Local, State, Federal

CEO Spotlight: Dean Janes, Imaging3 Inc Medical Device Maker Reflects on Recent Court Ruling
CCHIT Launches EHR Web Site

Dean Janes, Chairman and CEO

CEO Spotlight: Dean Janes, Imaging3 Inc Medical Device Maker Reflects on Recent Court Ruling

The Supreme Court ruled in an 8-1 decision in February that medical device makers in the United States cannot be sued for devices that have received approval from the US Food and Drug Administration.

In Riegel v Medtronic, plaintiff Charles Riegel sued the Fridley, Minn, company after a balloon catheter burst in his coronary artery during angioplasty in 1996. Riegel, who passed away in December 2004, suffered serious injuries as a result of the rupture, and alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law.

In an opinion delivered by Justice Antonin Scalia, the Supreme Court ruled that state product-liability suits are barred to the extent that they would impose requirements different from federal regulatory standards.

According to the Associated Press, the case has significant implications for the $75 billion-a-year health care technology industry. Axis Imaging News spoke with Dean Janes, chairman and CEO of medical device manufacturer Imaging3 Inc, Burbank, Calif, to learn how the court ruling affects his business and the industry as a whole.

IE: Tell me about your professional background. What kind of expertise do you have on this topic?

Janes: I am a biomedical engineer with more than 24 years’ experience. I’ve worked for Kaiser Medical Physics in Southern California as an in-house senior x-ray imaging engineer and as a national technical support engineer for Toshiba America Medical for cardiac catheter labs and angiography suites. I have filed three FDA 510(k)s for Imaging3 and have assisted on several others for different manufacturers. The Dominion is one such device that we are awaiting FDA approval on. The Dominion is a patented diagnostic imaging device that produces readings in three dimensions and real time.

IE: In terms of your specific company, how is the Supreme Court’s ruling significant?

Janes: It offers a layer of protection from undue litigation. The standards already in place are far more stringent than any others in existence throughout the world. Imaging3 is happy to maintain compliance with these standards and has done so since 1995. We obviously do not expect problems with our medical imaging devices, but it is nice to know we have some protection through this ruling.

IE: How does the ruling affect the medical device manufacturing industry as a whole?

Janes: From a business standpoint, this ruling is very important as our society continues toward ever-increasing litigation. Companies spend a great deal of time and money developing cutting-edge technology to better medicine and patient care with far greater scrutiny and standards than the rest of the world. However, even with the most altruistic intentions, mechanical and electronic devices can fail beyond the expectations of testing and design plans. Holding companies to an even higher standard than what currently exists will just increase costs even more, making health care less affordable and/or decreasing the quality due to manufacturers not desiring to enter a high-risk market. This would be especially burdensome if overseas companies aren’t required to maintain equal standards.

IE: Do you agree with the court’s opinion? Why should or shouldn’t the requirements for FDA approval be paramount to state laws?

Janes: I agree with the decision and it would be far too burdensome for companies to manufacture and sell devices with different and varying standards on a state by state basis, which is why we have a federal government agency like the FDA to set national standards as in their 21CFR. Currently, states cannot be less stringent in their legal requirements than the 21CFR federal requirements. This would also put an undue burden on states, as they would have to create or augment state agencies to mirror the FDA approval standards, adding costs to local medical systems.

IE: In the aftermath of the ruling, analysts have labeled it a win for business and a blow to consumers. Do you agree with this perspective?

Janes: I agree with the win for business. In my opinion, the consumer is already very well protected. FDA approval is a very difficult and sometimes expensive process. The FDA is staffed with very intelligent and professional experts in the many specific fields of medicine and physics. However, in this society we tend to believe too much in perfect technology, which simply does not exist. We already could have medicines and medical devices in the marketplace that could save lives tomorrow if we didn’t require such stringent standards and approval. But the risk would be more significant. If I created a device that could cure cancer tomorrow, I would have to test it for 2 to 4 years—many people would die from cancer in that time frame. The fact is that more people would die for the lack of my miracle machine than from the machine itself

IE: As reported by The New York Times, some have suggested that the industry’s newer technologies—sophisticated and profitable Class III devices such as defibrillators, pacemakers, and stents—may be so different from pre-1976 devices that they require a more thorough safety and effectiveness review. How do you account for their position, and do you agree with their sentiment?

