Skip to Content

Introduction

The Guideline for Prevention of Retained Surgical Items has been approved by the AORN Guidelines Advisory Board. It was presented as a proposed guideline for comments by members and others. The guideline is effective January 15, 2016. The recommendations in the guideline are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative or other invasive procedures may be performed.

Purpose

This document provides guidance to perioperative team members for prevention of retained surgical items (RSIs) in patients undergoing operative and other invasive procedures. Guidance is provided for implementing a consistent multidisciplinary approach to preventing RSIs, accounting for surgical items (ie, radiopaque soft goods, sharps and miscellaneous items, instruments), preventing retention of device fragments, reconciling count discrepancies, and using adjunct technologies to supplement manual count procedures.

An RSI is a rare but serious preventable error that can result in patient harm. Thus, perioperative team members are ethically and morally obligated to protect patients by preventing RSIs. Case reports of RSIs are documented in the literature, with a case series report dating from as early as 1884.1  Patient injuries from RSIs vary by the type of item retained (eg, sponge, metal), time to diagnosis, and location of the RSI.2 

The most common items retained are surgical sponges.3-7  Other reported RSIs include instruments,4,5,7,8  needles,8  and items such as guidewires.5,7,8 

Time to diagnosis of an RSI can vary greatly. According to Gawande et al,4  only 6% of RSIs are identified on the operative day. The time to diagnosis ranged from the operative day to 6.5 years, with a median time of 21 days.4 

The location of an RSI depends on the type of procedure performed. The abdomen and pelvis are reported to be the locations where RSIs are most often found.3,9  Retained surgical sponges in the abdomen or pelvis can migrate to the intestine, bladder, thorax, or stomach.10  Other locations for RSIs include the thorax, vagina, and other natural orifices.3  Retained radiopaque sponges have also been found in the spine, head, neck, and extremities.4,9 

Retention of items can have disastrous outcomes for patients, such as in the case of a patient’s death from myocardial infarction caused by an unintentionally retained pacing wire.11  In another report, a patient presented with a femur fracture from a retained surgical sponge near the bone.12  Retained surgical items (ie, guidewires, intravascular devices, broken instruments) in the vascular system can cause complications such as thrombosis, embolization, arrhythmia, tamponade, perforation, or even death.13-17 

Although patient injury largely depends on variables related to the item retained, overall outcomes are well-documented in the literature. Reported patient outcomes from RSIs include re-operation, readmission or increased length of hospital stay, physical harm, death, and emotional harm.2,3,18  Re-operation is the most common consequence, reported to occur in 64.8% to 69% of RSI cases.4,8  Readmission or increased length of stay from an RSI have been reported in 30% to 59% of cases.4-6 

Physical harm outcomes include infection, fistula development or obstruction, and perforation. Infection is the most reported physical harm, with occurrence ranging from 10% to 43%.4-6  Development of a fistula or obstruction has been reported to be 15% to 18%, and perforation has been reported to occur in 3% to 7% of RSI cases.4-6  Mehtsun et al19  categorized physical harm as being temporary in 78.1% of patients and permanent in 16.3% of patients with an RSI. Death is a less common event, occurring in 2% to 6% of cases.4,6,19  Although emotional harm has not been uniformly reported, one publication estimated the prevalence to be 1.1%.19  Further research is needed to assess emotional harm to the patient who has experienced an RSI as this value is likely to be underestimated.

In a survey conducted by Steelman et al,20  61% of perioperative nurses identified the prevention of RSIs as one of the top priorities for perioperative patient safety. Avoiding injuries from care that is intended to help patients was identified by the Institute of Medicine as one of six goals to achieve a better health care system.21  Because an RSI is an event that presents significant risk for patient harm, many states require public reporting when RSI events occur.22  Federal and state agencies, accrediting bodies, third-party payers, and professional associations consider an unintentionally retained foreign object or RSI to be a serious and largely, if not entirely, preventable event (eg, never event, hospital-acquired condition, sentinel event, serious reportable event).2,23  Consequently, health care organizations and providers will not be reimbursed for additional care provided as a result of an RSI.19,24,25  Although the exact costs are highly variable, RSIs can be costly and burdensome to the health care system. Two cost-analysis reports of RSIs in pediatric patients estimated additional hospital charges to be $35,68126  and $42,07727  for this complication in 2010 and 2009, respectively.

