Tuesday, September 11, 2012

4-day Webinar on Implanted Medical Devices


Join the webinar tomorrow:  

Begin reading my tweets from the bottom up.  Yes, I did express some frustration!


JjrkCh
God forbid there is any emotion expressed. Data is and process is king. #fda drag feet toward distant goal. Low standards. THE END
9/11/12 4:03 PM




JjrkCh
Start with telling the stories of human beings whose lives are being ruined by failed implanted medical devices. A ethical legacy. #fda
9/11/12 3:57 PM



JjrkCh
Correction: The demand for a registry came from harmed patients. #FDA #ptsafety
9/11/12 3:55 PM



JjrkCh
#FDA Patient Rep lost me when she discussed business payment model for data :-( Free patient access to public information in real time.
9/11/12 3:46 PM




JjrkCh
#FDA Patient Rep lost me when she discussed business payment model for data :-( Free patient access to public information in real time.
9/11/12 3:46 PM



JjrkCh
Anna McCollister-Slipp nailing it as #FDA Patient Representative: clone her! http://t.co/y4K6LMHC
9/11/12 3:44 PM

JjrkCh
800k Ortho patients in Australian registry. Opt out is option that few take. #FDA
9/11/12 3:42 PM



JjrkCh
Stephen Graves/Australian registry reassures #FDA that it is not costly or time-consuming. Wow! Get started now.
9/11/12 3:39 PM




JjrkCh
The sole mission of the #FDA is safety and effectiveness of medical devices. This should be the day job of the staff. Harmed patient says
9/11/12 3:37 PM




JjrkCh
#FDA Other countries may approve drugs/devices with less clinical testing than U.S. Must maintain our standards & build global network.
9/11/12 3:29 PM




JjrkCh
Tie broken cardiac leads to mended lives to sell importance of medical device registries. Lancet editor. #FDA
9/11/12 3:23 PM



JjrkCh
Lancet editor. Ten mile radius around #FDA is there an impact/buy in for national medical device registry? Scale larger area: collaborate
9/11/12 3:21 PM



JjrkCh
Medical device registry: one part that is missing is harm 'byproduct' of innovation. Abandon/ignore patients? Let's hear a plan. #FDA
9/11/12 3:18 PM

JjrkCh
"proprietary' needs of device companies should not prevent harmed patients from discovery using public and personal health records. #FDA
9/11/12 2:59 PM

JjrkCh
Different hospital systems? CMS could demand change or no $$. How's that for motivation? #FDA
9/11/12 2:58 PM

JjrkCh
UDI and standard EHR direct report to device registry and linked to insurance claim data. Real time safety monitor. Patient access! #FDA
9/11/12 2:49 PM



JjrkCh
Dr. Resnick: data identifies need of adequate surgeon experience with devices. Patient harm from device or inexperience. Still harmed.#FDA
9/11/12 2:44 PM



JjrkCh
Dr. Resnick touts big data monitoring ability to signal device failures. Reduction of patient harm with early signal. #FDA Aligned mission
9/11/12 2:42 PM




JjrkCh
Device failure should prompt investigation. Is FDA listening? Using CMS claims for post-market surveillance. http://t.co/y4K6LMHC
9/11/12 2:23 PM




JjrkCh
Even VA needs access to medical device UDI for registry/adverse event reporting to work. #FDA #ptsafety http://t.co/y4K6LMHC
9/11/12 2:18 PM





JjrkCh
VA real-time CART catches unexpected device problems. #FDA Immediate investigation/analysis. Prevents increasing patient harm.
9/11/12 2:14 PM





JjrkCh
"use liberated medical device data for prevention of patient harm" http://t.co/y4K6LMHC #FDA #PCORI
9/11/12 2:09 PM



JjrkCh
Of 1500 medical device clocks the average variance from correct time was 25 minutes! http://t.co/y4K6LMHC #FDA #ptsafety #s4pm
9/11/12 2:08 PM




JjrkCh
http://t.co/y4K6LMHC "BMW alerts owner of device problem, why can't healthcare?" #FDA
9/11/12 2:05 PM




DCPatient
It took an all-women planning committee to focus device industry on role of patients #medtechvision2012

9/11/12 11:42 AM



JjrkCh
1979: Swedish Hip Registry was established. Hip replacement failure rates were 16% 2001: reduced to 8%:U.S. still at 18% JBJS Maloney #FDA
9/11/12 1:09 PM

