This article appeared in the March issue of Surgical Products.

Surgical Products recently spoke with two product experts about the key characteristics of various products that help surgeons and OR staff members avoid wrong-site surgery and the mistakes and oversights that lead to them occuring. They discussed their company’s products, but also the thought process behind them and how they can truly help surgeons and staff do a better job at preventing "never" events.

SP: Obviously there are occasion breakdowns that occur in the operating room. What are some reasons why these communication breakdowns occur?

Jennifer Barber, Marketing Communications Specialist, Ansell: Communication breakdowns in the OR remain a top cause for wrong-site surgery. Other causes stem from failure to comply with procedures as well as the current organizational and safety culture in a particular facility. Contributing factors to a communication breakdown may include: Inadequate planning and review of medical records, miscommunication among members of the surgical team, lack of patient and family involvement when identifying the correct site, and failure to comply with the Joint Commission’s Universal Protocol to perform a time out before the procedure begins. Most importantly, a time out without full participation of every member of the surgical team will certainly increase the risk for a wrong-site surgery.

Holly Bengel, Category & Market Manager, Aspen Surgical:  I think one of the main reasons for a communication breakdown is silence in the operating room. Training your staff to work in a question-based environment, where they aren’t punished for asking questions, will really overcome any communication breakdowns. A good practice a lot of hospitals do is, after their time-out is performed, is to ask if there are any questions or concerns. This will allow for any questions or concerns to be addressed before moving forward with the procedure, which obviously could help deal with any situation that may arise. Also, staff rotation or patient hand-offs are also a source of potential communication breakdowns. Sometimes staff can change before the start of surgery, and staff can assume that processes have already taken place… when they have not.  So setting up protocols or procedures for each type of rotation or patient hand-off can really help eliminate some of those communication breakdowns that happen.

SP: There are standards, processes, and protocols that help surgeons and other staff from mistakes or oversights that lead to wrong-site surgery. Are they not enough to prevent problems from occurring? Why or why not?

Barber: The Joint Commission requires a time out before every procedure. Many facilities have policies in place to prevent “never events,” however, errors still occur. With non-compliance as a primary cause for wrong-site surgery, the Sandel TIME OUT product line provides cost-effective tools to help ensure that surgical teams adhere to this critical process.

Bengel: I think if used properly, protocols and time-outs and such can all be effective in preventing wrong-site surgeries. They are pretty comprehensive in terms of what they cover, which can be anything from anesthesia all the way to patient recovery. But I think that, in terms of technology, there definitely could be more done to help prevent these types of mistakes. I definitely think there is a market out there for it – if it wasn’t cost-prohibitive to do it. If there was an option out there that was easy and affordable, it would definitely be considered as a measure to ensure patient safety.

SP: How do some of your products help surgeons avoid the communication breakdowns or mistakes that lead to wrong-site surgery?

Bengel: One of Aspen Surgical’s core product lines is our skin markers. They are really the first line of defense in ensuring wrong-site surgeries don’t happen. A lot of the time after prep solution is used on the skin, the marking will almost be entirely erased and it’ll have to be re-marked again. Our WRITESITE skin marker allows for the skin to be marked per the universal protocol and ensures the site remains visible for the time-out and before the surgery takes place. Obviously, this helps maintain patient safety throughout the beginning of the procedure.

Barber: All Sandel TIME OUT products are bright orange and boldly display “TIME OUT” as a reminder to comply with the Joint Commission’s Universal Protocol. The time out beacon is designed to be placed over the surgical site or may stand on any highly visible place that will draw attention to the verification process prior to the start of the procedure. The time out Hood is designed to be placed over the scalpel that will make the first incision, as a final barrier and reminder to perform a time out.
Ansell also offers a complete line of bright orange time out skin markers designed to mark the correct surgical site prior to the procedure. In addition, all Sandel safety handles, safety scalpels, and skin markers come with a time out sleeve to reinforce the Universal Protocol. Customers can choose one product, a standard kit, or create a custom time out kit to meet their specific needs.

SP: Do you feel like this is a problem on the rise, or medical professionals are getting better at avoiding these kinds of issues? Why or why not?

Barber: According to a study lead by Johns Hopkins University School of Medicine, surgeons make serious errors over 4,000 times a year in the U.S. Data from the Joint Commission still show wrong-site, wrong-patient, and wrong-procedure surgery as being one of the top sentinel events. Many instances still go unreported so these statistics are most likely even higher than noted here. Organizations such as AORN and The Joint Commission have always had an emphasis on patient safety, but this past year both organizations partnered to raise awareness for Time Out Day in support of this critical issue. AORN provides comprehensive tools and resources to help facilities prevent wrong-site surgery and increase safety in their facility.

Bengel: Reporting has gotten a lot better, especially when it comes to near-misses. Hospitals are doing a good job of performing actions when they do have a near-miss, finding the root cause and doing a risk assessment to find out why a communication breakdown occurred or why a wrong-site surgery happened, and eliminating risks. With the checklists and protocols that hospitals have in place, I think they’ve done a really good job of becoming aware of the potential hazards in the OR. The more they can address the issues and foster an environment where questions can be raised without penalty, the more that will ensure patient safety is first and foremost in the operating room.