PRAGUE, Czech Republic – "We have had heavy weather in the Netherlands from the Dutch Health Care Inspectorate," said endoscopic surgeon Ivo Broeders, MD, PhD, of the department of surgery at University Medical Center Utrecht.

Charged with updating colleagues at the annual congress of the European Association of Endoscopic Surgery (EAES), held here last week, on concerns over the safety of endoscopic surgery raised by the Dutch Health Ministry, Broeders said, "This report is about our business at this very moment, not off in the future with new procedures like in the NOTES discussions."

Noting what it called a higher incidence of serious adverse surgery events and deaths among young adults who underwent endoscopic surgery, compared to traditional open surgery, the ministry launched an investigation of the risks presented by minimally invasive surgery (MIS) procedures.

The study covered surgeon competency as well as the quality of equipment and training programs at the eight leading surgical centers in the Netherlands.

The ministry was alarmed by general conditions, such as what it called a "variable and inadequate" training of surgeons in laparoscopic techniques, as well as highly variable reporting of results for surgeries that makes comparisons impossible across institutions.

The ministry's inspection also revealed specific concerns, such as an average of 36% of light cables in endoscopes not functioning properly and that almost a fourth of the devices had leaks in the outer linings.

The ministry report concluded that endoscopy "is a promising technique but the safety is not guaranteed."

"This is a very tough conclusion," said Broeders.

"In sports you may be called promising for a year or two, but we have been practicing endoscopy for 20 years and have demonstrated the effectiveness, yet the ministry is singling out endoscopy as being new and particularly unsafe," he told colleagues.

Heads began shaking in the audience as he listed the conditions the Dutch Health Ministry imposed on endoscopic surgeons and that the ministry says it will inspect for conformance this year.

The ministry has called for the implementation of uniform, national, pan-disciplinary training requirements for all basic laparoscopic techniques and the implementation of national guidelines for the inspection, maintenance and replacement of laparoscopic instruments and related equipment.

"Is this bad?" asked Broeders, who then shocked the audience by saying, "They have also called for video capture to be used as key tool for periodic control of surgeons."

The ministry's view, he said, is that periodic checks of pilots is mandatory, so why not surgeons?

To date, said Broeders, the Dutch societies of endoscopic surgeons "have done nothing in response to these conditions."

While hospitals are taking the ministry's report "very seriously," he said, the professional societies resent the singling out of endoscopy arguing the requirements for consistent training guidelines and equipment checks should be applied to all other areas of surgery as well.

"And what we do not have, and what we will oppose, is any program for periodic checking of surgeons and obligatory capture on video," Broeder said to approving nods from the audience.

"There is a lot of opposition among surgeons," he added. "We feel there is a lot of anger and even aggression against endoscopic surgeons."

Broeders said, "These are seen as harsh measures based on Oxford level 5 evidence."

The Dutch surgeons concede the minstry's points about the inconsistencies in recordingkeeping, but cite this failing as the strength of their argument that there is no evidence to warrant such sweeping measures.

One surgeon in the audience said he would risk playing the devil's advocate, noting that the Dutch Ministry "correctly identified three key issues, despite the challenge to their evidence. We all know that accreditation is dismal," he said.

"The archiving of information we have available on our screens, while we say it is difficult, we all know it is not," he added.

"And finally, our failure to create a competency-based curriculum is exactly right," he said. "They hit the nail on the head in all three areas, and while we don't like the message, we know it is true."

As for periodic checks of surgeon competency, "we need to admit that 70% of surgery depends upon what we see on the screen and how we then manipulate the instrument, yet 10% of surgeons simply do not have, or have lost, the physical and mental capacity to coordinate these movements," he said.