Infection Control Today: Clinical Update

Outbreak Investigation and Surveillance
Using Technology to Track an Epidemic
By Kathy Dix

With so many emerging infectious diseases, and new concerns about surgical instruments and other equipment carrying the diseases, outbreak investigation has gone high-tech. Infection control practitioners (ICPs), epidemiologists and sterile processing managers are using new tools to determine where a pathogen has gone.

“There are several software tools out there that can be used to track infections, outbreaks and clusters,” says Eileen Yaney, co-director of infection control at Saint Barnabas Medical Center in Livingston, N.J. “Some of them have been around a while and others are new. AICE software is out of Austin, Texas, and monitors and analyzes healthcareacquired infections (HAIs) since 1985. It investigates outbreaks and analyzes patient-risk factors and benchmarks data to National Nosocomial Infections Sureveillance System (NNIS) rates.

“Stericycle was presented at the national conference in Phoenix in June 2004. This is a comprehensive infection surveillance and outbreak management tool for the ICP. It can import patient demographics data from your admissions system — no need for additional data entry seems to be a plus,” Yaney adds. “There is also a surgical procedure component that can import information from your operating room (OR) system. It defines thresholds for outbreak monitoring. In the future, the lab data will be directly integrated also.”

She continues, “MedMined was developed by a physician in 1994 — Stephen Brossette, MD, PhD. MedMined, Inc. provides data mining analysis and related technical, clinical and financial consulting services to the healthcare community. They recently presented a Web-based conference on an emerging resistant organism.

“The Public Health Research Institute is an independent not-for-profit research center in Newark, N.J.,” Yaney says. “PHRI has collaborated with hospitals in identifying outbreak organisms through molecular– based diagnostic procedures. They are instrumental in helping hospitals link outbreaks to their source. And of course there is the NNIS program based out of the CDC, which is now being revised and called the National Health and Safety Network, which hospitals across the country participate in and send HAI data for analysis and comparison.”

Some of the most exciting technology is based on radiofrequency — which is being incorporated into surgical instruments for tracking purposes. Radiofrequency is not a new technology, but lately has taken great strides in its incorporation into multiple industries, including healthcare. For example, pharmaceutical giant Pfizer has announced that it will incorporate radiofrequency identification (RFID) tags that will allow wholesalers and pharmacies to authenticate all Viagra sold in the United States. This method uses small RF tags on product packaging, which are electronically scanned throughout the distribution cycle, from the initial manufacturing site to the retail pharmacy.

For the pharmaceutical industry, it may not provide a cost benefit — in fact, Pfizer does not anticipate any cost savings — but it is intended to improve patient safety. For other healthcare divisions, however, there are financial benefits to be realized.

The Censitrac™ system from Censis Technologies, Inc., is a true instrument tracking system. Instead of just tracking instrument trays, it tracks the instruments themselves. Censitrac offers the ability to locate any instrument, container or equipment item in its “last known location.” It also can identify the location of mobile equipment, identify and locate sterilizer-load contents, and identify and locate individual instruments used in a particular patient procedure, for example.

Censis utilizes a permanent laser marking on each individual instrument. Thus, there is no issue with durability. “It’s a bonded material,” adds Blair Myers, vice president of sales and marketing at Censis. “We initially started with the etching of instruments, but after a short period of time, hard water deposits [due to the poor quality of the water used in reprocessing] made it so you couldn’t read the marks.

“The technician scans the instrument when they’re assembling, and then they scan as they put it in sterilizers, on shelves, in case carts, etc. The most appropriate verbiage would be ‘last known location’ or ‘last scanned location’.”

During the process of assembling surgical sets, he says, the technician scans a bar code on the tray. That will then call for certain “ingredients” on a tray. Of course, the same instrument will not remain with the same set all the time. “If they’re calling for a clamp or retractor or any type of instrument, we might have a hundred army/navy retractors in the hospital, but that mark is like a fingerprint, so we can tell you it was number 37 of 100. We can tell you the precise instrument scanned into that set, so when we pull our sets, pill packs, all our items for a surgery, we scan those to a case cart, or we can scan them directly into an OR, or to a specific case.”

The benefits to this are two-fold — first, in terms of cost and loss of inventory, the ability to locate missing instruments is invaluable. Second, if a patient is found to have Creutzfeldt-Jakob disease (CJD) after undergoing surgery, for example, it is crucial to track the instruments used on that patient so the instruments can be destroyed or properly cleaned to rid them of any lingering prions.

Censitrac will associate what instruments were used with what patient; when it’s time for surgery, the case cart with all necessary instruments for the surgery goes into the OR with the patient. Those items have been scanned already, so a month or year later, when it becomes necessary to determine exactly where and on what patient an instrument was used, that information is available. “When there’s a contamination issue, we enter your case number and it pulls up every instrument used in your case — not the set. Our report will show you the exact breakdown of the exact instruments used in your case, and then you also have the ability to cross-reference. It would tell us all the other cases those instruments were involved in as well,” Myers says.

