Medical Device Link.

What if the instruments themselves could communicate with the service providers when problems arise? Some manufacturers of laboratory instruments are developing such systems.

These systems, called remote diagnostics, not only enable service engineers to troubleshoot laboratory equipment from afar but even allow them to prevent downtime by monitoring the performance of the instrument via a modem or Internet connection.

For example, service engineers from Beckman Coulter (Fullerton, CA) were doing a routine check on one of their Synchron LX instruments located in a laboratory in Woodland Hills, CA, using the system's remote diagnostic feature. The check showed that one of the instrument's modules was drifting out of calibration. Although the drift hadn't penetrated the red zone yet, it soon would. A service technician was dispatched, new module in hand, and the breakdown was averted. As a result, the laboratory experienced no costly downtime.

Not all laboratories employ remote diagnostics in such a prescient manner today, but that is clearly where the technology is headed. Since manufacturers–and in some cases, the machines themselves–can anticipate problems before they occur, many of the most common sources of instrument breakdown can be eliminated.

The reason remote diagnostics were developed in the first place was to fix problems and minimize machine downtime. When it comes to either fixing existing problems or preventing future ones, remote diagnostics can be initiated in three ways: by the customer, by the manufacturer, or by the machine itself.

If a motor is slowing down or pressure is dropping in a pump, this measurement will be indicated on a readout, which the engineer can view from wherever he or she is. The engineer may be able to determine the source of the problem based on the data provided by the readout. Alternatively, once the readouts are analyzed, the engineer may ask the operator of the instrument to perform various operations on the machine to help in the diagnosis.

To correct the problem, the engineer may direct the operator to make an adjustment or perform a simple part replacement. Or the engineer may decide to send a field engineer to the instrument site to make a repair. Either way, crucial time is saved and sometimes service trips are averted, a major boon to both customers and manufacturers.

Typically, Beckman Coulter's service engineers monitor customers' instruments on a weekly basis, downloading data for quality control, calibration, and metering, as well as other data, explains Donn Huynh, the company's manager of automation information systems.

Once the data are downloaded, the engineers analyze them to determine developing situations that can be addressed immediately to prevent a future problem. To increase their predictive powers, the engineers also create trend reports that can identify potential malfunctions.

This active approach is most fully realized on the company's Synchron LX chemistry system, but is applied in a less sophisticated version on its Access, Image, and Array chemistry systems, Gen-S hematology system, and DataLink, an instrument data manager. The company expects to add manufacturer-initiated remote diagnostics to its Synchron LX20Pro and CX Pro system as well, perhaps by early 2001, says Ron Berman, marketing manager for chemistry and automation.

This capability can be likened to that of a home smoke detector which "wakes up" when smoke wafts by regardless of whether the humans present can smell it. In much the same way, instruments that use this wake-up technology can alert the manufacturer when a function crosses a certain threshold, even if it is operating in an acceptable range at the time.

Such machine-initiated remote diagnostics technology improves on the other approaches in at least two ways. First, it can detect events or deteriorating trends that occur between weekly monitoring sessions and second, no human being has to perform the check-in, which saves on labor costs.

So far, no IVD manufacturer has rolled out wake-up remote diagnostics, but some may be close. The Mansfield, MA–based software company eMation has employed this wake-up technology in other industries. For example, it has placed systems in parts of Asia that warn public officials when river levels are approaching flood stage, says Dave Bennett, the company's manager for North American sales.

Although eMation has only recently entered the medical field, it is already working on prototypes that use the wake-up technology with approximately 10 medical instrument manufacturers.

Bio-Rad Laboratories (Hercules, CA) expects to feature its version of wake-up capability on its Variant II hemoglobin analyzer instrument sometime this year. Currently, the company uses remote diagnostics primarily in the reactive mode.

Other companies that expect to introduce wake-up software over the next few years, or that are at least seriously investigating the possibility, include Dade Behring, Ortho-Clinical Diagnostics, DPC, Beckman Coulter, and Bayer.

Installing Software. The same connection used to download data from a remote instrument can also be used to upload new software. Most of the company representatives interviewed for this article said they expect to add software upgrades to their remote capabilities and services in the foreseeable future.

