By Don Sadler
Despite all the amazing surgical advancements that have occurred in recent years, retained surgical items, or RSIs, remain a rare but potentially catastrophic event. These occur in approximately one out of every 10,000 surgical procedures, according to the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice. RSIs are one of the most frequent and costly surgical “never events.” They have been either the number one or number two Sentinel Event reported to the Joint Commission each of the past four years. The estimated cost of an RSI is approximately $525,000. This includes readmission and reoperation for RSI removal, legal costs, costs related to internal investigation and administrative time, public reporting fees and state penalties.
Negative Patient Outcomes from RSIs
RSIs can lead to a number of negative patient outcomes including infection, bowel perforation, adhesions, fistula, obstruction, abscess, pain, reoperation and even death.
“There is also emotional harm to patients and their families that is hard to quantify,” says Julie Cahn, DNP, RN, CNOR, RN-BC, ACNS-BC, CNS-CP, senior perioperative practice specialist with AORN.
“The reputation of clinicians and the institution may also be affected,” Cahn adds. “And perioperative team members in these events may experience a phenomenon known as ‘second victim’ where they feel disbelief, anxiety or fear about the event and potential future events.”
“RSIs are Sentinel Events that must be reported to the regulatory agencies,” says Sharon McNamara, BSN, MS, RN, CNOR. “But most important, they are avoidable errors that require astute attention to the administrative, practitioner and technology aspects of the prevention strategies implemented and sustained to protect patients from harm.”
Amanda Heitman, BSN, RN, CNOR, is a perioperative educational consultant who says she has had personal experience with retained surgical items. “Fortunately, with due diligence, good communication and standardization, we resolved it,” she says.
“However, I have had times where the surgeon is adamant that items are not in the patient,” Heitman adds. “They refused to stop to look until it was insisted upon by the team – and low and behold, the item was still in the patient. This is why I remind my team that we should do counts consistently in order to keep our patients safe.”
Tom Rawlings, COL (Ret.) USA, RN, MSN, CNS-CP(E), CNOR, lead clinical specialist for DinamicOR, says he was also involved in an RSI incident. “I notified the surgeon that a count was incorrect and he replied, ‘I don’t believe you.’ ”
“Before the case was complete, the surgical incision had to be reopened due to an unforeseen complication,” Rawlings continues. “I asked the surgeon to explore for a missing lap sponge and he did find a retained sponge. This is why it’s so important for all perioperative team members to feel empowered to speak up for patient safety.”
Most hospitals rely on strict counting protocols as the main safeguard to prevent RSIs. “Other methods of accounting for items used in the patient include methodical wound exploration, verbal and visual feedback about what is placed in and removed from the patient, and visual inspection of guidewires and instruments before and after use in the patient,” says Cahn.
“Unfortunately, none of these methods are foolproof and they’re all subject to human error,” Cahn adds.
Using Adjunct Technology to Reduce RSIs
One way that some hospitals are reducing incidences of RSIs is by using adjunct technology designed to detect items that have been left inside of patients following surgery. The AORN Guideline for the Prevention of Unintentionally Retained Surgical Items now recommends the use of adjunct technology devices that are FDA-cleared or deemed exempt from pre-market notification.
“Studies on specific adjunct technology devices show that when used according to the manufacturer’s instructions for use, they can increase the chance of identifying a count discrepancy for surgical soft goods with the imbedded technology,” says Cahn.
In an online FAQ, AORN describes these adjunct technology devices as follows:
“Adjunct technology devices use different processes to identify or locate items. The technologies include data-matrix codes, radiofrequency (RF) detection and radio-frequency identification (RFID). The data-matrix-coded sponge system identifies soft goods, the RF system locates soft goods and the RFID systems identify and locate soft goods.”
The FAQ stresses reviewing the manufacturer’s instructions for use for detailed information on a specific device. “The application of these devices in clinical practice may vary because of the differences between the technology used,” states the FAQ. “Manual counting is still performed when adjunct technology devices are used.”
Among the adjunct technology devices on the market today are Stryker SurgiCount (data-matrix) and SurgiCount+ (RFID), Haldor ORLocate (RFID) and Medtronic Situate (RF).
According to Cahn, AORN recommends the use of adjunct technology with soft goods. When it comes to using adjunct technology with instruments, AORN recommends that each facility perform its own evaluation.
“The evidence on use of adjunct technology with instruments in two recent studies with limited sample sizes shows that there may be some barriers to implementation of these technologies that need to be addressed before use in practice,” says Cahn.
The AORN Guideline for the Prevention of Unintentionally Retained Surgical Items recommends that an interdisciplinary team evaluate adjunct technologies before they’re implemented. Specifically, the team should evaluate:
- Manufacturer’s instructions for feasibility in practice
- The process for cleaning, disinfection and sterilization of reusable devices
- The process for cleaning and disinfection of equipment
- The preferences of perioperative personnel
- Associated costs
Potential interference of devices using RF and RFID with pacemakers, implantable cardioverter defibrillators (ICDs) or other electronic medical devices should also be evaluated before adjunct technology is implemented, since these devices have the potential to cause electromagnetic interference.
