Dr. Jeffrey Port is co-founder and chairman of RF Surgical Systems, a developer of solutions for the detection and prevention of retained surgical items.
Q: What is a retained surgical item?
Dr. Jeffrey Port: A retained surgical item is essentially anything used in an operation that is inadvertently left behind in the patient undergoing surgery. Most commonly, it's often a disposable item such as gauze, which represents the majority of retained surgical items.
No matter the complexity of the case, almost every single operation uses disposable gauze. These are collected during the operation and it's important for OR staff to ensure that what goes into a patient should also be taken out before the surgery is over. Unfortunately, it doesn't happen every time.
Nurses are required to count everything in the surgical field, but this is a challenge because the gauze is being handled across the field and being used for retraction, exposure and soaking up fluid. Gauze is the most common retained surgical item, but there are other items in the field, such as instruments, which can create a problem as well, although they make up a much smaller percentage [of retained surgical items]. Additionally, sutures themselves can be retained and while that is probably not a health risk, it is preferred to not leave a suture inside a patient's body post-surgery. These make up a small minority of the retained surgical items, while gauze is the cause of over 80 percent of retained surgical items.
Q: What is the potential harm — to both patients and an organization — that can come from retained objects?
JP: For patients, these retained items can lead to infection; they can lead to abscesses in body cavities, perforation, bleeding, obstruction. There have also been reported cases of death associated with leaving behind one of these items.
The reason why a retained object is so devastating to an organization is that retained surgical items are considered "never events." Because of that, they're highly publicized, they're made public record and they're reported. Even one retained item could call into question an organization's patient safety record or protocols. It can lead to not only an embarrassing situation, but it can impact the institution's ability to function. It's a tough problem because regardless of protocols, these never events sometimes occur.
For an organization, the consequences related to a retained object are that the event is often publicized. Additionally, there are untold costs related to re-operative expenses, legal issues and the compromised reputation of the institution. The event is most always an automatic settlement as it's a hard case to defend.
As of last year, CMS listed this as a never event, which means this is an inexcusable event they are not going to pay for. [CMS] estimates it costs up to $60,000 or more in re-operative costs for a patient with a retained surgical item, in terms of the costs that will be incurred by the institution.
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Q: Why are retained items such a challenge for organizations? Why does this happen?
JP: No matter how good human protocols are, they are subject to human error and can break down under certain situations. These breakdowns often occur when there's change in shift, during lengthy operations, during operations that have extra amounts of bleeding, operations that take place late at night and operations that switch from what's intended, such as a minimally invasive procedure that suddenly becomes an open incision. In cases such as this, a physician may be using a particular gauze type that's more suited for a smaller operation, thereby increasing the chance of leaving the gauze behind in the larger cavity.
If a retained case does occur, nurses have been able to rectify the counts 99.9 percent of the time at the end of the procedure. However, nurses do need assistance because under certain situations, human error can occur. What RF Surgical has suggested is bringing in an additional layer of safety as a new standard of prevention and detection of RSIs.
No operation is immune from this event. While we like to say that the event is dependent on the complexity of the case, we've seen never events occur in labor and delivery, ambulatory surgery, minimally invasive procedures and laparoscopic cases — none are immune to this problem.
Q: What are the standard protocols to prevent retained objects?
JP: Standard protocols state nurses are required to track gauze brought into and taken out of the operative field through manual counting. There's often a final count to ensure this matches up. While manual counting varies by institution, there are at least two counts that take place before the patient is finally closed. Then, nurses declare a final count, which hopefully matches what they've been recording as what's been placed into the case.
Almost all gauze is marked with a technology that's decades old. It's barium-impregnated, which shows up under x-ray, and it's radio-opaque. These filaments can be x-rayed if the counts are not rectified. If the final count is incorrect, operating room staff can bring in a portable x-ray machine to look for the filament. However, it can be quite challenging to see the retained surgical item since the quality of the x-ray is not very good since it's done in one plane. In other cases, the gauze can be crumbled up, so the filaments are not readily seen, or can be placed behind bone, the heart or in the pelvis.
Operating room staff can use anywhere from 10-100 pieces of gauze in a single operation. The gauze can really mount up in the room, and are often soaked in blood, so handling them and trying to recount them is quite a stress for the nurses.
For needles and instrument, operating room staff manually counts the trays of instruments to make sure they jive with what they started with. Needles are stuck into a container and operating room staff has the ability to count them. RF Surgical detection technology does not account for instruments or needles.
Q: Your company develops radio frequency technology to help prevent retained objects. How does this technology work?
JP: The technology has evolved to its current form, which has essentially three components. First, we have seamlessly incorporated our sensing technology into a cushioned gel pad, which is found in almost every OR table.
Next, there's a console that sits on a shelf or a boom in the OR.
Finally, we custom-designed a microtag that's inserted into all of the gauze pieces at the manufacturer. It arrives and doesn't look any different from regular gauze unless you inspect it closely, and then you will see there's a little harmless packet where our tag is incorporated into the gauze-woven product. That's the system.
The way it works from a 10,000 foot view is the tag is incredibly simple. It rings when it is excited by our console since it is set at a frequency we can pick up from at least16 inches of range, so we can even scan through the largest and most obese of patients. With the tag being tuned to a set frequency, when it gets excited, it has electromagnetic excitation, it rings back and we can recognize it through pretty sophisticated technology that's in the console. While the system appears to be very simple for the user, the technology is quite sophisticated in that it incorporates elements of radar-like technology and is able to detect the signal at the set frequency.
We are not trying to disrupt the OR nursing mandate of manual counting as it's been a standard for over 50 years. We think nurses do an incredible job. We thought that detection would be the most sophisticated, the most elegant [additional layer of safety]. So regardless of what the nurses come up with when they count, we need the system to corroborate that.
Every single procedure, whether there is suspicion or no suspicion, OR staff does their counts and are comfortable with their counts. If the counts are off, we ask you to try to find it as best as you can, and then incorporate our technology to help you. Even if the counts are correct, you go ahead and press a button and in under 30 seconds, the patient is scanned. There's a visual cue on the console that shows the human form being scanned. When it's complete, it says "scan complete," and if there's something detected, it gives an audio and visual signal that there's something in the patient or at least a tagged gauze product in the field.
At completion of counts, you scan patients. Because it takes less than 30 seconds, you can do it even as you're getting ready to close and even at the end. We recommend you do it a couple of times.
If the manual counts agree and our system agrees, then the patient progresses out of the OR to the recovery room.
There's also another component — a wand that attaches to the console you can use to scan under the drapes, garbage can, etc. If something is inadvertently thrown out, it's an adjunct you can use to start scanning around, looking for it in the room itself if there is a problem.
I want to add that it's not really when the counts are wrong that we get worried. The overwhelming majority of retained items occur are when the counts are falsely said to be correct. Otherwise the nurses would do something to intervene. Every case needs to be scanned; you can't really select out which is the one that needs to be scanned.
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