13 Summary of core topics, research questions and recommendations for the prevention of surgical site infection ...……….. Web appendices: www.who.int/gpsc/SSI-guidelines/en Appendix 1: Ov
Background
Target audience
The primary target audience for these guidelines is the surgical team, that is, surgeons, nurses, technical support staff, anaesthetists and any professionals directly providing surgical care.
Pharmacists and sterilization unit personnel should pay attention to the recommendations outlined in these guidelines They serve as a crucial resource for healthcare professionals tasked with creating national and local infection prevention protocols and policies, including policy-makers and those involved in infection prevention and control.
Involving senior managers, hospital administrators, and those responsible for quality improvement, patient safety, and staff education is essential for advancing the adoption and implementation of IPC guidelines.
Scope of the guidelines
The guidelines aim to prevent surgical site infections (SSI) in patients of all ages undergoing surgical procedures However, certain recommendations may not be applicable or lack evidence for the pediatric population The main outcomes evaluated for these recommendations include the incidence rates of SSI and mortality attributable to SSI.
The priority research questions that inform the evidence review and synthesis for each topic in these guidelines are detailed in the recommendations table found in the executive summary These questions have been elaborated in a PICO (Population, Intervention, Comparison, Outcomes) format, which can be accessed in full in web Appendices 2-27 at www.who.int/gpsc/SSI-guidelines/en.
The guidelines were developed following the standard recommendations described in the WHO
Handbook for guideline development (5)and according to a scoping proposal approved by the WHO Guidelines Review Committee
In summary, the process included: (i) identification of the primary critical outcomes and priority topics and formulation of the related PICO questions;
The process involves retrieving evidence through systematic reviews using a standardized methodology, assessing and synthesizing the gathered evidence, formulating recommendations, and finally, writing the content of the guidelines while planning for effective dissemination and implementation strategies.
The original plan for the guidelines featured a section on optimal implementation strategies for the recommendations, informed by a systematic literature review and expert insights However, due to the extensive scope and length of the document, and after consulting with the methodologist, this section was reconsidered.
Guidelines Review Committee secretariat, the
The Guideline Steering Group has opted not to include this section in the main document Instead, a brief chapter addressing this topic is provided, with a separate document to be released that will focus specifically on this subject to complement the guidelines.
The development of the guidelines involved the formation of four main groups to guide the process and their specific roles are described in the following sections.
The WHO Guideline Steering Group, led by the director of the Department of Service Delivery and Safety (SDS), included members from various teams, such as the SDS IPC team, the emergency and essential surgical care program, the Department of Pandemic and Epidemic Diseases, and the IPC team at the WHO Regional Office of the Americas.
The Group created the initial scoping document for guideline development, collaborating with the Guidelines Development Group (GDG) to pinpoint key outcomes and priority topics while formulating related questions in PICO format Additionally, they identified systematic review teams, the guideline methodologist, GDG members, and external reviewers.
The WHO Steering Group oversaw evidence retrieval and synthesis, organized GDG meetings, and prepared or reviewed the final guideline document They managed external reviewers' comments and handled the publication and dissemination of the guidelines Acknowledgements of the Steering Group members, along with their affiliations, can be found in the Annex (section 6).
The WHO Guideline Steering Group formed a Guidelines Development Group (GDG) comprising 20 external experts and stakeholders from six WHO regions, ensuring diverse representation from professional groups such as surgeons, nurses, IPC specialists, infectious disease experts, researchers, and patient advocates The selection process prioritized geographical diversity and gender balance GDG members contributed to drafting the guidelines' scope, formulating PICO questions, and identifying methodologies for systematic reviews, while also evaluating the relevant evidence.
Methods
WHO guideline development process
The guidelines were developed following the standard recommendations described in the WHO
Handbook for guideline development (5)and according to a scoping proposal approved by the WHO Guidelines Review Committee
In summary, the process included: (i) identification of the primary critical outcomes and priority topics and formulation of the related PICO questions;
The process involves systematically retrieving evidence through standardized reviews for each topic, assessing and synthesizing the findings, formulating recommendations, and crafting the content of the guidelines, along with planning effective strategies for dissemination and implementation.
The original plan for the guidelines featured a section on optimal implementation strategies for the recommendations, informed by a systematic literature review and expert insights However, due to the extensive scope and length of the document, consultations with the methodologist led to adjustments in this approach.
Guidelines Review Committee secretariat, the
The Guideline Steering Group has opted not to include this section in the main document Instead, a brief chapter addressing this topic is provided, with a separate document to be released that will focus specifically on this subject to complement the guidelines.
The development of the guidelines involved the formation of four main groups to guide the process and their specific roles are described in the following sections.
The WHO Guideline Steering Group, led by the director of the Department of Service Delivery and Safety (SDS), included members from various teams such as the SDS IPC team, the emergency and essential surgical care program, the Department of Pandemic and Epidemic Diseases, and the IPC team at the WHO Regional Office of the Americas.
