It uses ionizing radiation to destroy cancer cells and limit cell growth. The software required that three essential programming instructions be saved in sequence. Radiation therapy safety danafarber cancer institute. Impac entries % e v e n t 3 f r e e t p a t i e n t s clinic overall thera py 2 0 2 4 6 8 10 12 14 16 18 ju l07 a g s ep o ct nov d j an 8 f b m ry l 9 im e f r e q u e n cy im p ac p ro b p ort f ilm r b. A pinpoint beam strays invisibly, harming instead of healing the radiation boom series, front page, dec. Radiation therapy is a proven, effective and curative treatment for numerous cancers administered by highly trained and caring physicians, physicists and therapists. Radiation therapy documentation requirements noridian. Dose delivered by wrong mode of treatment, wrong treatment, or wrong treatment site.
In addition to treating cancer, radiation oncologists may also use ionizing radiation to treat benign. Radiation therapy is a highly regulated medical practice with historically low error and injury rates. Radiologists and radiation oncologists often prescribe radiation therapy for patients who have cancer or other serious diseases. A radiation therapy device malfunctions and delivers lethal radiation doses at several medical facilities. As radiation therapy treatments evolve, radiation therapists are assuming more responsibilities. Diagnostic test resultsreports, including imaging andor laboratory reports, including those prior to claim dates of service if related, to support medical necessity and reason for radiation therapy, if applicable. Radiotherapy is one of the main types of cancer treatment. Facilities delivering radiation therapy are required to report medical events. Radiation therapy process stony brook cancer center. It is a local treatment, which means it treats a specific part of your body. Volumes of pctcbct from ten patients who underwent radiation therapy were used to evaluate robustness of the hybrid dir for prostate cancer patients, using the dir algorithms in raystation v. When the time came to design the therac25, the partnership had dissolved. Radiation therapy for cancer national cancer institute. When radiation treatment turns deadly the new york times.
At low doses, radiation is used in xrays to see inside your body, as with xrays of your teeth or broken bones. Systematic setup errors occur when a patient is set up using incorrect positioning information. The therac25 medical radiation therapy device was involved in several cases where massive overdoses of radiation were administered to patients in 198587, a side effect of the buggy software powering the device. The process of radiation therapy will be customized for patients, depending on which form of radiation therapy patients and their physicians choose as their options. Reducing errors in radiation therapy through electronic. The first of these errors involved the entering of treatment data by the machine operator. Radiation therapy or radiotherapy, often abbreviated rt, rtx, or xrt, is a therapy using ionizing radiation, generally as part of cancer treatment to control or kill malignant cells and normally delivered by a linear accelerator. Safety and quality are extremely important to treating cancer patients not only in our radiation oncology department but throughout the nation. An investigation of the therac25 accidents stanford university. The therac25 is enclosed in a radiation treatment room in order to prevent unnecessary radiation. Questions and answers about radiation therapy navigating. Any wrong patient or wrong site imaged regardless of dose received should be reported, documented, and addressed internally within the facility.
While errors in the delivery of radiation therapy are rare and usually result in little or no injury to a patient, the real danger is if an error in administration goes undetected. These accidents highlighted the dangers of software control of safety critical systems. The truth is that any software program will probably contain one error for every. Their core duties still include serving as the primary contact for patients undergoing radiation therapy treatments that can last several weeks and administering the actual treatments. Z16772020 reason potential safety issue with the dose monitoring system safety interlocks which could result in a 1020% overdose of radiation. External beam radiation therapy for cancer national. Radiation therapy is regulated at both the federal and state level and is considered one of the most highly regulated medical practices. It was the third radiation therapy machine by the company, preceded by the therac6 and therac20. External beam radiation therapy comes from a machine that aims radiation at your cancer. The radiation oncology domain expert staff at cars analyzes each reported event and determines its cause and severity.
She needed a dose of radiation treatment in the adjacent lymph nodes to make. A number of patients received up to 100 times the intended dose, and at least three of them died as a. Regulation of radiation therapy one reason cited for the low incidence of errors occurring in the delivery of radiation therapy is the strict regulatory environment surrounding this practice. At high doses many times greater than those used for xray exams radiation can kill. Involves any equipment failure, personnel error, accident, mishap or other unusual occurrence with the administration of ionizing radiation that exceeds 0. Vincent hospital should be made to grant interviews in this case and others.
The future of radiation therapy verification is here. Errors in the delivery of rt over the period january 1, 1997, through december 31, 2002, were analyzed retrospectively. This checklist system has been successfully implemented in our department, identifying and improving clinical and communication issues. Purdy, and jeff michalski department of radiation oncology, washington university school of medicine, st. Overall, there are five basic steps of radiation therapy that we can share to give patients an idea of what to expect. The worlds first intrafractional treatment verification system. Stateoftheart technology for a new verification approach. Radiation therapy also called radiotherapy is a cancer treatment that uses high doses of radiation to kill cancer cells and stop them from spreading. When radiation misadministrations are caught early, subsequent treatment doses can be adjusted so that the patient avoids receiving an under or overdose.
