In wake of agreement, new normal for Invacare, providers
ELYRIA, Ohio – A Dec. 21 agreement with the Food and Drug Administration (FDA) will limit operations at Invacare’s Taylor Street manufacturing facility, but HME providers will still have access to the manufacturer’s manual and power wheelchairs, says Gerry Blouch, president and CEO.
Invacare may continue to manufacture and distribute wheelchairs and seating systems under certain conditions: when a patient requests the same or newer version of an existing product and the clinician submits a form acknowledging the agreement; and when an evaluation determines the product is medically necessary for a particular condition that can’t be addressed by another manufacturer’s product, and the clinician and physician submit a form acknowledging the agreement.
“There will be some additional documentation,” Blouch said. “At a time when the government is putting new rigors on documentation, it’s not the best news providers have had, but the forms don’t deviate from things they’re accustomed to. We’re confident that with our education and support, they’ll find the process reasonable.”
Additionally, Invacare may continue to fulfill orders and written quotes already in its system by Dec. 21, the date a district court approved the agreement.
Invacare acknowledges that the agreement will have an impact on operations. Following the agreement, Invacare announced that it would lay off 143 employees at its Taylor Street facility, almost 40% of its workforce there.
“We made that decision based on our best estimate of how successfully we’ll be able to sustain certain operations,” Blouch said.
To resume full operations, Invacare must successfully complete a third-party audit, followed by an FDA inspection. The manufacturer has started the first two phases of the audit: inspection of the qualification and validation procedures and documentation for equipment and processes at the Taylor Street facility; and review of the design control systems at the Taylor Street facility and its corporate headquarters. The third and final phase of the audit will involve a comprehensive review of compliance with the FDA’s quality systems regulations. Blouch can’t say how long the audit will take.
“There’s no cookbook for this process—how broadly and how deeply they go is impossible to judge,” he said. “We certainly believe it will come out well.”
Once Invacare has the green light from the FDA to resume full operations, it must continue to submit reports to the agency verifying its compliance for five years. While the process will be ongoing, providers shouldn’t doubt Invacare or its products, Blouch said.
“We understand and embrace our responsibility to be in compliance, but there are no recalls directly related to the agreement,” he said. “That doesn’t mean this isn’t serious, but the quality of our products continue to be outstanding. We will get our procedures in line and we will be a better company for it, but no one has to worry about the quality of our products.”