The Group created the initial scoping document for guideline development, collaborating with the Guidelines Development Group (GDG) to pinpoint key outcomes and priority topics They formulated related questions using the PICO format and identified systematic review teams, the guideline methodologist, GDG members, and external reviewers.
The WHO Steering Group oversaw evidence retrieval and synthesis, organized GDG meetings, and prepared or reviewed the final guideline document They managed external reviewers' comments and facilitated the publication and dissemination of the guidelines Acknowledgements of the Steering Group members, along with their affiliations, can be found in the Annex (section 6).
The WHO Guideline Steering Group formed a Guidelines Development Group (GDG) comprising 20 external experts and stakeholders from six WHO regions, ensuring diverse representation from professional groups such as surgeons, nurses, IPC specialists, infectious disease experts, researchers, and patient advocates The selection process prioritized geographical diversity and gender balance GDG members contributed to drafting the guidelines' scope, formulating PICO questions, and identifying methodologies for systematic reviews, while also evaluating the relevant evidence.
2 METHODS used to inform the recommendations, advised on the interpretation of the evidence, formulated the final recommendations based on the draft prepared by the WHO Steering Group and reviewed and approved the final guideline document The members of the GDG are presented in the Annex
Given the high number of systematic reviews supporting the development of recommendations for the guidelines, a Systematic Reviews Expert
The Systematic Review Expert Group (SREG) was established, comprising highly skilled researchers and professionals specializing in specific topics and systematic reviews Although the WHO IPC team carried out some reviews, the majority of SREG experts voluntarily contributed their expertise as an in-kind support from their institutions to aid in the development of guidelines.
The SREG conducted systematic reviews and meta-analyses, creating individual summaries that are accessible as web appendices to the guidelines Additionally, it evaluated the quality of the evidence and developed evidence profiles based on the Grading of Recommendations.
Assessment, Development and Evaluation (GRADE) methodology.
Some SREG members were also part of the GDG.
However, according to the Guideline Review
To prevent intellectual conflicts and adhere to the committee's guidelines, experts who led systematic reviews were excluded from the consensus decision-making process regarding recommendations related to their reviews, especially during voting Additionally, the GDG chair, as a member of the SREG, was also excluded from decisions on recommendations stemming from systematic reviews conducted by him and his team In instances where the chair presented evidence from these reviews, another individual facilitated the session to maintain impartiality.
GDG member was identified to act as the chair
The members of the GDG are presented in the
Acknowledgements and the full list including affiliations is available in the Annex (section 6.1).
This group included five technical experts with a high level of knowledge and experience in the fields
The group meticulously examined the final guideline document to pinpoint factual inaccuracies and provided feedback on the technical content, clarity, and contextual implications for implementation They ensured that the decision-making processes reflected the values and preferences of potential users, including healthcare professionals and policymakers However, it was outside the group's scope to alter the recommendations established by the Guideline Development Group (GDG).
Valuable feedback from the WHO External Peer Review Group resulted in revisions to the recommendation text and accompanying explanations Acknowledgements of the group members can be found, with a complete list and their affiliations available in Annex section 6.4.
Evidence identification and retrieval
The SREG gathered evidence on the effectiveness of interventions for preventing surgical site infections (SSI) from both randomized controlled trials (RCTs) and necessary non-randomized studies The Guideline Steering Group provided the SREG with the methodology and outlined the expected outcomes of the systematic reviews, agreeing on the format and timelines for reporting Utilizing a prioritized list of topics, questions, and critical outcomes identified by the WHO Guideline Steering Group, the GDG, and the guideline methodologist, the SREG carried out its analysis.
27 systematic reviews between December 2013 and October 2015 to provide the supporting evidence for the development of the recommendations
Systematic searches were performed across multiple electronic databases, including Medline (Ovid), the Excerpta Medica Database, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Central Register of Controlled Trials, and WHO regional databases, to identify relevant studies published after January 1.
The GDG and SREG determined that relevant studies published before 1990 were included without a time limit Reviews incorporated studies in English, French, and Spanish, while also applying specific inclusion and exclusion criteria based on study design, sample size, and follow-up duration to address particular research questions Both studies from low- and middle-income countries (LMICs) and high-income countries were considered, with search strategies and evidence summaries for each systematic review available in web Appendices 2-27.
(www.who.int/gpsc/SSI-guidelines/en)
Two independent reviewers screened the titles and abstracts of retrieved references to identify potentially relevant studies The full texts of all eligible articles were obtained and independently reviewed by two authors according to specific inclusion criteria Duplicate studies were excluded, and both authors extracted data into a predefined evidence table while critically appraising the retrieved studies.
