A Medical Device Daily

Biophan Technologies (West Henrietta, New York), a developer of MRI-compatible technologies, reported a research partnership with the FDA intended to help improve patient safety in MRI environments. No financial terms were provided.

Under a Cooperative Research and Development Agreement (CRADA), Biophan will collaborate with the FDA's Science and Engineering Laboratories in the Center for Devices and Radiological Health to help develop guidelines and standards for assessing the safety of cardiac pacemaker and neurostimulation leads used in the MRI environment. The CRADA between Biophan and the FDA is part of the government's initiative to address these public safety concerns.

Michael Weiner, CEO of Biophan Technologies, said, “The sad reality is that more than half of all recipients of pacemakers and other implanted devices today are estimated to be denied access to MRI post-implantation. This amounts to hundreds of thousands of people who are denied the benefits of MRI. Biophan believes that this is an untenable situation that must be, and can be, effectively remedied.”

The partnership could lead to a variety of solutions for the healthcare industry, Weiner noted, including a new generation of medical devices, manufactured to be fully MRI safe; enhancements to currently existing medical devices, to enable MRI safety; and either new or modified MRI technologies to enhance the safety of these imaging systems.

In other agreements:

• Zebra Technologies (Vernon Hills, Illinois), which focuses on delivering on-demand specialty printing solutions for business and process improvement, has signed a new two-year, full product line agreement with Amerinet (St. Louis) healthcare group purchasing organization.

The agreement follows a competitive bid process and makes Zebra's bar code, card and RFID printers as well as its supplies and service agreements available to Amerinet members, serving a range of applications from patient safety to materials management.

• Gulfstream (Savannah, Georgia) says that in 1989 it became the first aircraft manufacturer in the world to include MedAire medical safety and preparedness as an integral part of every aircraft it built.

This week, the company renewed its relationship with MedAire (Tempe, Arizona). As a result, every new Gulfstream aircraft will continue to include the ability of crew members to have direct access to the board certified emergency physicians within MedAire's 24/7 MedLink Global Response Center anytime during a trip, whether a medical incident occurs in flight or on the ground. Crew members will receive MedAire's management of inflight illness and injury training course as well as having their new aircraft equipped with MedAire's international first aid kit and anautomated external defibrillator from Philips Medical Systems (Best, the Netherlands).

CCHIT to publish EHR certification criteria

The Certification Commission for Healthcare Information Technology (CCHIT; Chicago) said that it will publish its criteria for certification of ambulatory electronic health record (EHR) products May 1 and begin taking applications for certification May 3. Applicants will be able to access the final certification criteria, test scripts, handbook and sample contract on the CCHIT web site. Drafts of the criteria and test scripts have been available for review since Nov. 30, 2005.

“We are hoping for a strong positive reception from the health IT industry,” said Mark Leavitt, MD, PhD, chair of the CCHIT board of commissioners. “Companies will find no surprises in the final criteria, which have been published and widely reviewed now for months. Any criteria not fully validated by the pilot test have been classified as provisional, meaning we will test them but not include them in the final scoring for 2006 certification. This gives us a way to further refine and validate criteria to be included in future years.”

The first certified products are expected to be announced by early July.

The application period will be open May 3-12.