Lack of Testing of Medical Devices Presents Unneed Risks

If you are one who has ever had the need of a medical device, you should be aware of the negative publicity circulating in recent months of problems which exist. Many have been recalled because of life-threatening situations, and earlier this year the FDA announced it would be revising its approval process. Many of these devices were approved without human testing, which is now required on newer devices.
Thousands of deaths and serious medical problems occurred from those devices which were recalled, including brain shunts, and pumps which administer cancer drugs, as well as external heart defibrillators. More than 23,000 reports of malfunction of these external defibrillators have been reported, many of which malfunctioned during life threatening situations.
The changes being considered by FDA mostly affect design and manufacturing flaws. External defibrillators are found in public places like schools, shopping centers and airports. The changes do not apply to implantable defibrillators which are similar to implanted pacemakers.
This is one more example of drug manufacturers’ failure to fully test their drugs and products before submitting them for approval to be offered to the public. It causes unnecessary delays in getting vitally needed drugs and devices to patients, and wastes the time of those who must protect the public from poorly tested products.

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