A Medical Device Daily

Shelhigh (Union, New Jersey) has denied all the claims by the FDA concerning its seizure of implantable medical devices last week (Medical Device Daily, April 19, 2007).

"I am deeply disappointed by the FDA decision which was made after the full cooperation of Shelhigh during an intensive 10 week inspection of our facility by the FDA," said Shlomo Gabbay, MD, founder and chief scientific officer of Shelhigh. He said that Shelhigh "fully addressed all observations raised by FDA personnel, repeatedly requested corrections of statements made by the FDA in their site report and also repeatedly requested meetings with the FDA to discuss any outstanding issues as well as concerns which arose during the 10 week inspection, and these meetings were also refused by the FDA."

The products seized included pediatric heart valves and conduits, surgical patches, dural patches, annulopasty rings and arterial grafts.

The FDA said that critically ill patients, pediatric patients and immuno-compromised patients could be at risk from the use of these devices, but Gabbay said, "These are the very same patients that Shelhigh products have been helping over the past 10 years, extending their lives often when no other solution was available to them." He said that Shelhigh No-React products are acknowledged as offering resistance to infection, even in cases of active infective endocarditis. Concerning the FDA's reference to two previous warning letters, Gabbay said that the first warning letter was from 2000 and all issues described in that letter were addressed; and that the second warning letter issued in 2005 was the one for which Shelhigh has sought verification pertaining to the actions implemented by Shelhigh.

"I can't explain why the FDA sometimes chooses to ignore factual information but it does happen," said Gabbay. "It is unfortunate that the FDA is stopping Shelhigh from shipping our life-saving products, and I remain hopeful that the FDA will quickly resolve whatever internal issues they have which have lead to their baffling seizure decision," said Gabbay. Shelhigh says that its No-React tissue products utilize glutaraldehyde fixation process while avoiding the acknowledged problems that accompany glutaraldehyde. Shelhigh offers a variety of cardiothoracic surgical solutions incorporating No-React tissue.

Kolodner named HHS HIT head

Mike Leavitt, secretary of U.S. Health and Human Services, has appointed Robert Kolodner as national coordinator for health information technology at the department.

As the national coordinator for HIT, Kolodner — who has served as interim coordinator since September — will advise Leavitt on all department HIT efforts and will maintain and direct implementation of the HHS strategic plan to guide nationwide adoption of interoperable health care IT systems.

Kolodner joined HHS from the Department of Veterans Affairs, where he served as chief health informatics officer of the Veterans Health Administration.

Leavitt said, "Rob's experience, dedication and enthusiasm have been evident in his work at the Veterans Health Administration and here at HHS."

Countermeasures to CBRN sought

Leavitt released for display in the Federal Register the HHS's roadmap for developing and purchasing countermeasures against a host of chemical, biological, radiological and nuclear (CBRN) threats.

The "Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats" prioritizes HHS' acquisition of vaccines, drugs and diagnostic tests, including purchases made under Project BioShield. The plan is published online at www.hhs.gov/aspr/ophemc.

"Since the terrorist attacks of September 11, our mission has been to protect Americans by securing medical countermeasures for a range of threats. We have made significant progress to increase our preparedness in this area, but there is much more we must do," Leavitt said. "This plan lays out our path forward in the coming years and will take advantage of our new authorities under the Pandemic and All-Hazards Preparedness Act to move forward with Project BioShield."

The PHEMCE plan assesses the state of medical countermeasure preparedness and identifies priority R&D and acquisition programs to increase emergency preparedness. The plan identifies the proposed acquisitions HHS plans to make under Project BioShield during the remaining five years of the program, as well as priority medical countermeasure programs that will be pursued through FY23.

The plan emphasizes the use of new authorities provided for Project BioShield under the Pandemic and All-Hazards Preparedness Act to support the research, development, acquisition, and availability of safe and effective medical countermeasures to protect the United States from CBRN threats.

HHS said that funding support by the National Institutes of Health for basic research, product development, and clinical research of CBRN medical countermeasures has grown more than 30-fold from FY01 to FY06. Funding for the Strategic National Stockpile has increased over 10-fold in that same period. This growth in funding has led to the acquisition and stockpiling of medical countermeasures and supplies when public health emergency needs exceed or are otherwise unavailable through local supplies.

The public will be able to submit comments on the PHEMCE Implementation Plan through the Federal Register.

HHS will hold a workshop July 31-Aug. 2 in Washington for feedback and discussion of the plan.