FDA proposes codes for medical devices to more efficiently catch defects

March 22, 2013

FDA proposes codes for medical devices to more efficiently catch defects

Article provided by The Cifarelli Law Firm, LLP
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The U.S. Food and Drug Administration, or FDA, is responsible for regulating manufactures of medical devices sold in the United States. The FDA has a broad list of requirements that medical devices must meet prior to being sold within the U.S., including:
-Registration with the FDA
-Providing the FDA with a list of all devices sold within the U.S.
-In some cases, authorization from the FDA

In an attempt to increase the safety of these devices, the FDA is proposing a new rule that attaches a unique code to each medical device. The code is designed to allow the FDA to track the devices more effectively. The proposal is intended to decrease the amount of time it takes to catch defects connected to the devices. These changes are proposed in an attempt to reduce the number of personal injuries experienced by patients.

How the proposed codes would work

The codes, known as unique device identifiers or UDIs, would be present both on the device and in a public database available online. The codes are similar to UPC codes used on grocery items and other consumer goods sold in stores throughout the country.

The FDA explains the UDIs would be composed of a series of numbers and letters containing both a device identifier and product identifier. The device identifier would be unique to the individual device model and the product identifier would provide information regarding the lot or batch number and expiration date.

One specific goal is the ability to reduce the rate of medical errors by allowing patients with defective devices to be contacted more rapidly. The FDA is hopeful that the changes will lead to increased patient safety and more efficient product recalls. These UDIs could allow for medical professionals to reach out to these patients and fix or remove the device before the patient is injured.

In addition, a database with basic information will be available to the public, allowing users of medical devices to proactively manage their healthcare needs.

Medical device defects and liability

Medical device recalls are issued when defects lead to injuries. A manufacturer of a medical device that does not comply with FDA standards is likely liable for any injuries that result from the use of its product.

Those injured due to a manufacturer's negligence may qualify for compensation to cover medical and rehabilitative costs as well as pain and suffering. If you or a loved one was injured by a medical device, contact an experienced personal injury lawyer to discuss your situation and better ensure your legal rights and remedies are protected.