dijous, 20 de setembre del 2018

FDA: Hurricane Florence should not affect medtech supply chain

FDA 3D printing

Though destructive, the effects of Hurricane Florence on the Eastern US are not currently affecting medical supply chains in the region, according to a post from FDA head Dr. Scott Gottlieb.

The federal watchdog said it is actively engaged in monitoring firms that manufacture “critically important medical products” and is closely coordinating with them to prevent any potential shortage issues.

“Flooding associated with a hurricane’s impact can be devastating. I am extremely proud of the many FDA employees who have already deployed to help North and South Carolina begin their recovery as quickly as possible. These men and women are also supported by hundreds of other FDA employees who are working diligently to do all they can to help support the hurricane response and recovery, whether it is helping keep consumers safe by providing advice on food safety and insulin storage, or helping farmers, pharmacies, manufacturers and the retail food sector recover and return to business. As part of our efforts to help prevent any medical product shortages as a result of Hurricane Florence’s impact, our team has been in ongoing, close contact with approximately 30 firms that manufacture critically important medical drugs. Fortunately, at this time, we do not anticipate any critical shortages of medical products, but we recognize we are not out of the clear and there continues to be threats of rapid flooding. If needed, we will not hesitate to tap into any of the measures available to us to help mitigate potential shortages. We are committed to working with states and other partners to assess the storm’s impacts over the coming weeks and take all steps possible to ensure the safety of the products we regulate, including medicines, medical devices, food, and the blood supply,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The agency also provided resources to pharmacies to check for possible contamination of medical devices. In its instructions to pharmacy owners and its own inspectors, the FDA warned that potentially damaged devices could post potential safety risks, and suggested discarding any significantly damaged items.

Included in the list of equipment which is sensitive to water damage were electronic devices including blood pressure measurement devices, glucose meters and digital thermometers.

The federal watchdog advised that owners and inspectors check all refrigerated products, including reagents, sterilants and disinfectants, to make sure they did not reach a temperature that could cause them to perform unreliably.

The agency also suggested that any water damaged test kits, supplies and simple products, including condoms, contact lenses, pregnancy tests and glucose meters, be discarded if wet or shows signs of having been wet.

The post FDA: Hurricane Florence should not affect medtech supply chain appeared first on MassDevice.



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