I'm not sure anyone could say it better that Terri Hall does in this interview:
-Wes
Dr. Wes
Musings in the life of an internist, cardiologist and cardiac electrophysiologist.
Sunday, March 18, 2012
Friday, March 16, 2012
Upcoming Engagements at the ACC Meeting
Yours truly will be participating in the following events during the upcoming American College of Cardiology meeting in Chicago:
I look forward to seeing everyone in Chicago next Saturday!
-Wes
- I'll take part in an editorial and unsupported videotaped discussion Saturday afternoon on the impact and role of social media in cardiology practice with Shelley Wood, managing editor of theheart.org, and fellow blogger who covers private practice issues for theheart.org, Dr Seth Bilazarian. (Air time TBD).
- Now, for those looking for something a bit different at the ACC, come join me for a talk and "Tweet-up" at PUBLIC Chicago (pssst, click the link to see the hip place I'll be talking), 1301 North State Parkway, Chicago, IL Saturday 24 Mar 2012 at 6:30 pm for a talk on "The Power of Social Media to Impact Health Care Policy and Delivery." (Kindly sponsored by Zoll Medical - invite here as pdf). I hope all three of my local Twitter followers will attend.
For those unable to attend in person, we'll be using the hashtag #zollacc12 on Twitter for the event. (You can follow along in realtime using Tweetchat or Twitterfall - I am not responsible for the content there). While the event is considered officially as a "New and Recent Fellows Reception," others are welcome. Message me at @doctorwes on Twitter if you have no clue how to use Google maps and need directions. (I hear taxis will be available for those unable to drive after the event.)
I look forward to seeing everyone in Chicago next Saturday!
-Wes
The Red Light
He was an older man, lying head-up in the Intensive Care Unit attached to telemetry and pulse oximetry monitors. A small plastic cannula irritated the columella of his nose. He lifted his hand to scratch the area, but the IV tubing in his hand did the work for him sooner than he expected. He looked at the wall behind him.
"So far so good," he thought.
A soft knock was heard on the wall outside his room.
"Come in," he uttered.
A bright young woman in a neatly-pressed pant suit entered, carrying a clip board.
"Hello, Mr. Smith, my name is Sally. I'm from the Office of Patient Advocacy. I was wondering if I could ask you a few questions about your stay here in the ICU."
"I don't see why not," he said, straining his head to see the wall behind him once more. He looked back at her. "Go ahead."
"How have the staff been here? Any problems?"
"No! They've been wonderful. Really. Can't say enough about them except 'Fantastic.'"
He quickly looked at the wall again, then tuned back.
"Have the staff been responsive to you when you needed something?" the advocate asked.
"I'll say! Couldn't be nicer, but the food still needs some work."
She jotted something on her clipboard then looked up and saw the man glancing at the wall behind him again.
"I'm sorry, Mr. Smith, is there something that's concerning you?"
He turned back to her and waved to her to come closer, looking concerned.
"You see that light back there, the yellow one?"
"Yes," she said.
"Well I don't know what it's for, but last night, the guy's next to me turned red and twenty people rushed into his room and beat the poor guy to death."
-Wes
"So far so good," he thought.
A soft knock was heard on the wall outside his room.
"Come in," he uttered.
A bright young woman in a neatly-pressed pant suit entered, carrying a clip board.
"Hello, Mr. Smith, my name is Sally. I'm from the Office of Patient Advocacy. I was wondering if I could ask you a few questions about your stay here in the ICU."
"I don't see why not," he said, straining his head to see the wall behind him once more. He looked back at her. "Go ahead."
"How have the staff been here? Any problems?"
"No! They've been wonderful. Really. Can't say enough about them except 'Fantastic.'"
He quickly looked at the wall again, then tuned back.
"Have the staff been responsive to you when you needed something?" the advocate asked.
"I'll say! Couldn't be nicer, but the food still needs some work."
She jotted something on her clipboard then looked up and saw the man glancing at the wall behind him again.
"I'm sorry, Mr. Smith, is there something that's concerning you?"
He turned back to her and waved to her to come closer, looking concerned.
"You see that light back there, the yellow one?"