Janes: I completely disagree; manufacturing capabilities of today make the 1970s look like the Stone Age. Engineers are far better trained; we have tools engineers in the 1970s could only dream about, which allow us to computer generate a design as well as test it prior to even building it. Machining, tooling, and fabrication processes are far more accurate than ever before, allowing more accurate, faster, and more efficient production of devices utilizing stronger and lighter composite materials. This not only equates to a more efficient manufacturing process but allows more time to be spent on design and testing than ever before, with final product specifications actually measuring up to the design standards.

IE: Is there anything else that you’d like to add about this ruling—what it represents now and for the future?

Janes: I didn’t grow up to be an engineer to create products that hurt people—as I believe is the case with most, if not all, engineers. When I create a device, I want it to be safe enough to use on my own family, a feeling shared by all of Imaging3 employees. The FDA does a very good job in setting standards for manufacturing as well as for their approval process. Yet, the FDA is overworked and understaffed. More money should be spent from the budget for the FDA as they have a more significant impact on your individual health, safety, and well-being.

CCHIT Launches EHR Web Site

At the annual HIMSS conference in Orlando, Fla, the Certification Commission for Healthcare Information Technology (CCHIT) announced the launch of a new Web site aimed at helping physicians make better-informed EHR decisions.

Designed to help educate physicians on EHR selection and the value of choosing CCHIT-certified products, www.EHRDecisions.com can help physicians better determine their readiness for moving to electronic health records, embark on the search for a solution, and prepare for the actual purchase and contract negotiations. Users can browse the Web site to read up on how to experience the full potential business and clinical benefits from an EHR, and physicians can take advantage of the direct pipeline to Certification Commission leadership and other experts, who will post regularly.

“Certification has helped with EHR selection decisions, but we’ve learned that physicians still need a lot more information to succeed in EHR adoption and gain full value from the technology,” said Mark Leavitt, MD, PhD, Commission chair. “By focusing this new Web site tightly on the knowledge physicians need to make better decisions about EHRs, we hope to help close that gap.”

With the organization’s main Web site serving as the official hub for formal information, the EHR Decisions promotes a more informal, community-based feel. The site features news from the Certification Commission, in addition to the electronic health records industry as a whole. Visitors have the opportunity to post comments and questions regarding EHR certification and adoption issues. CCHIT has plans to ex-pand the site over time, supporting short articles, informal blogs, and news feeds with community forums, podcasts, and videos.

“We know your top challenge is having time to even think about EHRs,” the Web site proclaims. “So we’ll experiment with different communications approaches and use what works best for you: short articles by experts, informal blogs, news feeds, community forums, even podcasts and videos if they prove helpful and popular.”

At the HIMSS meeting, there was also an update on the current certification program that outlined future plans for EHR certification.

“Our forecast is for continued growth and expansion,” Leavitt said. “With the strong endorsement and acceptance of health IT certification by care providers in multiple settings, we’ll continue building momentum into next year, adding new domains and refining existing ones. With the growing complexity of this work, however, we’ll also need to improve our own processes: better cross-group collaboration, more efficient feedback-gathering mechanisms, and an increased emphasis on technical testing will be themes for us next year.”

CCHIT is currently working on its updated ambulatory and inpatient certification criteria, as well the implementation of new programs to certify systems for child health, cardiovascular medicine, and emergency department requirements, all to be launched in July 2008. Certification of networks known as health information is now planned for launch in October, while proposed expansion areas for 2009 include long-term care, behavioral health, personal health records, and additional medical specialties to be determined later this spring.