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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SAFETY IS A PARTNERSHIP MANUFACTURER

Transcript of FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical...

Page 1: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

FDA Meeting June 9, 2010“User Training”

Donald A. Goer, Ph.D.Chief Scientist

Intraop medical Corporation

Page 2: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

Purpose of the Meeting

“Steps Manufacturer can take to help reduce misadministrations and

misaligned exposures”

Page 3: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

SAFETY IS A PARTNERSHIP

MANUFACTURER

Page 4: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

SAFETY IS A PARTNERSHIP

USER

Page 5: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

SAFETY IS A PARTNERSHIP

FDA

Page 6: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

A PARTNERSHIP IN SAFETY

USER MANUFACTURER

FDA

All must play their role—Manufacturers cannot do it all

Page 7: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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

Page 8: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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

Page 9: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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

Page 10: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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.

Page 11: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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

Page 12: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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?

Page 13: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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?

Page 14: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

IS IT TIME FOR INSTITUTIONS AND PERSONNEL TO BE ACCREDITED AND

CERTIFIED BEFORE THEY CAN USE SOME OF THE MORE COMPLEX TREATMENT TECONOLOGIES?

Page 15: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

AN EXAMPLE OF SUCCESSFUL TRAINING IN NEW TECHNOLOGY

TME SURGERY

Page 16: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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

Page 17: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

RESULTS

In most of Europe, the recurrence rate for rectal cancer is 10-15%;

In the U.S. it is 40-50%

Page 18: FDA Meeting June 9, 2010 User Training Donald A. Goer, Ph.D. Chief Scientist Intraop medical Corporation.

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.