The stress of needing surgery or a permanent surgical implant is daunting enough, but to then find yourself with a serious or potentially life-threatening injury as a result of your medical device is unimaginable. Yet, there are over 83,000 people worldwide who have been adversely affected by a medical implant or an infection resulting from a medical device.
Recently journalists and researchers of the International Consortium of Investigative Journalists (ICIJ), have started to fight back. Access to databases is now available that allows patients to search for information regarding the durability, safety and effectiveness of the medical devices being recommended to treat them. The organization is now able to provide critical information to the public and significant insights as to recalls and safety alerts. In addition, information is available for patient recourse. Today ICIJ is working to add information to the site on a regular basis, making it available worldwide. In addition, a website is available for patients to search for recalls, safety alerts and field safety notices of medical devices and their connections with their manufacturers.
While the new light being shined on this issue is important, there are more pressing matters for those who have already been injured and for the families of those who have died as a result of faulty medical devices or deadly infections. Patient and family recourse is often more difficult than expected. The ordinary course of action is a claim for malpractice against the physician, hospital and/or manufacturer. These cases are complex as they involve not only the medical tort issues but also the possible aspect of product liability. In all medical malpractice cases basic elements have to be proven including:
- A duty of care owed to the patient
- Breach/Negligence in the meeting of the duty of care
- Treatment was unreasonably negligent and no other health care professional would have proceeded in the same manner
Australia’s produce liability laws also have elements that would have to be met to sue the manufacturer of the medical device. These elements include;
- The common law tort of negligence which is fault-based;
- Breach of Australian Consumer Law.
And while this may be a difficult case to present and prove, it is one which the injured party should explore.
The Australian medical system has now taken steps to help define the various levels of defective medical devices that can create a cause of action. To date there are four categories for medical devices;
- Low risk – such as elastic bandages, tongue depressors, slings
- Low to Medium risks – such as contact lenses, x-ray film, intravenous tubing
- Medium risk – such as blood bags, surgical mesh
- High risk – such as pacemakers, cochlear implants, implantable defibrillators.
While all types of medical supplies create risk, the greatest risk is with those that are implanted and remain contained in the body. Currently, there is a great deal of controversy over the manner in which these devices are tested and then released as safe for use. It has been suggested that the various European companies who test for safety, are doing so haphazardly and at a rapid rate as the work is a for-profit venture. Hence, there may need to be a change in the manner in which the medical devices are scrutinized prior to being released for use.
Not all medical device infections occur in patients who have permanent medical devices implanted. If you contract an infection from a medical device while you are in the hospital, you might have a cause of action for this also. These devices that can cause infection during a hospital stay include;
- IV needles
While this does not happen often, it must be remembered that there is always a risk of infection any time a foreign medical device permeates the body. Therefore, it is imperative that all medical personnel and visitors are careful to wash their hands and use sterile gloves when working with, or being near a patient in the hospital.
In the event that you or a family member has contracted an infection from a medical device, it is important to bring the issue to the immediate attention of your physician. The sooner a serious condition is treated, the more likely a complete recovery is possible. However in the event that full recovery does not occur and you are left with a loss and physical damage it is imperative you seek legal counsel as soon as possible.
If you find yourself in need of assistance with this or any other legal issue, please contact the law offices of Owen Hodge Lawyers. At Owen Hodge, we are always happy to assist clients in understanding the full ramifications of any and all of your legal needs. Please feel free to call us at your earliest convenience to schedule a consultation at 1800 770 780.