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 Table of Contents  
Year : 2022  |  Volume : 8  |  Issue : 2  |  Page : 77-81

Patient Safety vis-à-vis Safe Surgery: The Current Perspective

Department of Hospital Administration, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

Date of Submission27-Jun-2022
Date of Acceptance10-Aug-2022
Date of Web Publication2-Sep-2022

Correspondence Address:
R Harsvardhan
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jigims.jigims_33_22

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Today, patient harm due to unsafe care is a large and growing global public health challenge and is one of the leading causes of death and disability worldwide. Most of this patient harm is avoidable. As countries strive to achieve universal health coverage and the Sustainable Development Goals, the beneficial effects of improved access to health services can be undermined by unsafe care. The benefits of having a strategic and coordinated approach to patient safety, addressing the common causes of harm, and the approaches to preventing it have been recognized by policymakers and political and health leaders worldwide. Patient safety is defined as “A framework of organized activities that creates cultures, processes, procedures, behaviors, technologies, and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make errors less likely, and reduce the impact of harm when it does occur.” Surgical care has been an essential component of health care worldwide for a long. As the incidences of traumatic injuries, cancers, and cardiovascular disease continue to rise, the impact of surgical intervention on public health systems will only continue to swell. Surgery is often one of the significant therapies that can alleviate disabilities and reduce the risk of death from common conditions. Every year, millions of people undergo surgical treatment, and surgical interventions account for an estimated 13% of the world's total disability-adjusted life years (DALYs). While surgical procedures are intended to save lives, unsafe surgical care can result in substantial harm.

Keywords: Disability-adjusted life years, health care-associated infection, safe surgery

How to cite this article:
Harsvardhan R, Choudhari S. Patient Safety vis-à-vis Safe Surgery: The Current Perspective. J Indira Gandhi Inst Med Sci 2022;8:77-81

How to cite this URL:
Harsvardhan R, Choudhari S. Patient Safety vis-à-vis Safe Surgery: The Current Perspective. J Indira Gandhi Inst Med Sci [serial online] 2022 [cited 2023 Mar 27];8:77-81. Available from: http://www.jigims.co.in/text.asp?2022/8/2/77/355320

  Introduction Top

An estimated 310 million major operations are performed around the world each year corresponding to one operation for every 30 people alive. Each year, an estimated 63 million people undergo surgical treatment due to traumatic injuries, another 10 million operations are performed for pregnancy-related complications, and 31 million more are undertaken to treat malignancies.[1] In industrialized countries, studies suggest that major complications are reported to occur in 3%–16% of inpatient surgical procedures, with permanent disability or death rates of approximately 0.4%–0.8%. In developing countries, studies suggest a death rate of 5%–10% during major surgery.[2] Ipso facto, interpolating the same to absolute numbers, minimum of seven million surgical patients could be harmed.

  Background Top

In October 2004, the World Health Organization (WHO) launched the World Alliance for Patient Safety in response to the World Health Assembly Resolution 55.18 urging the WHO and member states to pay the closest possible attention to the problem of patient safety. The Global Patient Safety Challenge aims at bringing together the expertise of specialists to improve the safety of care. The area chosen, for the first challenge in 2005–2006, was health care-associated infections. Clean care is safer care. The topic for the second Global Patient Safety Challenge was Safe Surgery Saves Lives.

Five facts about surgical safety are as follows:

  1. Complications after inpatient operations occur in up to 25% of patients
  2. The reported crude mortality rate after major surgery is 0.5%–5%
  3. In industrialized countries, nearly half of all adverse events in hospitalized patients are related to surgical care
  4. At least half of the cases in which surgery led to harm are considered to be preventable
  5. Known principles of surgical safety are inconsistently applied even in the most sophisticated settings.

Both global challenges aimed to gain worldwide commitment and spark action to reduce health care-associated infections and the risks associated with surgery, respectively.

  There were Other Initiatives Done by World Alliance for Patient Safety Top

Taxonomy for patient safety initiative, ensuring consistency in the norms and terminology used in patient safety work, as well as a classification framework – the International Classification for Patient Safety was framed as well as Patient Safety research initiatives were conducted to identify priorities for patient safety-related research in high, middle and low-income countries. Patient safety solutions program to identify, develop and promote worldwide interventions to improve patient safety. A comprehensive reporting and learning best practice guidelines were made by WAPS so as to aid in the design and development of existing and new incident reporting system. Patient Safety Curriculum guides (in two editions: the first for medical schools, followed by a multiprofessional edition) were introduced to assist in patient safety education in universities, schools and professional institutions in the fields of dentistry, medicine, midwifery, nursing and pharmacy. Partnership with Africa was made for sustainable hospitals to ensure patient safety.

