Medical Issues Associated with Radiotherapy Accidents ALBERT Wiley, JR., BNE, MD, PhD, FACR DIRECTOR,REAC/TS and WHO COLLABORATING CENTER at OAK RIDGE EMERITUS PROFESSOR,UNIV. WISC.-MADISON albert.wiley@orise.orau.gov IAEA International Conference on Radiation Protection in Medicine,Bonn,Germany December,2012 1 Where Do Radiation Accidents Occur? Irradiation facilities Nuclear reactors Isotope production facilities Materials testing (sealed sources) Materials testing (x-ray devices) X-ray and radiotherapy devices (medicine, research) Unsealed radionuclides (medicine, research) Transportation Military Source: REAC/TS Radiation Accident Registry DEATHS from RADIATION ACCIDENTS WORLDWIDE 1944-2012 *Recorded in REAC/TS RADIATION ACCIDENT REGISTRY United States New Mexico 3 Ohio 10 Oklahoma 1 Pennsylvania 1 Rhode Island 1 Texas 9 Wisconsin 1 Total U.S. 26 Other Algeria Argentina Belarus Brazil Bulgaria China (PR) Costa Rica Egypt El Salvador Estonia Israel Italy India 2 Japan 2 1 Marshall Isl 1 1 Mexico 5 4 Morocco 8 1 Norway 1 6 Panama 5 7 Russia 5 2 Spain 10 1 Thailand 3 1 USSR 29 1 UK 3 1 Yugoslavia 1 1 Total Non-U.S. 102 DEATHS FROM MEDICAL and OTHER RADIATION ACCIDENTS WORLDWIDE 1944-2012 *RECORDED in REAC/TS RADIATION ACCIDENT REGISTRY United States New Mexico 3 Ohio 10 Oklahoma 1 Pennsylvania 1 Rhode Island 1 Texas 9 Wisconsin 1 Total U.S. 26 Other(non US) Algeria Argentina Belarus Brazil Bulgaria China (PR) Costa Rica Egypt 2 1 1 4 1 6 7 2 Japan Marshall Isl Mexico Morocco Norway Panama Russia Spain 2 1 5 8 1 5 5 10 Estonia Israel Italy India El Salvador 1 1 1 1 1 USSR UK Yugoslavia 29 3 1 Thailand 3 MAJOR RADIATION “ACCIDENTS” WORLDWIDE 1944 – Mar 2012 United States Deaths Cause Medical misadministration 60Co – wrong graph paper used – underestimate of source strength and increased time of exposure Ohio 10 Texas 9 2 teletherapy equipment malfunction “54”– 25MeV 7 90Y loss from therapeutic microspheres Pennsylvania 1 Retained brachytherapy source – Wisconsin 1 Medical misadministration – “milli” Ci New Mexico 3 Criticality Rhode Island 1 Criticality Oklahoma 1 Radiography source - probable suicide Total 26 192Ir 198Au – miscalculation of “micro” to MAJOR RADIATION “ACCIDENTS” WORLDWIDE 1944 – Mar 2012 ACUTE, ASSOCIATED, AND NON-RADIATION DEATHS United States Deaths Cause Medical misadministration 60Co – wrong graph paper used – underestimate of source strength and increased time of exposure 2 teletherapy equipment malfunction “54”– 25MeV 7 90Y loss from therapeutic microspheres Ohio 10 Texas 9 Pennsylvania 1 Retained brachytherapy source – Wisconsin 1 Medical misadministration – 198Au – miscalculation of “micro” to “milli” Ci New Mexico 3 Criticality Rhode Island 1 Criticality Oklahoma 1 Radiography source - probable suicide Total 26 192Ir Malfunction “54” Background The most serious computer related accidents to date Therac 25 was a medical linear accelerator, a linac developed by Atomic Energy Of Canada Ltd (AECL) 11 Therac 25s were installed - 5 in US, 6 in Canada Background (Continued) Therac 25 was derived from its previous version Therac 6 and Therac 20 Differences from Therac 20 - Software is responsible for safety - Hardware safety interlocks removed - Less space and more economical Accidents 3 June 1985 – patient at Marietta GA received overdose 26 July 1985 – Hamilton ON patient severely burned, died November 1985 December 1985 – patient in Yakima WA received overdose 21 March 1986 – Tyler TX accident 11 April 1986 – 2nd Tyler TX accident 17 January 1987 – 2nd Yakima WA accident MAJOR RADIATION “ACCIDENTS” WORLDWIDE 1944 – Mar 2012 ACUTE, ASSOCIATED, AND NON-RADIATION DEATHS United States Deaths Cause Medical misadministration 60Co – wrong graph paper used – underestimate of source strength and increased time of exposure Ohio 10 Texas 9 2 teletherapy equipment malfunction “54”– 25MeV 7 90Y loss from therapeutic microspheres Pennsylvania 1 Retained brachytherapy source – 192Ir Medical misadministration – 198Au – miscalculation of “micro” to “milli” Ci Wisconsin 1 New Mexico 3 Criticality Rhode Island 1 Criticality Oklahoma 1 Radiography source - probable suicide Total 26 DEATHS FROM RADIATION “ACCIDENTS” in USA 1944 – Mar 2012 United States Deaths Ohio 10 Texas 9 Cause Medical misadministration 60Co – wrong graph paper used – underestimate of source strength and increased time of exposure 2 teletherapy equipment malfunction “54”– 25MeV 7 90Y loss from therapeutic microspheres Retained brachytherapy source – 192Ir PA 1 Wisconsin 1 Medical misadministration – “milli” Ci New Mexico 3 Criticality Rhode Island 1 Criticality Oklahoma 1 Radiography source - probable suicide Total 26 198Au – miscalculation of “micro” to PENN. ACCIDENT CLINICAL HISTORY 82 year old white female presented in November 1992 with a recurrent squamous cell cancer of the anus She had received prior treatment which included external beam radiation and chemotherapy (1991) TREATMENT PLANNED High Dose Rate (HDR) implant was prescribed using a 4.22 Curie iridium-192 source to traverse four perianal catheters (previously stitched in place) over a total treatment time of several minutes RADIATION ACCIDENT HDR source