Fda statement on radiation overexposures in panama fda. The truth is that any software program will probably contain one error for every 500 lines of code. Radiation measurement systems incorrect use of calibration report report specified n d,w but was interpreted as n k correction for atmospheric pressure bend, or institution had no inhouse barometer physicist used airport or transported aneroid barometer airport reported pressure corrected to sea level elevation was actually 3,500 ft. Radiation medical events conference of radiation control. At low doses, radiation is used as an xray to see inside your body and take pictures, such as xrays of your teeth or broken bones. Usefulness of hybrid deformable image registration.
These accidents highlighted the dangers of software control of safetycritical systems, and they have become a standard case study in health informatics and software engineering. Current software gives the ability to provide reliable and ubiquitous access to patient information, and to use complex treatment techniques such as intensity modulated radiation therapy imrt to upload treatment parameters automatically, thereby, improving efficiency and accuracy. Treatment process department of radiation oncology. The deidentified aggregated data are analyzed to evaluate populationbased trends, which in turn is used to improve the safety and quality of radiotherapy. The machine offered two modes of radiation therapy. As a radiation therapist, youll be part of the team that helps plans and administers these treatments, and. The therac25 was a computercontrolled radiation therapy machine produced by atomic. Software safety in radiation therapy pubmed central pmc. Treatment setup imaging a special ct scan called ctsimulation is acquired for every patient, and a mri, if needed, is also acquired. Radiation therapy, the use of ionizing radiation highenergy radiation that displaces electrons from atoms and molecules to destroy cancer cells.
Fatal dose radiation deaths linked to aecl computer errors. Current software gives the ability to provide reliable and ubiquitous access to patient information, and to use complex treatment techniques such as intensity modulated radiation therapy imrt to upload treatment parameters automatically, thereby, improving. Using xrays or a beam of electrons, radiation therapy machines kill. Radiation therapy has always been computer intensive and its increasing reliance on software is a twoedged sword. Based upon a previous design, the therac25 was an improved therapy system that could deliver two different kinds of radiation. During the course of an individual patients radiation therapy regimen, adequate dose coverage of the prescribed target volume and dose avoidance for organs at risk oar can be compromised. The therac25 was a radiation therapy machine manufactured by aecl in the 80s, which offered a revolutionary dual treatment mode. Actionable users should either perform an action or. In addition, i will examine the therac25s software bugs. Recall radiation therapy software error could result in. Radiation therapy training programs and requirements. Direct electronbeam therapy, in which a narrow lowcurrent beam of highenergy 5 mev to 25 mev electrons was scanned over the treatment. New elekta iviewdose software designed to provide an.
It was also designed from the outset to use software based safety systems rather than hardware controls. It is the biggest and most disastrous case of human error relating computer controlled radiation and human death to date. It took over 6 months to implement a new electronic safety checklist program. The princess margaret hospital is the largest radiation therapy center in canada and over the study period operated 17 radiation therapy units 10 varian linear accelerators 600c, 21ex, 2100c, 2100cd. It may also be used as part of adjuvant therapy, to. While reducing errors in radiation oncology should be a simple process, the reality is that it is a multistep process. Opinion efforts to reduce errors in radiation therapy.
Iqm the next generation of radiation therapy verification. The use of adaptive radiation therapy to reduce setup. The therac 25 was a radiation therapy machine manufactured by aecl in. Radiation therapy may be curative in a number of types of cancer if they are localized to one area of the body. Errors in radiation oncology md anderson cancer center. Radiation therapy is one of several treatments used to treat cancer by itself or in combination with other forms of treatment, most often surgery or chemotherapy. Youve probably seen an xray of your teeth or some other part of your body. Please see here for commonly asked questions about radiation therapy safety measures. These errors can result in devastating and sometimes fatal injuries, especially when the misadministration results in injury. This statement informs radiation therapy system users of radiation overexposures that occurred at panamas national institute of oncology.
The use of highlyfocused, rapid delivery techniques such as intensity modulated radiation therapy imrt and volumetric modulated radiation therapy vmat has increased the need for high accuracy in dose delivery to patients, particularly given the higher therapeutic doses used in stereotactic radiosurgery srs and stereotactic body radiation. Although these stories are more extreme than most software bugs. The therac25s software program, relatively crude by todays standards, probably contained 10 lines of code. Rare instances of radiation therapy errors resulting in severe injuries have been documented. Adaptive radiation therapy art is a feedback treatment process that optimizes a patients treatment according to the patient specific information measured during the. Vocational schools, colleges and universities with radiation therapy programs offer associates and bachelors degree programs. Once an operator enters treatment information at the terminal outside of treatment room, the magnets used to filter and control radiation levels are set. Radiation offers new cures, and ways to do harm the new.