Ms. PACS: The Wall Street Journal (WSJ) reported that “FDA Medical-Device Regulator Resigns”1 According to Daniel Schultz, M.D., who has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years, it was a mutual decision made between him and FDA Commissioner Margaret Hamburg, M.D., who just started in May.
After working there 15 years, was it time for Schultz to go, or was the bad press too much for Hamburg and the rest of the FDA to take? And was Schultz’s bad-wrap warranted? They say he was real ‘too friendly’ with the medical-device manufacturers. What’s wrong with making friends – as long as you know the right ones to make friends with. Apparently, Schultz made friends with the manufacturers and enemies with the FDA scientists. Hmm?
There were at least two highly publicized incidences regarding Schultz’s decisions:
Two years ago when Sen. Chuck Grassley (R., Iowa) held hearings on Dr. Schultz’s approval of a nerve stimulation device to treat depression, irrespective of objections from multiple FDA doctors. The senator again opened an investigation into a knee-surgery device made by ReGen Biologics Inc., also approved by Dr. Schultz despite numerous objections from FDA scientists and reviewers.
So, was Schultz the victim of political ambition – Grassley trying to do something ‘important’? Or was Schultz simply just breaking the rules?
We won’t know…at least not until Schultz’s ‘FDA-tell all’ novel makes the NY Times Best Seller list.
No hard feelings though – WSJ didn’t rat out any of the device manufacturers and their questionable dealings with the FDA this time around. To boot, Hamburg gave Schultz a warm adieu in a statement saying that "Dr. Schultz left a strong legacy and helped the division enhance understanding of medical-device use in children."
Now that they've cleaned house – what will happen with Schultz’s legacy? Will the FDA approval process for devices take even looooooonger? And should medical IT solutions start to fear heavy regulation in the future – especially with the new premium placed on healthcare IT by the Obama administration to save the economy (at least part of it).
As one observant blogger…blogged: “HIT is, in fact, a virtual medical device that other important countries (e.g., in the EU) are already moving towards regulating in a manner similar to physical medical devices.” (hcrenewal.blogspot.com)
So, look out PACS vendors – you may be next. Just make sure you make the right friends.
1. Mundy, A. FDA Medical-Device Regulator Resigns. The Wall Street Journal Online. 8.12.2009. http://online.wsj.com/article/SB125002014808123517.html
PACSman: I love it when Ahhhhnold shows up to terminate someone and then they use politically correct words like "it was a mutual decision." Why not just say, "We're not gonna pay you anymore and are giving your cubicle to some other Dilbert instead.... but you are welcome to stay if you wanna." People will leave faster than a truckload of illegals when someone yells out "Inmigracion!" My old church never terminated anyone either - instead they would "allow them to use their God-given talents in venues outside the church." At last count there were 3,927 people doing the Lord’s work there even though fewer than 50 were on payroll. Praise the Lord and pass the time cards...
OK, so maybe Sargent Schulz did "Know nothing" but that was no reason for Colonel Klink to can him even if it "would be in the best interest of the center and the agency." Maybe he was "too friendly" with medical device manufacturers. I don’t see anyone from the American College of Radiology (ACR) being canned because there were "too friendly" with vendors on the DICOM committees by allowing them to help develop industry "standards." Isn't that letting the wolf guard the hen house as well? Of course that could be why DICOM is unquestionably the most non-standard standard that ever existed- because everyone on the committee had input to it and had to be kept happy. Sure it's better than nothing.... but would we be talking about establishing vendor neutral archives (VNA) 25 years later if we just put down fast and hard rules that would have established a VNA 25 years ago and said this is the way it HAS to be instead of letting everyone do their own thing?
It's funny - a friend of mine says I micromanage my kids by asking them where they are going (in my car), what they will be doing (with the money they got from me), what time they will be coming back (to my house) and who they are with (because they are still my responsibility until they turn 18). Maybe I'm wrong, but I recall that micromanagement was a parental role in some parenting book I read - Dr. Spock maybe. Of course, it could have been Leonard Nimoy's "I Am Not Spock" book as well - or his "I Am Spock" book written 16 years later. Make up your mind Leonard will ya? No wonder why my kids are so screwed up. It's all Spock's fault. Now my friend is a great person, but our parenting styles are as different as night and day.That doesn't make one of us right and the other wrong except in our own eyes. To her I'm much too uptight and untrusting when it comes to my kids and perhaps rightfully so. I was a teen once myself and even though it was ages ago I remember how I was. Back then I knew it all and then some. Even as smart as I was though I actually enjoyed my micromanaged upbringing. I guess I'm just old school because she is a much more laid back and easy going parent than I am. Thankfully neither of us have to raise each others kids because while I interpret her style as one that allows her kids as much opportunity to express themselves as they feel they need, my kids would be expressing significant pain as they crawled into their bedrooms with two broken legs if they didn't follow rules I had set down to the letter, or at the very least to the spirit of the letter. Different strokes for different folks and all that jazz. If one of my kids- or both- turn out to be serial killers I'll know she was right but until then I'm sure I'll hear my kids saying. "If you hit me again I'll call DCF!!" "Here - speed dial 7 - tell them I said hi!" Thankfully I haven't had those issues (yet), but despite everything I ever swore would never happen, I have indeed turned into my parents - my house, my rules. "I'll leave then!!' "Don't let the door hit you in the a$$ on the way out....and make sure you shut it tight so the dog doesn't get out either please! Thank you, Love you. Be home by 11." I can just FEEL the love here...
