The problem of surgical items being inadvertently left in various body spaces after an operation, has been with us since the practice of surgery began. Retained Surgical Items (RSI) is the preferred term rather than retained foreign bodies or objects or uRFOs. Foreign objects include swallowed pennies, pins, shrapnel, bullets and other objects while surgical items are the tools and materiel that we use in procedures to heal not to harm. Retained surgical items are a surgical patient safety problem.
Here we have followed the AORN classification of surgical items and placed them into four groups; soft goods, sharps, instruments and small miscellaneous items. We have outlined safe strategies to prevent retention of each. It has been estimated that 2000 – 4000 RSI cases occur each year in the United States although we know from reporting systems that there is a wide spectrum of occurrence. Many hospitals have had no events for years while other facilities grapple with an event every quarter.
Requirements for state reporting vary as does the definition of what is considered retention. The National Quality Forum (NQF) definition is most frequently referenced. In 2011 the NQF reviewed all Serious Reportable Events (SREs) and posted on their public website the definition of when it is after surgery and all the SREs including unintended retention of surgical items.
RSIs can be discovered hours to years after the initial operation and a second operation may be required for removal. This type of case is a “canary in the OR coal mine” and is reflective of system problems in the operating room. It is rarely the result of a single individual error. New ways of thinking about human error and OR practices and understanding systemic changes in OR culture are required to prevent this event. System fixes require knowledge and information, a winning strategy, consistent multi-stakeholder engagement and leadership.
The most frequently retained surgical item is the cotton gauze surgical sponge which is available in a number of different sizes. Most reports of retained sponges refer to the 4"x4" raytex (an acronym we have coined to refer to a radiopaque textile) or the 18"x18" laparotomy pad. There have also been cases of retained OR towels. The most common sites are the abdomen/pelvis, the vagina and then the chest, although sponges have been retained in surgical wounds of every size and after almost any operation. Increased appreciation has occurred around the problem of retained vaginal sponges and miscellaneous items left behind after spontaneous vaginal births as well as elective gynecological operative cases. This has led to efforts to move better safety and preventive strategies to labor and delivery areas in addition to the OR and other procedural areas.
With retained sponges under better control, now we are seeing increased reports of retained small miscellaneous items, devices and unretrieved device fragments. These include intact but separated parts of surgical items, some of which are not radiopaque, broken pieces of instruments, small microneedles, trocars, guidewires and sheaths. These events occur in the OR and throughout the hospital and involve a wide variety of procedural items and an expanded list of provider stakeholders. The preventive strategies for these types of items are not applicable only to the OR since retained guidewires, sheaths and catheters are found after interventional vascular, cardiac and radiological procedures. Various types of providers now must develop standardized processes to account for all of the tools and parts of devices. Practices originating in the OR can be shared with these other clinical groups to help prevent retention and speed accountability.