WASHINGTON – A high-ranking Medtronic official appeared on Capitol Hill on Tuesday to ask Congress to make changes in the way government regulators inspect device manufacturing facilities for flaws.
Pat Shrader, Medtronic's vice president for global affairs, told a House subcommittee that inspections come with too little warning and are too "erratic" for companies to supply information, clarification and follow-up that might keep them from being sanctioned.
"Device facilities in the U.S. are often given very short advance notice of an inspection," Shrader told the House Energy and Commerce Health Subcommittee. "This short notice, plus the often erratic schedules of investigators, leads to challenges in assembling the appropriate team members to provide the required documents and materials requested by the FDA."
Shrader spoke not just for Minnesota-run Medtronic, but on behalf of the Advanced Medical Technology Association, the device industry's main trade group, which includes other major Minnesota employers, such as 3M, St. Jude Medical (through its new owner, Abbott Laboratories) and Boston Scientific.
Shrader called on Congress to standardize rules for inspections of device makers by the U.S. Food and Drug Administration (FDA). She also said FDA should schedule inspections based on facilities' history of compliance with the law — what Shrader called a "risk-based" system.
"H.R. 1736 does not limit or restrict FDA's authority to inspect medical device facilities in any way," she told the subcommittee. "Medtronic, just like all other companies in our industry, understands that robust FDA inspections serve an important oversight function to ensure the public that we are succeeding in producing safe and high-quality medical devices."
But, she added, "We have facilities that manufacture Class III [the most serious type of] devices. While the facilities have positive compliance profiles, they routinely experience as many as a half-dozen regulatory inspections a year, including multiple inspections by FDA."
Patient advocates say the serious injuries or deaths that can be caused by malfunctions of Class III devices warrants frequent inspections of device makers.
"Risk-based inspections makes sense to me," said Dr. Michael Carome, medical director of Public Citizen. "But I think it is more important that the FDA inspect facilities that make high-risk implantable devices."
Advance notice is another area where Carome disagreed with Shrader.
"The provision for advance notice," he said "could undermine the inspection by giving companies the ability to cover things up."
Jim Spencer • 202-662-7432