JjrkCh
2001: A national registry (cost: $10 - $20 million) through 2030 could potentially save $13 billion. AJRR & AAOS (11 years ago) #FDA
9/11/12 1:04 PM

JjrkCh
Discuss patient reporting to registries? Many of us would be willing to post updates. Just as reliable as other data sources. #FDA #PCORI
9/11/12 1:00 PM

JjrkCh
"nothing compels you to provide data than CMS withholding $$" That is right, CMS. That data belongs to the public. #FDA
9/11/12 12:54 PM

JjrkCh
Harmed patient EHR is not source of 'proprietary' information for AAJR. Data must be liberated to inform public health. #FDA #PCORI #s4pm
9/11/12 12:41 PM

JjrkCh
Orthopedic surgeons are invested in medical devices and are already paid avg $400k/yr. 95%+ male. Power and profit incentives. #FDA
9/11/12 12:39 PM

JjrkCh
Individual patients are at risk when providers/industry 'partner' to take regulatory authority from our elected representatives. AAJR, no!
9/11/12 12:37 PM

JjrkCh
Please, AAJR no! #FDA Patients are not full partners and are not given useful information from the registry. This is a smokescreen.
9/11/12 12:36 PM

JjrkCh
AJRR does not return repeated patient call to participate with registry team. Medical societies are conflicted and have had 20 years. #FDA


JjrkCh
#FDA Mention (list) of stakeholders does not include patients. Yeah. We this is clear!
9/11/12 10:56 AM

JjrkCh
“@DCPatient: Medical device industry discussing rising role of patients #medtechvision2012” Really!? Harmed patients, too?
9/11/12 10:54 AM

JjrkCh
How much taxpayer money has been spent on this 4 day meeting? #Congress #FDA
9/11/12 10:45 AM

JjrkCh
The old guard is lining up to 'reform' the system into the status quo. #PCORI #FDA Why should harmed patients trust this plan?
9/11/12 10:42 AM

JjrkCh
Public/private partnership is confirmed: it is not a question. Prefer public registry. Patient protection conflicts with profit. #FDA
9/11/12 10:39 AM

JjrkCh
Are people at risk of having implanted medical devices when their life expectancy is short anyway? #FDA Risk/benefit/cost. Research ethics.
9/11/12 10:35 AM

JjrkCh
Who is the guinea pig? The patient! #FDA
9/11/12 10:29 AM

JjrkCh
Registries do not compare the medical device against other device choice or no device. #FDA
9/11/12 10:27 AM

JjrkCh
Most medical device registries are limited and do not provide quality of life data. #FDA This is critical to patients.
9/11/12 10:24 AM

JjrkCh
Webinar attendees not informed of when the broadcast will resume. #FDA http://t.co/Y8hLUMHV A courtesy.
9/11/12 9:25 AM

JjrkCh
Holding information (perhaps causing further patient harm) done to prevent 'hysteria'. Trust us! #FDA Those harmed would disagree.
9/11/12 9:21 AM

JjrkCh
Clinical research: willing participants are not being engaged and physicians do not have experience. No wonder all the blunders! #FDA
9/11/12 9:12 AM

JjrkCh
@serious_skeptic @SpeakerLink Thank you for RT's http://t.co/Y8hLUMHV Join in webcast.
9/11/12 9:08 AM

JjrkCh
http://t.co/J2O3PVtV Patient harm from implanted medical devices highlighted by media and lawyers. Regulators are stuck in neutral. #FDA
9/11/12 9:03 AM

JjrkCh
Have I not been engaged? Why have I been ignored? #FDA http://t.co/Y8hLUMHV I want to be at the table.
9/11/12 8:58 AM

JjrkCh
http://t.co/Y8hLUMHV Great patient advocate speaks truth. #FDA
9/11/12 8:52 AM

JjrkCh
Perfecting data system long term. Patient harm is first indicator. Pay attention immediately! #FDA Conflicts from mission endanger.
9/11/12 8:48 AM

JjrkCh
Implant patients: you are the guinea pig and the provider considers outcome information as 'proprietary'. Your #FDA. Oh, informed consent?
9/11/12 8:42 AM

JjrkCh
Amazing high % of women receive medical devices but "experts" are male. Just saying. #FDA Surgical mesh http://t.co/EvRet6zf #PCORI
9/11/12 8:37 AM