unknowingly broke off inside one of the catheters Patient was transferred from the cancer treatment center back to the nursing home with the catheters in place A second HDR treatment was scheduled the following week DAY ONE (16 NOVEMBER 1992) 2 PM (4.5 hours post HDR) - first episode of vomiting - pelvic pain 2:30 PM (5 hours post HDR) - continued vomiting 5:30 PM (8 hours post HDR) - continued vomiting and pain 7:30 PM (10 hours post HDR) - difficulty moving bowels - difficulty voiding - tachycardia (P = 110) DAY FOUR (19 NOVEMBER 1992) (continued) 7 PM - small piece of gray-black tissue one inch long stuck to one of the catheters which was loose - continued nausea and pelvic pain 10:30 PM - pain radiating from vagina to abdomen with hypoactive bowel sounds - skin turgor poor and skin cool/dry DAY SIX (21 NOVEMBER 1992) 8 AM - pale, weak, tachycardia - rectal area reddened, swollen, and “hot” to the touch; continued diarrhea 3 PM - no dyspnea but occasional congested weak cough 5 PM - respirations “congested and labored” for which oxygen given - difficult to arouse; extremities cool 11 PM - patient expired PATIENT ABSORBED DOSE ESTIMATES FOR 4.22 CURIE Ir-192 SOURCE OVER 92.75 HRS Rectum (closest point) Bladder (closest point) Small bowel (closest point) Small bowel (median point) Left kidney (median point) Right kidney (median point) Bone Marrow (L1 Vertebral Body) Heart (median point) Lung (median point) Brain (median point) 7,770 Gy 2,080 Gy 330 Gy 95.8 Gy 36.7 Gy 31.2 Gy 19.7 Gy 9.4 Gy 6.1 Gy 0.9 Gy PERSONNEL DOSES RECEIVED Dose Range (cGy) 0.0 – 0.5 0.5 – 1.0 1.0 – 5.0 5.0 – 10 10 – 15 15 – 20 Number of Individuals 42 11 20 13 7 1 94 TOTAL CONCLUSIONS No other acute radiation effects seen in staff, other patients, or visitors, but be prepared to deal with unexpected staff/public exposures in such accidents. Cytogenetic studies performed at REAC/TS (ORISE) in Oak Ridge TN demonstrated that a certain group of staff and patients had a significant number of chromosomal abnormalities in peripheral lymphocytes, but fortunately only stochastic and no deterministic dose levels were observed. Psychological/legal issues! NRC CORRECTIVE ACTIONS – REQIREMENTS FOR HIGH DOSE RATE (HDR) RADIATION TREATMENT General implementation of a safety culture by: Requiring that physician and physicist must be at the HDR console during treatment. An independent radiation survey (separate from a functioning treatment room “area” monitor) must be done with a hand-held instrument prior to removal of patient from the HDR treatment room. HDR emergency procedures/supplies must be immediately available /reviewed and practiced periodically. Bialystok Radiotherapy Accident: In 2001, 5 patients were overexposed to linear accelerator radiations due to faults in the dose monitoring system and the failure of an electronic safety interlock , following sudden electric power transits. 34 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxx Diagnosis/Evaluation PE and Laboratory tests- serial CBCs, amylase,CB, electron spin resonance (ESR),some new proteomic and genomic organ specific blood tests offer promise. Imaging – MRI (with angiography), thermography, ultrasound, blood pooling nuclear studies, other radiographic studies as indicated Daily serial digital color photographs –time dependent SKIN reactions may often be good dosimeters. 42 Special Radiation Injury Issues Management of radiation injury is often medically and socially complex(morale problems for both patient and staff !) There may be incidental disfigurement, pain control and malfunction of multiple organ systems(ie, breast cancer/chest wall radiation fields may also injure heart, lungs, etc.) Psychosocial well-being of the patient must be constantly addressed in the longterm healthcare plan. 43 Summary The presented examples demonstrate the primary causes for radiotherapy accidents: “Human Factors” Lost or mishandled sources Pharmacology ,radiation unit issues with unsealed sources Bypassing Interlocks Calibration/programming/computer/treatment planning errors (IAEA DOSIMETRY LAB) and IAEA SAFRON program(rpop.iaea.org/safron) Inadequate “clinical monitoring of signs/symptoms” and “dose monitoring” DURING treatment(ie, training/written procedures and better on-line physics monitoring -- ? daily TL catheters in treatment field,”invivo dosimeters” for cyberknife,IMRT,etc.) Possible Medical Countermeasures Following an accident, what, if anything can be done medically to mitigate the radiation injury? 46 Something “to wish for”-- in people—this is mouse data! Antioxidant diet supplementation starting 24 hours after exposure reduces radiation lethality. Radiat Res 173(4): 462-468 (2010) Some Possible Countermeasures: Vitamin E: TS, DT3 Genistein, EUK-207 Curcumin derivatives Mn Porphyrin - AEOL 10150 Antioxidants in combination - Genistein + EUK-207 (a SOD-catalase mimetic) Others(? Steroids,anti-coagulants,antihistamines,pentoxphylamine,ace inhibitors,interferon,cytokines,HBO,etc.) Thank you! Questions? Note: Some of the slides of the Penn. HDR accident were from D. Flynn,MD ; and all of slides of the Bialystok, Poland accident came from IAEA STI/PUB/P1180,2004. 50