  The Global Patient Safety Action Plan (2021–2030) Top

The mission of the global action plan is to drive forward policies, strategies, and actions, based on science, patient experience, system design, and partnerships, to eliminate all sources of avoidable risk and harm to patients and health workers. There are seven strategic objectives of this plan. The first objective is dealing with zero avoidable harm to the patients and a rule of engagement in the planning and delivery of health care everywhere. Second objective deals with building high-reliability health systems and health organizations that protect patients daily from harm. The third objective deals to assure the safety of every clinical process. Patient engagement and empowerment are perhaps the most powerful tool to improve patient safety. Hence, engaging families to help and support the journey of a patient to safer health care is the fourth objective. Fifth objective deals to inspire, educate, skill, and protect health workers to contribute to the design and delivery of safe care systems. The sixth objective is to ensure a constant flow of information and knowledge to drive the mitigation of risk, a reduction in levels of avoidable harm, and improvements in the safety of care. To develop and sustain multisectoral and multinational synergy, partnership, and solidarity to improve patient safety and quality of care is the last goal.

  National Patient Safety Implementation Framework (2018–2025) Top

In 2015, during the 68th WHO Regional Committee for South-East Asia all Member States of the Region, including India, endorsed the Regional Strategy for Patient Safety in the WHO South-East Asia Region (2016–2025) aiming to support the development of national quality of care and patient safety strategies, policies, and plans and committed to translate six objectives of the regional strategy into actionable strategies at country level. In this context, the Ministry of Health and Family Welfare, Government of India constituted a multistakeholder Patient Safety Expert Group in August 2016. The group was given a task to operationalize the patient safety agenda at the country level and develop a National Patient Safety Implementation Framework (NPSIF). The goal of NPSIF is to improve patient safety at all levels of health care across all modalities of health-care provision, including prevention, diagnosis, treatment, and follow-up within the context of improving the overall quality of care and progressing toward universal health coverage (UHC) in coming decades. There are six guiding principles in the framework, namely, articulating health systems approach, defining evidence-based interventions, targeting all levels of care, adopting a patient-centered care approach, promoting collaborative actions, and ensuring sustainability and monitoring progress. Six strategic objectives have been identified for this purpose after due consultation with stakeholders and reviewing global and regional frameworks for patient safety. The first objective was to improve structural systems to support the quality and efficiency of health care and place patient safety at the core at national, subnational, and health-care facility levels. To assess the nature and scale of adverse events in health care and establish a system of reporting and learning is the second objective. The third objective ensures a competent and capable workforce that is aware and sensitive to patient safety. Health care-associated infections are a major challenge in ensuring patient safety to prevent and control health care-associated infections is the fourth objective. The fifth objective is to implement Global Patient Safety campaigns and strengthen patient safety across all programs. The sixth objective is to strengthen the capacity for and promote patient safety research.

  Prevention Top

The working group on the problem area selected (safety of surgical care) for the second Global Patient Safety Challenge, in 2007–2008, reached a consensus on four areas in which dramatic improvements could be achieved, as regards the safety of surgical care.

These are the following:

  • Surgical site infection prevention
  • Safe anesthesia
  • Safe surgical teams and
  • Measurement of surgical service.

  Surgical Site Infection Prevention Top

Surgical site infection accounts for about 15% of all health care-associated infections and about 37% of the hospital-acquired infections of surgical patients. Two-thirds of surgical site infections are incisional and one-third is confined to the organ space. In Western countries, the frequency of such infections is 15%–20% of all cases, with an incidence of 2%–15% in general surgery. Surgical site infections lead to an average increase in the length of hospital stay of 4–7 days.[3],[4],[5],[6] Evidence shows that proven measures, such as antibiotic prophylaxis within an hour before incision and effective sterilization of instruments, are inconsistently resorted to. This is often not due to the cost or lack of resources but due to the lack of a system in place. For example, antibiotics are given perioperatively in both developed and developing countries but they are often administered too early, too late, or simply erratically, making them less effective in mitigating patient harm.