"Yes," she said.
"Well I don't know what it's for, but last night, the guy's next to me turned red and twenty people rushed into his room and beat the poor guy to death."
-Wes
Labels:
humor
When Programmers Outnumber Doctors
Patience. You have have to have patience.
“It’s got to be me,” I tell myself. "I'm a computer guy. Surely there must be something I’m missing." "Why would they take away that functionality that we had before?" "Why so many buttons and choices?" "Seriously?"
Everyone wants something different from our electronic medical records these days. Administrators want numbers, doctors want pictures and meaningful narrative, nurses want every pill given and bed-rail elevated documented and every check-list completed. The geeks want it mobile. Our government, administrators, physician leaders and legal system say they need this piece of data or that piece of data and then, please people, give us some more data, will you?
So everything we think, eat, and breathe is entered on a computer. Right now, it's all about the computer. After all, we’re told the Electronic Medical Record sees everything and will be our salvation.
But now I’m seeing something new.
There’s so much data that we risk doctors becoming lost in it. It is entirely possible that we are in danger of not being able to find our most important clinical signals amongst the noise and clutter of all the data. Worse: time with patients is disappearing.
Our health care information gold rush has acquired teams of programmers to feverishly implement a myriad of bureaucratic information system requirements in just a few short years. To this end, these programmers have been extremely effective. But almost as incredibly, these same programmers have little perspective of what physicians do or how we interact with patients and THIER data. As a result, doctors are not only confronted by all of this this information placed before them, but waste preceious time sifting amongst the data and continue to be the fall-guy for data entry. Codes, quality measures, documentation requirements and, oh, yeah, the progress and operative notes, are all being entered by doctors. In return, our screens have become crowded intersections of buttons, flags, options, icons, colors, warning alerts and (if we're lucky) text. Oh yeah, and a new "upgrade's" coming next week.
Typing, clicking, choosing, clicking. That one? No? Maybe this one? Yeah. But wait, now what?
Entire industries have sprouted to address this problem and provide doctors scribes to enter all this data. But are there cost savings this way? With such a model, aren't we just changing our doctors from data entry to quality assurance personnel? (“Is this what you said?” “Which code should we use, doctor?”)
Few seemed concerned about the data flood and screen crowding that's upon us. In fact, most don’t acknowledge such a problem even exists.
If you're skeptical, just ask a doctor if he spends more time with his computer or his patients now.
Doctors need better information before us, not more of it. We don't need to know what "type" of order we entered, for instance. We need more time with our patients and less time with data entry. We need white space on our screens. Deciding what information goes and what stays for all caregivers should be a priority we consider going forward.
But we can never have enough data these days, can we? Like Play-doh, we play with it, we compile it, we shape it and twist it, then bounce it around.
But someewhere in there, we also make critical medical decisions with it.
So if Google can understand the value of white space on their front page, why can't we?
-Wes
“It’s got to be me,” I tell myself. "I'm a computer guy. Surely there must be something I’m missing." "Why would they take away that functionality that we had before?" "Why so many buttons and choices?" "Seriously?"
Everyone wants something different from our electronic medical records these days. Administrators want numbers, doctors want pictures and meaningful narrative, nurses want every pill given and bed-rail elevated documented and every check-list completed. The geeks want it mobile. Our government, administrators, physician leaders and legal system say they need this piece of data or that piece of data and then, please people, give us some more data, will you?
So everything we think, eat, and breathe is entered on a computer. Right now, it's all about the computer. After all, we’re told the Electronic Medical Record sees everything and will be our salvation.
But now I’m seeing something new.
There’s so much data that we risk doctors becoming lost in it. It is entirely possible that we are in danger of not being able to find our most important clinical signals amongst the noise and clutter of all the data. Worse: time with patients is disappearing.
