The surgeon and medical devices: adverse incident reporting and off-label use

Abstract

Recent events have highlighted the problems that can arise from the use of medical devices. The Poly Implant Prothèse breast implant affair and controversies surrounding metalon-metal hips have focused the attention of the public and clinicians on medical device regulation and the safety of implants. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of the devices but the agency's ability to do this depends on manufacturers, surgeons and other users to report any events that might point toward underlying safety issues. This article aims to clarify the roles and responsibilities of clinicians when using medical devices. It describes the range of incidents that they should report and how to report them. It also explores the implications of off-label use.

The Hybrid Tracheoesophageal Puncture Procedure

“…When a device is modified, liability is transferred from the manufacturer to the practitioner. 16 Therefore, it is incumbent upon the surgeon to ensure that risk is minimized compared to the potential benefits that may accrue to the patient. A thorough discussion of risks and benefits with the patient prior to surgery with the acquisition of informed consent is clearly important.…”

Polyaxial pedicle screw dislocation during screw tightening for posterior spinal lumbar stabilization

“…Furthermore, incidents and accidents with medical devices must be reported to the National Medicines Agency of each country and the manufacturers to prevent future possible complications. [2,5]…”

Over-the-counter (OTC) bruxism splints available on the Internet

“…This obligation, previously implicit in GDC's Standards for dental professionals, 30 has become explicit in the new Standards published September 2013. 31 Indeed, both the General Medical Council 32 and the Royal College of Surgeons 33 are now also keen to emphasise the responsibility of health care professionals in reporting problems with medical devices.…”