Training. Some remote diagnostic software–for example, packages that employ PC Anywhere–can be used to train the operators of the instrument. With PC Anywhere, the service engineer can effectively operate the instrument at a distance. The engineer sees exactly what the operator sees on the monitor screen and can track every keystroke.

If an operator in Seattle needs help learning a particular operation, an engineer in Miami can walk him or her through it, step by step. "Remote diagnostics has turned out to be far more useful than we anticipated when we put it in," says Nils Person, director of technical and field services for DPC. "We put it in with the idea that it would help us look
into the instruments and gain data, but we have found this teaching function extremely useful."

Supply Replenishment. Remote diagnostic products make possible fully automated reagent and control replenishment. In the past, a laboratory employee would send to the manufacturer a disk with downloaded information about the number of tests run, calibrations, repeats, and primes. From this information, the manufacturer could determine the types and quantities of supplies needed and send them off.

Using remote diagnostic products, replenishment can be automatic. On given days agreed to by the customer, service technicians can download the information themselves through the remote diagnostics connection.

"We can automatically replenish a customer's inventory and generate an invoice based on its usage rate," says Beckman Coulter's Berman. "Operators don't have to do any more inventory planning or worry about replenishment. We can deliver the needed materials to them on a just-in-time basis."

Several companies that are implementing the wake-up remote diagnostics technology also expect to include a replenishment service that is even easier. Effectively, wake-up software makes it possible for instruments not only to tell manufacturers when there is a problem, but also when their supplies need to be replenished. Without intervention, the instruments can order supplies and process billing for what they buy.

Bio-Rad Laboratories is actively planning such a feature. It expects an automatic replenishment function, funneled through an e-commerce Internet site, to be in place by 2002, says John Bussell, manager of the informatics systems business unit at Bio-Rad Laboratories. However, Bussell warns that customer acceptance may prove to be difficult because laboratories have not yet taken to e-commerce as much as the general public has.

Figure 1. eMation's enterprise level software.

Possibly the most advanced application of remote diagnostics is offered by eMation via what it calls its enterprise-level software (see Figure 1). The concept behind the enterprise package is that the same data gathered by service engineers from customers' instruments can be useful to other units of the manufacturer's business.

It works in the following fashion. The software resides on a server at the manufacturer's location. As data pour in from customers' devices around the world, they are directed to relevant divisions. For example, usage data might go to the marketing department as well as the resupply unit. If data indicate that an instrument is being underutilized, the manufacturer could direct support to the customer accordingly, notes eMation's Bennett.

"In other words, somebody would stop by and ask, 'We notice that you're not running as many tests as usual in the past couple of months. Are there problems?' " says Bennett. Remote diagnostics in this sense is not just information age instrument maintenance, it is also a valuable management tool.

Privacy Issues. More manufacturers are monitoring their customers' devices because many customers fear Big Brother having unlimited access to their instrument, and in particular, to their confidential patient results. To allay this concern, manufacturers are building in privacy programming that shields them from patient identification numbers. Therefore, if a service technician needs to examine lab results to analyze an instrument problem, there is no way to connect these results to specific patients. Even so, some healthcare organizations balk at giving manufacturers access that the organizations themselves don't initiate.

Cost. Customers also have to be convinced to buy in, literally, to the remote diagnostics concept. At a minimum, they need to install a phone line near the instrument. In the near future, high-speed Internet capability will be preferable.

If customers want manufacturer-initiated remote diagnostics service, things are likely to go more smoothly if they purchase a service contract that covers all parts and labor. Otherwise, such maintenance may arouse the customer's suspicions. In the early days of remote diagnostics, the manufacturer's good intentions often backfired, notes Emery J. Stephans, president of Enterprise Analysis Corp. (Stamford, CT).

Remote diagnostics services were first used on IBM computers outside the medical field. As Stephans recalls, "All of a sudden, a box would be delivered and people would call IBM and complain because they didn't order anything and didn't want to pay for it. It took a long time for IBM to explain the benefits of such monitoring. It was not something people expected."