Our health care information gold rush has acquired teams of programmers to feverishly implement a myriad of bureaucratic information system requirements in just a few short years. To this end, these programmers have been extremely effective. But almost as incredibly, these same programmers have little perspective of what physicians do or how we interact with patients and THIER data. As a result, doctors are not only confronted by all of this this information placed before them, but waste preceious time sifting amongst the data and continue to be the fall-guy for data entry. Codes, quality measures, documentation requirements and, oh, yeah, the progress and operative notes, are all being entered by doctors. In return, our screens have become crowded intersections of buttons, flags, options, icons, colors, warning alerts and (if we're lucky) text. Oh yeah, and a new "upgrade's" coming next week.
Typing, clicking, choosing, clicking. That one? No? Maybe this one? Yeah. But wait, now what?
Entire industries have sprouted to address this problem and provide doctors scribes to enter all this data. But are there cost savings this way? With such a model, aren't we just changing our doctors from data entry to quality assurance personnel? (“Is this what you said?” “Which code should we use, doctor?”)
Few seemed concerned about the data flood and screen crowding that's upon us. In fact, most don’t acknowledge such a problem even exists.
If you're skeptical, just ask a doctor if he spends more time with his computer or his patients now.
Doctors need better information before us, not more of it. We don't need to know what "type" of order we entered, for instance. We need more time with our patients and less time with data entry. We need white space on our screens. Deciding what information goes and what stays for all caregivers should be a priority we consider going forward.
But we can never have enough data these days, can we? Like Play-doh, we play with it, we compile it, we shape it and twist it, then bounce it around.
But someewhere in there, we also make critical medical decisions with it.
So if Google can understand the value of white space on their front page, why can't we?
-Wes
Thursday, March 15, 2012
The Anti-smoking Advertising Challenge
With the government's new, graphic $54 million dollar anti-smoking advertising campaign announced today by the Centers for Disease Control, we should remember that the annual advertising budget for the tobacco industry is about $15.3 billion dollars in the U.S. alone:
Still, it's a start.
-Wes
Click image to enlarge
-Wes
Tuesday, March 13, 2012
Crowdsourcing a Fellow's Social Media Talk
Pretend for a moment that you are an actively-engaged physician blogger on the internet. You are approached to give a talk at a national meeting on social media's importance to young, fledgling doctors entering their chosen field in medicine. You want to be relevant and truthful. You do NOT want to be boring. You have a pretty open forum to say anything you like.
If you only had forty minutes to convey your message, what would you say?
How would you present these ideas?
What would YOU want to hear (or see) at such a talk if you were in the audience?
Go ahead. Think about it a bit. Be creative. Help me construct my talk at the upcoming ACC meeting in Chicago on the 24th of March so it's one you'd want to attend.
Then let it rip in the comments section.
(Thanks in advance.)
-Wes
If you only had forty minutes to convey your message, what would you say?
How would you present these ideas?
What would YOU want to hear (or see) at such a talk if you were in the audience?
Go ahead. Think about it a bit. Be creative. Help me construct my talk at the upcoming ACC meeting in Chicago on the 24th of March so it's one you'd want to attend.
Then let it rip in the comments section.
(Thanks in advance.)
-Wes
Medicine 2018
It was Spring, 2018. She sat writhing in bed, complaining of nausea, feeling bloated and distended. The health care consultants who had gathered in the hall outside her room peeked in. Concerned, they began wringing their hands.
“Maybe if we tweet the symptoms, our health care social media friends can help us!”
So they did. The internet responded: “WTF?” and “How long has this been going on?” and “Maybe it’s acute appendicitis” and “F.O.S.?”
The consultants looked at each other, puzzled. “F.O.S.?”
Then it hit them: maybe she’s constipated!
So they electronically ordered a flat plat abdominal x-ray from their iPad 12 to be performed “as soon as possible.”
Within twenty minutes, a tired x-ray tech grabbed a blue gown outside, slathered his hands in antibacterial goo, donned plastic gloves and then entered the room. He followed the carefully outlined lines on the floor, placed there to minimize infection based on the laminar airflow characteristics of the room. He positioned the hard film plate behind the woman's belly, shot the picture of her abdomen, and shipped it off electronically to an eager radiologist in Dubai.
Within minutes the results returned. The ordering consultant's iDroid-10 was alerted. The results were shared with the other consultants. While impatient with the slow response time, they nonetheless peered at the results:
They paused and then looked at each other, confident they could affect a cure.
