by
Lisa Chamoff, Contributing Reporter | May 27, 2015
From the May 2015 issue of HealthCare Business News magazine
“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.”
