FDA chalks out new measures to scrutinize safety and efficiency of medical gadgets that are implanted in the bodies of patients needing them.
The Food and Drug Administration of U.S has chalked out a seemingly fool proof plan that will ensure stringent standards of safety and efficiency of medical gadgets that are used as implants in the bodies of millions of patients requiring them for various medical reasons.
The several medical devices available in the market today in the U.S accounts for a whopping $ 80 billion annually generating phenomenal profits for big firms such as Medtronic, Johnson & Johnson, Boston Scientific. Unlike medicines which are tried and tested through rigid series of clinical tests before they are introduced into the general market, gadgets are scrutinized for flaws attributed to defects in design or manufacturing defects of individual units, more often after they are introduced into the market.The FDA now intends to revamp this system by insisting on having encoded script for identification on every piece of gadget manufactured by a firm to scrutinize and detect malfunctions and side effects that could be caused by the device. They also plan to revamp computer databases where complaints and problems faced by clients are registered and submission of complaints of defects on paper will be completely reverted to digital processing and expand present real time based data base which collects information from several hundreds of hospitals that would hopefully track safety problems faster using more trained professionals.
The FDA has reported that they also plan to revolutionize their communication systems with each other and with the general public.
The proposed changes come after debates over the past one year following the recall of many such gadgets primarily related to cardiac diseases of the heart such as cardiac stents which prevent major blood vessels from collapsing, and implantable defibrillators that prevent those with weak hearts from dying.
These proposed changes have of course its share of criticism with many experts frowning down on these revamp plans as they say that these plans does not really address the risk and they add that without involving a large number of patients to volunteer for controlled experiments which itself is too risky.
Source-Medindia
MST
