Partnership for Patients Summit: Session 3: Patient Quality & Safety #cinderblocks #HCKC

Partnership With Patients Summit

Patient Quality and Safety Room A
Session 3
12:30- 1:45 Device Safety Panel



Doctors, nurses, radiographers, medical physicists, these are the credentials you might expect find for MRI safety advocates, but architect? But that’s what Tobias Gilk is, and in the past 10 years, he has become one of the industry’s most influential voices on issues of safety and protections against preventable accidents.


Going from simply designing MRI suites, to collaborating with clinical and technical experts, to serving on the MRI Safety Committee for the American College of Radiology, Tobias has provided MRI safety training for the Joint Commission, contributed to MRI safety standards published by the ACR, and design standards for the VA, and the Facilities Guidelines Institute. He is an internationally invited speaker and consultant and is another example of how those committed to safety can affect meaningful change.


Joleen Chambers became her brothers’ patient advocate after his 9/29/08 failed elbow implant “revision” surgery. (The elbow was originally implanted just four months earlier on 5/19/2008.) She researched and learned that FDA clears implanted medical devices through the 510(k) process that on 7/29/11 the Institute of Medicine reported is “flawed based upon its’ legislative foundation”.  This should not have happened to him. He should be cared for. Changes in federal public policy that she recommend: an implant registry, FDA patient/consumer voting stakeholder rights, device warranty, rescind medical device industry entitlement/pre-emption from state court.

**** Please remember these are my PERSONAL notes from this session and done during the session so excuse the typos and remember these may be my thoughts and impressions!  AND This is a PANEL with some Power Houses so it will be organized by How and when they speak…

  • Tibias Gilk: @tobiasgilk
    • An MRI Safety Architect?
      • Experience Architects first figure out what they DON’T need to know – First MRI Project was in 1997 (less than 2 months) – 2002 First MRI Project with ACR “White Paper” on MRI Safety – Aghast at hoe little the industry knows about MRI Safety
    • Radiology Safety in the News – Safety from Ionizing Radiation from CT Scans?  More MRI ?
    • MRI Safety: It’s all good – told that it is the safe option / Accreditation & Regulation assure patient safety / RMI safety has improved / Future looks event brights – actually there are few rules and regulations monitoring – we “believe” (drank the KoolAid) that it is safe – we need to know that MRI has its own risk factors
      • Except: Nobody knows that the lessons were / 10-yrs later, No Regulatory / Accreditation Safety STandars / MRI Accidents have skyrocketed (from 2000-2009 there was a 523% increase in Reported Accident Growth v. =90% procedure volume growth) / Risk-factors Make MRI …
    • Future Risk Factors: Aging population / Increasing Interventions & emergent imaging / MOre powerful magnet systems / declining reimbursements means reduction in staff
    • Eliminate 92% of Accidents
      • Nearly “all” MRI accidents are the result of “user” error 
      • Today’s MRI risks aren’t clinical (so Fail to capture the attention of clinicians) / Today’s MRI injuries & accidents result from policies & procedures / Contrast…. (couldn’t catch that)
    • Why Bother?
      • Because together we DO make a difference and we ARE making things better for all patients!
  • Joleen Chambers – Implanted Medical Devices (FiDA: FAILED Implant Device Alliance) –  @JJRKCH
    • Patient Advocate because of her brother who had a failed elbow implant that failed after just four months
    • Why Am I Here?
      • Mayo Clini saved her father’s life… TWICE
      • 2000 her mother had a spinal implant & stent
      • 2008 her brother received an elbow implant from Mayo Clinic (Tornier – the company that made the implant)
    • The purpose of implants is for pain reduction and improve function (specifically talking about the elbow implant)
    • What happens when your implant fails?
      • run around – first the surgeon (the “designer” of the device) then: Patient Affairs / Hospital Trustees (was no information on how to contact the Trustees) / State Medical Board / State Attorney General / FDA / Congressional Representatives
    •  Medical wants to rehabilitate the doctors – Not punish / penalize them 
    • Sue?  They were actively told NOT to sue … It is the MAYO CLINIC – can’t win
    • Patient Harm
      • Loss of Life / Loss of Civil Rights / Loss of Function / Loss of Job / Loss of Family / Financial Loss / Lost Trust
    • The IOM finds that the current 510(k) process if is Flawed based on its legislative foundation. (July 29, 2011) – This happens because of requirements for product approval – there are many products that need no clinical testing because of the way the requirements are set up 
    • Most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 501(k) process
    • Need Joint Registry BUT Proprietary / Not accessible to the patient / old technology / not transparent or All inclusive of devices – SILO’d 
    • Examples
      • Metal-on-Metal Hip: BMJ / BBC February 2012 report: global patient harm / June 2012 FDA expert panel conclusion: few reasons to use M-O-M implants 
      • Surgical Mesh: 2874 adverse events with 2008-2010, 7 deaths -I FDA warning of significant harm from transvaginal mesh July 2011 – Lawsuits too late 
      • ICD Leads – Cardiac: 128,000 St Jude Riata implanted worldwide with a 20% failure rate – the Riata was recalled but they didn’t notify the patients
    • Inspiration:
      • Regina Holliday
      • TMIT
      • pcori
      • Safe Patient Project
      • Partnership for Patients
      • Surfing the Heathcare tsunami
      • Escape the Fire
      • Patients Included – please include patients in ALL health conferences
    • Goals:
      • UDI – Post-market registry / Product warranty / patient-consumer FDA stakeholder equity / Rescind industry pre-emptions & entitlements




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