Current law does not prescribe what methods should be used to prevent RSIs, who should use them, or even that they need to be used. The law does, however, require that surgical items not intended to remain in the patient be removed. The doctrine of res ipsa loquitur (ie, “the thing speaks for itself”) is most applicable in RSI incidents. Therefore, time and effort in legal tort cases is spent assigning blame or fault for the act because it is not always necessary to prove negligence. Furthermore, the “captain of the ship” doctrine is no longer assumed to be true, and members of the entire surgical team as well as the health care facility can be held liable in RSI litigation.28-30  Although a review of legal case findings is outside the scope of this document, the evidence review undertaken for the development of this document indicated that legal expenses and settlement payments can vary greatly, adding to the health care costs associated with RSIs. Mehtsun et al19  estimated the cost of malpractice payments for a surgical retained foreign body to range from $51 to $3,988,829, with a mean of $86,247 and median of $33,953. In 2003, Gawande et al4  estimated malpractice claim expenses to average $52,581 per case.

Prevention of RSIs requires a multidisciplinary approach that aims to reduce the risks associated with RSIs. The risk for an RSI exists even in the smallest of incisions. The following risk factors have been significantly associated with RSIs:

  • incorrect count,3 

  • unexpected change due to intraoperative factors,3 

  • more than one surgical team,3,31 

  • no count (due to inability or emergent situations),3 

  • more than one procedure,3 

  • long procedure,3,31 

  • blood loss > 500 mL,3 

  • high body mass index (BMI),4,6 

  • emergency procedure,4  and

  • occurrence of a safety variance during the procedure.6 

Unexpected procedure events and equipment failure are specific risk factors that have been significantly associated with intravascular RSIs.32 

A long-standing and evidence-based strategy for preventing RSIs is to account for all items opened or used during the operative or invasive procedure. Health care organizations are responsible for employing standardized, transparent, verifiable, reliable practices to account for all surgical items used during a procedure. Counts of radiopaque soft goods, sharps, miscellaneous items, and instruments are performed to account for all items used on the surgical field. However, there is a significant potential for inaccurate counts with the use of manual counting practices.31,33,34  The use of adjunct technology may improve counting accuracy.8,35-39 

Beyond the count, systems and human factors play a significant role in contributing to RSIs. Therefore, behavioral changes and an understanding of risk-reduction strategies unique to each setting should be employed in the adoption of systems to account for surgical items. Improving system reliability to enhance the performance of human factors may reduce error and improve patient safety.40  A systems approach to preventing RSIs includes using standardized counting and reconciliation procedures, methodical wound exploration, radiological confirmation, adjunct technology, team training,41,42  and enhanced communication to promote optimal perioperative patient outcomes.2,18,43-46 

Further research is needed to determine the incidence of RSIs. Various estimates of RSI incidence have been reported in the literature (Table 1), although RSIs are widely thought to be underreported due to medicolegal consequences. Lack of a universal definition of RSI and varying reporting requirements have limited the ability to interpret RSI data.19,47  Other issues that complicate the interpretation of RSI incidence include selection bias (eg, severity of cases, patient or payer mix, voluntary reporting), time frames for data collection, varying use of RSI prevention methods, and different procedural settings (eg, hospitals, ambulatory centers).

The limitations of the evidence are that randomized controlled trials of RSI prevention interventions may expose patients to harm and, as such, would not be ethical.5  Case-control studies of RSI have been conducted and contribute valuable knowledge to the field. However, interpretation of these studies is limited by the nature of this type of research, which can only show association among study variables and cannot determine causation. Because of a lack of research on interventions to prevent RSIs, much of the available evidence is based on generally accepted practices, which were first published in the AORN “Standards for sponge, needle, and instrument procedures” in 1976.

The following topics are outside the scope of this document: retrieval techniques and treatment options for RSIs, management of broken surgical drains during removal, post-procedure management of broken central line catheters, and management of retained endoscopy capsules in the gastrointestinal tract.

Evidence Review

A medical librarian conducted a systematic search of the databases Ovid MEDLINE®, EBSCO CINAHL®, Scopus®, and the Cochrane Database of Systematic Reviews. The search was limited to literature published in English from 2009 through June 2014; editorials, news, and brief items were excluded. The lead author later requested supplementary searches on aspects of inaccuracy in counting and the roles of distraction, noise, and human factors in medical error. Between June 2014 and April 2015, the results of alerts established at the time of the initial search were assessed, and the lead author requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. Finally, the lead author and the medical librarian identified relevant guidelines from government agencies, professional organizations, and standards-setting bodies.

