6 Things You Need To Know About Medical Device Recalls
FOR IMMEDIATE RELEASE
August 17, 2020
6 Things You Need To Know About Medical Device Recalls
“Unless they’re using our solution, health providers are almost all reactive, not proactive -- and that’s putting patients at risk,” says Xcelrate UDI’s President
SEATTLE, USA - As hospitals and health facilities in the USA and globally try to cope with exploding demand on resources from COVID, an old problem is now in the spotlight: recalls that come too late to help front-line doctors, nurses and patients.
It’s not just protective equipment and hand sanitizer getting recalled because it is poor quality, counterfeit, expired, etc. Many of the sophisticated implants meant to prolong life can cause infection or even death in patients.
“Unfortunately, the U.S. Food & Drug Administration (FDA)’s activities don’t automatically translate into protection for patients unless health providers are proactive,” says Xcelrate UDI President Joan Melendez. “In recent years, we’ve seen millions injured, over 80,000 deaths and economic damage from this. The tragedy is that it is largely preventable.
“Already, more than 450 health facilities in the USA are using Xcelrate UDI to use innovative UDI (unique device identifier) barcode scanning technology to bridge the information gaps between data sources (provided by manufacturers and the FDA) for medical devices and physical supplies,” she explained.
There are many reasons why medical device recalls remain a big problem at many health facilities, worldwide -- and Xcelrate UDI helps them deal with these problems.
Medical device recalls from manufacturers are a growing problem. The FDA shows 48 medical device recalls in 2019. That compares negatively to just 32 medical device recalls in each of the previous two years.
Counterfeit medical devices are a global problem, not limited to developing countries. The World Health Organization estimates that 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
Every implant has an expiry date. That includes everything from pacemakers to titanium knee replacements and silicone breast.
Quality is job 1? When it comes to medical devices design, maybe not. Device design was the most common cause of FDA-determined recalls in recent years.
One of the biggest reasons for recalls is that in 99 percent of cases, medical devices never have to provide clinical data in the first place (The FDA requires the “least burdensome route” to approval). The recall often comes after faulty devices have already hurt patient outcomes.
In the USA, the FDA adds data from 9 different recall lists, which do not share the same information. Xcelrate UDI deals with this problem by always having the most up-to-date information from both the FDA and the manufacturer.
“I’m proud to say that Xcelrate UDI helps health providers deal proactively with all of these issues,” Melendez says. “A quick scan and an innovative process goes a long way to helping ensure patients are not being implanted with expired, counterfeit or recalled medical devices.”
Xcelrate UDI scans all barcodes at the point of care to quickly identify, log and prevent unsafe items (i.e. expired, recalled, counterfeit) from being implanted by presenting visual and audible warnings on the workstation screen and a physical vibration within the handheld scanner. This enables a safe item to be selected for implant.
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ABOUT XCELRATE UDI
Xcelrate UDI is a healthcare technology and consulting services company that leverages the power of UDI (unique device identifier) barcode scanning technology to bridge the information gaps between data sources (provided by manufacturers and the FDA) for medical devices and physical supplies. We focus on device traceability and improving patient safety. Our vision is to be the industry’s most trust partner in advancing UDI adoption to improve compliance with medical devices and reduce patient risk at the point of care.
MEDIA CONTACT
Jonathon Narvey
Mind Meld PR Inc.
jonathon.narvey@mindmeldpr.com
(604)230.2638
