Letters To The Editor: Letters & Announcements
To the Editor:
I read with interest the paper by Hayatsu et al. (1). In this study, epidural catheters were modified such that they had three platinum wire electrodes near the end, so that they could be used for electrical stimulation, and also could be used for multiple applications.
The production of this intricate equipment in the laboratory of the research group raises an important issue—that of product liability. The changing of an epidural catheter to a piece of equipment that may be used for percutaneous epidural spinal cord stimulation is viewed by the Consumer Protection Act as modification to a piece of equipment, and the “designing” anesthetist takes on the entire responsibility for the work done and any consequences (2).
By advertising the idea to colleagues in other hospitals, you become a manufacturer and the full rigor of regulations might apply. The Medical Device Regulations(3), which regulates every aspect of medical equipment development, became UK law in 1995 and was implemented in 1998.
1. Hayatsu K, Tomita M, Fujihara H, et al. The placement of the epidural catheter at the predicted site by electrical stimulation test. Anesth Analg 2001; 93: 1035–9.
2. Grant LJ. Regulations and safety in medical equipment design. Anaesthesia 1998; 53: 1–3.
3. Medical Device Regulations. 1994;SI No. 3017.