Retained Surgical Items

Purpose

This document provides guidance to perioperative team members for preventing unintentionally retained surgical items (RSIs) in patients undergoing operative and other invasive procedures. Guidance is provided for implementing a consistent interdisciplinary approach and using standardized procedures to prevent RSIs, accounting for surgical items (ie, radiopaque soft goods, sharps and miscellaneous items, instruments), preventing retention of device fragments, and reconciling count discrepancies. Guidance is also provided for use of adjunct technology during manual counting procedures.

An RSI is a rare but serious preventable error that can result in patient harm. Perioperative team members are ethically and morally obligated to protect patients by implementing measures to prevent RSIs. Prevention of RSIs requires an interdisciplinary approach that aims to reduce the risks and contributing factors associated with RSIs. In a survey conducted by Steelman et al¹  that included 3,137 responses from perioperative registered nurses (RNs), 61% of participants (n = 1,918) identified the prevention of RSIs as one of the top priorities for perioperative patient safety. The National Academy of Medicine identified avoiding injuries from care that is intended to help patients as one of six goals to achieve a better health care system.² 

Even though unintentionally retained items continue to be one of the most common sentinel events reported to The Joint Commission,³  these events are likely underreported^4-7  and underestimated.^8,9  This may be due in part to the lack of a universal definition of RSI¹⁰  and varying reporting requirements.^11,12  The true incidence of RSIs remains unknown in part because retained items may be undetected for months or years.⁷  In 2003, based on data from 1999, Gawande et al⁴  estimated that more than 1,500 RSIs occur annually in the United States. Since then, reports on the prevalence of RSIs have varied considerably depending on the source of the information (Table 1).

Surgical sponges are the most commonly retained items.^{3,6,8,9,13-22}  However, as the rates of minimally invasive procedures and the use of adjunct technologies to prevent retained soft goods increases, there could be a shift in the number and types of items that are retained compared to soft goods.^23,24  Other reported RSIs are instruments,^{4,8,9,14,21,22,25,26}  needles,^8,9  device fragments,^{14,21,22,25,27,28}  items such as guidewires,^7,8,14,21  and miscellaneous items (eg, rectal tube caps, drain bulbs).^21,22  Most counting discrepancies involve needles.^29,30 

The location of an RSI depends on the type of procedure performed. The abdomen³¹  and pelvis^19,32  are reported to be the locations where RSIs are most often found,^{6,10,13,15,33}  and surgical sponges retained in the abdomen or pelvis can migrate into the intestine, bladder, thorax, or stomach.^31,34,35  Retained surgical items have been reported in all body cavities.²⁵  Other reported locations of RSIs include the brain,^4,15  face,^4,25  eye¹⁵  and orbit,^36,37  ear,³⁸  mouth and airway,¹⁵  nasal cavity,^15,39  neck,^15,31  shoulder and axilla,^15,31  thorax^4,25,40  or chest,¹⁵  pacemaker or defibrillator pocket,¹⁵  breast,^15,16  back,¹⁵  spinal canal,⁴  extremities,^{4,15,18,25,27}  inguinal hernia,³¹  hip and gluteal region,¹⁵  vagina,^{4,15,25,28,40,41}  scrotum,¹⁵  and natural orifices.¹³ 

Retained surgical items have also been reported to occur during less-invasive procedures (eg, minimally invasive surgery [MIS], endoscopic procedures).^22,40,42,43  In a study of 308 retained object incidents that were reported to The Joint Commission between 2012 and 2018, excluding soft goods and guidewires, at least 156 incidences (50.6%) occurred during MIS.⁴² 

Reported methods of RSI discovery include symptoms,²⁵  radiological evaluation,^6,8,25,33  and physical examination.^6,25  Time to diagnosis of an RSI can vary greatly. Reports suggest that many RSIs are discovered between the time of occurrence and 2 months,^{4,8,9,25,31,33,40}  some have been found between 2 months and 5 years,^8,9,25,31,33  and others have been found after 5 years.^4,9,31,33  There have been reports of RSIs found after 20^44,45  to 40 years.^33,46 

Because an RSI is an event that presents significant risk for patient harm, many states require public reporting when RSI events occur.⁴⁷  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, health care–associated condition, sentinel event, serious reportable event).^48,49  Consequently, health care organizations and providers will not be reimbursed for additional care provided as a result of an RSI.^11,50,51 

A long-standing and evidence-based strategy for preventing RSIs is to account for all items opened or used during the operative or other invasive procedure. Health care organizations are responsible for employing standardized, transparent, verifiable, reliable practices to account for all surgical items used during a procedure. Counting radiopaque soft goods, sharps, miscellaneous items, and instruments is one method 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.^29,52,53  The use of adjunct technology can decrease counting discrepancies and has the potential to reduce the risk of RSIs.^8,40,54-57 

Beyond the process of counting, systems and human factors play a significant role in contributing to RSIs. Therefore, behavioral changes and education about risk-reduction strategies unique to each setting used during the adoption of systems may improve accounting for surgical items. Improving system reliability to enhance the performance of human factors (eg, compliance with policies and procedures, effective hand-over communication) may reduce the incidence of errors and improve patient safety.²³  A systems approach to preventing RSIs includes using standardized counting and reconciliation procedures, methodical wound exploration,¹⁵  radiological confirmation, adjunct technology, team training,^58,59  and enhanced communication to promote optimal perioperative patient outcomes.^48,60-63 

The limitations of the evidence are that randomized controlled trials of RSI prevention interventions could expose patients to harm and, as such, would not be ethical.²⁵  Case-control studies of RSIs 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 1976.⁶⁴ 

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 with a perioperative background conducted a systematic search of the databases Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, and the Cochrane Database of Systematic Reviews. The search was limited to literature published in English from January 2014 through December 2020. At the time of the initial search, weekly alerts were created on the topics included in that search. Results from these alerts were provided to the lead author until July 2021. The lead author requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. The lead author and the medical librarian also identified relevant guidelines from government agencies, professional organizations, and standards-setting bodies.

