The Healthcare Guys. Healthtech systems can stop breast implants from harming patients, says Joan Melendez

Breast implants have the capacity to kill. This problem isn’t new -- but the solutions are. It’s all about awareness and adoption.

Our Founder and President, Joan Melendez, recently published an article in The Healthcare Guys on the Allergan breast implant debacle, and how thousands of women’s’ lives have been affected.

Allergan’s recently recalled textured breast implants have threatened tens of thousands of women’s health.

But Joan commented on how recall notices can sometimes be ineffective in her recent Healthcare Guys article:

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.

So, what’s the solution? This has to be a collaborative effort between healthcare facilities, the FDA and even patients -- and manual data management is no longer an option. Joan explains: 

The Unique Device Identifier, introduced by the FDA to help track medical devices, isn’t helpful 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.

Does your healthcare facility struggle with medical recalls? Xcelrate UDI’s healthtech system may be the right solution for you.

Contact us to learn more about how our barcode scanning solution could help you save lives.