Updated: Nov 8, 2021
Recalls and expiry dates can turn a normal, safe medical device or product into a life-threatening implant.
But it doesn’t have to be this way, according to the founder and President of the healthtech company Xcelrate UDI, Joan Melendez.
Using the healthtech solutions available to us today, healthcare professionals can make the most of health data available to protect patients.
But how did the problem get so out of hand to begin with? In her latest article for The Healthcare Guys, Joan explains how ineffective communication threatens patient safety:
Recall notices from the FDA are outdated compared to modern alternatives, slowing down and rendering their communication methods ineffective.
The FDA’s medical device database relies on hand-typed entries from several groups of people to track adverse events, leading to inaccurate or missing data.
A notice on the FDA website notes that recall notices can be done using “telegrams, mailgrams, or first-class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: “medical device recall [or correction]”.
Worse than this, many breast implant adverse events were hidden from the public. Manufacturers are able to report adverse events using ”alternative summary reporting”, which allows thousands of adverse events to be hidden from the public, or even other healthcare workers.
Over 1 million incidents have been put into alternative summary reporting since 2016.
There are healthtech solutions that help bridge this gap in communication, but it’s down to healthcare providers to embrace them.
Joan talks about the introduction of a tracking barcode and how it can be used:
The Unique Device Identifier, introduced by the FDA to help track medical devices, isn’t help when it comes to breast implants. The number is stamped on the packaging rather than the implant itself. And when adverse event reporters are submitted, the UDI is often omitted.
Dedicated databases such as the National Breast Implant Registry may support the tracking of breast implants. Without automatic tracking and communication, and patient education, systems like this will likely remain incomplete.
“Healthtech systems can make the most of UDIs and ensure that the manufacturer, surgeon, and patient are all connected. There is no risk of missing or inaccurate information, and the onus is taken off of the patient as the systems will report issues in real-time.” Joan explained.
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