Quality assessment was conducted using the Cochrane Collaboration tool for evaluating the risk of bias in randomized controlled trials (RCTs) and the Newcastle-Ottawa Quality Assessment Scale for cohort studies Disagreements were addressed through discussion or, if needed, consultation with the senior author.
Meta-analyses were conducted using Review Manager version 5.3 to pool crude estimates as odds ratios (OR) with 95% confidence intervals (CI) through a random effects model The quality of the retrieved evidence was assessed using the GRADE methodology, which categorized the evidence into four levels: “high,” “moderate,” “low,” or “very low.”
High:We are very confident that the true effect lies close to that of the estimate of the effect.
We have a moderate level of confidence in the effect estimate, suggesting that the true effect is likely to be near the estimated value; however, there remains a possibility of a significant difference.
Low:Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low:We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect.
Table 2.2.1 GRADE categories for the quality of evidence
The results of the systematic reviews and meta- analyses were presented at four GDG meetings held in June 2014 and in February, September and
In November 2015, the evidence profiles and decision-making tables were reviewed to ensure clarity and consensus on scoring criteria Utilizing a standard GRADE decision-making table, recommendations were developed based on the overall quality of evidence, the balance of benefits and harms, values and preferences, and resource implications, as discussed among the GDG members Recommendations were classified as either “strong,” indicating confidence that benefits outweighed risks, or “conditional,” suggesting that benefits likely outweighed risks The final wording of the recommendations was achieved through consensus, and if consensus was not reached, the text was voted on, with the majority opinion of GDG members determining the outcome.
The GDG emphasized the phrase “the panel suggests considering…” in certain conditional recommendations to encourage users to engage in a comprehensive decision-making process and to allow for greater flexibility, particularly given the significant resource implications and feasibility concerns in LMICs Additionally, areas needing further research were identified, and after each meeting, final recommendation tables were distributed for written approval and comments from all GDG members.
Systematic reviews encompass patients of all ages, and the guidelines apply to both adult and pediatric patients unless otherwise noted in the recommendations or remarks.
Systematic reviews revealed a lack of studies focused on the pediatric population, prompting the GDG to evaluate the validity of recommendations on a topic-by-topic basis Consequently, some recommendations were found to be either inapplicable to children or unproven due to insufficient evidence.
The WHO secretariat prepared draft chapters of the guidelines with recommendations, which were shared with GDG members for final approval and feedback Suggested changes were integrated into a revised second draft For significant GDG comments that required substantial modifications, all members engaged in online or telephone discussions to achieve consensus on the text The edited second draft was subsequently circulated to external reviewers.
Peer Review Group and the Guideline Steering
The draft document underwent additional revisions to incorporate feedback from the group While most suggested changes to the wording of the recommendations or modifications to the document's scope were not accepted, three specific recommendations received similar feedback from reviewers, which the Guideline deemed significant.
The Steering Group engaged in additional discussions with the GDG via teleconferences, reaching a consensus to make minor adjustments to the recommendation text in response to the reviewers' feedback, all under the guidance of the methodologist.
The guideline methodologist ensured that the
GRADE framework was appropriately applied throughout the guideline development process.
The article discusses the comprehensive review of PICO questions and the outcomes of systematic reviews and meta-analyses, emphasizing the importance of participation in re-analyses to enhance quality It highlights the methodologist's role in evaluating evidence profiles and decision-making tables before and after GDG meetings, offering guidance in crafting the recommendations' wording and strength.
1 Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, et al.
Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis Lancet.
2 Report on the burden of endemic health are-associated infection worldwide A systematic review of the literature Geneva: World Health Organization; 2011.
3 Surveillance of surgical site infections in Europe 2010–2011 Stockholm: European Centre for Disease Prevention and Control; 2013 (http://ecdc.europa.eu/en/publications/Publicati ons/SSI(-in-europe-2010-2011.pdf, accessed
4 Guidelines for safe surgery; Safe Surgery Saves Lives Geneva: World Health Organization; 2009
(http://www.who.int/patientsafety/safesurgery/ tools_resources/9789241598552/en/, accessed
5 WHO Handbook for guideline development 2nd edition Geneva: World Health
Organization; 2014 (updated 23 July 2015) (http://www.who.int/kms/handbook_2nd_ed.pdf, accessed 13 July 2016).
6 Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, et al The Cochrane Collaboration's tool for assessing risk of bias in randomised trials BMJ 2011;343:d5928.
Important issues in the approach to surgical site infection prevention
Surgical site infection risk factors: epidemiology and burden worldwide
factors: epidemiology and burden worldwide
Surgical site infections (SSIs) are serious complications that can arise from any surgical procedure Despite being among the most preventable healthcare-associated infections (HAIs), SSIs continue to pose a significant challenge, contributing to increased patient morbidity and mortality, as well as incurring additional costs for healthcare systems and service payers globally.
