Surgical teams use manual counting protocols to reduce the risk of a surgical sponge being unintentionally left inside the patient during a procedure. While these counts are a vital safety practice, they are themselves prone to error. In its 2019 Top 10 Health Technology Hazards report, ECRI Institute addresses the hazards associated with retained surgical sponges and recommends broader adoption of technologies that supplement the manual sponge-counting process.
Retained Surgical Sponges – A Top Hazard
Surgical sponges that are unintentionally left inside the patient after the surgical site is closed can lead to infection and other serious complications, including the need for secondary operations. Although accurate data is hard to come by, available research suggests that every year thousands of U.S. patients could experience a retained surgical item (RSI), with surgical sponges being the most commonly retained item.
Manual counts – in which the surgical team verifies that all sponges are accounted for before concluding the procedure – are standard practice, but counts can be inaccurate. If miscounts result in a retained sponge, complications can ensue, with consequences for both the patient and the healthcare facility. These include:
Technologies that supplement the manual counting process are available and have been found to be effective when used correctly and consistently. ECRI Institute contends that broader adoption of these technologies could further reduce the risk that a surgical sponge will be unintentionally retained during a procedure.
The prevalence of this hazard – along with the availability, and underutilization, of technologies to help reduce the risk – led ECRI Institute to include this topic as Hazard No. 3 on its 2019 Top 10 list of health technology hazards. The nonprofit research organization produces its annual list to raise awareness about critical hazards associated with medical devices and systems and to promote solutions that can help prevent patient harm.
Manual Counts – An Imperfect Solution
Manual counting protocols are standard practice for reducing the risk that sponges or any other surgical soft goods will be unintentionally retained within the patient. However, manual counts have limitations – the possibility of a miscount being an obvious one. For instance, staff may conclude that all sponges have been accounted for when in fact a sponge is missing. In this case, the surgical team might not learn of the discrepancy unless (or until) the patient returns with a complaint of pain or discomfort. Several studies have found that in the vast majority of cases in which an unintentionally retained sponge was later identified, surgical staff had thought that the manual count was correct.
In other situations, staff may determine that a sponge is missing. Whether this determination is correct or incorrect, the surgical team must try to locate the sponge before surgical closure, extending the surgery and likely requiring an intraoperative X-ray.
Technology Options – An Underutilized Resource
Technology options consist of a scanning device that can count or detect proprietary sponges that incorporate a detectable tag. These technologies can be used to aid in the counting and/or detection of sponges (and other soft goods), thus serving as a technological adjunct to manual counts.
Current systems offer the following:
ECRI Institute has tested and rated two adjunct surgical sponge technologies, one that counts sponges and one that detects them. Both systems performed well in the organization’s testing. Similarly, studies conducted by individual hospitals have shown such technologies to be effective at reducing the likelihood of unintentionally leaving a surgical sponge inside a patient. (Refer to ECRI Institute’s 2019 Top 10 Health Technology Hazards for details about these studies.)
Despite their apparent effectiveness, such technologies have not yet been implemented widely. ECRI Institute estimates that approximately 20 percent of the hospitals in the United States use some form of adjunct technology to supplement the manual counting process or to aid in the detection of missing sponges.
Barriers to implementation likely include the added steps involved in incorporating the technologies into a surgical procedure as well as the added expense associated with their use. “It might take some time for OR staff to get used to a new workflow,” notes Julie Miller, senior project engineer in ECRI Institute’s Health Devices Group, “but facilities should also take into account the time and expense associated with a retained sponge.”
A cost analysis using ECRI Institute’s PriceGuide data shows that the use of proprietary tagged sponges could cost an additional $12 per procedure, compared with using traditional sponges. Additionally, ECRI Institute found during its testing that using a sponge counting or detection technology added about one minute (or less) to each testing scenario. Miller counters: “A minute of OR time isn’t cheap, but compare that to 18 minutes of OR time that might be required to locate a missing sponge, or to the unreimbursed costs associated with an RSI, which can add up to hundreds of thousands of dollars per occurrence if it results in litigation.”
It’s worth noting, however, that these systems are not designed to prevent retained suture needles, device fragments, or other types of RSIs. Rather, they address only surgical sponges, which are the most commonly retained item.
ECRI Institute Recommendations
While the use of counting or detection technologies is not currently required in the standard of care, ECRI Institute nevertheless encourages broader adoption of such technologies as a supplement to the manual counting process.
When employing an adjunct technology, ECRI Institute recommends that healthcare facilities:
This article supplements ECRI Institute’s 2019 Top 10 Health Technology Hazards report. An Executive Brief of the report can be downloaded from ECRI Institute as a free public service. The full 2019 Top 10 Health Technology Hazards Solutions Kit, which includes detailed problem descriptions and recommendations for addressing the hazards, requires membership in ECRI Institute programs. For more information, visit www.ecri.org/2019Hazards, or contact ECRI Institute by telephone at (610) 825-6000, ext. 5891, or by email at firstname.lastname@example.org.
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