Cases we handle
Defective Medical Devices
The Requirements Under the Law
Medical devices are only allowed on the market in the United States after careful consideration and adherence to state and federal distribution laws. All manufacturers of medical device or medical products are subject to strict rules and regulations in all aspects of production. Any design, idea, change, process, and quality control method requires intense safety protocols.
Federal standards are in place to ensure companies follow “good manufacturing practice.” This means that all manufacturers must produce a product that follows the approved design. To ensure compliance, the manufacturing company must implement and uphold policies and procedures that allow for the product to accurately follow the approved design. In order to maintain compliance, any change made to procedure or production must follow the same strict guidelines as the original product requirements.
Injuries Caused by Defective Medical Devices
If a defect exists in your medical device or medical product, you have suffered serious and permanent injury. Defective medical devices can result in a variety of injuries, including products becoming loose in the body, bone or tissue growth around the defective medical device, infections, the puncturing of organs or tissues, or hepatomas.
Moreover, your injury could be sourced in any one (or more than one) of the several stages a device or product travels through between you and the manufacturer. Could negligence be found at any of the following parties?
- The manufacturer
- The labeler
- The packager
- The distributor
- The vendor
Quality and Inspection of Medical Devices
A quality assurance program is always required in order to maintain proper performance by all products manufactured. These types of programs allow for the ability to monitor the effectiveness and safety of all devices. It is important to monitor all devices to determine any negative effects and record any irregularities in detail. Once a device or productsis created, a rigorous inspection must be performed in order to allow for distribution. These inspections must identify a thorough review of the device and its workings to make sure the device is in compliance with the specifications.
As mentioned above, detailed records are required to be maintained in the production of all medical devices. These reports allow for manufacturers to determine any risks or benefits and keep track of their effectiveness. In the event of a malfunction of the medical device, or even its success, written and oral documentation is required. Once documented, an investigation into the claims is performed and heavily reported. After the initial investigation into the failure or success of the device, another final investigation is performed to ensure the product(s) follow the specifications.
Was Your Medical Device Recalled?
In addition to heavy reporting and strict requirements, the manufacturing of medical devices is also regulated by the FDA. Every medicaldevice or medical productsmade must be approved by the FDA for distribution and use. Any changes or risks associated with the device, including injury or death, must be reported to the FDA. Once reported to the FDA, an investigation into the device is launched and thoroughly reported. Many are familiar with what is called a “product recall.” Product recalls are announced when a product, in this case medical device, contributes to injury, death, or malfunction.
In regards to medicaldevice or medical productsand their malfunctions, the FDA has a severity of consequences list that determines the level of recall. There are primarily three levels of recall when it comes to medical devices; simply level one, two, and three. Level one being the highest in that it can cause severe injury or death, and level two being the lesser in that it may cause temporary injury and not death. Level three is an unlikely risk of injury or death if the product were to malfunction or fall under the approved guidelines.
For more information, feel free to look through our North Carolina Personal Injury FAQs.
Call Kreger Law Firm at (888) 820-5885 to speak to a North Carolina Personal Injury Lawyer today