Still, remote diagnostics have proved so spectacularly useful that most major instrument manufacturers expect to incorporate these capabilities on all upcoming products. The service will also improve as society's technological infrastructure evolves. For example, as more laboratories move from dial-up modem capability to high-speed Internet access, the possibilities increase.

"With the advent of the Internet, DSL, and cable modemconnections, you're looking at faster ways to transfer information through a wire," says Beckman Coulter's Berman. "Going from a 56K dial-up modem to a cable modem is an unbelievable change."

Greater bandwidth, another innovation in Internet access, will also make a difference in remote diagnostics. Some manufacturers are currently experimenting with using Webcams so they can pick up clues about a customer's instrument that the instrument's data files will not provide.

Bandwidth improvements mean better video. "I see video as being very important," says Brian Wilcox, director of information management for Ortho-Clinical Diagnostics. "In many situations, video is the only way to actually understand what the problem is with the instrument. The problem could simply be an O-ring that has slipped off its positioning. No sensor will detect that, but with video we can see the problem."

Webcam diagnostics are not widely available today, but Bio-Rad Laboratories has gone beyond the experimental phase to slowly rolling out this capability and is now working out the bugs.

How remote diagnostics systems work A remote diagnostic system can monitor virtually all of the components of a laboratory instrument. In Beckman Coulter's remote diagnostic system (see Figure) eight classes of events that occur during the operation of the system are monitored continually. Chemistry. Errors in this category include measurements that exceed the critical high or low for a particular test. Test results that fall outside the instrument's range are also considered errors. Motion. This category includes all the moving parts on the instrument. Errors of such mechanical components as motors include any out-of-specification operations. Status. This category encompasses general system parameters such as voltage, air and vacuum pressures, the condition of the water, and the condition of the instrument's electronic modules. Instrument. Sensors in this category monitor the general operating performance of the system's hardware. Host Communication. This category monitors the quality of data transmission between the instrument and the host hospital or laboratory information system. Console. This category checks database structures and monitors errors such as data mismatches that can occur in the exchange between the instrument's software and the instrument. Input Device. All keystrokes, mouse clicks, and touch screen events are recorded and monitored in this category. Sample Processing. This category encompasses all events related to sample processing. Data Transfer   Most communications processes for IVD instruments involve a dedicated communications line system with a modem that dials into a computer system at a vendor or service provider's facility. Such systems commonly use one of two primary methods of data transfer. The instrument can dial into the repository on a regular basis (e.g., daily) to upload information marked for transfer to the host. Or, alternatively, the service provider can initiate the query as part of an ongoing maintenance program, such as under a warranty or a maintenance contract. A primary advantage of the dedicated communications line method is that information shared with the service provider is secure. A primary disadvantage is the expense of installing and maintaining a dedicated telephone line near the system. A second and growing method of communicating with the service provider's host is through an Internet connection. Many system developers are incorporating standard Ethernet connectivity that enables instruments to access to the user's network and the Internet. Such connectivity permits the movement of information from the instrument to various locations, whether on an internal network to the hospital or laboratory information system, or beyond the firewall to the service provider. The advent of tighter security systems and widespread adoption of the Internet is gradually making this mode of transmission more acceptable to the healthcare community. Going Wireless   Future development of data transfer methods is focused on wireless connectivity, which may be more appropriate for point-of-care and self-care applications. Methods currently in use include infrared, spread-spectrum radio, and short-range cellular. A number of players are already established. Their communications methods are based upon the IRDA, OpenAir, 802.11, or Bluetooth wireless communications standards, all of which share the drawback of implementation cost. Infrared, although the least costly, has the additional drawback of a line-of-sight requirement.

Contributing to this sidebar were Fred Mitchell, director of new business, and Amanda Griffin, marketing coordinator, at Colorado MEDtech Inc. (Boulder, CO); and Donn Huynh, manager of automation information systems at Beckman Coulter (Fullerton, CA).

A pilot himself, Stephans observes that some air crashes are thought to have resulted from computer glitches, not pilot error. The relevance to laboratory equipment is not lost on him. When a machine gets too smart and the person is just there to monitor it, he says, "bad things can happen. Are there going to be errors in the laboratory because now the instruments are so smart and the operators so dumb that we'll not catch them anymore?"