Censis does not produce RFID technology; however, if an instrument had an RFID transmitter, the Censis system could pick up that signal and show the location changes as the item moved from place to place.

“The infrastructure, the wiring and the sensors, that’s not us,” Myers explains. “We’re the software that manages it, so whether you’re scanning a bar code or sending out an RFID signal, our system processes and manages that data. We do not produce RFID technology; however, we can interpret the signal.”

Radiofrequency can also help with outbreak surveillance indirectly, by distributing the signals within the hospital environment. InnerWireless, Inc. provides a wireless distribution that “pumps” RF signals throughout a hospital to enable applications such as bar-coding and location asset tracking for drugs, medical instruments, machines and even patients.

“InnerWireless is a company that specializes in the distribution of radiofrequencies throughout buildings, and healthcare — hospitals — are one of our market segments,” says Jim McCoy, senior vice president and chief technology officer at InnerWireless.

“All of us have had situations where our cell phones don’t work well, and we stand by a window to get it to work better. That’s simply because the signal coming from the cell tower to your handset is at least partially blocked by the building, even by the windows themselves,”

McCoy clarifies. “More modern, thermally efficient windowpanes are more effective in blocking those radio signals. The new high-tech glass that’s very thermally efficient can block up to 99 percent of the radio frequency, so only a tiny percentage of the signal actually gets from the cell tower to the people inside the building.”

InnerWireless technology is intended to circumvent that problem — to take signals from the base station radios and distribute them inside the building much like a heating and air conditioning duct would take heated or cooled air from a central point and distribute it through duct work to create a uniform blanket of conditioned air, he adds. “We would take signals from two-way radios, pagers, cell phones, PCS phones, medical telemetry systems — a wide range of radiofrequency devices — but take their signals from a central point and distribute them in a smooth, uniform distribution through a building so the handsets or devices would function efficiently.”

McCoy adds, “It is, on the one hand, very simple; it does require a good bit of knowledge as to how the different radio signals propagate through the different building materials, and it requires a good bit of knowledge about the way the base stations and devices interact with each other. But once you have all of that knowledge in place, the ultimate design and implementation of the distribution system does work out to be relatively simple. Hence, it’s extremely reliable; very high-quality service can be provided.

“What we find in hospitals are two things — one, hospitals do rely very heavily on wireless services. Most caregivers have anywhere from one to three pagers — normally two — wireless or cordless voice services, the different patient monitoring equipment. Hospitals are concerned about interference of different systems and are interested in having a coordinated and managed wireless service. Since we can provide this distribution for multiple services, not just one, we can act on behalf of the hospital to help them develop wireless policies and — more importantly — to help them implement those policies with something of a universal shared infrastructure. We refer to what we do as a wireless utility, like an electric utility or water utility or telephony service being a utility. We believe modern buildings and in particular healthcare needs to look at wireless as a utility. It’s no longer a convenience; it’s an essential part of how people do their jobs.”

Clearly, this particular technology is not directly involved with surveillance or tracking; rather, it is a helpmeet for the surveillance or tracking software or systems that require a radiofrequency signal.

“As hospitals add the ability to track staff, patients and equipment, as well as consumable items, I think that should be able to assist in the management of infectious outbreaks and other situations like that,” McCoy says. “It seems that by having not only bar codes but RFID, wireless ID, and the direct wireless measurement of people and equipment, if you put a radio badge on your staff members — possibly on your patients, certainly on your equipment — you will be able to pull up a history of which caregivers, which patients, which equipment were in close proximity to each other at a given point in time. Maybe if the hospital had three or four portable blood warmers, there wouldn’t be any question about which one had been in the care unit that was exposed to an outbreak. You would know exactly which one would need to be sent to a specialized decontamination process. So it would simply take a lot of the guesswork out of making those associations between people, equipment and consumable supplies that could be involved in the spread or containment of infectious situations.”

“Any system you have is only as good as your people, no matter how high tech it goes,” says David Hoskins, RN, regional director for California Central Service Association in San Diego, and sterile processing supervisor for Sharp Memorial Hospital.

Sharp Memorial uses more old-fashioned methods of tracking instruments — following sterilization load records. “It’s very difficult because with instruments, they can be moved from one system to another,” he adds. “We’re in the process of looking at an instrument tracking system, which is common practice in a number of places where they’ve been able to get the funding. They bar code the trays, and they can track trays of instruments. Now, if one instrument is moved from one set to another, where it’s shared or borrowed back and forth, which sometimes happens, every individual instrument is not going to be able to be tracked.”

