A total of 31 different devices and drugs were used in 212 procedural steps performed in 26 cases. At least one procedural step involved off-label use of devices or drugs, or involved device modification in 22 of the cases.
Off-label device use included placing vascular sheaths in the urinary tract, using angiographic catheters to guide wires in the urinary tract, reshaping the tip of most guidewires, using sheaths for thrombosuction, and using angioplasty balloons to dislodge the arterial plug at fistula thrombectomy. Drugs that were used off-label included Fibrovein (sodium tetradecyl sulphate) for the treatment of venous malformations and intra-arterial injection of heparin. None of these caused any adverse incidents.
While these findings were not surprising to the study's authors, the audit reinforced the need for interventional radiologists to understand the clinical and legal implications. In their article published on 5 October, Dr. Rodrick C. Zvavanjanja and his co-authors recommended that radiologists who may be concerned about this issue seek their colleagues' opinions and those of their institution's risk-management team.
Interventional radiology has a history of innovation in the development of new procedures, and there is a need for troubleshooting problems, the authors noted. Different technical challenges present themselves with every patient case, requiring the ingenuity of the radiologist.
Guidelines from the U.K. Royal College of Radiologists do not include specific advice on individual examples of off-label use. Current guidelines advise radiologists to read the instructions for use. Similarly, radiologists should read relevant alerts from bodies such as the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). These alerts may contain updates not published on product packaging.
The authors suggested that it would be beneficial if the British Society of Interventional Radiology, the Cardiovascular and Interventional Radiology Society of Europe, and the Society of Interventional Radiology conducted a review of practices and current literature on off-label device use and device modification, then publish consensus guidelines for specific circumstances. They noted, however, that this would probably never occur due to the legal responsibilities that the societies' would have to assume.
When in doubt, consult with peers and risk-management teams, they concluded.
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