Patient Safety

Safe SurgeryWhy safe surgery is importantSurgical care has been an essential component of health care worldwide for over a century. As the incidences of traumatic injuries, cancers and cardiovascular disease continue to rise, the impact of surgical intervention on public health systems will continue to grow.

Surgery is often the only therapy that can alleviate disabilities and reduce the risk of death from common conditions. Every year, many millions of people undergo surgical treatment, and surgical interventions account for an estimated 13% of the worlds total disability-adjusted life years (DALYs).

While surgical procedures are intended to save lives, unsafe surgical care can cause substantial harm. Given the ubiquity of surgery, this has signicant implications: the reported crude mortality rate after major surgery is 0.5-5%; complications after inpatient operations occur in up to 25% of patients; in industralized countries, nearly half of all adverse events in hospitalized patients are related to surgical care; at least half of the cases in which surgery led to harm are considered preventable; mortality from general anaesthesia alone is reported to be as high as one in 150 in some parts of sub-Saharan Africa.

WHO and Surgical SafetyWHO has undertaken a number of global and regional initiatives to address surgical safety. Much of this work has stemmed from the WHO Second Global Patient Safety Challenge Safe Surgery Saves Lives. Safe Surgery Saves Lives set about to improve the safety of surgical care around the world by dening a core set of safety standards that could be applied in all WHO Member States.

To this end, working groups of international experts were convened to review the literature and the experiences of clinicians around the world. They reached consensus on four areas in which dramatic improvements could be made in the safety of surgical care: surgical site infection prevention, safe anaesthesia, safe surgical teams and measurement of surgical services.

Safe Surgery Saves Lives Frequently Asked QuestionsWhy is the Checklist important? 234 million major operations are performed annually across the world. This translates to roughly one operation for every 25 people and indicates that the safety of care is of signicant public health importance. For more on this statistic and its implications, see the following article in the Lancet: Moreover, given previously estimated rates of major complication and death following inpatient surgery, a conservative estimate is that 7 million patients suffer complications following surgery, half of which are probably preventable.

What is the Checklist and how was it developed? The WHO Surgical Safety Checklist is a 19-item tool that was created by an international group of experts gathered by WHO with the goal of improving the safety of patients undergoing surgical procedures around the world. Anaesthetists, operating theatre nurses, surgeons, patients and other professionals were extensively involved in its development. It involves the coordination of the operating team the surgeons, anaesthesia providers, and nurses to discuss key safety checks prior to specic phases of perioperative care: a Sign In prior to the induction of anesthesia, a Time Out prior to skin incision, and a Sign Out before the team leaves the operating room. Many of the checks are already routine in some institutions, but surprisingly, few operating teams accomplish them all consistently, even in the most advanced settings.

What were the ndings of the original trial? Between October 2007 and September 2008, the effects of the Checklist were studied in eight hospitals in eight cities (Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, The Philippines; Ifakara, Tanzania; London, UK; and Seattle, USA) representing a wide variety of economic circumstances and diverse patient populations. Data was prospectively collected on clinical processes and outcomes from 3733 patients before and 3955 patients after the Checklist was implemented. The results of the study were published in the New England Journal of Medicine on January 29, 2009 and demonstrated dramatic improvements in both processes and outcomes. Indeed, use of the WHO Checklist reduced the rate of deaths and complications by more than one-third across all eight pilot hospitals. The rate of major inpatient complications dropped from 11% to 7%, and the inpatient death rate following major operations fell from 1.5% to 0.8% after implementation of the Checklist. Moreover, the effect was of similar magnitude in both high and low/middle income country sites.

Has there been other evidence to support its use?Other studies have gone on to support this nding (current as of January 2014): Yuan CT, Walsh D, et al. Incorporating the World Health Organization Surgical Safety Checklist into practice at two hospitals in Liberia. Jt Comm J Qual Patient Saf 2012; 38: 25460. Sewell M, et al. Use of the WHO surgical safety checklist in trauma and orthopaedic patients. International Orthopaedics (SICOT) 2010; 35: 897901. de Vries EN, et al. Effect of a comprehensive surgical safety system on patient outcomes. New England Journal of Medicine 2010; 363: 192837. Askarian M, et al. Effect of surgical safety checklists on postoperative morbidity and mortality rates, Shiraz, Faghihy Hospital, a 1-year study. Qual Manag Health Care 2011; 20: 2937. Sewell et al. documented a decrease in early complications from 8.5% to 7.6%, mortality from 1.9% to 1.6% and surgical site infections from 4.4% to 3.5%: Sewell M, et al. Use of the WHO surgical safety checklist in trauma and orthopaedic patients. International Orthopaedics (SICOT) 2010; 35: 897901. Askarian et al. found that surgical complications decreased from 22.9% to 10%: Askarian M, et al. Effect of surgical safety checklists on postoperative morbidity and mortality rates, Shiraz, Faghihy Hospital, a 1-year study. Qual Manag Health Care 2011; 20: 2937