So what did Schultz do that was so wrong? He approved a knee repair device that the FDA scientists rejected on several previous occasions as unsafe. Apparently they felt they were "pressured to approve medical devices against their professional judgment." Did the guy take any under the table money? Not that has been proven. Did he do anything else wrong? Not really, except go against the scientists "better judgment" by taking actions on his own against their pettiness for "repeatedly reject(ing)" a product between 2006 and 2008 because the scientists apparently felt "the company's device had 'an increased risk' compared with products already on the market." An increased risk of what? Failing? Are they afraid they would bear the brunt of an "I've fallen and I can't get up" commercial because of a faulty knee repair device? What's the big deal? FDA scientists recommended rejecting another application from the same company in fall 2008, saying Regen had not shown "that patients who received the device experienced any benefit." Yeah, and? What's your point?
Years ago when I was a pharmaceutical rep we marketed a drug that had a much stronger placebo effect than a pharmacological one, yet it sold like hotcakes, and yes it did have FDA approval. I didn't see that commissioner being called on the carpet...OK, so maybe the FDA did blow it with Vioxx, but shouldn't the scientists be held accountable too? After all, last time I checked, "stuff" flowed down hill and the scientists had to approve that drug too.
You want to get on the FDA's case? Have them start enforcing the GMP reviews of the PACS and RIS vendor's software. Maybe that way one of my clients won't have freaked out when the system put the wrong patient's name with the wrong report, as it did most recently, and almost allowed his referring to do a slice and dice on the wrong patient. The vendor’s response? "Oops, our bad...We fixed it. See? All better!!" Make freeware conform to the same standards that commercially available software does or don't allow it to be used, period. Now I'm all for freeware, but who gets sued if someone screws up? I'll give you a hint- it won't be me.
Create STANDARDS for PACS - not guidelines, principles, standards of practice, or whatever you want to call it, but God-fearing, Devil- bashing, "Pe-raise Jesus!!" rules that say you will do it this way or we WILL shut you down with enforceable rules on how it should be done...Just like when I say be home at 11 p.m. then by God that means 11 or sooner - not 11:03, 11:07, or 7-11. And if you are going to be late, call. That's the lil’ green button on your phone - or at least on mine. Yours is too damn fancy anyway. And if you can text 2,765 times this past month alone, you can figure out how to press it - I'm preset 6, right next to the DCF. Don’t text me either. I’m old and have near zero tolerance to learn yet another technology.
So how will all this impact healthcare IT? Sorry folks, but I hope we put MORE RULES in place, not fewer, cuz the ones we have aren't worth a hill of beans. Make standards firm and fast and revisit and revise them as often as necessary... Not only is patient safety in jeopardy, but those using the system are in jeopardy and even the companies are in jeopardy by not overseeing software development and its ultimate use. I never could "detail" any of the meds we promoted for non-indicated uses. Why then can PACS vendors sell software that might not have even had to go through the 510-k process because it was "substantially equivalent" and was never reviewed? It not only needs to be reviewed but multiple times as well...Sure the FDA is tasked with doing a pre-market review which is supposed to trigger a GMP review in turn....but does it? Just like a geriatric driver needs to have his eyes examined every so often to keep his license current, so too does PACS and RIS software need to be reviewed often as well...
The problem is the FDA just doesn't seem to understand all the intricacies and subtle nuances that go into making PACS what it is. It's so much more than just another clinical IT system. Maybe Schultzie did "know nothing," but at least he didn't have a hidden past like Hogan did. General Burkhalter may be happy that you threw the baby out with the bath water, Colonel Klink, but your problems go a lot deeper than just knees, even though almost 450,000 of them were replaced last year. Yes, that's a lot of knees, but by comparison, according to the ACR, the U.S. has approximately 30,000 post-training, professionally active radiologists. Each radiologist read about 14,900 studies annually on average. You do the math - almost 450 MILLION radiology cases read across all age spectrums vs. 450,000 knees on patients where 90% were ages 65-70. Where should the concern be????
Captain Kirk was wrong when he told Spock in "Star Trek III - The Search for Spock" that "The needs of the one outweigh the needs of the many." Instead, at least relative to PACS, it needs to be "The needs of the many outweigh the needs of the one." That should be the FDA’s legacy....and Schultz’s too...
No comments:
Post a Comment