FDA- Last Friday, the US Food and Drug Administration imposed the much awaited rule to all medical companies, to include unique device identifiers (UDI) to their medical production that serves as a code that will trace details about the product.
The rule hopes to track the companies who keep on manufacturing sub-standard medical materials, as this is a threat to the health. Like for example, the product that contains too much lead may cause brain damage.
FDA Director Dr. Jeffrey Shuren stated that the said law will help them gain more information on how to properly use medical equipments, and to hunt medical groups who do not abide to the FDA standards. He added that UDI will be added to their data base system so that people can easily access for awareness.
FDA is determined to enforce the rule first to the medical devices such as pacemakers, defibrillators, heart pumps, and artificial joints, all of which are known to carry greater health risk and injuries if not working well.
The newly imposed rule created positive reactions in medical institutions, such as Pew Charitable Trust (PCT). Josh Rising, Director of PCT said that this step will improve safety standards among patients, and pull them out from the possibilities of physical harm that may lead to irreversible health complication and even death.
To fully enjoy the benefits the new coding system, FDA recommend the rule to be exercise on hospitals, health care insurances, health care related bills, physician's professional fee and other health transactions.
Due to the complexity of the said rule, FDA removed some of the demands such as requiring the drug companies to implant UDI codes on their medical product before releasing it to the market.
Also due to the medical industry's concern about the new coding system, FDA also removed the part in which individual used product such as bandages need not to put codes, hence only packages are now included to apply the said rule.
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