Welcome to the first RR&A Round-up. Here you’ll find news on recent regulatory events, as well as some exclusive discussions on the finer points of the implications for medical device companies. To kick off, we’ll go back to December to review some key recalls and regulations that came out last month.
On December 12, FDA released the Home Use Device Initiative to encourage safe development and use of medical devices in home settings.
Included are steps that manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions (labeling) for home care recipients, consumers, and caregivers. The draft guidance is intended to improve the design and quality of home use devices to eliminate or reduce errors that occur during use. It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling. The comment and suggestion period for the draft guidance ends in March.
Initiated by Zimmer Spine Inc., December 20, 2012
Zimmer Spine received reports of its PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force was applied to the Ardis Inserter. If the Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord (dural tear), cerebrospinal fluid leakage, significant blood loss and nerve injury. Long-term health risks may include disability, dysfunction, or death.
In November 2012, Zimmer issued a Medical Device Correction memo to inform surgeons and hospitals of the problem and to provide updated precautions and surgical technique guidance to decrease the risk of implant breakage. In this memo, Zimmer Spine also indicated that on or about May 2013, a redesigned inserter would be available for use when implanting the PEEK Ardis Interbody Spacer.
On December 20, 2012, Zimmer modified its Medical Device Correction memo and initiated a voluntary recall of all 315 units of the PEEK Ardis Inserter. Surgeons and hospitals were instructed to immediately stop using the Ardis Inserter and to return them to Zimmer Spine. Surgeons and hospitals were warned that surgery could not be performed as intended without the use of the Ardis Inserter. Therefore the PEEK Ardis Implant System is unavailable for use until FDA clears a redesigned inserter.