Presentation
Assessing Surgical Sponge Accounting Device Usability in Operating Rooms
DescriptionRetained foreign objects (RFOs) occur between 1 in 1000 and 1 in 18,760 operations (Bardes & Inaba, 2017; Wan et al., 2009; Al-Qurayashi et al., 2015; Birolini, Rasslan, & Utiyama, 2016; Kaiser et al., 1996; Stawicki et al., 2013). Objects that are unintentionally left in patients include sponges, needles, and surgical instruments (Smith, 2011; Gawande et al., 2003; Gualniera & Scurria, 2018; Bardes & Inaba, 2017; Wan et al., 2009). One solution to retained surgical sponges is sponge scanning and location technology, which has been available for more than 10 years (Rupp et al., 2012; Inaba et al, 2016). There are two primary types of devices: ones that scan and count the number of sponges brought into the sterile field, and others that help locate sponges in the Operating Room (OR) and/or in the patient. Both types require special sponges that have radio frequency identification (RFID) tags embedded in them. Some devices combine the scanning and locating capabilities such that, in theory at least, OR staff can have a count of how many sponges are in the sterile field and optionally use a handheld component to search for a missing sponge.
As part of a larger Patient Safety Learning Lab project to explore and reduce RFOs through sociotechnical systems analysis and intervention, an interdisciplinary human factors team, is studying the counting process, including the potential for technological assistance. In early discussions, OR staff repeatedly expressed concern with how the device operated. This led to a focused investigation of the device’s capabilities, the team members’ mental models of the device, integration into the wider system, and potential hazards associated with use.
METHOD
Qualitative interviews and observations were gathered to understand clinical team member’s mental models of how they thought the device was supposed to work. Additionally, more detailed work as done (WAD) process mapping of the device usage was gathered. This was then compared to the capabilities of the device, and the policy processes that the organization had laid out of the device’s usage. Additional quantitative data were collected, including asking 13 clinical staff members to fill out the System Usability Scale. Time studies were completed to understand how long it was taking team members to account for sponges using the device.
RESULTS
Counting Process. Despite the use of the device, staff were still required to follow standard procedures for accounting for sponges, including counting the sponges and documenting the number of sponges on the sterile field on a whiteboard. As a consequence, the device had to be used in addition to these regular demands and workload. Staff observed that the time to count a sponge differed depending upon their level of soiling, with staff noting that it sometimes took several seconds before the device would account for the sponge. Staff indicated that sometimes sponges had to be wiped down or left to dry in order to get them to be accounted for in the device. In comparison, manual counting of sponges can be more quickly and reliably performed, regardless of the level of soiling.
Functionality. Staff indicated that sponges often become covered with blood and tissue and that the scanner would have difficulty picking up on the sponge’s RFID tag. This led them to reasonably question whether the device would be able to sense a sponge when it was inside of a patient. Moreover, clinical staff provided anecdotes of times that they attempted to use the device to find a sponge in the patient, and the device was unable to detect the sponge.
Mental Models. The results also suggested that the conceptions that clinical staff had of the device’s abilities differed in important ways to the capabilities stated by the vendor. Additionally, it was found that, while training was received when the device was initially implemented, this different from the training that was received after the device had been in usage for several months. For example, the ability of the wand to detect a sponge was highly dependent upon very specific and controlled movements, and it could function unreliably if not carefully followed. Consequently, clinical workers experienced difficulty using the device, including continued experience of retained objects, and eventual voiced frustration to leadership.
Usability. The average SUS score was M = 58, suggesting that users would be more likely to discourage the use of the device rather than recommending it. Furthermore, the time study data suggested that as the level of saturation of the sponges increased, the more instances that it took longer for the device to account for a sponge (N = 19) than when the sponge was not saturated at all (N = 3).
OUTCOME
The interdisciplinary human factors led team shared their findings with leadership and suggested that the device may need to be put on hold or removed from the ORs. Leadership supported the decision to de-implement the device and will be working to explore other process and technological solutions to improve the sponge counting process in the OR
Al-Qurayshi, Z. H., Hauch, A. T., Slakey, D. P., & Kandil, E. (2015). Retained foreign bodies: risk and outcomes at the national level. Journal of the American College of Surgeons, 220(4), 749-759.