Search terms included 2D matrix, 3D micro tag, adverse event, adverse health care event, anti-Semitism, awareness, attitude to obesity, bar coding, bent hypodermic needles, biliary tract surgical procedures, blood loss, blood loss estimation, blood loss (surgical), bloodless medical and surgical procedures, broken hypodermic needles, cardiac catheters, catheterization (central venous), catheterization (peripheral central venous), catheters, catheters (indwelling), catheters (vascular), central venous catheters, count board, count discrepancies, count reconciliation, count sheet, covert racism, cross-disciplinary communication, cultural bias, cultural competency, cultural diversity, cultural pluralism. delivery of health care, dentistry (operative), device fragments, difference in treatment, discrepancies in treatment, discrimination, disparities, distraction, diversity, documentation, documentation of unresolved count discrepancies, emergency surgery, emergent surgical procedures, ethnic groups, ethnicity, forceps, foreign bodies, glidewires, guidewires, gossypiboma, health care delivery, health care disparities, health care errors, health status disparities, healthcare disparities, healthcare near miss, healthcare time out, healthcare timeout, heart catheter, heart catheterization, human error, human factors, hypodermic needle defects, hypodermic needle fragments, hypodermic needles, implantable catheters, implicit bias, incorrect count, indwelling catheters, instrument breakage, instrument label defects, instrument label fragmentation, intercardiac catheter, intraoperative awareness, intraoperative imaging, intraoperative radiograph, intravascular device defects, intravascular device fragments, interdisciplinary communication, invasive procedures, Islamophobia, lengthy procedure, long procedure, malleable ribbon, medical errors, microneedles, minimally invasive procedures, minorities, minority groups, minority health, missing surgical items, morbid obesity, multiculturalism, multidisciplinary communication, nationality, near miss, near miss (healthcare), needles, never event, noise, noise pollution, nurse’s role, nurse’s scope of practice, nursing, nursing care, nursing role, obesity, obesity (morbid), operating room nursing, operative procedures, people of color, perioperative nursing, pocketed sponge bag system, prejudice, preventing retained surgical items, pulmonary artery catheters, race, race factors, racial disparities, racial factors, racial bias, racial discrimination, racial prejudice, racism, radio frequency, radio frequency identification, radio frequency identification device, radiopaque, reporting retained surgical items, retained foreign bodies, retained instruments, retained intravascular devices, retained surgical instruments, retained surgical items, retained surgical needle, retained surgical tool, retention, robotic surgical procedures, root cause analyses, root cause analysis, scope of nursing practice, sentinel event, severe obesity, shift change, shift reports, situational awareness, skin color, skin tone, small suture needles, socially responsible surgery, soft goods, speculum, surgical blood loss, surgical clamps, surgical clips, surgical count procedure, surgical count reconciliation, surgical errors, surgical hemorrhage, surgical hooks, surgical instruments, surgical nursing, surgery (operative), surgical pause, surgical plug, surgical procedures, surgical procedures (operative), surgical sponges, surgical time out, surgical timeout, surgical traumatology, surgical valves, surgical wound examination, surgical wound exploration, suture needles, tantalum clips, textiloma, therapeutic sponge packing, throat pack, time out (healthcare), trauma surgery, traumatology, trocar, underserved patients, underserved populations, unequal treatment, unretrieved device fragments, urban population, vascular access devices, vulnerable populations, and weight bias.

Included were research and non-research literature in English, complete publications, and publications with dates within the time restriction when available. Excluded were non-peer-reviewed publications and older evidence within the time restriction when more recent evidence was available. Editorials, news items, and other brief items were excluded. Low-quality evidence was excluded when higher-quality evidence was available, and literature outside the time restriction was excluded when literature within the time restriction was available (Figure 1).

Figure 1

Flow Diagram of Literature Search Results

Adapted from Moher D, Liberati A, Tetzlaff J, Atman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. PLoS Med. 2009;6(6):e1000097.

Articles identified in the search were provided to the lead author for critical appraisal. The lead author distributed research articles to another evidence appraiser who independently evaluated and appraised each article using the AORN Research or Non-Research Evidence Appraisal Tools as appropriate. Each article was then assigned an appraisal score based on a consensus of the lead author and evidence appraiser. The appraisal score is noted in brackets after each reference as applicable.

Each recommendation rating is based on a synthesis of the collective evidence, a benefit-harm assessment, and consideration of resource use. The strength of the recommendation was determined using the AORN Evidence Rating Model and the quality and consistency of the evidence supporting a recommendation. The recommendation strength rating is noted in brackets after each recommendation.

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