SSI is both the most frequently studied and the leading HAI reported hospital-wide in LMICs (3, 4).
The prevention of surgical site infections (SSIs) has garnered significant attention from surgeons, infection control professionals, health care authorities, and the public, largely due to the perception that SSIs indicate substandard care This review aims to update global data on SSIs, with a particular emphasis on low- and middle-income countries (LMICs), assessing infection rates, associated risk factors, and the economic impact of these infections.
Summary of the available evidence
1 Burden of SSI a Evidence from high-income countries i USA
In 2010, an estimated 16 million surgical procedures were performed in acute care hospitals in the USA
(13) In a recent report on the rates of national and state HAIs based on data from 2014, 3654 hospitals reported 20 916 SSI among 2 417 933 surgical procedures performed in that year (5)
Of note, between 2008 and 2014 there was an overall 17% decrease in SSI in the 10 main surgical procedures As an example, there was a decrease of
17% in abdominal hysterectomy and 2% in colon surgery (5).
By contrast, a multi-state HAI prevalence survey conducted in 2011 estimated that there were 157
Between 2006 and 2008, surgical site infections (SSIs) were identified as the second most commonly reported healthcare-associated infection (HAI) Data from the National Healthcare Safety Network (NHSN) during this period revealed 16,147 SSIs occurring after 849,659 surgical procedures, resulting in an overall SSI rate of 1.9%.
AMR patterns of HAI in the USA have been described (16)and compared to a previous report
Among the 1,029 facilities that reported one or more surgical site infections (SSIs), Staphylococcus aureus was identified as the most prevalent pathogen, accounting for 30.4% of cases This was followed by coagulase-negative staphylococci at 11.7%, Escherichia coli at 9.4%, and Enterococcus faecalis at 5.9% The distribution of the top seven reported pathogens is summarized in Table 3.1.1.
3 IMPORTANT ISSUES IN THE APPROACH TO SURGICAL SITE
Rank Pathogen No of pathogens/ Antimicrobial No of isolates Resistance total SSI pathogens agent (s) tested (%) (%) reported (%)
2 Coagulase-negative staphylococci 2477 (11.7) NA NA NA
Table 3.1.1 Distribution and percentage of pathogenic isolates associated with SSI and resistant to selected antimicrobial agents, NHSN, 2009-2010*
The National Healthcare Safety Network (NHSN) monitors surgical site infections (SSI) and the prevalence of multidrug resistance in pathogens Key resistance markers include the multidrug resistance 1 gene (MDR1) and multidrug resistance 2 gene (MDR2), which indicate resistance to various antibiotic classes such as extended-spectrum cephalosporins (ESC4 and ESC2), fluoroquinolones (FQ3 and FQ2), aminoglycosides, carbapenems, and piperacillin/tazobactam Notably, carbapenems include imipenem and meropenem, while vancomycin (VAN) and aminoglycosides (AMINOS) like amikacin, gentamicin, and tobramycin are also critical in treatment protocols.
To investigate the costs of SSI, a study used the
2005 hospital stay data from the US Nationwide
Inpatient Sample, which represents 1054 hospitals from 37 states Extra hospital stay attributable to SSI was 9.7 days with increased costs of
US$ 20 842 per admission From a national perspective, SSI cases were associated with
406 730 extra hospital days and hospital costs exceeding US$ 900 million An additional 91 613 readmissions for the treatment of SSI accounted for a further 521 933 days of care at a cost of nearly US$ 700 million (18).
According to Control and Prevention, the estimated hospital costs associated with surgical site infections (SSI) range from US$ 1,087 to US$ 29,443 per infection, adjusted for 2007 levels SSI is recognized as the healthcare-associated infection (HAI) with the highest annual cost range, estimated between US$ 3.2 billion and US$ 10 billion Additionally, a European point prevalence survey of HAIs and antimicrobial use conducted in 2011-2012 highlighted significant findings from 20 networks across 15 European countries.
Union countries and one European Economic
Area country using a standardized protocol (21).
Hip prosthesis was the most frequently reported surgical procedure and represented 33% of all operations The cumulative incidence of patients with SSI was the highest in colon surgery with 9.5%
The incidence of surgical site infections (SSI) varies across different procedures, with rates of 3.5% for coronary artery bypass grafts, 2.9% for caesarean sections, 1.4% for cholecystectomies, 1.0% for hip prostheses, 0.8% for laminectomies, and 0.75% for knee prostheses Notably, there has been a decline in SSI rates for several procedures, including caesarean sections, hip prostheses, and laminectomies, indicating that prevention efforts and surveillance in participating hospitals have been effective.
Figure 3.1.1 Cumulative incidence for SSI by year and type of procedure: European Union/European Economic Area countries, 2008–2011
Data source: ECDC, HAI-Net SSI patient-based data 2008–2011
(http://ecdc.europa.eu/en/activities/surveillance/Pages/data-access.aspx#sthash.hHYRJ9ok.dpuf, accessed 21 May 2016).