Tray tracking systems, rather than individual instrument tracking systems, have that drawback; the bonus is that they are less timeconsuming. “Cameras, scopes, something that has separate serial numbers, might be possible to track — if you write those down in your records,” says Hoskins. “Currently we don’t do that for each one. What we do is we write it on the outside of the tray, so being able to track a specific instrument to a specific surgery case right now is just impossible.”

Hoskins dislikes the idea of the time investment required to scan individual instruments to a particular patient or case — especially in trays that tend to be stocked with 100-plus instruments. Hoskins has heard of one company that has used tracking devices in its gowns; this is particularly useful if a health system provides inventory to multiple locations or buildings.

“It’s possible in the future that they could build a surgical instrument, put one of those tracking devices in every instrument as it’s built,” Hoskins muses, “and then you would probably have the increased capability of tracking it to each individual patient, but they’re still having some technical difficulties as far as that surviving the sterilization process.

“If you put it on a common-use instrument like a kelly, are you going to put a separate number on every single kelly you have in your facility? The large volume of instruments used on some patients is quite high. If you have an open heart set, that might have 90 to 110 instruments in it; are you going to scan each instrument before you start the surgery case, to say it was used on this particular patient, to prevent it from being moved from one instrument tray to another? What you do if you have somebody with CJD, you’re going to stick to disposable instruments. You’re going to have a separate special case, and then you’re going to tag those instruments separately because they have to be treated separately anyway,” he points out.

RFID can be found in specific applications for tracking patients and ensuring patient identification as well. Precision Dynamics Corporation, for example, offers bar code and RFID wristband systems. “The wireless, automated and secure process of RFID ensures positive patient identification and fully streamlined operations,” says Daniel Hobin, manager of marketing communications at Precision Dynamics. “PDC’s Smart Band® RFID Wristband System acts as a portable, dynamic database that carries patient information to be used and updated during the patient’s stay.”

Also, he says, “Unlike bar code, RFID’s non- line-of-sight data transmission can be read through and around the human body, clothing, bed coverings and non-metallic materials.”

Agility Healthcare Solutions offers the AgileTrac 2.0, a Web-based, radiofrequency identification-enabled equipment management system that can be applied to various healthcare facility needs, including patient tracking and surgical-instrument management. It integrates comprehensive functionality into handheld RFID readers. AgileTrac is a technology infrastructure that includes hardware, data collection and systems integration middleware along with application software and user interfaces. Hardware includes universal active RFID and wirelessfidelity (Wi-Fi) networks for facility-wide equipment management. The system is designed to track, measure and improve utilization of items including mobile medical equipment, surgical instruments, supplies and pharmaceuticals, while improving patient flow, staff workflow and facility productivity.

Not every new offering is based on radiofrequency, however; Innovative Biosensors, Inc. provides a technology that can decrease time-to-result for pathogen detection and, in turn, assist in containing a potential outbreak situation.

“Innovative Biosensors Inc. has licensed from The Massachusetts Institute of Technology (MIT) a pioneering biosensor technology termed CANARY™ (Cellular Analysis and Notification of Antigen Risks and Yields) and plans to develop tests for emerging infectious agents that are fast, portable and sensitive,” says Joe Hernandez, founder and CEO of Innovative Biosensors.

The patented, self-contained biosensor system can generate a sensitive and specific result with minimal amount of reagents in less than five minutes, making it a cost-effective alternative to traditional laboratory testing, Kephart adds. “In addition, the biosensors can be engineered to detect one target or several targets of interest simultaneously and used to perform a wide variety of bioassays.”

Designed for portable, real-time detection, the system can be operated by minimally skilled personnel, who can perform tests and analysis at the site of sampling using a small, transportable instrument.

The CANARY technology offers a number of very important advantages that is designed to revolutionize the way researchers and physicians test for highly infectious diseases, including speed and sensitivity; specificity; and ease-of-use: The protocol is simple, and the instrument is lightweight and can be battery operated. This enables use at the site of sampling or incorporation in a central laboratory.

MedMined’s technology-based service reduces the incidence of HAIs by identifying correctable process breakdowns causing infections, and focusing hospital staff on quality issues as they emerge. The service requires no data entry, using existing data sources and personnel.

MedMined is a comprehensive service that allows hospitals to focus their efforts on targeted process improvement rather than manually searching for opportunities to improve. The service includes ongoing extraction of existing electronic clinical data from hospital systems; translation of non-standardized laboratory data into uniform information amenable to population-wide analysis; patented data mining / artificial intelligence analysis service that identifies specific, unsuspected opportunities for process improvement; clinical support, educational tools and training to ensure that information leads to real change; electronic data reporting/analysis tools to make daily workflow more efficient; measurement of clinical improvement and the structure to provide ongoing positive feedback to staff that do implement process change (so as to reinforce positive behaviors); and measurement of clinical and financial outcomes to allow executive management and financial assessment.