The FDA has cited three device firms for a range of compliance issues including inadequate design and device validation procedures as well as inadequate procedures for receiving, reviewing and evaluating complaints.
Following a Jan. 23 to Feb. 3 visit to Signal Medical, Marysville, Mich., FDA inspectors determined that the company had not validated the packaging design for the firm’s hip implant system to ensure that it met specifications, including maintenance of sterility. The agency noted a risk analysis the company performed in 2015 but said it failed to consider, among other issues, the packaging used, in part, to maintain sterility of the hip system components.
According to a Form 483, results of validation testing in 2016 for several of Signal’s hip system components showed the following: failures of the inner and outer pouches for dye penetration, seal strength and internal pressurization (bubble) testing. A complaint filed in 2016 described a hip stem component found to have perforated both the inner and outer pouches when opened in the operating room. FDA says Signal continued to ship hip components even after being notified of the packaging failures.
The FDA said Signal failed to take preventive and corrective action including for a rust-colored patch or staining issue affecting its implants. The agency said the company did not validate a cleaning process to remove from its devices excess iron deposits implicated in the staining issue. In addition, Signal did not review, evaluate or investigate complaints involving instrument disassembly, instrument fracture or compromised sterile barrier of an implant.
Kindara: FDA inspectors visited Kindara’s Boulder, Colo., facility Jan. 25 to Feb. 8, and determined that the firm could not provide documentation of software validation for the Kindara mobile app, which is designed to interface with the Wink Digital Fertility Monitor for fertility prediction based on basal body temperature.
The device transmits biometric data via Bluetooth to the Kindara mobile app. The FDA inspectors found the firmware that performs the device functions was not validated according to an established protocol. Kindara first marketed the Wink device in May 2016 and the firmware has not changed since, FDA says. Inspectors found that while Kindara received software defect reports from customers, these were not logged or evaluated for medical device reporting procedures.
Wieland Designs: During a February visit to medical furniture manufacturer Wieland Designs, Goshen, FDA inspectors found no documented investigators or corrective action reports for 1,439 out of 1,500 complaints received by the firm since July 2015.
Complaints included the following: a missing brake lever for locking the brake on a wheelchair, a chair missing brake pedals, device brakes on casters that allowed the wheels to slide on the floor, and a nonworking brake paddle.
The FDA inspectors, according to a Form 483, also found that procedures have not been established to control product that did not conform to specified requirements, that rework and re-evaluation activities had not been documented in the device history record and that a correction or removal in order to reduce a health risk posed by a device was not reported in writing to FDA as required.
The companies did not return requests for comment.