Table 1.
Incidence of Retained Surgical Items (RSIs) by Publication Year
Author (Year)  RSI Definition  Data Source  Incidence (RSIs per surgeries) 
Hempel et al1 (2015)  Various  Secondary (21 incidence studies)  1:10,000 
The Joint Commission2 (2015)  Unintended retention of a foreign object after surgery (after completion of skin closure)  2004-2014 reports to The Joint Commission  986 RSIs total, surgery data not reported 
Moffatt-Bruce et al3 (2014)  Not provided  Secondary4,10  0.3:1,000 to 1:1,000 
Stawicki et al4 (2013)  Unintentionally retained surgical item after final skin or fascial (if skin is left open) wound closure  2003-2009, multicenter  1:6,975 
Chen et al5 (2011)  AHRQ Patient Safety Indicator 5 definition: ICD-9-CM codes 998.4, 998.7, and E891.x  2003-2007 fiscal years, Veterans Affairs hospitals  0.12:1,000 
Shah & Lander6 (2009)  ICD-9-CM codes 998.4 and E871.0  2003, Kids’ Inpatient Database  1:32,672 
World Health Organization7 (2009)  Not discussed  Secondary  1:5,000 to 1:19,000 as high as 1:1,000 
Cima et al8 (2008)  Object unintentionally retained at time of final wound closure or end of procedure if no wound  2003-2006, Mayo Clinic Rochester  1:5,500 or 0.178:1,000 
Egorova et al9 (2008)  Retention of surgical instrument, needle, or sponge  2000-2004, Major academic health center and affiliated hospitals  1:7,000 
Gawande et al10 (2003)  Retention of a surgical instrument or sponge  1985-2001 closed claims in Massachusetts  1:8,801 to 1:18,760 
Hyslop & Maull11 (1982)  Retained surgical sponge  Not reported  Celiotomies 1:1,000 
Author (Year)  RSI Definition  Data Source  Incidence (RSIs per surgeries) 
Hempel et al1 (2015)  Various  Secondary (21 incidence studies)  1:10,000 
The Joint Commission2 (2015)  Unintended retention of a foreign object after surgery (after completion of skin closure)  2004-2014 reports to The Joint Commission  986 RSIs total, surgery data not reported 
Moffatt-Bruce et al3 (2014)  Not provided  Secondary4,10  0.3:1,000 to 1:1,000 
Stawicki et al4 (2013)  Unintentionally retained surgical item after final skin or fascial (if skin is left open) wound closure  2003-2009, multicenter  1:6,975 
Chen et al5 (2011)  AHRQ Patient Safety Indicator 5 definition: ICD-9-CM codes 998.4, 998.7, and E891.x  2003-2007 fiscal years, Veterans Affairs hospitals  0.12:1,000 
Shah & Lander6 (2009)  ICD-9-CM codes 998.4 and E871.0  2003, Kids’ Inpatient Database  1:32,672 
World Health Organization7 (2009)  Not discussed  Secondary  1:5,000 to 1:19,000 as high as 1:1,000 
Cima et al8 (2008)  Object unintentionally retained at time of final wound closure or end of procedure if no wound  2003-2006, Mayo Clinic Rochester  1:5,500 or 0.178:1,000 
Egorova et al9 (2008)  Retention of surgical instrument, needle, or sponge  2000-2004, Major academic health center and affiliated hospitals  1:7,000 
Gawande et al10 (2003)  Retention of a surgical instrument or sponge  1985-2001 closed claims in Massachusetts  1:8,801 to 1:18,760 
Hyslop & Maull11 (1982)  Retained surgical sponge  Not reported  Celiotomies 1:1,000 

References

1.

Hempel
S
,
Maggard-Gibbons
M
,
Nguyen
DK
, et al.  .
Wrong-site surgery, retained surgical items, and surgical fires: a systematic review of surgical never events
.
JAMA Surg
.
2015
;
150
(
8
):
796
805
. [
IIIB
]

2.

Summary Data of Sentinel Events Reviewed by The Joint Commission
.
The Joint Commission
. http://www.jointcommission.org/assets/1/18/2004_to_2014_4Q_SE_Stats_-_Summary.pdf. Accessed November 10,
2015
.

3.