JjrkCh
Patients less (not more) conflicted than providers, regulators and industry. They want safe and effective: aligned with #FDA mission.
9/11/12 8:20 AM

JjrkCh
http://t.co/SXINe4UC The elephant in the room. #FDA Patients need to be there. Investigative journalists/lawyers indicate patient harm.
9/11/12 8:18 AM

JjrkCh
Data mining focus allows industry/providers to remove themselves from the patient harm (elephant) in the room. #FDA #PCORI #ptsafety #s4pm
9/11/12 8:12 AM

JjrkCh
List of stakeholders, none included patients/advocates. This is wrong! Visuals tell all. #PCORI #FDA #ptsafety #s4pm
9/11/12 8:09 AM

JjrkCh
#FDA Identify what is working: none include patient advocates/consumer organizations. Ignored again! #ptsafety #PCORI #s4pm
9/11/12 8:06 AM

JjrkCh
http://t.co/y4K6LMHC What is broken? Harmed patients would say: justice and continued care. #FDA No one takes accountability but patient.
9/11/12 8:04 AM

JjrkCh
Join this webinar! http://t.co/y4K6LMHC Important 4 day FDA meeting on implanted medical devices. #FDA #PCORI #s4pm #ptsafety
9/11/12 8:01 AM

JjrkCh
'the purpose of this meeting is to solicit public feedback' but panels and audience are loaded with industry/regulator stakeholders.#FDA
9/10/12 2:40 PM

JjrkCh
#FDA Public session. Medtronic cheerleader takes the microphone again. Please, please require them to fund a harmed patient travel.
9/10/12 2:23 PM

JjrkCh
Professional society registries do not help patients find safe and effective medical devices. Just as 'proprietary' as mfg. #FDA
9/10/12 2:22 PM

JjrkCh
We may all be patients but we are not all harmed patients. They are not well represented at this meeting. Truth. #FDA
9/10/12 2:20 PM

JjrkCh
#FDA Public session. Prof society, industry rep, govt agencies. Need more patients. Webinar participation restricted. Why? Call in # ?
9/10/12 2:17 PM

JjrkCh
#FDA Public input session now. Restricted to in person/not webinar participants. Pt: potential for prof. society bias? #ptsafety #PCORI
9/10/12 2:15 PM

JjrkCh
Each patient is a case study to improve our system. Wrongheaded top-down system reform allows this kind of circular conversation. #FDA
9/10/12 1:44 PM

JjrkCh
How many harmed patients must line up before these bureaucrats and executives see the data? Talk, talk, talk. Get to work! #FDA
9/10/12 1:39 PM

JjrkCh
J&J metal-on-metal hips removed the halo from this corporation. Patient harm not compensated. Not too big to criticize. #FDA
9/10/12 1:37 PM

JjrkCh
Surgical mesh, metal-on-metal hips, defibrillator leads all failed and harmed thousands of patients. Profit justifies harm? #FDA
9/10/12 1:32 PM

JjrkCh
Harmed patients get to see J&J and Medtronic up front at #FDA meeting. Conflicted? You bet! #ptsafety #PCORI #s4pm Mr. Cellophane
9/10/12 1:21 PM

JjrkCh
#FDA Q. Yes! I would volunteer my time for implanted medical device safety. #ptsafety #PCORI #s4pm
9/10/12 1:10 PM

JjrkCh
Medical device industry cannot demand. It is a privilege to have access to the US healthcare market. Play fair. #FDA #PCORI #ptsafety
9/10/12 1:07 PM

JjrkCh
#FDA must take the lead or stop saying that it regulates medical devices. No apology for putting public health first. #ptsafety #PCORI
9/10/12 1:05 PM

JjrkCh
#PCORI Thank you for standing up for the patients in the governance of medical device regulation. It is public health! #FDA
9/10/12 1:00 PM

JjrkCh
#FDA should hire creators of solutions that demonstrate passion/talent. Health 2.0, DataPalooza, etc.
9/10/12 12:59 PM

JjrkCh
Governance balance must have #FDA and elected officials primary responsibility. Private lead has been given 20+ years. Created mess.
9/10/12 12:57 PM

JjrkCh
Anna McCollister Slipp #FDA about engaging patients. "give patients more credit/power" to benefit of all. #ptsafety #PCORI #s4pm Woot!
9/10/12 12:55 PM

