Financial constraints have many hospitals questioning if it is worth investing in surgical instrument tracking technology. Still, with increasing liability risks, is it worth it not to?

August 19, 2011

An instrument marked with a barcode is placed under a scanner to be tracked during its cycle of use.

In hospitals across the country today, the increasing concerns related to lawsuits due to retained foreign objects, as well as reduced or eliminated reimbursement for surgical errors and complications, has resulted in stronger attention being paid to documentation processes. However, for tracking certain items such as surgical instruments – an area in which no regulation or requirement exists for hospitals to track these items – the tightening of hospital budgets has created a dilemma for facilities to find the proper solution for tracking without breaking the bank.

According to Clay Cannady, Vice President of Marketing and Business Development of Microsystems, a provider of instrument tracking software for the sterile processing department (SPD), the issue of finding a solution to track surgical instruments is not new.

“There has always been a historical emphasis on instrument tracking because there is a whole host of things that professionals who are managing the sterile processing function are accountable for,” Cannady says. “They are responsible for their staff, their inventory as well as larger quality assurance and infection control initiatives.”

Today, most facilities practice some version of instrument or tray tracking as part of the record-keeping required to successfully navigate a Joint Commission audit and to document Association for Advancement of Medical Instrumentation (AAMI) compliance. However, how a hospital tracks instruments, and to what capacity, is not regulated.

Brian O’Connell, CEO of Key Surgical, explains many facilities continue to rely on manual counting and marking of instruments in the SPD to build instrument sets for delivery to the OR. This allows the facility to track the tray containing the set of instruments, but not the instrument itself.

“Right now, the hospital can say, ‘We replaced Bill Smith’s hip with this tray of instruments,” O’Connell says, “but now that we’ve done ten more hip cases, we have no idea which instruments were in that particular case because we have five different hip sets that we keep in the hospital, and we just make sure that each hip set has 20 of one type of instrument, six of another type and so on.’”

Recently, technology to not only track instruments at the tray level, but at the individual device level, has emerged to allow hospitals to more thoroughly track surgical instruments and document their use in the SPD and the OR. The process of implementing an instrument tracking system, however, is not simple, nor inexpensive, and it’s important for facilities considering this technology to understand all the aspects of implementation before making a final decision.

One of the first instrument tracking solutions to arrive in the surgical marketplace has been barcode technology. Similar to putting a barcode on a carton of milk at the grocery store, or putting a license plate on a car, this technology involves applying a unique mark to every instrument in a hospital, and using scanners that communicate back to software to track where instruments are in their cycle of use.

A unique tag placed on an instrument allows it to be counted, monitored and tracked using RFID technology.

A license plate for your instrument
On a broad scale, O’Connell says, instrument tracking involves three main components:

  1. The instrument to be tracked.
  2. Marking and identifying the instrument with a unique number or mark.
  3. The software program that does the actual tracking.

One of the first instrument tracking solutions to arrive in the surgical marketplace has been barcode technology. Similar to putting a barcode on a carton of milk at the grocery store, or putting a license plate on a car, this technology involves applying a unique mark to every instrument in a hospital, and using scanners that communicate back to software to track where instruments are in their cycle of use.

Key Surgical provides an instrument marking solution called the KeyDot®, a laser-etched barcode label that is attached to an instrument via an adhesive. The label can be applied by any SPD professional on a clean instrument. Other instrument marking solutions include etching the code into the instrument itself.
Before a facility can think about how they’ll mark their instruments, though, they must go through the more difficult, yet crucial, process of selecting a software solution to implement a barcode tracking technology.

“Selecting software is somewhat unique in the individual experience,” Cannady says. “Software can be a little bit problematic because all vendors can say, ‘oh yes, I can do that,’ but can they do it in an intuitive way? Can they do it in a two-mouse click, one-screen way? Or is it a seven-mouse click, three-screen way? To say it is all in the details when it comes to software purchasing is probably an understatement.”

When making purchasing decisions for instrument tracking software, Cannady recommends talking with other hospitals that have purchased the system you think you want and also talk to hospitals that have purchased other systems. Ask about their training and the implementation process. Also, the software solution should be somewhat tailored to the unique needs of the particular hospital.

“If the hospital knows broadly what they’re objectives and requirements are and can provide those to the vendor, then the vendor can come in with a specific plan for accomplishing those things,” Cannady says.

RFID tagging of instruments
Another recent technology for instrument tracking involves the utilization of radio-frequency identification (RFID) to continuously track instruments throughout their cycle of use without the use of a scanner.

