FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical...
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Transcript of FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical...
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FDA Meeting June 9, 2010“User Training”
Donald A. Goer, Ph.D.Chief Scientist
Intraop medical Corporation
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Purpose of the Meeting
“Steps Manufacturer can take to help reduce misadministrations and
misaligned exposures”
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SAFETY IS A PARTNERSHIP
MANUFACTURER
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SAFETY IS A PARTNERSHIP
USER
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SAFETY IS A PARTNERSHIP
FDA
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A PARTNERSHIP IN SAFETY
USER MANUFACTURER
FDA
All must play their role—Manufacturers cannot do it all
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A PARTNERSHIP IN SAFETY
USER MANUFACTURER
FDA
Independent Auditors, Monitors,
Assessors, and Accreditors
Professional SocietiesASTRO, AAPM, ASRT
State Licensure and Audits
Independent QA GroupsRPC
International AuditorsBSI, TUV
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Role of RT in Cancer Care
1 IN 3 WILL DEVELOP CANCER IN THEIR LIFTIME;
3 OF 4 FAMILIES WILL HAVE A FAMILY MEMBER THAT HAS CANCER
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Traditional Role of Manufacturer in User Training
• Operator manual and updates• Operator training (at user facility or at
company or both)• Service training• User networks
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Complications of Current Technology
• The technology of 2010 is far more complicated than the technology of the 90’s
• We cannot use the training methods of 20 years ago to ensure the safe and proper administration of complex radiation treatments.
• Training the User by the manufacturer alone will result in a better situation, but not the optimal situation.
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Some Sobering Facts
• 30% of participants wishing to be credentialed for RTOG/NCI Trials, could not pass the RPC Test for IMRT for H&N Cancer to within 7% or 4 mm.
• 15% of participants wishing to be credentialed for RTOG/NCI Trials, could not pass the PPC Test for Prostate IMRT
• 30% of participants wishing to be credentialed for RTOG/NCI Trials, could not pass the PPC Test for Thorax treatments
“Challenges in Credentialing Institutions and Participants in Advanced Multi-Institutional Clinical Trials”, G.Ibbott, et. al., Int. J. Rad. Oncol. Biol. Phys., Vol 71, #1, ppS71-75, 2008
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USER TRAINING IN THESE SOPHISTICATED TREATMENT DELIVERY
TECHNIQUES IS NOT ADEQUATE
IF HOSPITALS SEEKING CREDENTIALLING TO TRIALS HAVE A 30% PROBLEM IN MEETING ACCEPTABLE STANDARDS, WHAT DOES THAT SAY FOR THE 2000 CENTERS PERFORMING RADITATION THERAPY TODAY?
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THE COST OF QUALITY?
AN RPC TEST COSTS ~ $75/YEAR.
WOULD YOU WANT TO BE TREATED AT A CENTER THAT WOULD NOT PAY $75/YEAR TO
INDEPENDENTLY ASSESS A BASIC PART OF THEIR QA?
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IS IT TIME FOR INSTITUTIONS AND PERSONNEL TO BE ACCREDITED AND
CERTIFIED BEFORE THEY CAN USE SOME OF THE MORE COMPLEX TREATMENT TECONOLOGIES?
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AN EXAMPLE OF SUCCESSFUL TRAINING IN NEW TECHNOLOGY
TME SURGERY
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Dutch TME training• TME surgery for rectal cancer showed a
significant improvement in cure over the previous surgical techniques.
• The Dutch (and others in Europe), required ALL surgeons who were engaged in rectal cancer to pass a certification program, which involved observing a procedure, being proctored during a procedure and being observed during a procedure.
• Only surgeons who Passed this training were certified to do TME surgery
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RESULTS
In most of Europe, the recurrence rate for rectal cancer is 10-15%;
In the U.S. it is 40-50%
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Conclusion• IF IMPROVED TREATMENT CARE IS OUR GOAL, USER
TRAINING WITH ACCOMPANYING ACCREDITATION TO PERFORM CERTAIN TREATMENTS SHOULD BE A REQUIREMENT
• SITE CREDENTIALLING TO PERFORM CERTAIN TREATMENTS SHOULD BE PUBLIC INFORMATION
• ALL CENTERS PERFORMING RADIATION TREATMENTS SHOULD BE INDEPENDENTLY ASSESSED BY AN OUTSIDE AGENCY LIKE THE RPC
• Consumers should know whether institutions offering “state of the art” treatments are credentialed to provide the treatment.