Invacare Update: Third Certification Audit Approval Delayed

Approval of Invacare Corp.'s third and final certification audit, due to the U.S. Food & Drug Administration (FDA) as part of the ongoing FDA consent decree that halted the production of manual and power wheelchairs and components in Elyria, Ohio, has been delayed.

The third-party expert conducting the audit met with Invacare representatives on Dec. 20 and informed them that "some additional work is required in a few particular areas before the final certification report can be provided to the United States FDA," Invacare said in a Dec. 23 news release.

Invacare described the third audit as "a comprehensive review of the company's compliance with the FDA's Quality System Regulation (QSR) at the impacted Elyria facilities."

A New Complaint Handling System

Invacare added that the third-party auditor's remaining concerns center on the manufacturer's new system for handling complaint and risk review processes.

Lara Mahoney, Invacare's director of investment relations & corporate communications, told Mobility Management, "We used to receive complaint data through a variety of areas. Someone would call into customer service or [a complaint] might come in through the sales force, through returns, through technical service. Now, with our new system, we can better track complaints and trend the data to keep better track of that. It all goes through one complaint handling system. All of these different sources of data are now funneling through one system."

The new system handles complaints involving all Invacare products, regardless of category - DME, respiratory, or complex rehab technology.

"We're adding and training associates to help finish the backlog, and we're to the point where we're closing out more complaints than are opened," Mahoney says. "We just need to work through that process a little further to meet the third party's expectations."

In addition, the third-party auditor will be looking for proof that the new system is a viable long-term solution.

"We have to manage the backlog, prove that we have this sustainable system, that it's effective," Mahoney says.

The Timeline Going Forward

In earlier announcements, Invacare said it was hoping to get approval of the third certification audit in November 2013.

Invacare now expects the third-party auditor to return in February to examine the quality system again.

After the third certification report is approved and submitted to the FDA, the agency will conduct its own investigation, which could be the final step before Invacare is able to return to normal operations.

Invacare executives signed the FDA's consent decree in December 2012. In a Dec. 20, 2012, news announcement, the FDA said its inspections of Invacare, "have documented violations of FDA's Quality System regulations, along with failures to properly report adverse events to the agency."

The consent decree prevented Invacare from designing, manufacturing and distributing manual and power wheelchairs and components.

In July, Invacare announced that the second certification report had been approved. That allowed Invacare to "resume design activities on the critical new product development projects that will help us regain our custom power wheelchair marketshare when we exit the injunctive phase of the consent decree," said Invacare CEO/President Gerald B. Blouch.

In May, Invacare said its first certification report had been approved, which regarded "qualification and validation documentation for equipment and processes at the Taylor Street manufacturing facility." The approval permitted the Taylor Street facility "to resume manufacturing and distributing parts, components, accessories and subassemblies to Invacare facilities other than the Taylor Street or corporate facilities, for further manufacturing or to provide service related to medical devices manufactured at those other Invacare facilities." In its Dec. 23 announcement, Invacare said it could not predict when the third certification report would be completed.

"While we are disappointed that the final certification report is not ready to be filed, we have made significant progress in our quality systems improvements over the past two years," Blouch said in the news release. "Notwithstanding our extension of the timeline resulting from the complexities of this process, the fact remains that our associates have done an incredible amount of work. We remain fully committed to meeting the expectations of our third-party auditor and ultimately the FDA so we can return to full operations at our corporate and Taylor Street manufacturing facilities."

Mahoney adds that the new complaint handling system, among other changes, are meant to strengthen Invacare for the long term.

"This is our new updated quality system that will be ongoing," she says. "All the improvements that we're making to our quality system are going to make us a better company. These are good, strong improvements we've been making. It's not just to get through the consent decree. It's to continue going forward."

About the Author

Laurie Watanabe is the editor of Mobility Management. She can be reached at lwatanabe@1105media.com.

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