PA-PSRS has received several reports describing injuries to patients from retained foreign objects related to interventional radiology (IR) procedures performed outside of the operating room (OR) setting. IR utilizes imaging guidance to perform diagnostic and therapeutic procedures in a minimally invasive manner. However, despite the smaller incision size typical during minimally invasive procedures, the risk for the retention of foreign objects remains. This article focuses on the use of sponge, sharp, and instrument counts—a process routinely used in the OR setting—during invasive IR procedures. Risk reduction strategies are presented, including practices and technologic solutions, which are applicable to the prevention of the retention of foreign objects in IR practice.
PA-PSRS previously published a report from the Patient Safety Officer of a facility who wished to share the lessons learned in the facility’s main operating room (OR) suite (see the June 2006 Patient Safety Advisory). During a procedure in the OR, the interventional radiology (IR) team entered the OR to perform their part of the procedure. An OR nurse noted that the IR team had added a VERSALON™ (nonradiopaque) sponge to the surgical field. A count was performed, and a sponge was missing and could not be accounted for because it was nonradiopaque. One of the lessons shared with PA-PSRS was that the radiology team now uses only radiopaque sponges for IR procedures.1
Since that article appeared, PA-PSRS has received several reports describing injuries to patients from retained foreign objects related to IR procedures performed outside of the OR setting. These reports indicate that it is important to use radiopaque sponges during any IR procedure in order to prevent the retention of foreign objects following IR procedures. Despite the minimally invasive nature of IR procedures, foreign objects may still be retained. This article focuses on the use of sponge, sharp, and instrument counts—a process routinely used in the OR setting—during invasive IR procedures. Discussion centers on the nature of IR procedures, risk factors associated with the retention of foreign objects applicable to the IR setting, and risk reduction strategies.
Evolving Scope and Complexity of Interventional Radiology
IR utilizes imaging guidance—primarily fluoroscopy, computed tomography, and ultrasound—to perform diagnostic and therapeutic procedures in a minimally invasive manner.2 IR is a rapidly expanding area of medicine that has evolved to accommodate increasingly complex equipment and procedures.3 IR has evolved from a predominantly diagnostic specialty into a specialty where therapeutic procedures are also performed.4 The growth in the field has been made possible by technological advances in catheters, instrument and imaging system design and manufacture, and radiological expertise, all leading to a significant increase in minimally invasive techniques.5 Examples of current interventional procedures include arterial stent grafts, percutaneous tumor ablation, embolization of fibroids, tumor chemoembolization, insertion of central venous catheters, and percutaneous biopsy and drainage procedures.5
The progressive move towards “minimally invasive” IR techniques has been associated with less physiological disruption, smaller “entry points,” reduced intra- and postoperative complications, and earlier discharge.6 However, the potential for patient safety risks during IR practice remains, despite the smaller incision size typical during minimally invasive procedures. A case study described by the Association of periOperative Nurses (AORN) illustrates one of these risks: the retention of a foreign object.7 An open surgical technique was used to place a small radiopaque gauze sponge into the incision site to control bleeding during an endoscopic saphenous vein harvesting. The sponge was retained after the leg incision was closed. AORN notes that “despite the minimally invasive technique and small incision size, multiple occurrences have been associated with this practice.”7 AORN’s case study analysis further notes that the hazards related to minimally invasive procedures can be overlooked. “Perioperative clinicians should remain aware of the placement of surgical sponges when incisions are large enough to engulf a sponge.”7
Reports to PA-PSRS
Several reports submitted to PA-PSRS describe the retention of foreign objects related to IR procedures.
A patient had a venous port placed in interventional radiology. The chest port was removed approximately two weeks later, and a 4x4 gauze was removed from the port pocket.
A patient was admitted following a port placement two weeks prior. The patient underwent port removal for suspected infection, and a piece of gauze was discovered in the port pocket.
A patient underwent right lower extremity angiography by a vascular surgeon in the cardiac catheterization lab. A subsequent chest x-ray revealed that a guide wire had been retained in the patient’s aorta.
In one case, the facility’s investigation revealed that an instrument count was not performed. The third case illustrates that IR procedures may be performed in a setting other than a dedicated IR suite, underscoring the need for uniform policies and procedures to prevent the retention of foreign objects no matter where the IR procedure occurs. While retained foreign objects during IR procedures are reported to PA-PSRS less frequently than in surgical procedures, they represent the potential for significant patient harm. Patient complications associated with retained foreign objects may include sepsis, infection, return to the OR, increased length of hospital stay, readmission, fistula formation, bowel obstruction, visceral perforation, and death.8 As indicated by the PA-PSRS reports, despite minimally invasive technique and small incision size, foreign objects may still be retained during IR procedures and present risk. Accordingly, there is a need for adequate IR policies and procedures for the prevention of retained foreign objects. In the cases above, the retained sponges may have been prevented by the completion of a sharp, sponge, and instrument count. This procedure is routinely performed in the OR, but it is not yet widely used during invasive IR procedures outside of the OR setting.