Bardes, J. M., & Inaba, K. (2017). The use of radiofrequency detection to mitigate the risk of retained surgical sponges. Advances in surgery, 51(1), 219-227.
Birolini, D. V., Rasslan, S., & Utiyama, E. M. (2016). Unintentionally retained foreign bodies after surgical procedures. Analysis of 4547 cases. Revista do Colégio Brasileiro de Cirurgiões, 43(1), 12-17.
Gawande, A. A., Studdert, D. M., Orav, E. J., Brennan, T. A., & Zinner, M. J. (2003). Risk factors for retained instruments and sponges after surgery. New England Journal of Medicine, 348(3), 229-235.
Gualniera, P., & Scurria, S. (2018). Retained surgical sponge: Medicolegal aspects. Legal Medicine, 31, 78-81.
Inaba, K., Okoye, O., Aksoy, H., Skiada, D., Ault, G., Sener, S., Lam, L., Bejamin, E., & Demetriades, D. (2016). The role of radio frequency detection system embedded surgical sponges in preventing retained surgical sponges: a prospective evaluation in patients undergoing emergency surgery. Annals of surgery, 264(4), 599-604.
Kaiser, C. W., Friedman, S., Spurling, K. P., Slowick, T., & Kaiser, H. A. (1996). The retained surgical sponge. Annals of surgery, 224(1), 79-84.
Smith, C. D. (2011). The retained surgical specimen, an unappreciated retained foreign object. Journal of Laparoendoscopic & Advanced Surgical Techniques, 21(8), 737-739.
Stawicki, S. P., Moffatt-Bruce, S. D., Ahmed, H. M., Anderson III, H. L., Balija, T. M., Bernescu, I., Chan, L., Chowayou, L., Cipolla, J., Coyle, S. M., Gracias, V. H., Gunther, O. L., Marchigiani, R., Martin, N. D., Patel, J., Seamon, M. J., Vagedes, E., Ellison, E. C., Steinberg, S. M., & Cook, C. H. (2013). Retained surgical items: a problem yet to be solved. Journal of the American College of Surgeons, 216(1), 15-22.
Rupp, C. C., Kagarise, M. J., Nelson, S. M., Deal, A. M., Phillips, S., Chadwick, J., Petty, T., Meyer, A. A., & Kim, H. J. (2012). Effectiveness of a radiofrequency detection system as an adjunct to manual counting protocols for tracking surgical sponges: a prospective trial of 2,285 patients. Journal of the American College of Surgeons, 215(4), 524-533.
Wan, W., Le, T., Riskin, L., & Macario, A. (2009). Improving safety in the operating room: a systematic literature review of retained surgical sponges. Current Opinion in Anesthesiology, 22(2), 207-214.
As part of a larger Patient Safety Learning Lab project to explore and reduce RFOs through sociotechnical systems analysis and intervention, an interdisciplinary human factors team, is studying the counting process, including the potential for technological assistance. In early discussions, OR staff repeatedly expressed concern with how the device operated. This led to a focused investigation of the device’s capabilities, the team members’ mental models of the device, integration into the wider system, and potential hazards associated with use.
METHOD
Qualitative interviews and observations were gathered to understand clinical team member’s mental models of how they thought the device was supposed to work. Additionally, more detailed work as done (WAD) process mapping of the device usage was gathered. This was then compared to the capabilities of the device, and the policy processes that the organization had laid out of the device’s usage. Additional quantitative data were collected, including asking 13 clinical staff members to fill out the System Usability Scale. Time studies were completed to understand how long it was taking team members to account for sponges using the device.
RESULTS
Counting Process. Despite the use of the device, staff were still required to follow standard procedures for accounting for sponges, including counting the sponges and documenting the number of sponges on the sterile field on a whiteboard. As a consequence, the device had to be used in addition to these regular demands and workload. Staff observed that the time to count a sponge differed depending upon their level of soiling, with staff noting that it sometimes took several seconds before the device would account for the sponge. Staff indicated that sometimes sponges had to be wiped down or left to dry in order to get them to be accounted for in the device. In comparison, manual counting of sponges can be more quickly and reliably performed, regardless of the level of soiling.
Functionality. Staff indicated that sponges often become covered with blood and tissue and that the scanner would have difficulty picking up on the sponge’s RFID tag. This led them to reasonably question whether the device would be able to sense a sponge when it was inside of a patient. Moreover, clinical staff provided anecdotes of times that they attempted to use the device to find a sponge in the patient, and the device was unable to detect the sponge.