  Safe Anesthesia Top

Anesthetic complications remain a substantial cause of surgical death globally, despite safety and monitoring standards which have significantly reduced unnecessary deaths and disability in developed countries. Three decades ago, a patient undergoing general anesthesia had an estimated done of 5000 chances of death. The incidence of 24-h perioperative deaths per 100 anaesthetics was 2.57.[7],[8],[9] With improvements in knowledge and basic standards of care, the risk has dropped to one in 200,000 in the developed world – a 40-fold improvement. The avoidable anesthesia-associated mortality in developing countries has been estimated at 100–1000 times the rate reported in developed countries.

  Safe Surgical Teams Top

Teamwork is the fundamental tenet of all effectively functioning systems involving multiple people. In the operating room, where tension may be high and lives are at stake, teamwork is an essential component of safe surgery. Three elements contribute to a team's culture: the structure of the team, the perception of team roles, and team members' attitude to safety issues. Improving team characteristics should aid communication and reduce patient harm.

  Measurement of Surgical Services Top

A major problem in surgical safety has been a shortage of basic data. Efforts to reduce maternal and neonatal mortality during childbirth have been critically reliant on routine surveillance of mortality rates and systems of obstetric care to monitor successes and failures. Similar surveillance has not been undertaken for surgical care as is needed. Data on surgical volume are available for only a few countries and are not standardized. Routine surveillance to evaluate and measure surgical services must be established if public health systems are to ensure progress in improving the safety of surgical care. Further, the working group on the problem area selected (safety of surgical care) for the second Global Patient Safety Challenge, from 2007 to 2008, also reached a consensus in defining 10 essential objectives that should be met by every surgical team during surgical care. These include the team will operate on the correct patient at the correct site, using methods known to prevent harm from anaesthetic administration, while protecting the patient from pain, recognize and effectively prepare for a life-threatening loss of airway or respiratory function, recognize and effectively prepare for risk of high blood loss, avoid inducing an allergic or adverse drug reaction known to be a significant risk to the patient. To use methods which are known to minimize the risk of surgical site infection, prevent inadvertent retention of sponges or instruments in surgical wounds, secure and accurately identify all surgical specimens, effectively communicate and exchange critical patient information for the safe conduct of the operation. Hospitals and Public health systems will establish routine surveillance of surgical capacity, volume and results. In industrialized countries, the rate of major complications has been documented to occur in 3%–22% of inpatient surgical procedures, and the death rate 0.4 to 0.8%.[5],[6] Nearly half the adverse events in these studies were determined to be preventable. Studies in developing countries suggest a death rate of 5%–10% associated with major surgery.[10],[11] Infections and other postoperative complications are also a serious concern around the world. Avoidable surgical complications thus account for a large proportion of preventable medical injuries and deaths globally. Adverse events have been estimated to affect 3%–16% of all hospitalized patients, and more than half of such events are known to be preventable.[12],[13],[14],[15],[16] Despite dramatic improvements in surgical safety knowledge, at least half of the events occur during surgical care. Assuming a 3% perioperative adverse event rate and a 0.5% mortality rate globally, almost 7 million surgical patients suffer significant complications each year. Surgical safety has, therefore, emerged as a significant global public health concern.[17] Just as public health interventions and educational projects have dramatically improved maternal and neonatal survival, analogous efforts might improve surgical safety and quality of care.