JjrkCh
Knee/total hip arthroplasty are 2 of the most common surgical procedures performed and represent the greatest Medicare expenditure #FDA
9/10/12 12:52 PM

JjrkCh
Medicare insures virtually all Americans 65 and older—a population that consumes roughly a third of all of medical spending. WSJ 102510 #FDA
9/10/12 12:50 PM

JjrkCh
2010 While about 80% of the nearly 500,000 submissions #FDA gets already come in electronically, on the device side it’s only about 15%.
9/10/12 12:48 PM

JjrkCh
The US government pays for so many medical devices. Require this information to be liberated! #FDA #PCORI Private interests conflicted.
9/10/12 12:45 PM

JjrkCh
Thank you for RT @CUsafepatient @EPCoalition @JointJunk Watching FDA/CDRH webinar at http://t.co/R6a8Hwgt
9/10/12 12:43 PM

JjrkCh
#FDA #PCORI Engaged patients must be repeatedly invited. We feel like the last kid chosen for kick-ball. On team, but the 'dis stings.
9/10/12 12:28 PM

JjrkCh
#fda National registry was needed and discussed years ago. Profit incentives prevailed over patient safety. #ptsafety
9/10/12 11:04 AM

JjrkCh
Industry cheerleader during #FDA public comment time. Yeah, I am fuming! Walk the talk . . . industry and regulator love-fest. #ptsafety
9/10/12 11:00 AM

JjrkCh
Medtronic trumps a webinar patient advocate comment during public comment time. Bad visual. #FDA #ptsafety
9/10/12 10:58 AM

JjrkCh
#FDA panel using public comment time. My webinar comment not being read by Nathan Ivey. Handicap the patient stakeholder . . . Grrr!
9/10/12 10:55 AM

JjrkCh
Stakeholder trying to communicate what the patient wants. Is #FDA listening!? http://t.co/pXAVDiT1
9/10/12 10:53 AM

JjrkCh
@EPCoalition I am tweeting from the webcast. Thx. for being there, too! http://t.co/pXAVDiT1
9/10/12 10:51 AM

JjrkCh
How much more slowly can regulators go? Patient harm is mounting. #FDA #ptsafety #PCORI #s4pm Warranties, compensation?
9/10/12 10:47 AM

JjrkCh
Patient trust fuels providers, regulators and industry. Without change, erosion of trust is assured. 'Patients Included' not visible. #FDA
9/10/12 10:45 AM

JjrkCh
#FDA My FDA/UDI statement could be read by a staff member. Website is clunky for submitting it. Pls be responsive to patients/advocates.
9/10/12 10:38 AM

JjrkCh
A national registry (cost: $10 - $20 million) through 2030 could potentially save $13 billion. AJRR & AAOS 2009 #FDA #PCORI #ptsafety #s4pm
9/10/12 9:47 AM

JjrkCh
2010 American Joint Replacement Registry proposes to capture national data on 90% of hip & knee replacement and revision surgeries. #FDA
9/10/12 9:46 AM

JjrkCh
Collaboration includs patient representatives? Regulators/industry together are not representative of the patient/consumer population.
9/10/12 9:42 AM

JjrkCh
Are any of the registry stakeholders patient representatives? Is the information available to all stakeholders? #FDA
9/10/12 9:40 AM

JjrkCh
#FDA Ortho rehab panel patient representation is essential. Besides 'trust us' explain how this representation is demonstrated. #PCORI
9/10/12 9:38 AM

JjrkCh
If #FDA no power to require industry to release patient information. Congress could change the FDA Charter. 1976 regulations fail. #PCORI
9/10/12 9:33 AM

JjrkCh
Mayo Clinic has a joint replacement registry but it is not accessible to patients. #FDA
9/10/12 9:29 AM

JjrkCh
FDA adverse event report website is clunky. Try http://t.co/cVpOf69R Much more effective site.
9/10/12 9:26 AM

JjrkCh
Number one expenditure of Medicare is joint replacement. Free that government data! It belongs to the public. #FDA #PCORI #ptsafety #s4pm
9/10/12 9:23 AM

JjrkCh
#FDA Admits implant device regulation not protecting patients. Mitigate purgatory and harm caused patients before protecting profit.
9/10/12 9:21 AM