Reaching for their iDroid-10s in unison, each clicked through their multiple apps. They scrolled forward, past the ones for drug dosing, clinical formulas, Grand Rounds chats, differential diagnostic analyzer, EKG, pulse oximetry, World of Warcraft Residency Training tool, and even a retina reader…
Wait!
Maybe we have a Facebook friend that can help us!
They clicked on the iDroid-10 Facebook app and updated their status:
“Need digital dis-impaction at our local facility. Anybody game?”
Within seconds, they got 20 “Likes” but no takers.
“Damn it,” they thought.
“Looks like we’ll have to hire a doctor.”
-Wes
“Maybe if we tweet the symptoms, our health care social media friends can help us!”
So they did. The internet responded: “WTF?” and “How long has this been going on?” and “Maybe it’s acute appendicitis” and “F.O.S.?”
The consultants looked at each other, puzzled. “F.O.S.?”
Then it hit them: maybe she’s constipated!
So they electronically ordered a flat plat abdominal x-ray from their iPad 12 to be performed “as soon as possible.”
Within twenty minutes, a tired x-ray tech grabbed a blue gown outside, slathered his hands in antibacterial goo, donned plastic gloves and then entered the room. He followed the carefully outlined lines on the floor, placed there to minimize infection based on the laminar airflow characteristics of the room. He positioned the hard film plate behind the woman's belly, shot the picture of her abdomen, and shipped it off electronically to an eager radiologist in Dubai.
Within minutes the results returned. The ordering consultant's iDroid-10 was alerted. The results were shared with the other consultants. While impatient with the slow response time, they nonetheless peered at the results:
They paused and then looked at each other, confident they could affect a cure.
“Evidence of stool fills the entire ascending, transverse, descending colon and rectum. No free air. No evidence of obstruction.”
Reaching for their iDroid-10s in unison, each clicked through their multiple apps. They scrolled forward, past the ones for drug dosing, clinical formulas, Grand Rounds chats, differential diagnostic analyzer, EKG, pulse oximetry, World of Warcraft Residency Training tool, and even a retina reader…
Wait!
Maybe we have a Facebook friend that can help us!
They clicked on the iDroid-10 Facebook app and updated their status:
“Need digital dis-impaction at our local facility. Anybody game?”
Within seconds, they got 20 “Likes” but no takers.
“Damn it,” they thought.
“Looks like we’ll have to hire a doctor.”
-Wes
In the Mail: Zoll Medical to acquired by Asahi Kasei
Imagine: a wearable defibrillator company valued at a cool $2.2 billion. Not bad. (Amazing what happens when you survive a FDA "reconsideration" of your technology.
But who's Ahashi Kasei?
-Wes
But who's Ahashi Kasei?
-Wes
Monday, March 12, 2012
I Am So Screwed
I thought I'd start the week off right, get up early, have a cup of coffee, and get prepared for the week ahead, Little did I know what was in store for me when I checked my e-mail.
Margaret Polaneczky, MD (aka, @tbtam the incredibly bright OB-GYN of The Blog That Ate Manhatan fame) had left a comment on my last post suggesting I check out my profile on the CMS's Physician Compare website.
What I found was so discouraging, so demoralizing, so indicative of what we can expect from our newly-contructed computer databases compiled by a Central Authority without its own quality assurance checks, that every US doctor and patient should demand an immediate halt to what we're creating until the developers of this mess can prove they can get it right.
You see, according to the government's database, I'm not a cardiac electrophysiologist.
That's right. I do not practice cardiac electrophysiology and never have. Instead, I am just a general cardiologist. Never mind that I have searchable credentials and billings to prove it.
And if that's not enough, according to the same database, I have offices in 254 locations (I'm not kidding). Something as simple as my vocation and office locations are already completely screwed up.
And that is not even the half of it.
Mark Hamer, MD, whom I replaced at our facility in 2001 and has practices in Rochester, NY since then, is still listed as working here in Chicago. John Alexander, MD, a prominent cardiothoracic surgeon at our facility? He's retired now and no longer sees patients. Yet there they are: fully credentialled and, according to our government's CMS physician finder database, working from the same 254 offices that I work in.
