PPE (Personal Protective Equipment) went from an obscure medical abbreviation to one of the most popular words and products of 2020.
The more supply and demand there was, the more data was needed. But this mismanaged situation led to patients and healthcare staff being put at risk.
Healthtech Founder and President Joan Melendez, spoke to healthline about how this protective equipment ultimately became a problem:
The FDA has dropped the ball, said Joan Melendez, founder and president of Xcelrate UDI, a health tech startup that’s primary interest is keeping patients and healthcare workers safe from faulty medical devices, biologics, and equipment.
Melendez described Xcelrate UDI as a “medical device barcode scanning solution” that goes beyond compliance to improve patient and healthcare worker safety before use and at the point of care.
Another big reason why there are so many problems with poor-quality PPE, she told Healthline, is that the FDA has failed to properly report when a manufacturer has products recalled or has been removed as a seller, or has a product that’s failed to meet criteria under emergency use authorization laws.
“There are more than a dozen databases on the FDA’s website for medical device recalls alone,” Melendez said. “The FDA website is a mess. The right hand doesn’t know what the left hand is doing, leaving manufacturers, distributors, and providers to rely on data that is inaccurate or old. How can you ‘do no harm’?”
Melendez said corruption in the PPE industry is still rampant in part because hospitals are forced to buy from unknown distributors due to shortages.
Without proper identification or vetting as a result of an emergency use authorization, inferior products get through, she said.
“Did you know that 60 to 70 percent of the PPE brought in through [emergency use authorization] is ineffective?” Melendez said.
“This puts our healthcare workers at greater risk. They assume they are protected using a N95, when it’s basically no more effective than a surgical mask, which in my opinion is less effective than a tissue,” she said.
Using Xcelrate UDI’s database, healthcare facilities can quickly find out whether or not the PPE and other medical products they receive are recalled, damaged or counterfeit. It’s a much needed piece of technology that’s rapidly improving patient safety.
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