According to Phil Allen, Vice President of Sales at ORLocate, the company’s RFID-based system automatically counts, monitors and tracks surgical instruments, as well as surgical sponges, through a unique RFID tag that identifies each individual instrument and tracks it throughout the entire surgical process – from the SPD to surgery and back to the SPD. Various non-intrusive antennas read the RFID tags and communicate back to software with a touch screen interface to indicate to staff where the instruments are at all times. According to Allen, RFID tracking can help reduce the risk of retained surgical items, eliminate manual counting procedures, increase tray/set accuracy and provide custom reports to improve overall efficiency.

“In approximately every 1,500 surgery cases, there is a retained surgical item left in a patient,” Allen says. “This is a huge non-reimbursable expense for the hospital and costs the U.S. approximately $2 billion per year. Automatic counting and tracking of surgical instruments and sponges with complete reconciliation at the end of surgery can help provide higher quality and safer care.”

Furthermore, Allen says instrument shrinkage can be a large expense for a hospital, something RFID tagging and tracking can help reduce. 

“I talked with one hospital that loses thousands of dollars in instruments per year,” he says. “This technology decreases that risk by allowing for hospitals to always know where the instruments are.”

Still, RFID-based tracking technology comes with its own unique challenges. Allen says to be prepared for a minor change in workflow, as the system essentially eliminates manual counting in the OR of instruments, as well as sponges, and replaces it with automatic counting. Cost-wise, RFID technology is on the higher-end of tracking technologies available. Furthermore, RFID tagging of the current inventory can be time-consuming, and it's important to note that not all items can be tagged. The RFID tag requires 3 mm of flat surface to secure accurately, so items such as blades and needles cannot be tagged.

To offset some of these challenges, ORLocate provides an on-site retrofit lab to tag the instruments. The company's system also contains a safety measure to track untagged items and will not allow the surgical case to close without these items being accounted for, Allen says. 

Tracking motivation
Despite new technology, the marketplace has been slower than expected to adapt to tracking instruments at the device level because hospitals have a hard time financially justifying the expense, O’Connell says.

“The thought was that everyone is going to want to do this because we’ll know where everything is all the time,” O’Connell says, “but hospitals are asking, ‘We’re going to spend $100,000 doing that? How is that going to make us better than where we are today?’”

With the healthcare landscape changing to one that is held more financially accountable for surgical errors and complications, however, it may be worthwhile for hospitals to consider the value in knowing where instruments are at all times, and in which patients they are used.

“In a non-automated environment, there is a tremendous amount of time and energy lost looking for instruments, and that can be really paralyzing, especially when you start delaying OR procedures, or taking shortcuts to prepare instrumentation for delivery to the OR for use,” Cannady says. “The derivative problems that come out of a lack of organization or a lack of specific information are just multiplied time and time again. It’s wasted time. It’s wasted money. It’s increased risk.”

Ultimately, it comes down to accountability, Cannady says. Knowing who was responsible for the decontamination process or for assembling a particular tray or for sterilizing it or recording the outcomes for the sterilization/biological monitoring process can be invaluable for a hospital in terms of risk management.

“To be able to know what you need to do, to be able to do it in a way that conforms to internal policies or recommended standards, and to be able to document it so you can go back and show that the work was done appropriately and effectively is absolutely essential from a patient liability and risk management standpoint,” Cannady says.

Furthermore, tracking instrumentation can provide hospitals with inventory control to help them realize cost-savings.

“An average size hospital might own 50,000 instruments,” O’Connell says. “If all of a sudden, one gets lost, or is dropped on the floor, broken and sent out for repair, staff don’t know at any given time what the status is of those instruments.

You can end up losing instruments or buying more than you need. It’s a way to manage inventory if you know something about all of those individual instruments. Hospitals want to know where their money is and make sure they don’t have too much or too little money tied up in instruments.”

The future
Despite the economic challenges, for the facilities considering implementing a new instrument tracking technology, Cannady recommends involving all interested and involved parties.
“This is a decision that impacts the information technology staff, the SPD and OR teams, and you need to get the financial people involved, because this is a significant capital investment that requires quantifiable, financial returns,” he says. “The best thing to do is start with a group of people that can develop an informed opinion and help drive a decision.”

O’Connell mentions some type of regulatory instrument tracking is in the works. The Food and Drug Administration (FDA) is working on establishing Unique Device Identification (UDI) standards.

Regardless of regulations, instrument tracking technology is something surgical facilities should consider for the future, Cannady says.

“Investments that pay for themselves again and again are the right thing to do regardless of whether somebody is making you do it, suggesting you do it, or they don’t care whether you do it,” he says. “If you look at the clinical impact of the sterile processing function, items that are not processed properly can lead to very grave results. Clinically, operationally, financially, it really makes good sense.”