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Govt Floats Draft Orders for Quality Control of Diagnostic Electrical Medical Devices

Central government has floated draft orders to chart out quality control rules for diagnostic electrical medical equipment like automated blood pressure monitors, thermometers and like. Separate orders for electrical medical equipment, Sphygmomanometers (used to measure blood pressure), clinical electrical thermometers, blood glucose monitoring systems for self-testing diabetes, gloves and surgical blades, have been floated. Electrical medical equipment includes cardiac defibrillators, infant radiant warmers, multi-functional patient monitoring equipment and pulse oximeters (used to measure level of oxygen in a patient’s body). A draft order has also been floated to regulate the quality of disposable and non-disposable surgical as well as rubber and polyvinyl chloride gloves as also surgical blades. The aforesaid equipment will have to bear the standard mark under a license from the Bureau of Indian Standards (BIS). The same may not apply to products meant for export, and that they will have to conform to specifications required by the foreign buyer, the order clarifies. BIS will be the certifying and enforcing authority along with a district-level officer in the respective state’s Department of Industries for making sure that the equipment manufacturers and those who market it, comply with the orders. The Department of Pharmaceuticals has invited comments from all stakeholders on how to better regulate the equipment. The Ministry has requested that comments be sent by April 15 on the proposed draft order which is called the Medical Devices – Medical Electrical Equipment (Quality Control) Order. – The Hindu BusinessLine