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Copyright © 2012

People, Places, Processes & Products that Influence the Supply Chain

 
 

INSIDE THE CURRENT ISSUE

February 2011

The instacount PLUS instrument management system from Aesculap

The instacount PLUS instrument
management system from Aesculap

Vendors, providers scan progress, potential in instrumentation tracking

by Julie E. Williamson

Just two weeks after a major medical center installed an instrument tracking system it found itself in the throes of a Creutzfeldt-Jakob Disease crisis. The facility, which suspected CJD in a craniotomy patient and confirmed it three days after the procedure was performed, had to pinpoint the instrument trays in question and notify the patients who might have been subsequently exposed.

Fortunately, because the newly-adopted tracking system could accurately trace every instrument set and process – and then tie it back to a specific patient/procedure – the hospital was able to quickly determine which trays were in question and then notify the appropriate patients. Although any recall situation is frightening and unfortunate, it could have been far worse.

"What involved four patients could have easily involved 40," said Michael Mancebo, director of sales for TGX Medical Systems, Carmel, IN. "But with just several clicks, they were able to instantly access all of the historical data of a tray. Obviously, the sooner you can do that – and the more information you have at your fingertips – the better."

This is hardly an isolated example. The myriad endoscope-related recalls that made headlines over the past few years serve as another reminder of the benefits of robust tracking capabilities. Clay Cannady, vice president of sales, marketing and business development for Mequon, IL-based Materials Management Microsystems, described separate scope-related recall incidents at two hospitals within an integrated delivery. One hospital had already gone live with Microsystems’ tracking solution; the other had signed on, but hadn’t yet installed.

"The one with the system in place had all the key information in hand about the scope, the processes and the procedures that took place. That hospital sent out 28 letters. The other facility had to send about 3,200 letters because it had no way of tracking the instruments to the patients," Cannady said. "Having access to pertinent information is the difference between a manageable situation and one that becomes a clinical and PR nightmare."

Pushing the boundaries

Today, the capabilities and benefits of instrument tracking solutions are far-reaching. What was once viewed by some facilities as an inventory management tool that could help sterile processing and operating room professionals track instrument use and whereabouts has evolved into something much more powerful.

IMS’ Ready Tracker-Tray application

IMS’ Ready Tracker-Tray application

"The most basic level of instrument tracking is increasingly becoming just a starting point," noted Cannady. "Sure, there’s value in being able to track instruments from an inventory perspective, but these days it’s really becoming more about true resource management and compliance."

Customers can chalk that up to tracking solutions’ increased interface capabilities that allow the software to connect with processing equipment, surgery scheduling systems and materials management procurement systems, to name a few, and enable the hospital to automatically capture and link data between different software solutions.

"These equipment interfaces – and having information readily available – help support the overall objectives of having the right instruments in the right place and at the right time, thus positively enhancing patient safety," reasoned Jim Creason, senior vice president of business development for Censis Technologies Inc., Franklin, TN.

Process compliance and error reduction are also critical functions of today’s comprehensive tracking solutions. SPDs with washer and sterilizer interfaces, for example, reap the benefits of electronic documentation of results, which streamlines work, eliminates opportunity for human error and greatly improves the ability to handle internal or Joint Commission audits, added Cannady. He pointed out that with a biological monitoring interface, users have access to real-time status information, tools for managing recalls down to the individual device, and the means for providing notifications to surgeons and infection control professionals in the event that unfit instrumentation comes in contact with patients.

"Operationally for the department and clinically for the hospital this continues to be huge," he said.

Put simply, advanced capabilities of today’s leading tracking solutions have allowed the systems to serve as the hub that links all instrument-related information. This begins by eliminating manual logs and Excel documents used for tracking, according to Sally Hartley, product manager for Integrated Medical Systems International Inc., Birmingham, AL. "An instrument tracking system should also measure user and station productivity – data that can be used to set proper staffing levels and improve employee productivity."

Healthmark’s HangTimeKit includes HTKLabels to record the date a flexible endoscope was reprocessed and an HTKTest to check for gram negative bacterias.

Healthmark’s HangTimeKit includes HTKLabels to record the date a flexible endoscope was reprocessed and an HTKTest to check for gram negative bacterias.

Stepping up the upgrades

Vendors are consistently upping the ante in terms of their systems’ capabilities, too – and increasingly these upgrades and updates are offered inexpensively (and, in some cases, even free of charge). The goal is to provide more scalable solutions that allow healthcare customers to push their tracking and data capture capabilities to new heights – as quickly as they are able and as far as the technology will allow.