SSI: surgical site infection; CABG: coronary artery bypass graft; CHOL: cholecystectomy; COLO: colon; CSEC: caesarean section; HPRO: hip prosthesis; KPRO: knee prosthesis; LAM: laminectomy.
A study published in 2004 reviewed data from 84 studies and estimated the economic costs of SSIs in Europe to range between ú 1.47–19.1 billion
It predicted also that the average patient stay would increase by approximately 6.5 days and cost
3 times as much to treat an infected patient
The analysis suggested that the SSI-attributable economic burden at that time was likely to be underestimated (10).
In France, approximately 3% of surgical procedures lead to infections, incurring an annual cost of nearly €58 million Additionally, patients with surgical site infections (SSI) face a mortality risk that is 4 to 15 times higher, along with a threefold increase in their hospital stay duration.
In Switzerland, the prevalence of surgical site infections (SSI) was found to be 5.4% in a study involving 50 acute care hospitals as part of the Swiss Nosocomial Infection Prevalence surveillance programme Additionally, a 13-year multicentre SSI surveillance from 1998 to 2010 reported varying SSI rates: 18.2% after 7,411 colectomies, 6.4% after 6,383 appendicectomies, 2.3% after 7,411 cholecystectomies, 1.7% after 9,933 herniorrhaphies, 1.6% after 6,341 hip arthroplasties, and 1.3% after 3,667 knee arthroplasties.
In Italy, the SSI rate reported by the “SistemaNazionale di Sorveglianza delle Infezioni del SitoChirurgico” (national SSI surveillance system) from
Between 2009 and 2011, Italian surgical wards reported a surgical site infection (SSI) rate of 2.6% per 100 procedures, totaling 1,628 cases out of 60,460 procedures Notably, 60% of SSIs were identified through surveillance conducted within 30 days post-discharge The highest SSI rates were observed in colon surgery (9.0%), rectal surgery (7.0%), laparotomy (3.1%), and appendectomy (2.1%).
A recent report from National Health Service hospitals in England revealed cumulative surgical site infection (SSI) rates from January 2008 to March 2013 The data indicated that large bowel surgery had the highest SSI rate at 8.3% (95% CI: 7.9–8.7 per 1000 inpatient days), followed by small bowel surgery at 4.9% (95% CI: 4.3–5.7), and both bile duct, liver, and pancreatic surgery also at 4.9% (95% CI: 4.1–5.9) Cholecystectomy had an SSI rate of 4.6% (95% CI: 3.1–6.6).
The lowest rate was reported for knee prosthesis
Between April 2010 and March 2012, data indicated that the median additional length of hospital stay due to surgical site infections (SSI) was 10 days, with a range of 7 to 13 days Over this two-year period, a total of 4,694 bed-days were lost in Australia.
A study evaluated the time trends in SSI rates and pathogens in 81 Australian health care facilities participating in the Victorian Healthcare
Associated Infection Surveillance System A total of 183 625 procedures were monitored and 5123
SSIs were reported S aureus wasthe most frequently identified pathogen, and a statistically significant increase in infections due to ceftriaxone- resistant E coliwas observed (relative risk: 1.37;
Data from the Japan nosocomial infection surveillance system showed that 470 hospitals voluntarily participated in SSI surveillance in 2013
A retrospective study from 2006 to 2008 revealed that surgical site infections (SSI) significantly increased postoperative hospitalization duration and healthcare costs Patients with SSI experienced an average hospitalization extension of 20.7 days and an increase in healthcare expenses by US$ 8791 Specifically, in abdominal surgeries, SSI led to an average hospitalization increase of 17.6 days and an additional cost of US$ 6624 Furthermore, a recent assessment using the Japan nosocomial infection surveillance system indicated that the cumulative incidence of SSI was 15.0% for colon surgeries and 17.8% for rectal surgeries.
A multicentre surveillance study from 2000 found that surgical site infections (SSIs) accounted for 17.2% of all healthcare-associated infections (HAIs) reported across 15 acute care hospitals Additionally, the 2009 national SSI surveillance system report detailed the incidence and risk factors associated with SSIs across seven different types of surgical procedures, revealing an SSI rate of 3.68% per 100 operations.
(22/1169) after craniotomies, 5.96% (14/235) for ventricular shunt operations, 4.25% (75/1763) for gastric operations, 3.37% (22/653) for colon surgery, 5.83% (27/463) for rectal surgery, 1.93% (23/1190) for hip joint replacement and 2.63%
Between 2010 and 2011, a web-based surveillance study was conducted across 43 hospitals to assess the incidence of surgical site infections (SSIs) following 15 surgical procedures The study found an overall SSI rate of 2.10% from a total of 18,644 operations, with variations observed across different types of surgery Additionally, a systematic review of literature from 1995 to 2010 indicated that the incidence of SSIs in the Republic of Korea ranged from 2.0% to 9.7%, highlighting the epidemiological and economic impact of these infections.
