Initial Clinical Evaluation of a Handheld Device for Detecting Retained Surgical Gauze Sponges Using Radiofrequency Identification Technology

Department of Anesthesia, Stanford University, Palo Alto, California, United States
Archives of Surgery (Impact Factor: 4.93). 08/2006; 141(7):659-62. DOI: 10.1001/archsurg.141.7.659
Source: PubMed


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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    • "Surgical sponges may cause adverse effect such as sepsis, intestinal obstruction, fistulization, perforation and its complication may lead to death with the death incidences ranging from 15% to 22%.[4647] "
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    ABSTRACT: Retained foreign bodies (RFBs) are a surgical complication resulting from foreign materials accidently left in a patient's body. This review attempts to give an overview of different types of RFBs, problems related to them and their management after the surgical operation. The internet was searched using the Google and Google scholar. In addition, relevant electronic journals from the University's library such as Entrez (including PubMed and PubMed central), Since Direct, Scirus,,,, Scopus,, Cochrane library,, and World Health Organization Hinari. It shows that the major reasons of RFBs are emergency surgical operation with unplanned changes, patient high body mass index, and poor communication. To prevent this textile material should be radiopaque marked and must be counted once at the start and twice at the conclusion of all surgical procedures. If the count is incorrect, then radiography or manually re-exploration should be performed. Ultrasonography, computerized tomography, magnetic resonance imaging and radio frequency identification are also used in the proper identification of RFBs. Safety practice should be robust and simple enough to protect patient under the most chaotic of circumstances. Proper communication among the personnel participating in surgery aimed at preventing this medical negligence would help in mitigating such errors. Finally, the surgeon should not only follow the standard recommended procedure, but also report cases of RFBs.
    No preview · Article · Mar 2014
    • "Prevention of gossypiboma can be done by simple precaution like keeping a thorough pack count and tagging the packs with markers. Newer technologies are being developed that will hopefully decrease the incidence of RFP, like radiofrequency chip identification (RFID) by barcode scanner.[20] The overall objective of this system would be to eliminate errors in the sponge count by removing the human error factor. "
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    ABSTRACT: Gossypiboma or textiloma is used to describe a retained surgical swab in the body after an operation. Inadvertent retention of a foreign body in the abdomen often requires another surgery. This increases morbidity and mortality of the patient, cost of treatment, and medicolegal problems. We are reporting case of a 45-year-old woman who was referred from periphery with acute pain in abdomen. She had a surgical history of abdominal hysterectomy 3 years back, performed at another hospital. On clinical examination and investigation, twisted ovarian cyst was suspected. That is a cystic mass further confirmed by abdominal computerized tomography (CT). During laparotomy, the cyst wall was opened incidentally which lead to the drainage of a large amount of dense pus. In between pus, there was found retained surgical gauze that confirmed the diagnosis of gossypiboma.
    No preview · Article · Jul 2011
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    • "The potential of Radio Frequency IDentification (RFID) technology within health care environments has been assessed by several studies, showing positive effects on patient safety and logistics concerning patients and medical products [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14]. Expenditure levels , development of standards concerning RFID systems' performance testing, and mandates from the government and major retailers driving the adoption of RFID technology in healthcare, underline the current and foreseen widespread use of RFID within health care [15] [16]. "
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    ABSTRACT: RFID offers great opportunities to health care. Nevertheless, prior experiences also show that RFID systems have not been designed and tested in response to the particular needs of health care settings and might introduce new risks. The aim of this study is to present a framework that can be used to assess the performance of RFID systems particularly in health care settings. We developed a framework describing a systematic approach that can be used for assessing the feasibility of using an RFID technology in a particular healthcare setting; more specific for testing the impact of environmental factors on the quality of RFID generated data and vice versa. This framework is based on our own experiences with an RFID pilot implementation in an academic hospital in The Netherlands and a literature review concerning RFID test methods and current insights of RFID implementations in healthcare. The implementation of an RFID system within the blood transfusion chain inside a hospital setting was used as a show case to explain the different phases of the framework. The framework consists of nine phases, including an implementation development plan, RFID and medical equipment interference tests, data accuracy- and data completeness tests to be run in laboratory, simulated field and real field settings. The potential risks that RFID technologies may bring to the healthcare setting should be thoroughly evaluated before they are introduced into a vital environment. The RFID performance assessment framework that we present can act as a reference model to start an RFID development, engineering, implementation and testing plan and more specific, to assess the potential risks of interference and to test the quality of the RFID generated data potentially influenced by physical objects in specific health care environments.
    Full-text · Article · Dec 2010 · Journal of Biomedical Informatics
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