"In order to provide a completely scalable solution for our customers, we introduced several new entry-level products that are focused on specific areas of traceability and management, such as endoscope tracking, count sheet management and electronic sterilization record-keeping," said Creason, adding that these products are economically priced, easy to learn and quick to implement. "The new modular design of Censitrac allows the customer to upgrade into expanded functionality whenever they are ready."

Getinge’s T-DOC Instrument & Asset Management System also undergoes frequent scheduled releases, the latest of which focuses on the user interface and live connections to even more equipment. "We offer a wide variety of modules and integration options to enhance our product line," said Hana Scheichenost, national manager, T-DOC Instrument & Asset Management System, Getinge USA, Rochester, NY.

At IMS, automating proactive maintenance schedules and alerting customers when their instruments need service has been a top priority. The company has built in audible and visual alerts for each upcoming maintenance requirement – and the same information can be found in a report on the administrative side (although the alerts really serve the critical end user). "That information, at the fingertips of the staff members who handle the instruments every day, can greatly improve compliance with scheduled maintenance," noted Hartley. "It can ensure that the surgical team never has the frustration of instruments not functioning as expected because they haven’t been maintained."

One of Lawson Software’s latest enhancements also helps ensure proper instrument maintenance. One new feature, for example, tracks the number of times an instrument was used, which gives staff insight into inventory use and helps ensure that devices are properly rotated and maintained.

As part of Microsystems’ technical support agreement, customers are provided an annual upgrade that includes all enhancements since their previous upgrade. "Perhaps the most significant upgrade relates to case cart management capabilities that are also an important element in enhanced surgery scheduling integration tools," Cannady explained.

TGX Medical Systems’ Alex Gold instrument tracking system recently released several new modules – all offered at no additional cost to customers. The case management module, for example, interfaces with all major OR management systems and provides case conflicting for requested instrumentation. It also provides SPD staff with real-time priority lists based on case volume to ensure all required instrumentation is processed and ready for use on time for each scheduled case. Additionally, a new loaner tracking module lets the hospital check if instrumentation is complete upon delivery. Beyond that, it stores images of a particular tray or trays, and records case time, procedure name, physician name, and case number. Loaners can then be tracked through sterilization and dispatched to the case. Upon completion of the case, the trays can then be tracked through decontamination and to where it is stored while it awaits vendor pick-up.

CareFusion has also introduced a new loaner instrument module, along with one that tracks sterilization and repair management functions. Each quarter, CareFusion customers receive enhancements and new product releases, according to Jennifer Anderson, vice president of marketing, medical specialties, CareFusion. "Instrument tracking systems that have fully developed modules for both the central sterile supply and operating room processes have afforded great efficiencies in the central supply department within hospitals in three ways. First, tracking systems have provided automation to manual processes, therefore ensuring the correct instruments are available for the procedure. Also, tracking systems ensure accurate management of capital equipment, driving reduction in hospital expenditures related to replacement of lost equipment. Finally, but most important, tracking systems help reduce the need for flash sterilization, therefore helping reduce infections within the hospital and increasing patient safety," explained Anderson.

Greensboro, NC-based SurgiDat has recently added its loaner set and implant management systems, which can be used in concert with the company’s Serenity system or independently. "Serenity will track receipt, return, reconciliation, and expiration with the ability to easily trace to the patient," noted Brian Newton, SurgiDat’s vice president of sales.

Additionally, SurgiDat added to its upgrade lineup the Serenity Audit & Recall solution, a free, web-based software solution that replaces manual paper record systems. The expandable electronic system provides audit, recall and tracking of sterilized goods with full reporting, count sheets and compliance. "There are no license or maintenance fees and the system provides an immediate cost savings over paper record systems," added Newton. Further, SurgiDat recently upgraded its Enterprise Activity-based Costing platform, which simplifies user and administrative menus and increased interface capabilities with preference cards, OR scheduling, purchasing, and other instrument management systems. "SurgiDat is now capable of sitting on top of all touch points and managing all requirements of interoperative data or costing of sterilized and soft goods to a patient and procedure."

Lawson Surgical Instrument Management

Lawson Surgical Instrument Management

Regs cast wider tracking net

Healthcare organizations that haven’t yet embraced instrument tracking solutions will likely find themselves joining in soon thanks to some key regulations and standards on the horizon.

