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Database could protect patients from defective medical device

Inherently defective and flawed devices continue to harm patients in California for many reasons, but a significant contributor is a simple lack of information on the providers' side. It can be difficult to understand how this can happen in a world perpetuated by 24-hour news cycles and viral videos on social media, but most manufacturers are not exactly eager to cut into their profits by sounding the alarm about a defective medical device. It is possible that a lack of information regarding dangerous devices could soon end as the Food and Drug Administration pushes forward with the Global Unique Device Identification Database.

The GUDID database allows medical professionals and hospitals to access information regarding medical devices. While the GUDID will soon contain information regarding Class I, II and III devices, the deadline for manufacturers to submit information regarding Class I devices -- those that present the lowest level of risk -- is not until 2018. Those that present the highest risk to patients -- Class III -- have already been submitted, while Class II devices must be fully submitted by Sept. 24, 2016.

While this move to require manufacturers to submit valuable information regarding their devices will hopefully make a positive impact in the medical community, experts caution not to expect results any time soon. The new GUDID requirements are not applicable to devices that are already being commercially distributed. On top of that, manufacturers have a full three years to clear out their inventories that contain these devices.

With thorough research, testing and then FDA approval, it can be difficult to understand just how a defective medical device can even make it to the market in the first place. Since these previous safety protocols have failed to keep California patients safe, it is understandable that the FDA is hoping to add another protocol to the process. If effective, it could potentially allow great access to device information that could prevent patients from being wrongly injured by negligent manufacturers, although it is usually possible to hold them financially responsible through the successful actions of products liability suits.

Source: healthcaredive.com, "UDI: Increasing visibility of medical devices", Meg Bryant, May 19, 2016

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