Surgical site infection surveillance: definitions and methods and impact
surveillance: definitions, methods and impact
The surveillance of HAI is one of the core components of an effective IPC programme (1, 2)
However, defining, detecting, reporting and interpreting HAI, including SSI, is challenging and requires expertise, time and resource dedication
Definitions of surveillance and SSI
Surveillance is defined as “the ongoing, systematic collection, analysis, interpretation and evaluation of health data closely integrated with the timely dissemination of these data to those who need it” (3)
There are numerous definitions of Surgical Site Infections (SSI), with a systematic review identifying up to 41 distinct definitions Among these, only five are recognized as standardized definitions established by multidisciplinary groups Notably, over one-third of the studies referenced the US CDC definitions from 1988 or 1992 The review's authors advocate for a unified definition to facilitate longitudinal analysis and benchmarking, yet they acknowledge the absence of a definitive gold standard test for surgical wound infections Additionally, many countries implement the Healthcare-Associated Infections (HAI) SSI protocol developed by the European Centre for Disease Prevention and Control (ECDC).
The main goal of surveillance is to gather data on surgical site infection (SSI) rates to assess the extent of the issue This data must be analyzed to uncover trends and interpret the results accurately Ultimately, surveillance data should inform the development of improvement strategies and assess the success of these interventions Additionally, sharing SSI rate feedback with relevant stakeholders is crucial for effective response and action.
The landmark study in the 1970s highlighted the significant benefits of Healthcare-Associated Infection (HAI) surveillance, demonstrating that an Infection Prevention and Control (IPC) program incorporating both surveillance and control measures effectively reduced nosocomial infections in the USA.
SSI rates significantly (5) Importantly, surveillance of SSI is part of the WHO safe surgery guidelines
(6) Many countries have introduced mandatory surveillance of HAI, including SSI, such as the UK and certain states in the USA, whereas other countries have voluntary-based surveillance, such as
France, Germany, and Switzerland exhibit significant variations in surveillance types, duration, and methods National networks and interconnected systems, such as the CDC NHSN, ECDC HAI Surveillance Network (HAI-Net), and the International Nosocomial Infection Control, are increasingly being established.
Standardized definitions of Healthcare-Associated Infections (HAI) and Surgical Site Infections (SSI) enable inter-hospital comparisons and benchmarking A crucial aspect of these surveillance networks is providing feedback to individual hospitals.
Research suggests that a "surveillance effect," akin to the Hawthorne effect observed in clinical trials, may arise; this means that merely being aware of being observed can enhance practices or adherence to guidelines.
A successful surveillance program can lower surgical site infection (SSI) rates by encouraging institutions to investigate why their rates exceed benchmarks By identifying process indicators, institutions can address areas of "underperformance" and implement local initiatives for improvement However, evidence regarding the effectiveness of surveillance networks on SSI rates is mixed; some studies indicate a reduction in SSI rates following network participation, while others show no significant effect This discrepancy highlights a critical methodological concern that warrants further examination.
The addition of smaller hospitals to a network, without considering their years of participation, can obscure the reduction in the time trend of surgical site infection (SSI) rates This issue was addressed in analyses of German data, where hospitals were categorized by their participation year, and in studies from the Netherlands and Switzerland, which stratified SSI rates by surveillance time in consecutive one-year periods, using the first year as a reference The findings from the Dutch and German studies indicated a decline in SSI rates over time following surveillance, while the Swiss study did not observe a similar trend.
Conversely, as shown in clinical trials, intensive surveillance may lead to the detection of higher SSI rates than under standard surveillance conditions.
As an example, in a recent clinical trial comparing skin antiseptic agents for caesarean section, the SSI rate was 4.0% in one arm and 7.3% in the other
(15).These rates seem higher than the most recently available data from the ECDC, which show an SSI rate of 2.9% (inter-country range:0.4%-6.8%) (16).
Country (name of network) Duration of surveillance Procedures Change in SSI rate Reference England
SSISS: surgical site infection surveillance service; ISO-RAISIN: Infections du Site Opératoire-Réseau d’alerte, d’investigation et de surveillance des infections nosocomiales; KISS: Krankenhaus Infektions Surveillance System; PREZIES: Preventie
Ziekenhusinfecties door surveillance; SENIC: study on the efficacy of nosocomial infection control.
Table 3.2.2 Temporal trends of SSI rates after surveillance in selected networks*
The US Association for Professionals in Infection Control and Epidemiology states that there is no definitive method for designing or implementing surveillance Nonetheless, certain minimal requirements have been established to ensure the quality of surveillance.
