44fd22a-ed5d-4120-a78b-8881747131fd;Theme:6d71bd59-c3bc-4cd5-9c9f-1ab4e53fc320;Theme:0d054575-ca21-4209-b7c5-6120fc0ed647 |
}} | }} | ||
{{Tags | {{Tags | ||
| − | |||
|Has Timepoint=7-6-2011 | |Has Timepoint=7-6-2011 | ||
|Has Location=USA; United States | |Has Location=USA; United States | ||
|Has Virtue And Value=Respect; Honesty | |Has Virtue And Value=Respect; Honesty | ||
|Has Good Practice And Misconduct=Ethical approval by necessary body; Conflict of interest; Informed consent | |Has Good Practice And Misconduct=Ethical approval by necessary body; Conflict of interest; Informed consent | ||
| − | |Related To Research Area=Basic medicine | + | |Related To Research Area=Basic medicine; LS 04.07 - Cardiovascular diseases; LS 07.01 - Medical engineering and technology |
}} | }} | ||
Latest revision as of 18:29, 25 October 2020
ResourcesCases
Unlicensed usage of medical devices on patients: a case of accusations
What is this about?
The case is about a factual controversy that surrounded the experimental usage of a heart valve device called a Myxo ring. A doctor accused the inventor of the device of using the Myxo ring on patients with surgical needs without informing them the device is not licensed. The university refused the accusations arguing that the ring is FDA approved. Some conflict of interests issues are also discussed.
Why is this important?
The development of innovative materials and devices for better treatment and health care are significant goals of medicine. New materials and devices must be tested on patients in a professional infrastructure, in controlled settings while properly following the ethical and legal regulation on clinical trials on medical devices. Informed consent and independent REC approval are necessary conditions.
