The three main categories of contributing factors identified by Steelman et al in three recent studies of retained items reported to the Joint Commission between 2012 to 2018 were problems related to human factors , ineffective leadership , and communication breakdown .”
on the different types of adjunct technology ,” she says . “ It is important to note that evidence on a specific type of adjunct technology device is not generalizable to all devices and is specific to that manufacturer , even if the system uses the same type of technology .”
Other guidance can be found in AORN ’ s document , Prevention of Retained Surgical Items : Product Evaluation of Adjunct Technology , which explains , “ The process of selecting adjunct technology devices gives healthcare organizations a systematic way to determine and document which devices will best meet their needs . The selected devices must be acceptable for clinical care and prevent unintentionally retained surgical items . The selection process includes collecting information that will allow the organization to make informed decisions about which devices to implement . The more this process can be standardized across clinical settings , the more information can be used to compare experiences among healthcare facilities .”
AORN says that a key feature of the process is an in-use product evaluation , which , it points out , is not the same as a clinical trial : “ Whereas a clinical trial is a sophisticated scientific process requiring considerable methodological rigor , a product evaluation is simply a pilot test to determine how well a device performs in the clinical setting . Although the process does not need to be complex , it does need to be systematic .” AORN provides a 10-step approach for selecting a product for implementation :
➊ Organize a product selection and evaluation team
➋ Set priorities for product consideration
➌ Establish criteria for product selection and identify other issues for consideration
➍ Obtain information on available products
➎ Obtain samples of devices under consideration
➏ Develop a product evaluation survey form
➐ Develop a product evaluation plan
➑ Tabulate and analyze the evaluation results
➒ Select and implement the preferred product
➓ Perform post-implementation monitorin
In its 2019 Top 10 Health Technology Hazards report , ECRI addressed the hazards associated with retained surgical sponges and recommended broader adoption of technologies that supplement the manual sponge-counting process .
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 .
Standard Procedure for Preventing RSI
AORN ’ s Guideline for Preventing Unintentionally Retained Surgical Items makes the following recommendations :
• Use a consistent accounting methodology for all surgical counts .
• Conduct a count of soft goods , sharps , miscellaneous items , and instruments during the phases of the procedure .
• Conduct a count before the procedure to establish a baseline ( the initial count ) before the patient enters the OR or procedure room , when possible .
• An additional count may be performed at designated intervals ( as part of a second time out ) during lengthy procedures .
• Establish the standardized sequence in which the counts should be conducted in the organization . The counting sequence should have a logical progression ( order of standardized count board or sheet , proximal to distal from the patient ).
• Items being counted should be viewed concurrently by two individuals , one of whom should be the RN circulator , and counted audibly .
• The scrub person should separate and point out items on the sterile field while audibly counting . The RN circulator should separate and point out items off the sterile field while audibly counting .
• During the initial count and when adding items to the sterile field , count packaged items according to the number in which the item is packaged .
• When introducing items to the sterile field , verify that the package contains the number of items on the product label . Packages that contain an incorrect number of items or items with a manufacturing defect ( e . g ., missing marker , tag , or chip ) should be
• If the count is interrupted , restart the count for the type of item ( e . g ., laparotomy sponge ) that was being counted when the interruption occurred .
• Do not consider the final count complete until all surgical soft goods , sharps , instruments , and miscellaneous items ( e . g ., viscera retainer ) used in closing the incision are removed from the patient and returned to the scrub person .
• A count can be requested by any perioperative team member . When any member of the perioperative team requests a count , the count should be performed .
• If an item is passed or dropped from the sterile field , the RN circulator should retrieve it using standard precautions , show it to the scrub person , isolate it from the field , and include it in the final count .
• Do not subtract or remove items from the count .
• Keep all counted items inside the OR or procedure room until the counts are completed and reconciled .
• Do not remove linen and waste containers from the OR or procedure room until all counts are completed and reconciled and the patient has been transferred out of the room .
• Remove used or open counted items from the OR or procedure room before another procedure begins .
• Perform a structured hand-over communication of accounting procedures at times of relief of the RN circulator or scrub person .