There’s an old story about a farmer who lost a horse, and the neighbor said “such bad news.” Then the horse came back with a bunch more in tow, and the neighbor said “such good news!” Then the farmer’s son broke his arm breaking one of the new horses and … well you get the idea. Sometimes you can tell the difference, sometimes not.
With that in mind, we examine two stories appearing recently in the pages of Medical Device Daily.
CMS; Trustees report is happy, happy
The Centers for Medicare & Medicaid Services announced recently the Medicare hospital (Part A) trust fund picked up two additional years of solvency, and CMS said “Medicare spending per beneficiary has grown quite slowly over the past few years and is projected to continue growing slowly over the next several years.”
Continue growing slowly over the next several years? Maybe. Or maybe the recession really did impose drag on Medicare spending and the economic recovery will push growth back to 6% per annum.
Mark Pauly of the Wharton School appeared at a recent confab on the Trustees report, and he remarked that hospitals and makers of therapeutics and diagnostics often shelve big plans when Medicare spending slows. Once spending growth resumes, however, all bets are off.
CMS also claimed the Affordable Care Act helped put a lid on Medicare inflation, but Pauly pointed out that many such fixes exert an ephemeral effect, as was the case with managed care.
I’m not trying to unload on CMS here – it is their job to make the government’s case after all – but I doubt anyone who’s familiar with the territory broke out the bubbly in response to the report, which one could say was bad news for makers of champagne.
Warning letter to Edwards; very big ouch
Edwards Lifesciences announced recently it had received a warning letter from FDA, but it was one of the longest warning letters I’ve ever seen, and I’ve seen a bunch.
Edwards announced a recall during the course of the inspection, but one of the big issues was the firm’s validation of an oven used in the processing of the QuickDraw venous cannulae, which seems to have led to breakage of the cannulae on six occasions.
Are six broken cannulae conspicuous? I can’t say because I have no idea how many were manufactured during the period in question, but worse yet in FDA’s view was that the company changed its story about the cause of the broken cannulae.
I’m not arguing criminal negligence, just that this is interventional cardiology, not a region that’s particularly forgiving of problems, which is why FDA is not particularly forgiving of problems, either.
I’d also point out the agency recently raised the question of Park doctrine in a warning letter to a food producer, and makers of these very high-risk devices would do well to read the tea leaves. Is it a stretch to think government prosecutors would invoke Park doctrine over the results of an inspection of a device maker?
Not if someone died.
The good news here is the Edwards compliance team will visit the plant in Draper, Utah, and tighten some bolts. The bad news is device makers must push the boundaries of design and materials science to reliably manufacture these smaller, more complex devices, and it doesn’t take a big mistake for problems to arise.