"The Unique Device Identification regulations and the use of GS1 standards should encourage instrument and tray/set tracking," predicted Keith Lohkamp, product strategist for Lawson Software, Minneapolis, MN. "For example, if the FDA requires serialization for instruments as part of the UDI regulations then instrument manufacturers will be uniquely identifying instruments and likely marking these instruments. Data about these instruments from the manufacturer can then be used to help pre-populate surgical instrument management systems, and for automated data collection, simplifying adoption and implementation." And because UDI information will be used for things like recalls, Lohkamp said there will be even more incentive to track at a very detailed level.

Some anticipate a trickle-down effect that begins with surgical instrument manufacturers before flowing to the rest of the supply chain. "From our discussions with the FDA, we know the timeline is within five years from the regulations becoming final for Class I medical devices," Creason said. "Ultimately, it will be the Joint Commission or the hospitals themselves that will push the requirement to track individual instruments to the patient level."

In the meantime, though, some facilities are predominantly tracking at a tray level and reserving unit-based tracking to higher-dollar, more intensive devices, such as neurology instruments and endoscopes. "We’ve certainly seen a greater interest in the concept of instrument-level tracking, but implementation has not always kept up with interest. The average healthcare facility has an inventory of 1,500 instrument trays, and it takes commitment and coordination to put the technology in place to track each instrument," said Whitney Ligon, director of corporate software, IMS. "The staff must be trained so they are comfortable with the technology. It requires a commitment from administration, the manufacturer and the end user alike."

Alex Gold’s new Loaner Tracking Module (TGX Medical Systems) lets CSSDs create a loaner label that identifies the doctor’s name, vendor name, date of procedure, presence of implants, and the number in the series, (i.e., 1 of 6).

Alex Gold’s new Loaner Tracking Module (TGX Medical Systems) lets CSSDs create a loaner label that identifies the doctor’s name, vendor name, date of procedure, presence of implants, and the number in the series, (i.e., 1 of 6).

Newton is also seeing a greater movement toward tracking loaner sets, implants, trays, peel packs, and wrapped goods, and he stressed that the primary drivers are reduction of liability and requirements to measure information and increase productivity. "Approximately, 80 percent of the US market still utilizes manual records and date/load stickers to track sterilization," he added.

Some instrument manufacturers are already taking steps to assist customers with unit-based tracking, however. The majority of Aesculap surgical instruments, for example, are already manufactured with a data matrix code that includes an individual code – the UNICOS-Code – for each instrument. "This means each instrument marked with an UNICOS-Code is uniquely identifiable," pointed out Michael Chow, senior product manager, services marketing, Aesculap Inc. The instrument carries the UNICOS-Code both in plain text and encoded in a machine-readable data matrix. The information that can be read consists of the article number (part number) and a five-character unique identifier. "This data matrix code can be read with a 2-D camera system and tracked individually through a hospital’s instrument management system," he said, adding that customers that purchase instruments that already have the data matrix on them will save time and money because they won’t have to etch the individual devices themselves.

Radio frequency identification could also play a critical role in simplifying unit-based tracking – and it’s a capability that numerous vendors predict is just around the corner. "The current limitation of instrument tracking is that it takes too long to scan all of the instruments in a set," said Chow. "We believe that the next big improvement for instrument tracking will be the use of RFID technology on individual instruments. [This] would significantly improve the time it takes for the individual instrument to be read and quickly identify the set, the contents – and determine if any instruments are missing."

Maximizing ROI

Enhanced interface and data capture capabilities have made today’s instrument tracking systems more robust, but like other software-based systems, the degree of benefits and rewards are dependent upon proper, consistent use. As vendors were quick to point out, many customers still aren’t taking full advantage of their investment.

"Incomplete utilization and poor compliance from hospital staff are some of the biggest shortcomings we see," confirmed IMS’ Hartley.

Because of the inherent training challenges regarding full-scale implementation and compliance (or, in some cases, even basic compliance), vendors have become more committed than ever to stepping up their educational offerings.

Microsystems, for example, is creating an educational platform that consists of monthly webinars. These will cover a range of related topics, some of which will address connectivity and help customers drive maximum value from their system – and their collective processes throughout the department. Other webinars being developed will help customers build a value case for tracking and connectivity solutions.

"All employees who process instruments and trays need to have a strong, hands-on understanding of how to use the software, and they must commit to using it every time. But sometimes, that can be overwhelming. Many healthcare facilities believe that more is better, but in some situations less is more," Hartley stressed. "Implementing a product and expecting the staff to use everything at once is a mistake. Start with the core and build from there, and invest in training to improve staff buy-in. Those are the keys."

 

February 2012
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