A search of the literature found no studies that addressed the risk of retained foreign objects in IR practice. It is unknown at this time whether this is due to the rapidly evolving nature of IR practice, the underreporting of these events. However, there is recognition among professional societies of patient safety risks inherent in IR practice, even though there are not as of yet any guidelines regarding perioperative counts in the IR setting. The American College of Radiology’s (ACR) task force on patient safety has identified a list of preventable errors, most of which the task force notes as relevant to IR; however, the retention of foreign objects is not specifically listed.9 The Society of Interventional Radiology (SIR) has recently formed a safety and health committee and publishes the IR Safety Rounds series to publicize lessons learned that are relevant to IR practice.10 Both ACR and SIR publish procedure-specific guidelines relevant to the practice of IR; as of yet, none address the potential for retention of foreign objects during IR procedures.9,10
The American College of Surgeons (ACS) offers guidelines for the prevention of retained foreign objects after surgery, which it notes can be adapted to areas other than the traditional OR, including “other areas where operative and invasive procedures are performed.”9 Similarly, AORN recommends best practices for the prevention of retained foreign objects, which include that “sponges should be counted on all procedures in which the possibility exists that a sponge could be retained.”7 ACS and AORN suggest that sponge, sharp, and instrument counts should be utilized during any invasive IR procedure, due to the invasive nature of the procedure and the possibility that a sponge, sharp, or instrument may be retained.7,9
Risk Factors for Retained Foreign Objects Related to IR
Risk factors unique to IR have been identified in the context of the implementation of Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™.3 These factors may be useful to consider in the effort to prevent the retention of foreign objects during IR procedures. Interventional imaging procedure rooms, where both diagnostic and therapeutic procedures have historically been performed, are now being used for minimally invasive surgery and image-guided procedures. These rooms may not provide the structured surgical environment required to control the flow of materials, supplies, and personnel needed for these invasive procedures.3,11 If IR procedures are performed within the OR, traditionally designed OR suites may not be able to accommodate the wide variety of imaging equipment and number of specialists required. The large amount of equipment and personnel that may be involved can result in a crowded, potentially noisy room. In addition, equipment and supplies may need to be moved among different areas, and multiple procedures may also be performed.3 The potential variation in location, equipment, and personnel is an important consideration in crafting policies and procedures to prevent the retention of foreign objects during IR procedures.
Safe Practices/Risk Reduction Strategies
In July 2006, AORN, with the support of ACS, published the following best practices for preventing the retention of a foreign object:7,9
- Consistently performing surgical counts according to national standards and facility policy
- Promoting an environment that is focused on, and attentive to, the patient’s perioperative care
- Using only x-ray detectable sponges, towels, miscellaneous items, and instruments in the surgical wound
- Conducting a methodical wound exploration before wound closure and whenever a count discrepancy is noted
- Employing radiographic or other technology as needed to ensure that all potential foreign objects have been removed from the surgical site
- Documenting the outcomes of the surgical count, items intentionally used for packing, and actions taken to rectify a count discrepancy
- Providing resources to support safe practices to prevent retention of foreign objects
- Developing and reviewing count policies and procedures though a collaborative process to promote consistency in practice across disciplines
- Making count policies and procedures readily available in the practice setting
AORN’s recommended practices for sponge, sharp, and instrument counts may be adapted to various practice settings, including IR.12
For further consideration, refer to “Additional Measures,” which discusses elements from a Pennsylvania healthcare facility’s surgical count policy.
A recent study evaluated the use of x-ray-detectable, numbered gauze sponges to determine ease of use and effect on the flow of a procedure. The sponges have a number sewn in the corner with suture material approved by the U.S. Food and Drug Administration. The numbered radiopaque sponges were found to be easy to use, and did not lengthen or affect the flow of the procedure.13
In addition, studies have evaluated the use of radio-frequency systems and bar-code technology.13-15 Bar-coding systems involve tagging surgical items and scanning each item with a handheld wand as the item enters the body, thereby identifying every item used during the procedure.13,14 Radio-frequency systems items utilize a radio-frequency identification chip embedded in surgical items that can be detected through tissue with a handheld wand.13,15 Incorrect use of the wand and failure to scan the entire surgical surface, thereby missing a sponge, have been identified as potential problems with these technologies.13,15
Sponge, sharp, and instrument counts are routinely used in the OR to prevent the retention of foreign objects. The consistent use of counts during invasive IR procedures could promote a similar outcome. Facilities’ policies and procedures need to include the use of sponge, sharp, and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting.
- Pennsylvania Patient Safety Reporting System. Non-radiopaque sponges in the operating room: how one department can affect another. PA PSRS Patient Saf Advis [online]. 2006 Jun [cited 2007 Nov 30]. Available from Internet: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/
- Staner D, Yetter E, Gordon G, et al. Current topics of interest in interventional radiology. MO Med 2005 Mar-Apr:102(2):131-6.
