FDA waives product registration for PPE amid pandemic

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    AMID a shortage in personal protective equipment (PPE), ventilators, and respirators, the Food and Drug Administration has waived the mandatory product registration/notification for manufacturers “who will only operate within the public health emergency period.”

    “Due to this pandemic, there has been a continuous rise in the number of hospitalized patients, which consequently resulted in the increase in the demand for PPE, ventilators, and respirators to manage severe cases of COVID-19,” the FDA said in Circular No. 2020-014.

    However, testing of the finished product to ensure the quality and safety “shall be done by the appropriate accredited laboratory by the Philippine Accreditation Bureau,” it also said.

    Manufacturers looking to pursue production of the medical devices after the pandemic are required to secure a license to operate.

    “Manufacturers, who intend to continue to produce PPE, ventilators, and respirators for commercial use shall apply for product notification registration within three months after the lifting of the State of Public Health Emergency throughout the Philippines,” said the FDA.

    Since the beginning of the coronavirus disease (COVID-19) outbreak in the country in January, medical facilities and hospitals have reported experiencing shortages in PPE, respirators, and ventilators as the number of patients surged.

    PPE USAGE GUIDELINES

    The Department of Health is set to come out with guidelines on the proper use of PPE sets, especially in medical facilities.

    In a press briefing last week, Health Secretary Francisco Duque III the guidelines will include which PPE sets should be used in clinics, triage areas, in contact tracing, handling suspected or confirmed cases, and in checkpoints.

    “We expect that through this system, we can have a more strategic use of our PPE while we ensure the safety of our healthcare workers amid the limited supply we have,” he said.

    Duque appealed anew to allow healthcare workers to use medical grade PPE sets, like N95 respirators. “If we are just in our barangays or communities, it is enough that we use cloth masks,” he said.

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