A comprehensive surveillance plan should outline clear goals and objectives while maintaining a rigorous and consistent approach to monitoring Key components include standardized definitions and calculation methods, sufficient trained personnel in epidemiology, robust informatics and computer support, and effective evaluation methods to assess the surveillance process.
For a surveillance programme to be successful, there should be a method of data validation to ensure that data are accurate and reliable (22), particularly for benchmarking purposes, as discussed further (23).
In the field of SSI, most surveillance systems target colorectal surgery and total hip and knee arthroplasty The most common outcome indicator is the cumulative SSI incidence (or SSI
Denominator data for any given period reflect the total number of procedures within each category, while patient counts can also serve as denominators, though they are less accurate due to the possibility of multiple infections in a single patient The numerator data indicates the number of surgical site infections (SSIs) during that same timeframe Comprehensive demographic information, including age, sex, timing and choice of antimicrobial prophylaxis, American Society of Anesthesiologists score, operation duration, and wound contamination class, is collected for all patients Additionally, details regarding the site of infection and type of SSI—whether superficial, deep, or organ/space—are documented for those affected by SSIs Linking this data with microbiological information can provide further insights.
The gold standard is prospective direct surveillance, although it is time- and labour-intensive and costly
(24) The CDC recommendations describe indirect methods of surveillance (sensitivity of 84-89%; specificity 99.8%) as a combination of:
1 Review of microbiology reports and patient medical records.
2 Surgeon and/or patient surveys.
3 Screening for readmission and/or return to the OR.
4 Other information, such as coded diagnoses,coded procedures, operative reports or antimicrobials ordered (24)
The importance of post-discharge surveillance
A significant proportion of surgical site infections (SSIs) are identified after patient discharge, with estimates ranging from 13% to 71% The decreasing length of hospital stays over recent decades has likely shifted the burden of infections from inpatient to outpatient settings Additionally, implant-associated infections may not manifest until a year post-procedure, highlighting the importance of post-discharge surveillance However, there is currently no established gold standard for this surveillance, and a systematic review has found only seven studies comparing various surveillance methods.
(26) Due to variations in data collection and classification, as well as missing information regarding diagnostic criteria, no synthesis of post-discharge surveillance data was possible
The authors concluded that more research is required regarding the measurement of SSI after hospital discharge.
There has been recent controversy regarding the
The CDC has decided to reduce the duration of post-discharge surveillance from one year to 90 days following specific procedures, aiming to simplify the process and minimize delayed feedback However, this change has not been widely implemented across the board A recent report analyzed historical prospective surgical site infection (SSI) surveillance data from a network in the USA and compared it to the retrospective application of the new guidelines.
A study revealed that 9.6% of surgical site infections (SSIs) identified by the previous CDC definitions were missed under the new definitions, with 28.8% of these undetected cases related to hip and knee prostheses The missed SSI rates varied by procedure, notably high for hip (8.8%) and knee prostheses (25.1%) Additionally, an analysis from the Dutch SSI surveillance network indicated that the rates of missed SSIs were 6% for hip and 14% for knee prostheses Crucially, the research highlighted that the new CDC post-discharge surveillance method resulted in a greater risk of failing to detect SSIs compared to the earlier approach.
How to report surveillance data
There is ongoing debate in the literature about the most effective outcome indicator for surveillance systems reporting surgical site infection (SSI) rates Some researchers advocate for using the incidence density of in-hospital SSIs, as it accounts for varying lengths of hospital stays and different post-discharge surveillance methods This approach necessitates the accurate recording of patient discharge dates.
Importance of a clean environment in the operating room and decontamination of medical
environment in the operating room and decontamination of medical devices and surgical instruments
Environmental contamination has historically been underestimated in its impact on healthcare-associated infections (HAI) Recent studies highlight the critical role that a contaminated healthcare environment plays in the spread of microorganisms To mitigate this risk, it is vital to ensure that operating rooms (OR) are cleaned thoroughly every day, and that proper mechanical ventilation is in place to prevent surgical wound contamination from unfiltered air.
In the operating room (OR), it is essential to dilute and eliminate microorganisms released from skin scales Chapter 4.23 of these guidelines provides specific recommendations for optimal ventilation systems in the OR, including evidence-based insights on the use of laminar flow.
Environmental cleaning and waste management in the OR
Cleaning involves eliminating dust, dirt, and contaminants from surfaces to maintain a hygienic environment for both patients and staff It is essential to adhere to general principles of good practice during the cleaning process Specific cleaning requirements for different surfaces are outlined in Table 3.3.1.
To maintain a clean environment, start each day by wiping all flat surfaces with a clean, lint-free moist cloth to eliminate dust and lint It is essential to clean hand-touch surfaces and areas that may have been exposed to patients' blood or body fluids by first using a detergent solution, followed by disinfection in accordance with hospital policy, and allowing them to dry properly.
