Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

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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