Original ArticleRadiographic Detectability of Retained Neuropatties in a Cadaver Model
Introduction
An unintentionally retained foreign body is a potential risk of any invasive procedure. Surgical sponges are the most common type of unintentionally retained foreign bodies (26). Retained surgical sponges (RSS) are chemically inert but induce an inflammatory response in situ. Patients may develop an acute exudative reaction or chronic fibroblastic encapsulation (23). Complications vary depending on the RSS location (13). Serious complications include formation of an abscess or fistula, perforation of a viscus, sepsis, and mortality 6, 18, 20, 26. The median time to discovery is 2.2 years (26), but RSS may remain undetected for ≥40 years 7, 25, 28.
RSS are theoretically preventable and are classified by the National Quality Forum and the Joint Commission as “never events.” In some jurisdictions, hospitals are financially penalized for never events (17). In malpractice suits, RSS are deemed indefensible. Documentation of correct surgical counts and adherence to standards of care does not indemnify the responsible surgeon or the team (12). The legal and compensation costs per RSS incident vary greatly, ranging from $37,000 to $2.3 million (8).
In neurosurgery, neuropatties are the commonest surgical sponges that pose a risk for RSS. When the final count does not agree with the “on-table count,” current standards require that plain radiographs of the operative site be taken before/after wound closure to exclude the possibility of a RSS. Commonly, RSS occur in patients in whom the counts were “correct” 4, 6.
Despite meeting industry testing standards for radiopacity, surgical sponges are not easily detected on plain films in clinical situations (23). The detectability of surgical sponges has been assessed using analogue plain film imaging, 5, 15, 22, 24, 27, but the detectability thresholds of neuropatties using digital imaging technology under clinical conditions is unknown.
The present study assessed the detectability of currently available neuropatties implanted in common neurosurgical sites in an adult cadaver model, using clinical radiographic digital imaging techniques and clinician readers.
Section snippets
Preparation of Operative Sites Model
A cadaver was obtained from the Body Donation Program in the Faculty of Medicine at University of British Columbia. The specimen was a mature man in whom the cause of death was unknown. There was no evidence of surgery involving the head or spine. An ileostomy was noted on the abdomen. At the time of dissection, the brain had undergone some autolysis. There was no radiographic evidence of implanted foreign body or of pathologic soft tissue calcification.
Three surgical sites were chosen: the
Interpretive Reliability
The interobserver consistency was quantified using the intraclass correlation coefficient. There was strong agreement between the 6 readers despite differences in training and experience (Table 2).
Overall Sensitivity and Specificity
Despite minor variability between individual responses, the 95% confidence intervals (CI) from every sensitivity analysis performed on aggregated data from the first and second readings overlapped. Reader performance with isolated projections in the first sitting was identical to performance on paired
Discussion
The true incidence of RSS is unknown but is estimated to be between 1 in 5500 and 1 in 18,760 surgeries (8). Past studies have used malpractice claims as a surrogate data source, which likely underestimate incidence due to undetected asymptomatic patients, unreported near-misses, and patients who do not pursue a malpractice claim. Even with the proliferation of centralized, mandatory reporting systems, detection of RSS occurrences remains a challenge.
There are case-related risk factors for RSS
Conclusion
In summary, under simulated operating room conditions and using currently available neuropatties and plain radiograph imaging technology, ½ × ½ in or smaller neuropatties are not reliably detected on digital radiographs. If the institutional protocol includes intraoperative imaging when the neurosurgical sponge count cannot be resolved or for high risk situations, tomographic imaging should be considered to rule out a retained neuropatty if intraoperative radiographs are negative.
Acknowledgments
We thank Dr. Yogesh Thakur, medical physicist, and his team for their expertise in validating clinical parameters for imaging the anterior and posterior cranial fossae. The recommended parameters were derived from signal-to-noise calculations on radiographs of neuropatties affixed to a phantom head model and parameters were qualitatively verified in the cadaver model. We also thank our colleagues who participated as readers in this study.
References (28)
- et al.
Incidence and characteristics of potential and actual retained foreign object events in surgical patients
J Am Coll Surg
(2008) - et al.
Preventable errors in the operating room: retained foreign bodies after surgery—part I
Curr Probl Surg
(2007) - et al.
Surgical never events in the United States
Surgery
(2013) Retained surgical sponge 40 years after laminectomy. Case report
Surg Neurol
(1988)Standards for sponge, needle, and instrument procedures
Aorn J
(1976)- The ORNAC Standards for Perioperative Registered Nursing Practice, 10 ed., 2011, Operating Room Nurses Association of...
- et al.
Using a data-matrix-coded sponge counting system across a surgical practice: impact after 18 months
Jt Comm J Qual Patient Saf
(2011) Retained surgical swabs: possible causes for errors in x-ray detection and an atlas to assist recognition
Br J Radiol
(1978)- et al.
Risk factors for retained instruments and sponges after surgery
N Engl J Med
(2003) - et al.
Retained surgical sponges, needles and instruments
Ann R Coll Surg Engl
(2013)
Textiloma as a complication of transsphenoidal surgery
Neurosciences (Riyadh)
Natural history of the retained surgical sponge
South Med J
International A: ASTM F640-79(2000) Standard Test Methods for Radiopacity of Plastics for Medical Use
The retained surgical sponge
Ann Surg
Cited by (2)
Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century
2018, World NeurosurgeryCitation Excerpt :CT imaging may be useful for detecting retained small materials in cases of RNHMs. Recently, Luo et al.61 revealed that X-ray examination did not demonstrate small surgical sponges in a cadaveric study, suggesting the importance of an accurate sponge counting and careful tracking of sponges during the surgery. On CT study, foreign body granulomas appear as well-circumscribed masses with hyperdense materials and demonstrate capsular enhancement at the surgical site.1,62,63
Incorrect Surgical Counts: A Potential for Retained Surgical Items
2021, Journal of Doctoral Nursing Practice
Conflict of interest statement: The authors declare that the article content was composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.