According to Dr. Polaneczky, I can expect it will take at least a 6-months to correct these errors on the CMS database. (And, if you'd like some ocean-front property in Arizona, I can sell you that, too.)
I am so screwed.
But as bad as it is for me, I'm not the only one who's screwed, am I? You see, if this is as good as the government can get at culling their vast repository of information collected by hoards of coders, billers, and legions of other non-medical folk upon whom they entrust to get the data right, we are in trouble in many more ways than this. One only has to imagine the issues that arise when our government regulators turn to similarly-contructed databases to make life-and-death payment decisions. We ALL had better reconsider the wisdom of our complete reliance on such unverified databases going forward.
One thing is now perfectly clear: just because our government health care regulators have all this quality assurance and billing data at their disposal, they have no earthly idea how to use it correctly.
-Wes
Margaret Polaneczky, MD (aka, @tbtam the incredibly bright OB-GYN of The Blog That Ate Manhatan fame) had left a comment on my last post suggesting I check out my profile on the CMS's Physician Compare website.
What I found was so discouraging, so demoralizing, so indicative of what we can expect from our newly-contructed computer databases compiled by a Central Authority without its own quality assurance checks, that every US doctor and patient should demand an immediate halt to what we're creating until the developers of this mess can prove they can get it right.
You see, according to the government's database, I'm not a cardiac electrophysiologist.
That's right. I do not practice cardiac electrophysiology and never have. Instead, I am just a general cardiologist. Never mind that I have searchable credentials and billings to prove it.
And if that's not enough, according to the same database, I have offices in 254 locations (I'm not kidding). Something as simple as my vocation and office locations are already completely screwed up.
And that is not even the half of it.
Mark Hamer, MD, whom I replaced at our facility in 2001 and has practices in Rochester, NY since then, is still listed as working here in Chicago. John Alexander, MD, a prominent cardiothoracic surgeon at our facility? He's retired now and no longer sees patients. Yet there they are: fully credentialled and, according to our government's CMS physician finder database, working from the same 254 offices that I work in.
According to Dr. Polaneczky, I can expect it will take at least a 6-months to correct these errors on the CMS database. (And, if you'd like some ocean-front property in Arizona, I can sell you that, too.)
I am so screwed.
But as bad as it is for me, I'm not the only one who's screwed, am I? You see, if this is as good as the government can get at culling their vast repository of information collected by hoards of coders, billers, and legions of other non-medical folk upon whom they entrust to get the data right, we are in trouble in many more ways than this. One only has to imagine the issues that arise when our government regulators turn to similarly-contructed databases to make life-and-death payment decisions. We ALL had better reconsider the wisdom of our complete reliance on such unverified databases going forward.
One thing is now perfectly clear: just because our government health care regulators have all this quality assurance and billing data at their disposal, they have no earthly idea how to use it correctly.
-Wes
Sunday, March 11, 2012
Let's Make a Deal
It's a beautiful Sunday morning and I'm sitting in front of a computer, partly because I feel rejuvenated after slowing my blog-pace a bit, and partly out of a sense of obligation to post something on this blog.
In blogging, if you don't write, you die. It's a simple as that.
Not that you have to post much, but if it doesn't have relevance, you'll die, too. So here I am, trying to find something relevant, when I stumble upon an article from earlier this week from AMA Medical News entitled: "HHS seeks physician comments on meaningful use rules."
* sigh *
In the article, a member of the Department of Health and Human Services (HHS) likens the rules for Meaningful Use, Part 2 (MU-II) to a game show:
The reality for doctors is this: we see that hospitals have hired legions of personnel, practice managers, IT specialists, and consultants to creatively implement the law - a law written on losely-outlined imperatives which are all closely tied to the threat of withholding payments from the government should anyone dare to do anything different. We are promised "efficiencies." We are promised the value for care that the software patch will provide. But we soon see that entire workflows are being reconstructed by computer programmers with absolutely no appreciation for what WE feel and do that is important to patient care. Rather, it's all about what documentation will be required to meet the demands of MU-II to earn governmental monetary Brownie points.