JjrkCh
How many patients could afford to be present in the room? Industry reps. paid. Disadvantaged patient stakeholders. http://t.co/R6a8Hwgt
9/10/12 9:16 AM

JjrkCh
Medical device industry engagement not problem. Engage patients and advocates! #FDA #ptsafety #PCORI Public health trumps 'Proprietary'
9/10/12 9:13 AM

JjrkCh
Sadly, not valued though am tenacious/respectful Patient Rep and testified at two town hall meetings. http://t.co/R6a8Hwgt #FDA explain!
9/10/12 9:07 AM

JjrkCh
http://t.co/R6a8Hwgt Who are the patient representatives attending this meeting? Am I represented? #ptsafety #PCORI #s4pm
9/10/12 9:02 AM

JjrkCh
Limit direct-to-consumer marketing of harmful implanted medical devices. Accurate info. Innovation must be better than current device. #FDA
9/10/12 9:00 AM

JjrkCh
Data/sources FDA uses on registry must be accessible to patients! Stakeholder has most meaning to those with real skin in the game. #FDA
9/10/12 8:57 AM

JjrkCh
http://t.co/R6a8Hwgt Give meeting virtual attendees a hashtag to report/meet on Twitter. Grateful to be included today! #FDA
9/10/12 8:54 AM

JjrkCh
Patients with failed implanted medical devices are the folks that believed in the medical device industry. Friends, not foes! #ptsafety
9/10/12 8:52 AM

JjrkCh
Stakeholders: patients? Then give us the vote! Invite us to all important meetings/conferences. #ptsafety #PCORI #FDA
9/10/12 8:51 AM

JjrkCh
Consumers Reports for implanted medical devices. Long time coming. #ptsafety #PCORI #FDA http://t.co/R6a8Hwgt
9/10/12 8:50 AM

JjrkCh
Oh, yeah, #FDA medical device UDI will benefit patients, but not quickly enough. A slow start. #ptsafety Med societies: old sly promise.
9/10/12 8:48 AM

JjrkCh
When patient harmed, device industry insulated from feedback. Easy denial of harm by judicial entitlements. Expect more harm. #FDA
9/10/12 8:46 AM

JjrkCh
#FDA Medical device industry fees lower than pharma fees. FDA understaffed and Charter limits ability to regulate. Patients in peril.
9/10/12 8:44 AM

JjrkCh
#FDA #medicaldevice Patient Representative selected by consumer groups, not OSHI. Must be voting stakeholder. #ptsafety #PCORI #s4pm
9/10/12 8:42 AM

JjrkCh
#FDA Patient reported adverse events would be useful to patients considering medical device implant. Identify filtered information.
9/10/12 8:40 AM

JjrkCh
http://t.co/pXAVDiT1 Patients are at risk by poorly regulated implanted medical devices. #FDA #medicaldevice #PCORI #ptsafety
9/10/12 8:35 AM

JjrkCh
Stop telling patients what you are going to do: do it! Patient harm is a national shame. #ptsafety #s4pm Help harmed patients!
9/10/12 8:29 AM

JjrkCh
http://t.co/R6a8Hwgt Like Dorothy in Wizard of Oz, govt and industry already had access to info.: "proprietary' and financial conflict.
9/10/12 8:28 AM

JjrkCh
http://t.co/R6a8Hwgt Like Dorothy in Wizard of Oz, govt and industry already had access to info.: "proprietary' and financial conflict.
9/10/12 8:28 AM

JjrkCh
IOM 7/29/11 report stated 510(k) should not be used for implants. FDA chose not to follow recommendations. Patient harm prompted this mtg.
9/10/12 8:26 AM

JjrkCh
"unique' medical device challenges are used as excuse. US is behind globally because industry evades regulation by writing legislation.
9/10/12 8:24 AM

JjrkCh
Dr. Shuren 'four day public meeting'? - news to me! "collaborative" though patient representatives restricted to public meetings. #ptsafety
9/10/12 8:22 AM

JjrkCh
http://t.co/R6a8Hwgt FDA public meeting/interactive meeting now. Safer implanted medical devices. #ptsafety #MeshGoneWrong
9/10/12 8:19 AM

JjrkCh
#ptsafety #s4pm Mtg: To begin at 9aET the FDA/CDRH National #medicaldevice Postmarket Surveillance System, 9/10/12 http://t.co/qsMUY1Te”
9/10/12 7:06 AM

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