In “The City on the Edge of Forever” a Star Trek episode that aired in 1967, Mr. Spock complained that he was unable to gain access to the data in his tricorder, lamenting that he could, if only he were able to tie his device in with the ship’s computers, a remarkably prescient vision of the present-day dilemma of interconnectivity. What Healthcare Technology Management professional hasn’t felt exactly the same way, like futuristic breakthroughs in testing equipment were “on the edge of forever,” when faced with a challenge in the field?

While the technology has advanced, test equipment still has a long way to go, says Purna Prasad, director of clinical technology and biomedical engineering at Stanford University Medical Center, in the heart of California’s Silicon Valley.

“It has not evolved with the speed of technological advancements,” Prasad says, “and that is where biomedical engineers are facing a problem.”

Prasad says that ideally test equipment would be application-based and operating in a mobile environment, so technicians can just use their own smart-phone, tablet or laptop, without having to carry around three or four pieces of equipment every time they go out. Even better, says Prasad, biomedical test equipment would automatically connect with the computerized maintenance management systems, requiring the intervention of technicians only when safety characteristics are violated. For now that is just “beam me up” thinking, and for it to happen, says Prasad, “manufacturers will have to think outside the box.”

The present state of the test-equipment landscape has manufacturers trying to address the challenge that many biomedical engineering departments are stretched thin. “People at facilities now are trying to do more with less,” says Michael Bayliss, global sales manager for Datrend Systems. Beyond that, the push to integrate data throughout the health care delivery system means that manufacturers must develop devices that communicate with electronic health records systems, while ensuring that equipment is safe to use on the patients and meets the functional specifications of the manufacturer.

One device that illustrates the focus on greater productivity and app-like ease of use is the vPad-IN, an infant incubator and infant radiant warmer testing system that Datrend recently introduced. It uses the same Android tablet technology that comes with Datrend’s electrical safety analyzers, and which Bayliss says allows technicians to multi-task during the testing, which can be a time-consuming process.

“The minute you open up an incubator, you have to wait for it to re-stabilize,” Bayliss says. “Running an automated test wirelessly avoids having to re-start. Because you’re using a tablet, you can also use it for internet access and email.”

Safety issues and ensuring recommended service are also trends that are emerging, pushed in part by CMS requiring that imaging equipment, lasers, and new equipment without a long enough history to establish an adequate risk-based assessment for maintenance would have to follow OEM guidelines for preventative maintenance.

For example, CareFusion offers biomedical engineers software that communicates with their medical devices, says Gregory Alkire, vice president of sales and marketing for Pronk Technologies. “When you went to test their device you had to have a very specific simulation,” Alkire says. “We created a custom setting to meet that need.”

While there is a move in the biomedical testing industry toward automation and the creation of electronic test records, this has gone much more slowly than the mainstream shift to EMRs for patient records, since HTM departments get to choose whether they use paper or electronic records, Alkire says.

“Ten years ago, you’d think that everyone was going to be headed to electronic test records,” Alkire says. “My sense is that it’s moving very slowly in terms of the biomed departments, in part because there are not ideal solutions for it. It can take more time using automation with records than documenting results on paper. There’s much slower adoption than you’ve seen on the health care side.”

Despite the slower pace, however, companies are providing solutions to increase productivity, minimize human error, and improve data traceability for regulatory compliance. In March, Fluke Biomedical launched improvements to Ansur, its test automation software platform.

The update includes the addition of an electronic signature, a feature that allows users to create their own signature to sign test reports electronically. This new feature is compliant with the FDA requirement, 21 CFR Part 11. The Ansur 3.0 update also includes customizable authorization levels, allowing organizations to set different user access levels, particularly if they want to reduce the ability to alter a procedure, and customizable test fields. maintaining the integrity of the data, says Shirin Khanna, senior marketing manager for Fluke Biomedical.

“Testing is meaningless if you can’t show you did it, and did it as required,” Khanna says. “The beauty of Ansur is that it caters to organizations looking to reduce total test time, perform the tests quickly and document the data easily as well as organizations that prefer collecting comprehensive information to monitor trend and risk.”


Automation in X-ray testing
The same focus on automation and workflow extends to X-ray test equipment. Aside from recently adding a Survey sensor for X-ray leakage and scatter radiation to its RaySafe X2 X-ray measurement system, which was introduced in November 2012 and updated a year later with the RaySafe X2 Prestige, the company is looking to make the software on the base unit more useful while on the job. Generally, technicians use the base, which operates on an Android platform, and then transfer data to their computers, says Göran Zelander, senior product manager for diagnostic X-ray at Unfors RaySafe, which was acquired last year by Fluke Biomedical.

“We are incorporating features in the X2 base unit software to minimize the need to connect a PC while performing measurements,” Zelander explains. RaySafe has added features at the request of users, including the ability to add notes to a measurement and to access old measurements. “When you perform measurements with the RaySafe X2, you can scroll through exposures captured during that session, and earlier sessions,” Zelander explains. “Previously, when a user would change a sensor or shut off the RaySafe X2, the earlier measurements would no longer be viewable on the base unit. We learned this wasn’t optimal for our customers, so we made improvements to the software to enable users to access stored measurements.”

The base unit also shows the entire waveform and the company added a zoom function, providing a simpler way to see what happened at a specific time of a long exposure. “Ease of use means productivity gains, and that’s what it’s all about,” says Zelander A technical boost to data connectivity was unveiled by Radcal at RSNA 2014 and recently at the ECR 2015. It’s Accu-Gold Nugget, which the company states is the first Wi-Fi device for data transmission after each X-ray exposure by any non-invasive diagnostic x-ray meter.

Patrick Pyers, vice president of sales, marketing and business development for Radcal, says the traditionally-used Bluetooth is not reliable, especially when it comes to radiological testing. The Bluetooth signal can easily be dropped because of a lead wall or other instrument interferences. Wi-Fi is less prone to interference, Pyers says, and is a strong and secure connection to the measurement device.

“With a five-minute exposure, as the Accu-Gold Plus is capable of measuring, it provides a lot of data points so you need a stable connection,” Pyers says. Using Wi-Fi also opens the device up to various operating systems, according to Pyers. At last year’s RSNA, the company did a demonstration where they connected the device to Google Glass to show the new technology’s futuristic capabilities.

One changing aspect of the X-ray testing sector is the rise of digital mammography, which uses different beam qualities. At the same time RaySafe launched the software release, it also expended to measure kVp also on tungsten rhodium, which is a common beam quality in digital mammography.

“Every time manufacturers add a beam quality, we have to verify our system,” Zelander says. “For that, we are closely collaborating with mammography manufacturers to make sure that our solutions always cover the beam qualities of the different digital mammography machines.”

Portable and rugged
As with all electronics, smaller is better, but can also be more fragile, and prone to breakage. So the trend toward more portable also creates the need for greater ruggedness. One of the latest offerings from Datrend looks like the kind of tablet one would take on a camping trip. The vPad-ES Rugged includes the company’s electrical safety analyzer, housed in a waterproof, lockable, protective case that is designed for field engineers on the road, who work in harsh environments and travel long distances, Bayliss says. The tablet can be taken out of the case and used remotely with Bluetooth. “It just makes it a little bit easier to carry around,” Bayliss says. “We looked at doing a specialized case and just thought this was a better solution.”