Worldwide around 234 million major operations are performed every year, or one operation per 25 people. Surgery is now almost twice as common as childbirth, yet major morbidity complicates 3–16% of all in-patient surgical procedures in developed nations alone, according to figures calculated by the World Health Organisation (WHO).
According to Dr Atul Gawande, team leader of the WHO's safer surgery working group, the Safe Surgery Saves Lives project, ten to 100 times more complications result from surgery than childbirth.
Permanent disability or death rates in developed countries occur at rates of 0.4–0.8%. But nearly half of the adverse events in these studies have been identified by the WHO as preventable.
In the UK, a study of 38 surgeons in 14 NHS hospitals reported in the British Medical Journal found that, although serious errors were rare, "most" of the surveyed surgeons had experience of operating on the wrong part of the body.
Thomas Weiser, MD, a Harvard School of Public Health research fellow on the Safe Surgery Saves Lives project, says that many hospitals had safety checks in place but their use was often inconsistent.
"Many developed settings perform a 'time out' where the team confirms the patient identity, procedure, and site of operation. Teams are using this time to perform an expanded briefing," he says. "[But] their consistent use [of such checks] is dismayingly variable."
Such checks also had never been elaborated to the extent that the WHO's Safe Surgery Saves Lives project had done, Weiser alleges.
Only 3.5% of operations globally are done in developing nations. Developing country death rates in surgery reach an estimated 5–10%. Mortality from general anaesthesia in sub-Saharan Africa is about one in 150, according to the WHO.
If there's a 3% perioperative adverse event rate and 0.5% mortality rate globally, nearly seven million patients a year suffer major complications relating to surgery. One million die during or immediately after surgery every year.
Adverse outcomes are tricky to quantify because the range of cases is so diverse. However, the team believes that post-operative morbidity and mortality are likely to be even more common than suggested by these figures, as few countries offer reliable information about adverse surgical outcomes.
Safer surgery checklist
Weiser says a new WHO surgical safety checklist has been created from the recommendations of surgeons, nurses, anaesthesiologists and patient safety organisations worldwide via several consultation meetings and working groups.
"[The checklist] identifies key safety steps during perioperative care that should be accomplished during every single operation no matter the setting, type of surgery, or resource limitation," he declares.
Guiding principles were simplicity, wide applicability and measurability – the ability to measure changes in the process or outcome of surgical care.
"In addition, the safety steps had to reduce the likelihood of serious, avoidable surgical harm and be unlikely to introduce unmanageable costs or additional risks to patient safety," Weiser says.
The checklist – to be followed by operating teams, surgeons, anaesthesia providers and nurses during surgery – sets out key safety checks to be adhered to at three specific points in perioperative care. These include "sign in" prior to anaesthesia, "time out" just before skin incision, and "sign out" before the team leaves the operating theatre, Weiser says.
The safety practices include confirmation of patient identity by all team members, objective patient airway assessment, use of pulse oximetry for monitoring, appropriate intravenous access for cases with high blood loss, appropriate timing of antibiotic administration and counting of sponges at the end of the case.
In the "sign in" phase, the coordinator must check if the surgical site on the patient's body was properly marked and whether the patient's known allergies were checked. During the "sign out" phase, the coordinator must ensure that instruments, sponges and needles are counted, to prevent the accidental leaving behind of any of this equipment in the patient's body.
A checklist coordinator in each phase must confirm that the team in the operating theatre has adhered to the checklist requirements before starting to operate.
"Many of the checks are already routine in most developed settings but, surprisingly, few operating teams accomplish them all consistently, even in the most advanced settings," he says. "We hope to show improvements in both the process and the outcome of care using our pilot sites to evaluate the checklist."
Verdict so far
Weiser said the preliminary results from 1,000 patients undergoing surgery at the eight pilot sites worldwide show basic safety practices carried out 68% of the time, up from a more usual 36%.
Some of the hospitals piloting the checklist achieved almost 100% adherence to basic safety practices following the implementation of the checklist. This has resulted in "substantial" reductions in complications and deaths in the 1,000 patients, according to a WHO statement.
"Final results on the impact of the checklist are expected in the next few months," the WHO said.
Some 260 professional societies, health organisations, ministries and NGOs had endorsed the concept of the Safe Surgery Saves Lives programme at the time of writing. Boyes Turner Reading, Berkshire lawyers who specialise in medical negligence claims, said that 2,000 NHS patients die each year as a result of errors in treatment.
"According to the National Patient Safety Agency, there were 129,000 reported incidents in which patients were put at risk. The National Audit Office in 2005 also reported that half of all incidents could have been avoided if staff had learnt the lessons of previous mistakes," the legal firm said in a statement.
A clinical negligence lawyer at Boyes Turner, Rosaline Wong, says the safer surgery checklist, which has been tried in a modified way at London's Great Ormond Hospital for Children in recent months as one of the eight pilot initiatives worldwide, is needed.
"As a clinical negligence lawyer, I worry about the complacent remarks made by some theatre staff who regard the 'catch-all checklist' as superfluous because safety checks have been in place as a matter of course for years," Wong explains.
"Year on year, I deal with a number of claims arising from operating on the wrong part of the body or leaving swabs or instruments in the patient. If the new tool can reduce potentially lethal consequences, improve the safety of surgery and help to improve care, it will be worth it."
Successful implementation of the WHO's safer surgery checklist would probably depend on a culture of teamwork and safety, she adds.
In the US, organisations such as the Association of periOperative Registered Nurses (AORN) have endorsed the project and checklist.
"The benefits will be that we'll be able to compare results across the world in terms of what safe environments are and what the practices are that produce safe surgical outcomes," says Linda Groah, executive director of AORN.
Groah, a registered nurse, says the initiative was one of the first times that nurses, surgeons and anaesthesiologists had been brought together to agree on a minimum standard of care for safe surgery.
What happens now?
The Safe Surgery Saves Lives project's Weiser says the next move is to build on that momentum to promote the widespread use, implementation and dissemination of the checklist.
The aim is for the checklist to be used during every surgical intervention.
"We are hoping to build a network of participating hospitals, clinicians, organisations and health providers through the WHO website," Weiser adds.
The checklist was launched late June 2008 and will be disseminated worldwide by the end of 2008 after the eight pilot studies' evaluation has been concluded. The team's goal is to have the checklist used in 2,500 hospitals worldwide by the end of 2009.