Initial clinical evaluation of a handheld device for detecting retained surgical gauze sponges using radiofrequency identification technology
ABSTRACT A handheld wand-scanning device (1.5 lb, battery powered, 10 x 10 x 1.5 in) has been developed to detect commonly used surgical gauze sponges, which have been tagged with a radiofrequency identification (RFID) chip. We tested the hypothesis that this wand device has a successful detection rate of 100%, with 100% specificity and 100% sensitivity.
Prospective, blinded, experimental clinical trial.
Stanford University Medical Center, Stanford, Calif.
Eight patients undergoing abdominal or pelvic surgery.
Eight untagged sponges (1 control per patient) and 28 RFID sponges were placed in the patients. Just before closure, the first surgeon placed 1 RFID sponge (adult laparotomy tape; 18 x 18 in, 4-ply) in the surgical site, while the second surgeon looked away so as to be blinded to sponge placement. The edges of the wound were pulled together so that the inside of the cavity was not exposed during the detection experiments. The second (blinded) surgeon used the wand-scanning device to try to detect the RFID sponge.
A successful detection was defined as detection of an RFID sponge within 1 minute. We also administered a questionnaire to the surgeon and nurse involved in the detections to assess ease of use.
The RFID wand device detected all sponges correctly, in less than 3 seconds on average. There were no false-positive or false-negative results.
We found a detection accuracy of 100% for the RFID wand device. Despite this engineering success, the possibility of human error and retained sponges remains because handheld scanning can be performed incorrectly.
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ABSTRACT: Data concerning the incidence of gossypiboma tend to fluctuate and is difficult to estimate because of a low reporting rate lest medico-legal implication. Gossypiboma is frequently located in the abdominal and pelvic cavities after gynecologic and upper abdominal surgical operations but can also follow thoracic, orthopedic, and urological and neurosurgical procedures. In medical literature, there are few articles about the medico-legal evaluation of gossypiboma although it is typically subjected to a medico-legal process. In this article, we reported a 22-year-old female case with intraabdominal gossypiboma following a cesarean procedure and discussed the importance of medico-legal evaluation of gossypiboma.Forensic science international 02/2010; 198(1-3):e15-8. DOI:10.1016/j.forsciint.2010.01.013 · 2.12 Impact Factor
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ABSTRACT: Introduction. Retained surgical foreign bodies (RSFB) constitute a theoretically preventable surgical morbidity. Despite numerous case reports and clinical series, very few studies exist that adequately address the issue of RSFB. Moreover, published reports lack the ability to detect clinically important differences among the proposed risk factors for RSFB. This meta-analysis examines existing data for previously unrecognized risk factors for RSFB. Methods. Eighteen potentially relevant studies were considered for this meta-analysis. Two retrospective, case-control studies of RSFBrelated risk factors contained suitable group comparisons between patients with and without RSFB, thus qualifying for further statistical analysis. Comprehensive Meta Analysis 2.0 (BioStat, Inc., Englewood, NJ) software was used to analyze the following proposed risk factors for RSFB: (a) patient age and gender; (b) body-mass index; (c) surgical count not performed; (d) incorrect surgical count; (e) duration of operation; (f) estimated blood loss >500 mL or transfusion requirement in the operating room; (g) emergent nature of surgical operation; (h) operation after hours (5 pm); (i) unplanned change in surgical procedure; (j) more than one major procedure performed; (k) change in operating room nursing staff; and (l) involvement of multiple surgical teams. Results. Frequent changes in nursing staff and operation after hours were not significantly associated with RSFB in either study but reached near-significance in our meta-analysis. Of note, six variables found to be independently associated with RSFB in only one of the two studies were determined to be significantly associated with RSFB in this meta-analysis. In addition, duration of operation, while not statistically significant in either of the two studies, was found to be significantly associated with the occurrence of RSFB by meta-analysis. Six remaining variables were confirmed not to be significantly associated with RSFB. Conclusions. This analysis demonstrated that seven of 13 previously studied variables are significantly associated with the incidence of RSFB. These findings provide a meaningful foundation for future patient safety initiatives and clinical studies of RSFB occurrence and prevention. Further, large prospective studies evaluating effects of specific changes at the institutional level (i.e., universal surgical counts, radiographic verification of the absence of RSFB, radiofrequency labeling of surgical instruments and sponges) on the incidence of RSFB should be undertaken using variables derived from the current analysis. Citation: Wang CF, Cook CH, Whitmill ML, Thomas YM, Lindsey DE, Steinberg SM, Stawicki SP. Risk factors for retained surgical foreign bodies: a meta-analysis. OPUS 12 Scientist 2009;3(2):21-27. Keywords: Retained surgical foreign bodies, RSFB, Patient safety, Metaanalysis, Risk factors, Clinical performance improvement Copyright 2007-2009 OPUS 12 Foundation, Inc.
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