European Medical devices Reporting

2012 news | personal injury| clinical negligence | leighday

HOSPITAL: March 2007

10 questions on the medical device

The medical device is intended to prevent the occurrence of serious incidents involving medical devices, through preventive or corrective action.

"The medical device is intended to monitor incidents or potential incidents resulting from the use of medical devices as defined in Article L.5211-1 of the Code of public health, " says the article R.5212- 1 of the same code. These devices are equal to the consumable disposable or reusable, the passive or active implants, as well as equipment.

The medical device includes (Article L.5212-2 of the Code of Public Health - CSP):

- The reporting and recording of incidents or potential incidents;

- The registration, evaluation and use of this information for the purpose of prevention;

- The completion of all studies or work on the safe use of medical devices;

- The implementation and monitoring of corrective actions decided.

For these tasks to be fulfilled, medical devices listed is fixed by order of the Minister of Health, on the proposal of the Director General of the French Agency for the Safety of Health Products (AFSSAPS), must meet the traceability rules to "quickly identify patients for whom the medical devices were used a lot" and "lots from which the medical devices used in a patient" (Article R.5212-36 of the CSP) .

European directives called "technical harmonization" aimed at ensuring the free movement within the European Union, industrial products to meet strict safety requirements. The amended 90/385/EEC of 20 June 1990 on active implantable medical devices and 93/42/EEC of 14 June 1993 concerning medical devices European directives have been transposed into national law by law No. 94 - 43 of 18 January 1994 and No. 98-535 of 1 July 1998. The provisions of these two laws are codified in Articles L.5211-1 et seq of the CSP.

Incidents or potential incidents to be reported without delay defined in Article L.5212-2 of the CSP. They are particularly serious and are intended to implement because of a device which resulted or is likely to have led to "death or serious deterioration in the health of a patient, user or third ". Reporting is mandatory.

2011-03-01 13:00:06 by csipodunk

McAfee/Intel

Would this indicate that a virus is capable of invading a processor? Other related links at the bottom of the full cnet article.
March 1, 2011 6:18 AM PST
Intel completes McAfee acquisition
by Lance Whitney
Intel has completed its $7.68 billion acquisition of McAfee.
The completion of the deal, announced yesterday, follows approvals by the various boards of directors and stockholders, as well as reviews by the Federal Trade Commission, the European Commission, and other regulatory groups

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