Ask any doctor today what most of their group meeting are spent discussing and I would venture to say most would say that much of their meetings are spent discussing the new software upgrade coming around the corner that will lay the groundwork for qualifying for juicy government handouts for implementing MU-II. Most of MU-II is about constructing a way to handle bundled payments. As if doctors care about bundles. We care about the details, the history, we care about communication with our patients rather than a screen. We care about outcomes and costs, none of which we're allowed to see. These are the things that affect our patients, not meaningful use rules.
So it is no wonder Mr. Posnack likens the rule making process and importance of comments to the TV show "American Idol." After all, he's required by law to make us play his game. It's supposed to be fun!
But as doctors see these increasingly complex computer games consume more and more of their precious time with patients and see their compensation tied to chart completion rather than patient care, the game has already lost its luster.
Yeah, time to get outside.
-Wes
In blogging, if you don't write, you die. It's a simple as that.
Not that you have to post much, but if it doesn't have relevance, you'll die, too. So here I am, trying to find something relevant, when I stumble upon an article from earlier this week from AMA Medical News entitled: "HHS seeks physician comments on meaningful use rules."
* sigh *
In the article, a member of the Department of Health and Human Services (HHS) likens the rules for Meaningful Use, Part 2 (MU-II) to a game show:
Steven Posnack likens the rule-making process and importance of public comments to the TV show "American Idol." "Every once in a while, the fan favorite is voted off because everyone thought they were safe and so they don't vote for them," said Posnack, director of federal policy for the Office of the National Coordinator for Health Information Technology. In the rule-making world, he said, good policy can be eliminated because people don't express their satisfaction with what they like. This is why the Dept. of Health and Human Services' Centers for Medicare & Medicaid Services and the ONC hope people in the health information technology world -- including physicians -- will take the time to read the proposed stage 2 meaningful use rules and express their opinions, both good and bad.Like doctors have any say in this, really. It's the law now. We weren't asked to be involved (really) with this to computer thing to begin with, so to come to us this late in the process seems like an afterthought. We should comment now? (Like they'll reprogram things based on what we say? I'm not seeing it.)
The reality for doctors is this: we see that hospitals have hired legions of personnel, practice managers, IT specialists, and consultants to creatively implement the law - a law written on losely-outlined imperatives which are all closely tied to the threat of withholding payments from the government should anyone dare to do anything different. We are promised "efficiencies." We are promised the value for care that the software patch will provide. But we soon see that entire workflows are being reconstructed by computer programmers with absolutely no appreciation for what WE feel and do that is important to patient care. Rather, it's all about what documentation will be required to meet the demands of MU-II to earn governmental monetary Brownie points.
Ask any doctor today what most of their group meeting are spent discussing and I would venture to say most would say that much of their meetings are spent discussing the new software upgrade coming around the corner that will lay the groundwork for qualifying for juicy government handouts for implementing MU-II. Most of MU-II is about constructing a way to handle bundled payments. As if doctors care about bundles. We care about the details, the history, we care about communication with our patients rather than a screen. We care about outcomes and costs, none of which we're allowed to see. These are the things that affect our patients, not meaningful use rules.
So it is no wonder Mr. Posnack likens the rule making process and importance of comments to the TV show "American Idol." After all, he's required by law to make us play his game. It's supposed to be fun!
But as doctors see these increasingly complex computer games consume more and more of their precious time with patients and see their compensation tied to chart completion rather than patient care, the game has already lost its luster.
Yeah, time to get outside.
-Wes
Thursday, March 08, 2012
On Medtronic's Most Recent Medical Device "Correction"
Yesterday, Medtronic, Inc, the world's largest medical device manufacturer, notified me in clinic about another problem with one of their lines of defibrillators via a Dear Doctor letter (1 Mbyte) headed by the line "URGENT: MEDICAL DEVICE CORRECTION."
It seems this term is now commonly seen on other Medtronic device advisories as well.
I wondered how the marketing and legal folks at Medtronic could use that term on the top of such a letter. After all, there is no "correction" that I can see in their "Dear Doctor" letter given to me.
