The Impact of a Medical Safety Device System

January 09, 2013

The Impact of a Medical Safety Device System

The U.S. Food and Drug Administration recently developed a safety system that will eventually place a label with a unique identification number on every medical device coming into the market. This procedure holds promise to revamp the current system and create a much more efficient process for both patients and health care providers should those medical devices malfunction or otherwise harm patients.

New Medical Device Identification System

In addition to the product's batch and serial number, the new label will also include a tracking bar code and a picture of the product. All of these identification pieces will make it possible to trace a defective product back to the manufacturer and to pinpoint the location of similar, possibly defective products that are currently in the public market or in use by patients.

The proposal has not yet been approved, but once it is, it will be slowly implemented over a few years. Products that may be particularly dangerous to human life will be the first to require labels. Pacemakers and other life-sustaining devices are at the top of the list. As years progress, all other devices will also require unique identification labels, such artificial knees and hips.

The Impact of the System

The new system aims to create a more efficient system. Devices that prove to be defective or harmful can be accurately identified, reported, reviewed and analyzed. In turn, medical device errors and malfunctions should decrease because device manufacturers can more easily learn from their mistakes or negligence with concrete information. This standard will also allow manufacturers to recall a product in a more efficient manner, knowing exactly where to find a faulty product by tracing its shipment history.

Along with all of these benefits, the unique identification information will be entered into an electronic health record system, further simplifying the identification and recall process. Answers will be at the fingertips of those trying to correct a problem. An electronic system allows doctors to know exactly who has a faulty product, and makes for a quick identification in case of a problem with the device.

Personal Injury From Defective Products

Defective products on the market can result in serious injury and even death. This makes the recall process particularly essential when a problem is discovered. However, with the current system in place today, many recalls are not effective because tracking down a product is difficult.

When a product is faulty due to the negligence of a company and someone is injured as a result, the injured party is not without remedy. Through a personal injury lawsuit, monetary compensation may be sought for various damages, including medical expenses, pain and suffering and lost wages. If you or someone you love has been hurt by a defective medical device, contact an experienced personal injury lawyer to discuss your legal options.

Article provided by The Lawrence Firm, PSC
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