Effective environmental cleaning is crucial before any disinfection process, as it removes dirt, debris, and other materials Utilizing a neutral detergent solution enhances cleaning quality by preventing biofilm build-up, which in turn boosts the efficacy of chemical disinfectants When using disinfectants, it is vital to follow the manufacturer's instructions for preparation and dilution, as incorrect concentrations can diminish their effectiveness.
In addition, high concentrations of disinfectant may damage surfaces. ủ Cleaning should always start from the least soiled areas (cleanest) first to the most soiled areas
When cleaning, always start from the highest surfaces and work downwards to prevent debris from falling onto already cleaned areas It is essential to discard detergent and disinfectant solutions after each use Avoid cleaning methods that create mists, aerosols, or disperse dust, such as dry sweeping, dry mopping, or spraying While routine bacteriological monitoring is not mandatory, it can be beneficial for identifying potential outbreak sources and for educational purposes.
Table 3.3.1 Cleaning requirements for various surface types in ORs
(floors, walls, ceilings, window sills, etc.)
Surface contaminated with blood and body fluids
Any surface with frequent contact with hands.
Not in close contact with the patient or his/her immediate surroundings.
Any areas that are visibly contaminated with blood or other potentially infectious materials.
Requires special attention and more frequent cleaning.
Afterthorough cleaning, consider the use of appropriate disinfectants to decontaminate these surfaces.
Requires cleaning on a regular basis with detergent only or when soiling or spills occur Also required following patient discharge from the health care setting.
Require normal domestic cleaning with detergent only.
Clean toilet areas at least twice daily and as needed.
Cleaning must adhere to established protocols, such as daily, weekly, or post-patient use schedules It is essential to utilize suitable personal protective equipment and employ cleaning methods that are appropriate for the specific types of surfaces, in accordance with the designated cleaning schedules.
Regularly updated schedules and procedures are essential, along with comprehensive education and training for all cleaning staff It is crucial to consult the manufacturer's instructions for medical equipment to prevent any damage from disinfectants.
Requires prompt cleaning and disinfection (see below).
All spills should be promptly and thoroughly cleaned, with surfaces disinfected in accordance with hospital protocols It is essential to wear domestic heavy-duty gloves during this process, and a single-use plastic apron should be utilized if there is a risk of body contamination The use of a gown and mask is not required.
When handling chemicals with spill risks, it is essential to wear appropriate protective gear such as face shields or goggles, depending on the disinfectant used All waste generated in the operating room must be collected in closed, leak-proof containers, while soiled linen should be securely placed in plastic bags for proper disposal Additionally, all reusable medical devices should be sent to the sterile services department or decontamination unit for reprocessing.
To ensure proper hygiene, the operating table, including the mattress and surfaces, must be thoroughly cleaned with a detergent solution Additionally, all areas that have been in contact with a patient or their bodily fluids require disinfection using a suitable disinfectant solution, following local protocols.
At the end of each day, a comprehensive cleaning of the surgical suite is essential, including scrub sinks, utility areas, hallways, and equipment, regardless of usage Soiled linens must be disposed of in closed, leak-proof containers, and all contaminated waste should be replaced with clean containers Sharps containers should be closed and removed when they are three-quarters full Surfaces should be cleaned from top to bottom with detergent, and disinfectants may be used as needed before allowing them to dry To minimize microbial contamination, walls, ceilings, and floors should also be thoroughly cleaned with detergent and allowed to dry Routine disinfection or fumigation of the operating room is unnecessary, even after contaminated surgeries.
3.3.2 Decontamination of medical devices and surgical instruments
Decontamination is a complex and highly specialized subject This section provides a brief summary on the decontamination and reprocessing of reusable medical devices and patient care equipment
Figure 3.3.1 Example of cleaning frequencies in preoperative and postoperative care areas
Reproduced with permission from reference 6.
In countries with established programmes, decontamination is a speciality in its own right and is an independent, quality-assured and accountable service delivered to health care institutions
The entire process of decontamination is highly regulated and governed by clearly defined guidelines and standards, which are established at both national and international (International
Organization for Standardization) levels This ensures validation of the processes and patient safety (7-10).
In low- and middle-income countries (LMICs), the field of decontamination science is still developing, with limited structured decontamination programs, as highlighted during the recent Ebola outbreak The scarcity of sterile instruments and inadequately designed operating rooms, along with insufficient sterile services, significantly contributes to the prevalence of surgery-associated infections (SSIs) in these regions.
The WHO and Pan American Health Organization (PAHO) have developed a manual for decontamination and reprocessing in healthcare facilities to enhance care standards and support operational activities.
In the USA, decontamination specifically refers to the reprocessing that occurs after cleaning, while in the UK and Europe, it encompasses the entire process, including cleaning This distinction is important and is highlighted in this chapter (see Table 3.3.2).