- Knight F, Galvin R, Davoren M, et al. The evolution of universal protocol in interventional radiology. J Nurs Radiol 2006 Dec;25(4):106-15.
- Rilling W. Interventional radiology training: current status and the rationale for change. J Vasc Interv Radiol 2006 Nov;17(11 Pt 2):159-62.
- Sabharwal T, Fotiadis N, Adam A. Modern trends in interventional radiology. Br Med Bull [online]. 2007 Apr 30 [cited 2007 Jun 8]. Available from Internet: http://bmb.oxfordjournals.org/cgi/content/full/ldm006v1.
- Leaney B. What’s new in vascular interventional radiology? Aortic stent grafting. Aust Fam Phys 2006 May;35(5):294-7.
- Best practices for preventing a retained foreign body. AORN J 2006 Jul;84(1 Supp 1):S30-6.
- Gawande AA, Studdert DM, Orav EJ, et al. Risk factors for retained instruments and sponges after surgery. N Engl J Med 2003 Jan 16; 348 (3):229-35.
- American College of Surgeons. Statement on the prevention of retained foreign bodies after surgery. Bull Am Coll Surg 2005 Oct;90(10).
- Miller D. Safety in interventional radiology. J Vasc Interv Radiol 2007 Jan;18(1 Pt 1):1-3.
- Rostenberg B. “Surgicology” is coming! Designing for the convergence of surgery and interventional radiology. Health Facil Manage 2005 Jun;18(6):49-52.
- Association of periOperative Nurses. Recommended practices for sponge, sharp, and instrument counts. AORN J 1999 Dec;70(6):1083-9.
- Pelter MM, Stephens KE, Loranger D. An evaluation of a numbered surgical sponge product. AORN J 2007 May;85(5):931-6, 938-40.
- Fabian CE. Electronic tagging of surgical sponges to prevent their accidental retention. Surgery 2005 Mar;137(3):298-301.
- Macario A, Morris D, Morris S. Initial clinical evaluation of a handheld device for detecting retained surgical gauze sponges using radiofrequency identification technology. Arch Surg 2006 Jul;141(7):659-62.
To prevent the occurrence of the retention of a sponge in a pocket following interventional radiology (IR) procedures, one Pennsylvania healthcare facility developed a policy and procedure for surgical counts specific to the IR department. Elements of the policy include the following:1
- A count of surgical sponges, sharps, and other miscellaneous items will be done on all IR cases when the possibility exists that an item could be retained. This includes all procedures that involve a surgical pocket.
- X-ray detectable gauze will be used in all cases that involve a surgical pocket.
- Items to be counted during IR procedures involving a surgical pocket will be counted
- prior to incision to determine baseline,
- at the time of permanent relief of scrub or circulator, and
- at the closure of pocket/incision closure.
- Any item added to the surgical field will be counted. Sponges will be separated to allow viewing by each participant of the sponge and the x-ray detectable strip.
- The performing operator will be notified to inspect the surgical pocket and confirm the absence of a retained foreign object with x-ray in the event of a count discrepancy.
In addition to formulating the policy and procedure, the facility conducted a mandatory training program for all staff involved with IR procedures. The facility also performs a quarterly audit of 10 cases to ensure that the policy is followed.
- Interventional Radiology Department. Policy & procedure: surgical counts. 2007 Apr. (Pennsylvania healthcare facility name withheld at facilty’s request.)
The following questions about this article may be useful for internal education and assessment. You may use the following examples or come up with your own.
- Factors that contribute to the risk of the retention of foreign objects during interventional radiology (IR) procedures include all EXCEPT which of the following?
- Using nonradiopaque sponges
- Failing to mark the operative site
- Performing multiple procedures during a case
- Failing to perform sponge, sharp, and instrument counts
- During an IR procedure, a sponge, sharp, and instrument count should be performed at which of the following times?
I. Prior to incision to determine baseline
II. At the time of permanent relief of scrub or circulating nurse
III. At the closure of pocket/incision closure
IV. Whenever a count discrepancy is noted
- A sponge, sharp, and instrument count should be performed during an IR procedure ONLY if the procedure involves a surgical pocket.
- Risk reduction strategies for the prevention of the retention of foreign objects during IR procedures include all EXCEPT which of the following?
- X-ray detectable gauze will be used in all cases that involve a surgical pocket.
- Any item added to the surgical field will be counted.
- Documentation of the outcome of the surgical count will occur only if there is a count discrepancy.
- A count of sponges, sharps, and other miscellaneous items will be done on all IR cases when the possibility exists that an item could be retained.
- The performing operator will be notified to inspect the surgical pocket and confirm the absence of a retained foreign object with x-ray in the event of a discrepancy.