{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T04:57:47Z","timestamp":1791089867228,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,10,29]],"date-time":"2017-10-29T00:00:00Z","timestamp":1509235200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Applied Clin Med Phys"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a risk\u2010based quality management program for Gamma Knife radiosurgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A team consisting of medical physicists, radiation oncologists, neurosurgeons, radiation safety officers, nurses, operating room technologists, and schedulers at our institution and an external physicist expert on Gamma Knife was formed for the FMEA study. A process tree and a failure mode table were created for the Gamma Knife radiosurgery procedures using the Leksell Gamma Knife Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection for failure mode (D) were assigned to each failure mode by 8 professionals on a scale from 1 to 10. An overall risk priority number (RPN) for each failure mode was then calculated from the averaged O, S, and D scores. The coefficient of variation for each O, S, or D score was also calculated. The failure modes identified were prioritized in terms of both the RPN scores and the severity scores.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The established process tree for Gamma Knife radiosurgery consists of 10 subprocesses and 53 steps, including a subprocess for frame placement and 11 steps that are directly related to the frame\u2010based nature of the Gamma Knife radiosurgery. Out of the 86 failure modes identified, 40 Gamma Knife specific failure modes were caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the Gamma Knife helmets and plugs, the skull definition tools as well as other features of the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all external beam radiation therapy techniques. The failure modes with the highest hazard scores are related to\u00a0imperfect frame adaptor attachment, bad fiducial box assembly, unsecured plugs\/inserts, overlooked target areas, and undetected machine mechanical failure during the morning QA process.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process. The results of the present study give us a basis for the development of a risk based quality management program for Gamma Knife radiosurgery.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acm2.12205","type":"journal-article","created":{"date-parts":[[2017,10,30]],"date-time":"2017-10-30T04:32:40Z","timestamp":1509337960000},"page":"152-168","source":"Crossref","is-referenced-by-count":36,"title":["Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery"],"prefix":"10.1002","volume":"18","author":[{"given":"Andy Yuanguang","family":"Xu","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jagdish","family":"Bhatnagar","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greg","family":"Bednarz","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Flickinger","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Arai","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonet","family":"Vacsulka","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery University of Pittsburgh Medical Center Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenzheng","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology New York Presbyterian Hospital\/Columbia University Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Monaco","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery University of Pittsburgh Medical Center Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay","family":"Niranjan","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery University of Pittsburgh Medical Center Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. Dade","family":"Lunsford","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery University of Pittsburgh Medical Center Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Saiful","family":"Huq","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Pittsburgh Cancer Institute Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,10,29]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"316","article-title":"The stereotaxic method and radiosurgery of the brain","volume":"102","author":"Leksell L","year":"1951","journal-title":"ACTA Chirurgica Scandinavica"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.46.9.797"},{"key":"e_1_2_7_4_1","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1227\/00006123-198902000-00001","article-title":"Stereotactic radiosurgery of the brain using the 1st united states 201\u2010cobalt\u201060 source Gamma\u2010Knife","volume":"24","author":"Lunsford LD","year":"1989","journal-title":"Neurosurgery"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/isbn.978-3-318-00267-6"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1586\/ern.12.16"},{"key":"e_1_2_7_7_1","volume-title":"Failure Mode and Effect Analysis: FMEA from Theory to Execution","author":"Stamatis DH","year":"2003"},{"key":"e_1_2_7_8_1","series-title":"Wiley Series in Probability and Statistics","volume-title":"System Reliability Theory: Models, Statistical Methods, and Applications","author":"Rausand M","year":"2004"},{"key":"e_1_2_7_9_1","volume-title":"Procedures for Performing a Failure Mode, Effects and Criticality Analysis","author":"USA Department of Defense, MIL\u2010P\u20101629","year":"1949"},{"key":"e_1_2_7_10_1","volume-title":"Design Analysis Procedure for Failure Modes, Effects and Criticality Analysis (FMECA)","author":"Society for Automotive Engineers, ARP926","year":"1967"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0001-2092(06)61343-4"},{"key":"e_1_2_7_12_1","first-page":"233","article-title":"A hands\u2010on guide for healthcare facilities","volume":"33","author":"Failure mode and effects analysis","year":"2004","journal-title":"Health Devices"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2007.06.081"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2008.10.038"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1118\/1.3517837"},{"key":"e_1_2_7_16_1","volume-title":"Quality and Safety in Radiotherapy: Learning the New Approaches in Task Group 100 and Beyond (Medical Physics Monograph)","author":"Thomadsen B","year":"2013"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/1748-717X-8-127"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1120\/jacmp.v14i5.4329"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1945-1474.2011.00199.x"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1118\/1.4918319"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2014.12.033"},{"key":"e_1_2_7_22_1","unstructured":"Elekta Instrument AB.Possible misalignment of the coordinate frame to the frame adapter. 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