By way of background, the letter explained there is a problem with a very small subset of Medtronic's Entrust (US market) and Escudo (overseas market) line of defibrillators which began to be used in 2005. After 30 months of implant, a drop from 3.0V to 2.61V (ERI) can occur in 1 week to six months in rare cases. It is estimated that there are approximately 39,000 patients with these devices still implanted worldwide with 21,600 of the remaining devices in U.S. patients. The root cause of the defect described in the letter is thought to be a battery short that develops as the battery in consumed. Consequently, the battery may not last the expected three months after the device reaches its initial elective replacement indicator and doctors are advised to replace the generator immediately once the device reaches this indicator. Importantly, no deaths have occurred as a result of this defect but there is a theoretic potential that a device might not reach an effective discharge voltage after the battery depletion occurs. For doctors and patients, this alert ranks pretty low on the concern scale, provided patients are monitored closely and have their battery-reaching-ERI alerts programmed "ON." (Please see the above linked letter for full details)
This issue of what to call these device alerts is not a small issue. In early 2005 when a rash of serious ICD problems began to surface, they were uniformly called "device recalls." But the Heart Rhythm Society recognized the problems with this nomenclature:
As a result, the terms "advisory alert" or "safety alert" were proposed to describe less serious communications with doctors and patients regarding important device communications.
So why now "important device corrections?" In cases like this, I feel it would be best that device manufacturers stick with terms that industry and physician groups have agreed so that the appropriate level of concern is conveyed to doctors and patients alike without sugar-coating the defects. That way when these letters are issued, we're all on the same page.
-Wes
It seems this term is now commonly seen on other Medtronic device advisories as well.
I wondered how the marketing and legal folks at Medtronic could use that term on the top of such a letter. After all, there is no "correction" that I can see in their "Dear Doctor" letter given to me.
By way of background, the letter explained there is a problem with a very small subset of Medtronic's Entrust (US market) and Escudo (overseas market) line of defibrillators which began to be used in 2005. After 30 months of implant, a drop from 3.0V to 2.61V (ERI) can occur in 1 week to six months in rare cases. It is estimated that there are approximately 39,000 patients with these devices still implanted worldwide with 21,600 of the remaining devices in U.S. patients. The root cause of the defect described in the letter is thought to be a battery short that develops as the battery in consumed. Consequently, the battery may not last the expected three months after the device reaches its initial elective replacement indicator and doctors are advised to replace the generator immediately once the device reaches this indicator. Importantly, no deaths have occurred as a result of this defect but there is a theoretic potential that a device might not reach an effective discharge voltage after the battery depletion occurs. For doctors and patients, this alert ranks pretty low on the concern scale, provided patients are monitored closely and have their battery-reaching-ERI alerts programmed "ON." (Please see the above linked letter for full details)
This issue of what to call these device alerts is not a small issue. In early 2005 when a rash of serious ICD problems began to surface, they were uniformly called "device recalls." But the Heart Rhythm Society recognized the problems with this nomenclature:
Terminology should be commensurate with risk. HRS has previously recommended that the term “recall” not be used in reference to devices that do not require removal or explant, as it may foster miscommunication and lead to unnecessary and potentially harmful interventions. Research supports the concept that the specific wording chosen to warn patients has critical implications and that some words (urgent, danger, FDA) and some phrases (FDA Public Safety Warning, Product Danger Alert, Public Safety Warning) are perceived as being just as important as phrases that include the word “recall.” The term “recall” has regulatory and legal implications that extend beyond cardiac rhythm management devices and substantial hurdles must be overcome to change the terminology. Nevertheless, the FDA is encouraged to explore the legal and regulatory alternatives to facilitate the establishment of a simple and intuitive nomenclature to publicly communicate important information out implanted medical device performance.
As a result, the terms "advisory alert" or "safety alert" were proposed to describe less serious communications with doctors and patients regarding important device communications.
So why now "important device corrections?" In cases like this, I feel it would be best that device manufacturers stick with terms that industry and physician groups have agreed so that the appropriate level of concern is conveyed to doctors and patients alike without sugar-coating the defects. That way when these letters are issued, we're all on the same page.
-Wes
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