By Tony Nicholson
Interventional radiologists, scientists and industry working together have produced real benefits for patients. Interventionists are great innovators themselves and have contributed by designing new equipment or modifying existing equipment for new and useful indications. Examples include:
- Thrombin injection for pseudoaneurysms
- Modification of wires and catheters for successful access
- Using certain self-expanding arterial stents for venous access
- Recombinant tissue plasminogen activator for dialysis fistulae
- Certain thrombectomy devices for dialysis fistulae
- Some types of super stiff wires for EVAR device delivery
- Septostomy needles for crossing superior vena cava occlusions
- Injecting particles, pushing coils or passing a microcatheter through certain diagnostic catheters
- Use of and or reversal of EVAR limbs for iliac aneurysms of ruptures
Despite the fact that many of the above and more have a long history of safety and evidence-based effectiveness, all are actually off-label use of devices and materials. Many interventional radiologists are not aware of this. However off-label use can be a legal problem, depending on the legal system in each country. Basically, in many European countries it is a rule that if the product is not used according to the instructions for use, the doctor is responsible for the outcome. When everything goes well nobody will complain.
Companies might even use such off-label clinical success as an oblique marketing tool, but if there is a complication, the patient can pursue the doctor for misconduct and the company will take no responsibility. The first legal cases involving off-label use have occurred.
Malfunctioning devices used according to instructions for use have been excused censure because some other device used in their deployment was used off-label. A good example of this is the specific requirement in instructions for use for specific support wires. Use of a non-instructions for use recommended support wire may mean that the company accept no responsibility if the device malfunctions.
Why is the industry not making sure that proven indications are included in instructions for use, or being more generic in their advice regarding supplementary equipment? We can only guess but money and responsibility probably play a role here. Yet, it seems wrong for companies to accept the plaudits but deny any responsibility. Interventional radiologists could, of course, stop using any off-label devices and products, but that would not be in the interest of our patients. It is time the industry got together with physician leaders to sort this problem out.
Tony Nicholson is a consultant vascular and interventional radiologist at the Leeds Teaching Hospitals, NHS Trust, UK. He chaired a session on off-label usage at the BSIR 2010 meeting, Liverpool, UK.