While one of the main focuses of the FDA is making sure that healthcare providers and patients have the most complete information about medical devices, the agency is not always effective in rapidly disseminating this information. In some cases, affected individuals have to closely monitor the internet and other information sources to learn crucial information safety information, including alerts about product recalls. Oftentimes, learning key information quickly can be a matter of life or death for patients who rely on these medical devices to preserve their health and keep them alive. However, the FDA does not have the apparatus necessary to push this information out instantaneously. In order to more quickly disseminate medical device recall information to those who need it, a private company has launched an app that aims to improve the way that these key alerts are distributed.
The USDA has had an app to alert consumers about food recalls in place for several years. As soon as the food recall is announced, the app will send an alert to consumers advising them of the specific nature of the recall. This app was intended to remove some of the inaccuracies about the recalls that were spread by word of mouth and to speed the distribution of the data. As there are potential life and death issues relating to tainted food, the app sends notifications straight to your phone.
Medical devices can have similar critical health and safety issues. For example, there have been known defects in pacemakers that can result in the battery draining and the device failing. Similarly, insulin pumps have experienced safety issues surrounding the possibility that they can be hacked. Many times, patients do not have the ability to learn of potentially serious safety issues until it was too late and they suffered injury or death from their medical devices. So far in 2019, 50 million Americans have been affected by medical device recalls. This is nearly one in every six people in the country.
At the same time, there is also a variety of speculation and misinformation that is circulated when there is a safety issue related to a medical device. Patients and their family members often have no way of knowing whether their device is truly safe, and go through a stressful period of uncertainty while they wait for further information and attempt to contact their healthcare providers. The developer of the app was motivated by a particular incident involving his daughter’s medical device which resulted in a life-threatening condition for her.
Mobile technology has changed the way that users consume information. Many receive alerts and data through the apps on their phone. Users are increasingly using their devices like a personal computer. While users can search internet data on their devices, the app revolution is beginning to overtake more traditional information sources. Nevertheless, the FDA still largely restricts its information to the internet and users have to search for it in the public realm. At the same time, there is a gap between the information that is available and the user. The FDA does put information out into the public as an open source for programmers to work with on their own. However, the agency does not take any steps to help programmers. Enter private industry which has devised a solution of its own to the issue.
While the FDA continues to rely on its long-established means of releasing crucial information, a company named SoomSafety has built an app that can track medical device recalls. Not only does the app track recalls, but it can also track information pertaining to specific medical devices. The way that the device works is relatively simple. Users will first download the app onto their smartphone or tablet. They can then scan the barcode of the device into the app. Each medical device is assigned this barcode as a means of tracking the device that is listed on the medical device information card. SoomSafety’s app will then scan FDA’s open source information. When it locates information that pertains to a specific medical device, it will send an alert to the patient. This can encompass both product recalls and any other safety information concerning the product.
Beyond recall information, the app will also provide users with other safety and use information that relate to their medical device. This places it conveniently at the patient’s fingertips so that they have it handy whenever they need it as opposed to having to spend time looking up the information.
The app is believed to be the first of its kind, and it is available to users free of charge in the Apple store. Those who use or have any kind of medical device should download the app and use it to track their medical device so they can know of any developments. Now that this app has been developed, it is likely that there will be further refinement and advancement of the technology behind it to give patients even more information rapidly. The hope is that this technology can be used even more widely to stretch beyond just medical devices.
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