Mental Models. The results also suggested that the conceptions that clinical staff had of the device’s abilities differed in important ways to the capabilities stated by the vendor. Additionally, it was found that, while training was received when the device was initially implemented, this different from the training that was received after the device had been in usage for several months. For example, the ability of the wand to detect a sponge was highly dependent upon very specific and controlled movements, and it could function unreliably if not carefully followed. Consequently, clinical workers experienced difficulty using the device, including continued experience of retained objects, and eventual voiced frustration to leadership.
Usability. The average SUS score was M = 58, suggesting that users would be more likely to discourage the use of the device rather than recommending it. Furthermore, the time study data suggested that as the level of saturation of the sponges increased, the more instances that it took longer for the device to account for a sponge (N = 19) than when the sponge was not saturated at all (N = 3).
OUTCOME
The interdisciplinary human factors led team shared their findings with leadership and suggested that the device may need to be put on hold or removed from the ORs. Leadership supported the decision to de-implement the device and will be working to explore other process and technological solutions to improve the sponge counting process in the OR
Al-Qurayshi, Z. H., Hauch, A. T., Slakey, D. P., & Kandil, E. (2015). Retained foreign bodies: risk and outcomes at the national level. Journal of the American College of Surgeons, 220(4), 749-759.
Bardes, J. M., & Inaba, K. (2017). The use of radiofrequency detection to mitigate the risk of retained surgical sponges. Advances in surgery, 51(1), 219-227.
Birolini, D. V., Rasslan, S., & Utiyama, E. M. (2016). Unintentionally retained foreign bodies after surgical procedures. Analysis of 4547 cases. Revista do Colégio Brasileiro de Cirurgiões, 43(1), 12-17.
Gawande, A. A., Studdert, D. M., Orav, E. J., Brennan, T. A., & Zinner, M. J. (2003). Risk factors for retained instruments and sponges after surgery. New England Journal of Medicine, 348(3), 229-235.
Gualniera, P., & Scurria, S. (2018). Retained surgical sponge: Medicolegal aspects. Legal Medicine, 31, 78-81.
Inaba, K., Okoye, O., Aksoy, H., Skiada, D., Ault, G., Sener, S., Lam, L., Bejamin, E., & Demetriades, D. (2016). The role of radio frequency detection system embedded surgical sponges in preventing retained surgical sponges: a prospective evaluation in patients undergoing emergency surgery. Annals of surgery, 264(4), 599-604.
Kaiser, C. W., Friedman, S., Spurling, K. P., Slowick, T., & Kaiser, H. A. (1996). The retained surgical sponge. Annals of surgery, 224(1), 79-84.
Smith, C. D. (2011). The retained surgical specimen, an unappreciated retained foreign object. Journal of Laparoendoscopic & Advanced Surgical Techniques, 21(8), 737-739.
Stawicki, S. P., Moffatt-Bruce, S. D., Ahmed, H. M., Anderson III, H. L., Balija, T. M., Bernescu, I., Chan, L., Chowayou, L., Cipolla, J., Coyle, S. M., Gracias, V. H., Gunther, O. L., Marchigiani, R., Martin, N. D., Patel, J., Seamon, M. J., Vagedes, E., Ellison, E. C., Steinberg, S. M., & Cook, C. H. (2013). Retained surgical items: a problem yet to be solved. Journal of the American College of Surgeons, 216(1), 15-22.
Rupp, C. C., Kagarise, M. J., Nelson, S. M., Deal, A. M., Phillips, S., Chadwick, J., Petty, T., Meyer, A. A., & Kim, H. J. (2012). Effectiveness of a radiofrequency detection system as an adjunct to manual counting protocols for tracking surgical sponges: a prospective trial of 2,285 patients. Journal of the American College of Surgeons, 215(4), 524-533.
Wan, W., Le, T., Riskin, L., & Macario, A. (2009). Improving safety in the operating room: a systematic literature review of retained surgical sponges. Current Opinion in Anesthesiology, 22(2), 207-214.
Event Type
Oral Presentations
TimeWednesday, April 29:15am - 9:37am EDT
LocationHarbour C
Hospital Environments (HE)