The Netherlands Surgical Patient Safety System found a signicant reduction in in-hospital mortality (1.5% to 0.8%) and in overall complications (27.3 to 16.7 per 100) after implementation of a comprehensive surgical checklist: de Vries EN, et al. Effect of a comprehensive surgical safety system on patient outcomes. New England Journal of Medicine 2010; 363: 192837.Improvements have been broader than just morbidity and mortality. Semel et al. suggested that its use was cost-saving too: Semel ME, et al. Adopting A Surgical Safety Checklist Could Save Money And Improve The Quality Of Care In U.S. Hospitals. Health Affairs 2010; 29: 15939. Kearns et al. and Sewell et al. found most users felt the Checklist improved communication: Kearns RJ, et al. The introduction of a surgical safety checklist in a tertiary referral obstetric centre. BMJ Quality & Safety 2011; 20: 81822. Sewell M, et al. Use of the WHO surgical safety checklist in trauma and orthopaedic patients. International Orthopaedics (SICOT) 2010; 35: 897901.Studies have also suggested an improvement in safety attitudes: Kawano T, et al. Improvement of teamwork and safety climate following implementation of the WHO surgical safety checklist at a university hospital in Japan. J Anesth 2013. doi: 10.1007/s00540-013-1737-y. Haynes AB, Weiser TG, Berry WR, et al. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Quality & Safety 2011; 20: 1027

Why does the Checklist work? There are several theories as to why the Checklist has been able to produce the results it has. The original study suggests that it is multifactorial, and that improvement could be because of the checklist itself, the formal pauses, the resultant push for uptake of technology, and improved teamwork and communication. We know that it is not as effective at reducing morbidity and mortality when only partially completed, so it is not just one component that is driving the results.

Does the Checklist apply to all low- and middle-income countries? Four low-income countries contributed to the original WHO study. Adapted appropriately, the Checklist can be an effective tool in these settings when adoptedd as part of a wider push for improvement in patient safety culture. WHO acknowledges that implementation of its Checklist needs to be well considered; limited availability of resources and less structure around patient safety provides a different context for effective use. Further research needs to be undertaken to better understand what, if any, modications need to be made to the Checklist for use in low- and middle-income countries (LMICs).

My hospital is quite large with many operating rooms. How can I implement a checklist in this environment? The key to successful implementation is to start small. Start with a single operating room on one day and see how it works. This will guide you to strategies for altering the checklist to t your needs, as well as identify potential barriers to its successful adaptation.

We already do these things. Why should we use a checklist? While most or all of the items on the WHO Checklist may already be done at your hospital, we have found that in most hospitals there are opportunities for improvement in consistency. The checklist helps ensure that important safety steps are followed for each and every operation.

Our surgical teams dont want to use the WHO Surgical Safety Checklist unless they can change a few of the elements. Is it okay to make changes to the Checklist? Yes, the Checklist was not intended to be comprehensive, and we encourage modications for local use. We understand that the Checklist, while intended to be universally applicable, is not always a perfect t for all institutions. Modications can be made to include items that are deemed essential. However, please avoid making the Checklist too comprehensive. The more items added to it, the more difcult it will be to successfully implement. Please refer to the Checklist Adaptation Guide, before making any changes, for recommendations on modifying the Checklist.

Who should be in charge of running the Checklist? Although every member of the operating team surgeons, anaesthetists, nurses, technicians and other operating room personnel is involved in its execution, a single person should be responsible for leading the discussion of all components of the Checklist. This is essential for its success. This will often be a circulating nurse, but it can be any clinician or health-care professional participating in the operation. This individual can and should prevent the team from progressing to the next phase of the operation until each step has been satisfactorily addressed.

My team often stays together for the whole day. Must we introduce ourselves before every surgery? The most critical time for introductions is at the beginning of an operative day. There is no need to repeat introductions if they have already been made. However, if new members join a room, they should introduce themselves as should every member of the team present. Even if everyone knows each other, introductions are important as they serve to reinforce team communication (and can help avoid the embarrassment of having to ask the name of someone with whom one has been working for a long time!).

Should we memorize the Checklist? No. Checklists are created to avoid the pitfalls of memorization and omissions that occur when standardized processes are not clearly written and dened. The goal of the Checklist is to help ensure that teams consistently follow a few critical safety steps and thereby minimize the most common avoidable risks endangering the lives and well-being of surgical patients.

We are already very busy in the operating room. Isnt this just one more task using up valuable time? Once the Checklist has become familiar to operating teams, it requires very little extra time to perform. Most of the steps are incorporated into existing workow and the remainder will add only one or two minutes to the OR time. However, the Checklist can also save time be ensuring better coordination between the teams, minimizing slowdowns for tasks like retrieval of additional equipment.

While there is enthusiasm amongst some clinicians for the Checklist, there are others who do not see the value of this initiative. Can we still use the Checklist? Yes. Implementation should always begin with the most enthusiastic. Go after the low hanging fruit, namely those interested in improvement! The Checklist can be implemented by an individual clinician in cases in which he or she participates, a selected service or operating room suite at a hospital, or on a hospital-wide or even system-wide basis. Focus energy on those areas and individuals who are receptive to the idea at rst and as they become accustomed to the Checklist and its benets, they will help spread it to their peers.

I have additional questions not covered by the FAQ. Can I speak to someone? Please contactpatientsafety@who.int.