Abstract

Objective: To determine the practice in UK hospitals regarding the level of patient involvement and consent when representatives of commercial surgical device manufacturers attend and advise during operations.

Methods: An anonymous postal questionnaire was sent to the senior nurse in charge in all 236 UK gynaecology theatres in 2004. 79/236 (33%) replies were received.

Results: Operating departments were visited every 2 weeks on average by a representative of the surgical device manufacturer. Actual operations were attended every 10 weeks, although there was much variation. 33/79 (42%) units consistently obtained patient consent for visits, usually orally, whereas 40/79 (51%) units did not. 65/79 (82%) units had no guidelines for surgical device representative visits. 91% of nurses in charge believed that there should be guidelines to protect both patients and staff. 6/79 (8%) units were preparing local guidelines at the time of the survey.

Conclusions: Currently, patient safety, confidentiality and autonomy are being protected by a minority of NHS operating theatres when surgical device representatives attend surgery. National guidelines would hopefully ensure that fully informed patient consent is obtained and that representatives are fully trained and supervised.