Surgical Device tested in Leeds
A team from Medical Device Usability arrived at the simulation centre at St James’s Hospital, Leeds on Monday 24th April, to make preparations ahead of a two-day formative study.
Ultimately, the medical device being tested will be used in open and laparoscopic surgery. So, the two user groups taking part in the study were Operating Department Practitioners (ODPs) and surgeons from across a range of specialities, such as liver transplant and cardiothoracic. In order to keep the testing as realistic as possible a simulation room was prepared to look like an actual operation was being performed and everyone was dressed in surgical scrubs, see photo (client device not visible).
When the team arrived on Monday afternoon the first task was to get the device PAT tested so it could be used in the simulation centre. The pilot study then took place on Tuesday which allowed for any final minor tweaks to paperwork to be completed ahead of the study starting on the Wednesday morning.
As the nurses and surgeons had to work independently on some tasks, but together on others, the study needed careful co-ordination so that the right people could be called in at the correct time to complete the tasks. Consequently, the sequence of timings had to be carefully synchronised so that the 45 minutes the surgeon was involved fitted seamlessly into overall test session, which lasted a total of 90 minutes.
A thank you should be given to the staff at St James’s Hospital simulation centre for enabling us to create a suitably realistic environment and running such an elaborate study.
The final report is now being written up and planning work for the summative study in the US, which is planned for late summer, is already underway.