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”

SAFETY IS A PARTNERSHIP MANUFACTURER

SAFETY IS A PARTNERSHIP USER

SAFETY IS A PARTNERSHIP FDA

A PARTNERSHIP IN SAFETY USER MANUFACTURER FDA All must play their role—Manufacturers cannot do it all

A PARTNERSHIP IN SAFETY USER MANUFACTURER FDA Independent Auditors, Monitors, Assessors, and Accreditors Professional Societies ASTRO, AAPM, ASRT State Licensure and Audits Independent QA Groups RPC International Auditors BSI, TUV

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

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

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.

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

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?

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?

IS IT TIME FOR INSTITUTIONS AND PERSONNEL TO BE ACCREDITED AND CERTIFIED BEFORE THEY CAN USE SOME OF THE MORE COMPLEX TREATMENT TECONOLOGIES?

AN EXAMPLE OF SUCCESSFUL TRAINING IN NEW TECHNOLOGY TME SURGERY

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

RESULTS In most of Europe, the recurrence rate for rectal cancer is 10-15%; In the U.S. it is 40-50%

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.