Cahn says that incidences of this type of interference have been published in children having congenital cardiac surgery with a temporary pacemaker. “The pacemaker stopped sending an electrical signal to the heart and the heart stopped beating for several seconds when an adjunct technology device with RF was used,” says Cahn.
“Therefore, adjunct technology devices with RF or RFID should be used with caution in patients with pacemakers, ICDs or other electronic medical devices,” says Cahn. “We recommend setting pacemakers to asynchronous mode before using these types of devices, when possible.”
Keys to Reducing RSI events
Heitman believes that consistency is the key to reducing RSI incidences. “We need to do the same process every single time,” she says. “Standardization, good communication and teamwork are critical”.
“It’s not difficult to count to 10, but you would not believe how many things can make it harder,” says Heitman. “Rushing, distractions and human error are all potential factors.”
Rawlings points to communication as a key factor in reducing RSIs, along with strict adherence to policies and procedures.
“One of the biggest failure points in RSI incidents is staff not following policies on surgical counts, especially during handoffs for shift changes and breaks,” says Rawlings. “Clear communication among the perioperative team members during these times and throughout the case is crucial to preventing RSIs.”
Concurrently verifying and having proper visualization from both the circulator and the scrub is another important step in reducing RSIs. “Neither should just assume that the count is correct when they may physically not be able to see it,” says Heitman.
One area of uncertainty Heitman points out is deciding what specific items absolutely must be counted. “There are the usual items like sponges, sharps and instruments,” she says. “But with new technology and surgical methods, non-traditional items like guidewires and wound therapy foam may need to be added to the list.”
For example, Heitman says she once worked with a new staff member who told her that where she came from previously, the policy stated that they had to count trocars, the cap to their inject needle and marker and even the paper ruler. “I feel that this constant adding of miscellaneous items can cause further issues with inconsistency and errors,” she says.
For McNamara, the best way to reduce RSIs is for health care organizations to embody the premise that “patient safety is number one.”
McNamara encourages health care organizations to devise a risk management plan. “This plan should include a safe, anonymous reporting mechanism practitioners can use to report RSIs and inappropriate behavior that may impact the ability to properly carry out patient safety initiatives such as sponge, sharp and instrument counts,” she says.
It’s critical that any risk management system provide safety for a whistleblower. “The risk management department should have an organized system to do root cause analysis on actual RSIs and near misses with transparency for patients and practitioners,” says McNamara. “If staff don’t know that the facility has had an RSI, the common belief is that ‘we do not have that problem.’ ”
“Practitioners never plan to deviate from best practices,” McNamara points out. “But the human condition can cause slips, lapses and drift that may cause deviation from the planned intention.”
When it comes to using adjunct technology to help reduce RSIs, McNamara is a believer in the technology. “However, it does not replace the manual counting processes,” she stresses. “It merely assists in identifying counting discrepancies.”
Rawlings says that he has worked in facilities that used adjunct technology to help reduce RSIs. “This technology can be beneficial in assisting surgical teams with the count process,” he says. “But you have to remember that it does not replace any aspect of the surgical count; rather, it is used in addition to the surgical count to ensure that no RSIs are present.”
Not surprisingly, there are obstacles to the widespread use of adjunct technology to help reduce RSIs. Two of the biggest are cost and the need for a change in perioperative practices.
“In an ever-increasing cost-conscience environment, adjunct technology might not be considered necessary, especially if a facility has never had an issue with RSIs,” says Rawlings. “Of course, a change in practice must be adopted to incorporate this technology in the surgical count process.”
McNamara concurs.
“Change is a difficult concept for surgical teams, especially if they don’t perceive RSIs as an issue in their facility,” she says. “Implementing new technology requires a learning curve for all practitioners and is frequently seen as requiring additional time, which appears to cause inefficiencies or disruption in the procedure flow.”
To offset cost objections, McNamara recommends developing a strong business plan that considers cost savings due to less time spent resolving counting discrepancies, fewer reoperations, less additional hospital care and savings in legal settlement fees. “This could reveal savings for the organization, especially if they have had a history with RSIs,” she says.
Cahn points to research on specific adjunct technology devices showing that a facility could save as much as $417,000 by preventing one RSI per every 10,000 procedures.
Providing a Safe Environment
McNamara believes there are three victims when an RSI occurs: the patient, the practitioners and the organization. “Eliminating RSIs provides a safe environment in which practitioners can practice and give safe care to their patients,” she says.
“The goal of every hospital should be zero preventable harm,” adds Rawlings. “A multidisciplinary team using professional guidelines and evidence-based practices should work together to create the right policies for preventing RSIs.”
AORN offers a free Center of Excellence in Surgical Safety: Prevention of RSI program aimed at helping facilities evaluate their processes and provide education to personnel about RSIs. Visit https://www.aorn.org/education/facility-solutions/rsi to learn more.
