Electrotherapy device specialist, Zynex Medical has been issued a stern warning letter from the U.S. FDA pertaining to its NexWave chronic pain device and IF8000 electrical stimulator. The letter follows an audit earlier this year and deals with Zynex’s response to that audit’s report, which it seems was found wanting in some key areas.
To be honest, having read the letter, which you can find here, it smacks of a lack of attention to the application of a quality system rather than any fundamental problem in the way the company goes about its day job. Sadly for Zynex, their dirty laundry is now being fully washed in public. For us industry watchers that’s all very entertaining, but for your average medical professional it might be thoroughly befuddling, so here are a few examples of Zynex’s shortfalls, according to the FDA, interpreted by us:
The Complaint Handling procedure does not ensure complaints are evaluated to determine if they are reportable according to the FDA’s instructions. In fact, not only that, but numerous complaints had not been processed at all, let alone any decisions made about whether they constituted events that needed further action. Zynex said they’d correct the situation, but hadn’t provided revised procedures, leaving the FDA with an open goal.
Design control procedures, specifically design input, failed on several counts, most notably the bit where a procedure exists to establish that the design will fulfil the demands of the original intended use. Again the company said it would modify its procedures, but failed to provide those modifications, again leaving FDA no choice but to sound dissatisfied.
Design verification procedures were inadequate, which basically means key “does it work?” questions remained unanswered.
If you’re getting the picture that the agency is dissatisfied with both the audit findings and the company’s responses thus far, you’ll not be far off the mark. There’s a bunch more in the letter, all of which is inherently correctable and none of which means the company’s products are fundamentally unsafe. But when they’re being found wanting in so many areas, from complaint handling, through design processes, recording, corrective/preventive actions, internal audits not being performed to schedule, reporting etc etc, one wonders whether the eye is fully trained on the ball.