A Systematic Review: Prevention of Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires
This systematic review provides an overview of the prevalence, root causes, existing guidelines, and the effectiveness of interventions to prevent wrong-site surgery, retained surgical items, and surgical fires. These events can potentially have devastating consequences for patients, as well as healthcare providers and facilities. Most importantly, all three events are considered preventable and must not be deemed to be an acceptable risk of surgery.
Investigators with the VA Evidence-Based Synthesis Program, located within the West Los Angeles VA Medical Center, conducted this systematic review at the request of the VA National Center for Patient Safety. For this review, investigators identified 125 empirical studies and four guidelines published from 2004 through February 2013 that met review criteria -- including studies that examined VA-specific data -- in order to answer the following four key questions.
Key Question #1
What is the prevalence of wrong-site surgery, retained surgical items, and surgical fires?
This review identified 28 studies reporting prevalence estimates for wrong-site surgery, 20 studies reporting on retained surgical items, and 3 on surgical fires. Findings show:
Prevalence of wrong-site surgery
- The median prevalence estimate for wrong-site surgery was 0.09 events per 10,000 surgical procedures.
- Two recent surveys showed that 50% of spine surgeons had performed one or more wrong-level spine operations during their career.
- Lifetime prevalence estimates cover a wide time span and include the pre-Universal Protocol period, thus newer estimates may change.
Prevalence of retained surgical items
- The median prevalence estimate for retained surgical items was 1.43 events per 10,000 surgical procedures.
- The most commonly reported item was a surgical sponge.
- Retained surgical items occurred even after surgical counts were recorded as correct.
Prevalence of surgical fires
- Estimates of per procedure surgical fires were not found.
- One survey showed that 23% of responding otolaryngology and head and neck surgeons had experienced at least one operating room fire in their career, and an analysis of the American Society of Anesthesiologists Closed Claims database highlighted that operating room fires accounted for nearly one-fifth of monitored anesthesia care claims.
Key Question #2
What are the identified root causes of wrong-site surgery, retained surgical items, and surgical fires?
Investigators identified 23 root cause analyses for wrong-site surgery, 18 studies reporting on retained surgical items, and 15 on surgical fires. Findings show:
Root cause analyses for wrong site surgery
- The root cause analyses report a large number of individual causes, risk factors, or contributing factors; however, a frequently reported cause for wrong-site surgery events was communication problems between staff members within or across units, e.g., incorrect information, misperception.
- A number of studies reported that not following policies, not performing safety procedures in a meaningful way, inadequate policies, and the lack of procedural standardization contributed to events.
Root cause analyses for retained surgical items
- Given the prevalence, only a limited number of root-cause analyses for retained surgical items were identified. Contributing factors noted in these analyses were case specific, e.g., emergency procedures, or related to the surgical environment, e.g., shift changes, incomplete counts, or poor communication.
Root cause analyses for surgical fires
- Surgical fires were caused by combinations of ignition sources, fuels, and the presence of oxygen.
- Fire risk increased with procedures involving the face and neck.
- Based on a survey for otolaryngologists, one study identified different fire scenarios and determined that the most common ignition sources were electrosurgical units, lasers, and light cords. Common fuels were endotracheal tubes and drapes or towels; in the large majority of cases, supplemental oxygen was in use.
Key Question #3
What is the quality of current guidelines in use to prevent wrong-site surgery, retained surgical items, and surgical fires?
Based on four guidelines, findings show:
- Common themes were the regular use of checklists, importance of standardized communication between the surgical team members, standardized steps to translate pre-procedure information, and multiple rechecking throughout the operative process.
- Specific steps and protocols for preventing wrong-site surgery, retained foreign bodies, and surgical fires were outlined in detail for all guidelines.
Key Question #4
What is the effectiveness of the individually identified interventions for the prevention of wrong-site surgery, retained surgical items, and surgical fires?
Investigators identified 70 evaluations of diverse intervention approaches aiming to prevent wrong-site surgery, retained surgical items, and surgical fires. Findings show:
- There are relatively few conclusive evaluations of interventions, and they present a number of challenges in design and interpretation. Interventions lacked validation, and most studies had insufficient or no comparators. Also, sample sizes were inadequate and follow-up periods were typically short.
- Apart from global Universal Protocol evaluations aiming to prevent wrong-site surgery, the level of evidence was very low.
- Investigators identified only a few empirical intervention evaluations focused on preventing surgical fires, and only one study evaluated the approach in more than 200 procedures.
This evidence synthesis will be used to develop a standardized, single, strong recommendation to VA facilities in the effort to eliminate these events.
Several states have now introduced mandatory reporting of wrong-site surgery, retained surgical items, and surgical fires; therefore, a comprehensive analysis of the regularly published state records could provide a valuable addition to the existing prevalence estimates. Moreover, as more data are collected, analyses of a large number of root cause analyses for Joint Commission accredited hospitals will be available; studies should employ multivariate analyses analyzing multiple, competing potential causes. Future intervention studies should not rely on standard statistical tests and evaluation formats, given that changes in the frequency of a rare event are investigated. Other methods of empirical evaluation, such as the use of adherence to process measures identified in institutional root cause analyses, use of near miss data, and the use of run charts or statistical process control would advance the evidence base to determine which interventions can successfully reduce the frequency of wrong-site surgery, retained surgical items, and surgical fires.
Comment from Operational Partner:
"The VHA, through collaboration between the National Surgery Office and National Center for Patient Safety, has a robust mechanism for reporting and tracking of adverse events including incorrect surgery, retained surgical items, OR fires, and OR burns. The report confirms VA's position as a healthcare leader in this regard." William Gunnar, M.D., National Director of Surgery, VA Patient Care Services.
A Cyberseminar session on this ESP Report will be held at a future date. To register, go to the HSR&D Cyberseminar web page.
This report is a product of VA/HSR&D's Quality Enhancement Research Initiative's (QUERI) Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers — and to disseminate these reports throughout VA.
Hempel S, Maggard MA, Nguyen D, Dawes AJ, Miake-Lye IM, Beroes JM, Shanman R, Shekelle PG. Prevention of Wrong Site Surgery, Retained Surgical Items, and Surgical Fires: A Systematic Review. VA-ESP Project #05-226;2013.
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