  Issues and Challenges Top

There are few underlying challenges to improving surgical safety. First, it has not yet been recognized as a significant public health concern. Due to the often high expense of surgical care, it is assumed to be of limited relevance in poor- and middle-income countries; however, the WHO Global Burden of Disease report in 2002. It showed that a significant proportion of the disability from disease in the world is due to conditions that are treatable by surgical intervention. Debas et al. estimated that 11% of the 1.5 billion disability-adjusted life years are due to diseases treatable by surgery. Problems associated with surgical safety are well recognized in developed and rather tested in developing countries. The second underlying problem in improving surgical safety has been a paucity of adequate and reliable data. Efforts to reduce maternal and neonatal mortality at childbirth have relied critically on routine surveillance of mortality rates and systems of obstetric care so that successes and failures could be monitored and recognized. Similar surveillance has been widely lacking for surgical care. The WHO Patient Safety Program found that data on surgical volume were available for only a minority of the WHO member states. The third underlying problem in ensuring surgical safety is that existing safety practices do not appear to be used reliably in any country. Lack of resources is an issue in low-income countries, but it is not necessarily the most important factor. For example, surgical site infection remains one of the most common causes of serious surgical complications, yet evidence indicates that proven measures, such as antibiotic prophylaxis immediately before incision and confirmation of effective sterilization of instruments, are inconsistently followed. This is not due to cost but due to the lack of systems in place. Last but not the least, measurement of impact is a key component of this challenge. Meaningful metrics ought to be identified, even if they relate only to surrogate processes, and they must be reasonable and quantifiable by stakeholders in every way. If the principles of simplicity, applicability, and measurability are followed the goal of successful implementation can be achieved easily. There is no single remedy available which can improve surgical safety. It calls for reliable completion of a sequence of necessary steps in care, not just by the surgeons but by the team of health-care professionals working in sync within a supportive health-care delivery system for the benefit of the patient, which is the end objective.

  Conclusion Top

With proper planning and checklist, steps are easily accomplished and are making a profound difference in the safety of surgical care and reducing mortality and morbidity. The introduction of the WHO Surgical Safety Checklist into operating rooms in various hospitals around the world was associated with marked improvement in surgical outcomes. Postoperative complication rates fell by 36% on average, and death rates fell by a similar amount.

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Conflicts of interest

There are no conflicts of interest.

  References Top

WHO – Patient safety/safe surgery. Availablefrom: https://www.who.int/patientsafety/safesurgery/en/. [Last accessed on 2022 Jun 25].  Back to cited text no. 1
Safe surgery save lives – WHO/IER/PSP/2008.07. World Health Organization; 2008. Reprint 2009. Available from: https://apps.who.int/iris/bitstream/handle/10665/70080/WHO_IER_PSP_2008.07_eng.pdf?sequence=1.  Back to cited text no. 2
Debas HT, Gosselin R, McCord C, Thind A. Surgery. In: Disease Control Priorities in Developing Countries. 2nd ed. Washington DC: International Bank for Reconstruction and Development and The World Bank Disease Control Priorities Project; 2006.  Back to cited text no. 3
Hansen D, Gausi SC, Merikebu M. Anaesthesia in Malawi: Complications and deaths. Trop Doct 2000;30:146-9.  Back to cited text no. 4
Gawande AA, Thomas EJ, Zinner MJ, Brennan TA. The incidence and nature of surgical adverse events in Colorado and Utah in 1992. Surgery 1999;126:66-75.  Back to cited text no. 5
Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6.  Back to cited text no. 6
Kable AK, Gibberd RW, Spigelman AD. Adverse events in surgical patients in Australia. Int J Qual Health Care 2002;14:269-76.  Back to cited text no. 7
Ronsmans C, Graham WJ, Lancet Maternal Survival Series Steering Group. Maternal mortality: Who, when, where, and why. Lancet 2006;368:1189-200.   Back to cited text no. 8
Ouro-Bang'na Maman AF, Tomta K, Ahouangbévi S, Chobli M. Deaths associated with anaesthesia in Togo, West Africa. Trop Doct 2005;35:220-2.  Back to cited text no. 9
McKenzie AG. Mortality associated with anaesthesia at Zimbabwean teaching hospitals. S Afr Med J 1996;86:338-42.  Back to cited text no. 10
Heywood AJ, Wilson IH, Sinclair JR. Perioperative mortality in Zambia. Ann R Coll Surg Engl 1989;71:354-8.  Back to cited text no. 11
Bickler SW, Sanno-Duanda B. Epidemiology of paediatric surgical admissions to a government referral hospital in the Gambia. Bull World Health Organ 2000;78:1330-6.  Back to cited text no. 12
McConkey SJ. Case series of acute abdominal surgery in rural Sierra Leone. World J Surg 2002;26:509-13.  Back to cited text no. 13
Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The quality in Australian health care study. Med J Aust 1995;163:458-71.  Back to cited text no. 14
Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377-84.  Back to cited text no. 15
United Kingdom Department of Health. An Organization with a Memory. London: Department of Health; 2000.  Back to cited text no. 16
Kable AK, Gibberd RW, Spigelman AD. Adverse events in surgical patients in Australia. Int J Qual Health Care 2002;14:269-76.  Back to cited text no. 17


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