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Drs. Statler et al respond
434 䡲 Letters to the Editor
a retained nonmarked sponge) was, in fact, in our institution, and involved a very experienced IR clinician working as part of a very high functioning, safety-conscious IR team. In the root cause analysis that followed, it was concluded that there are certain IR procedures for which sponge counts and marker sponges are appropriate. Further underscoring the potential for retained sponges in this setting, an identical event occurred here with pacemaker placement. The fact that these cases were not published does not in any way lessen their importance to patient care. The Committee (1) asserts that sponge counts prolong a procedure and do not necessarily prevent retained foreign bodies. After performing sponge counts in IR procedures involving an incision for nearly 5 years, it is clear that the process does not materially prolong the procedure. In addition, the widely practiced “time out” definitely prolongs a procedure, yet it is embraced universally and recommended by every major regulatory agency. If something that can potentially make a procedure safer takes a little time, it is worth doing. Our current process is simple: for procedures that involve an incision, the standard 4 ⫻ 4 sponges are removed from the tray and marker sponges are placed on the tray. They are counted at the beginning and end of the procedure in a formal sponge count, which is documented. In addition, because the sponges used in procedures that involve an incision are marker sponges, they will be visible on the final radiograph in the event of a counting error. This has become part of our culture of patient safety, and we now embrace it. In summary, the SIR has missed an important opportunity to improve the safety of patient care in IR procedures. The Committee should reconsider their position before more patients are affected by retained foreign bodies in IR procedures.
REFERENCE 1. Statler JD, Miller DL, Dixon RG, et al. Society of Interventional Radiology position statement: prevention of unintentionally retained foreign bodies during interventional radiology procedures. J Vasc Interv Radiol 2011; 22:1561–1562.
Drs. Statler et al respond: We appreciate your interest in this Society of Interventional Radiology (SIR) guideline. It is the result, in part, of outside pressure to institute mandatory sponge and instrument counts for all procedures performed in the interventional radiology (IR) suite. We agree that retained foreign bodies are a serious complication of invasive procedures and can
None of the authors have identified a conflict of interest. DOI: 10.1016/j.jvir.2011.12.006
Statler et al 䡲 JVIR
have catastrophic consequences. However, this complication is vanishingly rare in the practice of IR. In our analysis of retained foreign bodies, we could find no literature to support routine sponge and instrument counts for IR procedures performed in the IR suite. This is particularly true when careful visual and tactile inspection of the operative field is performed before closure, in cases in which an incision is made. This guideline applies only to IR procedures performed in the IR suite. We do not suggest that sponge and instrument counts never be performed. SIR believes that counts can be useful in IR procedures in which a careful visual and tactile inspection do not suffice to exclude a retained foreign body. Sponge counts are also appropriate at a facility where retained foreign body has occurred and should be accompanied by appropriate training of all providers who perform these procedures. This is compatible with your current practice. It is difficult to equate mandatory counts in the IR suite with mandatory time-out procedures. The time-out addresses many potential pitfalls of a procedure, and is substantiated by peer-reviewed analyses of adverse outcomes (1,2). These pitfalls include patient identification, procedure and site identification, and drug allergies and apply equally to all medical specialties including IR. SIR endorses this practice for all procedures performed in IR suites. There is no evidence that retained foreign bodies occur in IR with the same frequency that they are seen in surgical practice. There are no data to support the use of routine sponge or instrument counts for all IR procedures performed in IR facilities. John D. Statler, MD Virginia Interventional and Vascular Associates Fredericksburg, Virginia Department of Radiology and Radiologic Sciences Uniformed Services University Bethesda, Maryland Donald L. Miller, MD Center for Devices and Radiologic Health Food and Drug Administration Silver Spring, Maryland Robert G. Dixon, MD Department of Radiology University of North Carolina Chapel Hill, North Carolina
REFERENCES 1. Schlack WS, Boermeester MA. Patient safety during anaesthesia: incorporation of the WHO safe surgery guidelines into clinical practice. Curr Opin Anaesthesiol 2010; 23:754 –758. 2. Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences. Arch Surg 2010; 145:978 – 984.