Moffatt-Bruce
SD
,
Cook
CH
,
Steinberg
SM
,
Stawicki
SP
.
Risk factors for retained surgical items: a meta-analysis and proposed risk stratification system
.
J Surg Res
.
2014
;
190
(
2
):
429
436
. [
IIIA
]

4.

Stawicki
SP
,
Moffatt-Bruce
SD
,
Ahmed
HM
, et al.  .
Retained surgical items: a problem yet to be solved
.
J Am Coll Surg
.
2013
;
216
(
1
):
15
22
. [
IIIB
]

5.

Chen
Q
,
Rosen
AK
,
Cevasco
M
,
Shin
M
,
Itani
KM
,
Borzecki
AM
.
Detecting patient safety indicators: How valid is “foreign body left during procedure” in the Veterans Health Administration?
J Am Coll Surg
.
2011
;
212
(
6
):
977
983
. [
IIIB
]

6.

Shah
RK
,
Lander
L
.
Retained foreign bodies during surgery in pediatric patients: a national perspective
.
J Pediatr Surg
.
2009
;
44
(
4
):
738
742
. [
IIIA
]

7.

WHO Guidelines for Safe Surgery 2009.
Geneva, Switzerland
:
WHO Press
;
2009
. [
IVB
]

8.

Cima
RR
,
Kollengode
A
,
Garnatz
J
,
Storsveen
A
,
Weisbrod
C
,
Deschamps
C
.
Incidence and characteristics of potential and actual retained foreign object events in surgical patients
.
J Am Coll Surg
.
2008
;
207
(
1
):
80
87
. [
IIIB
]

9.

Egorova
NN
,
Moskowitz
A
,
Gelijns
A
, et al.  .
Managing the prevention of retained surgical instruments: what is the value of counting?
Ann Surg
.
2008
;
247
(
1
):
13
18
. [
IIIA
]

10.

Gawande
AA
,
Studdert
DM
,
Orav
EJ
,
Brennan
TA
,
Zinner
MJ
.
Risk factors for retained instruments and sponges after surgery
.
N Engl J Med
.
2003
;
348
(
3
):
229
235
. [
IIIA
]

11.

Hyslop
JW
,
Maull
KI
.
Natural history of the retained surgical sponge
.
South Med J
.
1982
;
75
(
6
):
657
660
. [
VB
]

Search terms included the subject headings surgical count procedure, surgical instruments, operative surgical procedures, foreign bodies, medical errors, postoperative complications, re-operation, surgical wound infection, accident prevention, documentation, situational awareness, human error, noise, and interdisciplinary communication. Other subject headings and key words were included to address the concepts of specific surgical items, root causes of errors in surgical counts, and methods for preventing RSIs. Complete search strategies are available upon request.

Excluded were non-peer-reviewed publications, evidence from other disciplines when evidence from the perioperative setting was available, and case reports that did not provide recommendations for preventing RSIs. Lower-level or lower-quality evidence was excluded when higher-level or higher-quality evidence was available. Opinion leaders have established accounting protocols for prevention of RSIs that were not published in peer-reviewed literature during the time frame of this systematic literature search, and thus these were excluded from this document (Figure 1).

Figure 1.
Flow Diagram of Literature Search Results

Flow Diagram of Literature Search Results

Articles identified by the search were provided to the project team for evaluation. The team consisted of the lead author and four evidence appraisers. The lead author divided the search results into topics and assigned members of the team to review and critically appraise each article using the AORN Research or Non-Research Evidence Appraisal Tools as appropriate. The literature was independently evaluated and appraised according to the strength and quality of the evidence. Each article was then assigned an appraisal score. The appraisal score is noted in brackets after each reference, as applicable.

The collective evidence supporting each intervention within a specific recommendation was summarized and the AORN Evidence Rating Model was used to rate the strength of the evidence. Factors considered in the review of the collective evidence were the quality of the evidence, the quantity of similar evidence on a given topic, and the consistency of evidence supporting a recommendation. The evidence rating is noted in brackets after each intervention.

 

Note: The evidence summary table is available at http://www.aorn.org/evidencetables/.

 

Editor’s note: MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL. Scopus is a registered trademark of Elsevier B.V., Amsterdam, The Netherlands.

Read MoreShow Less

Access Options

If you would like to learn more about purchasing a subscription to this content, please click the appropriate button below.

Learn about facility access

Learn about individual access