Anyone who requires a medical device, regardless of purpose, has a right to expect that the manufacturer has fully tested all elements of its design and that it is fitted in accordance with their specifications and recommendations.
But what happens if a device is surgically implanted and later becomes defective or was faulty in design? Any individual in such a situation should seek both medical and legal advice. If it can be shown that the patient was a victim of negligence in relation to the medical device, they may be entitled to recourse for the losses suffered.
What Types of Medical Devices could be Defective?
All medical devices must be designed, tested, and implanted in a clinically safe manner. Within the EU, medical device companies, regardless of where they are based, must carry the CE mark. To carry this mark, the organisation must meet the essential requirements of all relevant European Medical Device Directives.
Broadly speaking there are four categories of medical devices, as follows:
Non-invasive devices: Corrective glasses and frames, wheelchairs, walking aids, dressings.
Invasive medical devices (for short, medium, or long-term use: Stents, surgical tools, prosthetic joints, intra-ocular lenses, aneurysm clips, breast implants, total hip, knee and shoulder joint replacement systems.
Active medical devices: TENS devices, hearing aids, muscle stimulators and incubators.
Special Rules: Including contraceptive, disinfectant and radiological diagnostic medical devices.
The above list only covers a small number of the vast range of items that are defined as medical devices. Such devices do not need to be highly technical in nature; indeed, a suture or plaster can be considered a medical device. When considering a claim for a defective medical device, it is not only faulty long-term components which are surgically implanted that can form the basis of a medical negligence claim. Many of the devices within any of the four categories above, if not designed, manufactured, used, or implanted correctly, could cause serious long-term injury.
How can I bring a claim for Defective Medical Device Negligence?
You may be able to bring a claim if it can be proven:
The device used was in any way defective, and this led you to suffer injury and loss.
Your medical device did not conform to the necessary safety standards, and you suffered injury / loss as a result or;
The surgeon who implanted it failed to do so in the manner of a competent doctor and you suffered injury / loss as a result.
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