a retained nonmarked sponge) was, in fact, in our institution, and involved a very experienced IR clinician working as part of a very high functioning, safety-conscious IR team. In the root cause analysis that followed, it was concluded that there are certain IR procedures for which sponge counts and marker sponges are appropriate. Further underscoring the potential for retained sponges in this setting, an identical event occurred here with pacemaker placement. The fact that these cases were not published does not in any way lessen their importance to patient care. The Committee (1) asserts that sponge counts prolong a procedure and do not necessarily prevent retained foreign bodies. After performing sponge counts in IR procedures involving an incision for nearly 5 years, it is clear that the process does not materially prolong the procedure. In addition, the widely practiced “time out” definitely prolongs a procedure, yet it is embraced universally and recommended by every major regulatory agency. If something that can potentially make a procedure safer takes a little time, it is worth doing. Our current process is simple: for procedures that involve an incision, the standard 4 ⫻ 4 sponges are removed from the tray and marker sponges are placed on the tray. They are counted at the beginning and end of the procedure in a formal sponge count, which is documented. In addition, because the sponges used in procedures that involve an incision are marker sponges, they will be visible on the final radiograph in the event of a counting error. This has become part of our culture of patient safety, and we now embrace it. In summary, the SIR has missed an important opportunity to improve the safety of patient care in IR procedures. The Committee should reconsider their position before more patients are affected by retained foreign bodies in IR procedures.
REFERENCE 1. Statler JD, Miller DL, Dixon RG, et al. Society of Interventional Radiology position statement: prevention of unintentionally retained foreign bodies during interventional radiology procedures. J Vasc Interv Radiol 2011; 22:1561–1562.
Drs. Statler et al respond: We appreciate your interest in this Society of Interventional Radiology (SIR) guideline. It is the result, in part, of outside pressure to institute mandatory sponge and instrument counts for all procedures performed in the interventional radiology (IR) suite. We agree that retained foreign bodies are a serious complication of invasive procedures and can
None of the authors have identified a conflict of interest. DOI: 10.1016/j.jvir.2011.12.006
Statler et al 䡲 JVIR
have catastrophic consequences. However, this complication is vanishingly rare in the practice of IR. In our analysis of retained foreign bodies, we could find no literature to support routine sponge and instrument counts for IR procedures performed in the IR suite. This is particularly true when careful visual and tactile inspection of the operative field is performed before closure, in cases in which an incision is made. This guideline applies only to IR procedures performed in the IR suite. We do not suggest that sponge and instrument counts never be performed. SIR believes that counts can be useful in IR procedures in which a careful visual and tactile inspection do not suffice to exclude a retained foreign body. Sponge counts are also appropriate at a facility where retained foreign body has occurred and should be accompanied by appropriate training of all providers who perform these procedures. This is compatible with your current practice. It is difficult to equate mandatory counts in the IR suite with mandatory time-out procedures. The time-out addresses many potential pitfalls of a procedure, and is substantiated by peer-reviewed analyses of adverse outcomes (1,2). These pitfalls include patient identification, procedure and site identification, and drug allergies and apply equally to all medical specialties including IR. SIR endorses this practice for all procedures performed in IR suites. There is no evidence that retained foreign bodies occur in IR with the same frequency that they are seen in surgical practice. There are no data to support the use of routine sponge or instrument counts for all IR procedures performed in IR facilities. John D. Statler, MD Virginia Interventional and Vascular Associates Fredericksburg, Virginia Department of Radiology and Radiologic Sciences Uniformed Services University Bethesda, Maryland Donald L. Miller, MD Center for Devices and Radiologic Health Food and Drug Administration Silver Spring, Maryland Robert G. Dixon, MD Department of Radiology University of North Carolina Chapel Hill, North Carolina
REFERENCES 1. Schlack WS, Boermeester MA. Patient safety during anaesthesia: incorporation of the WHO safe surgery guidelines into clinical practice. Curr Opin Anaesthesiol 2010; 23:754 –758. 2. Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences. Arch Surg 2010; 145:978 – 984.