{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T20:03:24Z","timestamp":1787169804009,"version":"build-2736575974"},"reference-count":12,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Materiovigilance is a method for tracking, documenting, and analyzing the causal factors of adverse outcomes or complications associated with the use of medical devices. In addition, it recommends that the Indian regulatory authority takes necessary steps with the aim of enhancing patient safety. The present study was taken up as there are hardly any studies available in the public domain on adverse events due to radiotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>OBJECTIVE:<\/jats:title>\n                    <jats:p>The objective of the study is to analyze the pattern of adverse events due to medical devices used in the department of radiation oncology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>It was a cross-sectional study carried out from June to September, 2022. The patients who were treated with the medical devices in radiation oncology at Victoria Hospital affiliated with Bangalore Medical College and Research Institute, Bengaluru, were included. The medical device used on the patients causes adverse events. The data were collected from the patient's health records available in the department of radiotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Total 40 adverse events collected as per inclusion and exclusion criteria were analyzed. All the adverse events associated with medical devices were filled in the medical device adverse event reporting form and submitted to materiovigilance program, which also included the causality assessment. All the adverse events were caused due to external beam radiotherapy\/teletherapy device. Dermatitis was the most common adverse event found in the reported cases (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 20, 50%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION:<\/jats:title>\n                    <jats:p>Materiovigilance program is in budding stage. It was observed that the adverse events in patients were due to medical devices used in radiation oncology. Medical devices with skin-sparing effect (radiation is converged onto tumor) should be promoted and more research and engineering are required in designing of advanced medical devices for the treatment of cancer across the globe.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/ijp.ijp_818_22","type":"journal-article","created":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T00:54:31Z","timestamp":1691369671000},"page":"162-166","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":3,"title":["A cross sectional analysis of medical device associated adverse events with radiotherapy devices - A materiovigilance study"],"prefix":"10.4103","volume":"55","author":[{"given":"M. V.","family":"Raghav","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Geetha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V. S.","family":"Purushotham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Mamatha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Rajesh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajeev","family":"Raghuvanshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivekananda","family":"Kalaiselvan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shatrunjay","family":"Shukla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Hariharan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. Naveen","family":"Gowda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R1-4-20240903","doi-asserted-by":"crossref","first-page":"790","DOI":"10.1016\/S1470-2045(12)70211-5","article-title":"Global cancer transitions according to the human development index (2008-2030): A population-based study","volume":"13","author":"Bray","year":"2012","journal-title":"Lancet Oncol"},{"key":"R2-4-20240903","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1038\/nrclinonc.2012.203","article-title":"Past, present, and future of radiotherapy for the benefit of patients","volume":"10","author":"Thariat","year":"2013","journal-title":"Nat Rev Clin Oncol"},{"key":"R3-4-20240903","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1038\/nrd4003","article-title":"Strategies for optimizing the response of cancer and normal tissues to radiation","volume":"12","author":"Moding","year":"2013","journal-title":"Nat Rev Drug Discov"},{"key":"R5-4-20240903","doi-asserted-by":"crossref","first-page":"206","DOI":"10.2471\/BLT.19.232785","article-title":"Implementation of adverse event reporting for medical devices, India","volume":"98","author":"Shukla","year":"2020","journal-title":"Bull World Health Organ"},{"key":"R6-4-20240903","doi-asserted-by":"crossref","first-page":"175","DOI":"10.4103\/picr.PICR_26_18","article-title":"Materiovigilance: An Indian perspective","volume":"9","author":"Meher","year":"2018","journal-title":"Perspect Clin Res"},{"key":"R7-4-20240903","doi-asserted-by":"crossref","first-page":"10","DOI":"10.4103\/0973-8398.100125","article-title":"Regulatory guidelines for medical devices in India: An overview","volume":"6","author":"Radhadevi","year":"2012","journal-title":"Asian J Pharm"},{"key":"R8-4-20240903","first-page":"497","article-title":"Materiovigilance programme of India (MVPI): A step towards patient safety for medical devices","volume":"12","author":"Kumar","year":"2016","journal-title":"Eur J Biomed Pharm Sci"},{"key":"R9-4-20240903","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1016\/j.pharma.2021.09.003","article-title":"Materiovigilance in health centers: The role of notifiers to ensure safer use of medical devices","volume":"80","author":"Bechar","year":"2022","journal-title":"Ann Pharm Fr"},{"key":"R10-4-20240903","doi-asserted-by":"crossref","first-page":"277","DOI":"10.1007\/s40257-016-0186-4","article-title":"Radiodermatitis: A review of our current understanding","volume":"17","author":"Singh","year":"2016","journal-title":"Am J Clin Dermatol"},{"key":"R11-4-20240903","doi-asserted-by":"crossref","first-page":"107","DOI":"10.3747\/co.27.6233","article-title":"Radiotherapy side effects: Integrating a survivorship clinical lens to better serve patients","volume":"27","author":"Dilalla","year":"2020","journal-title":"Curr Oncol"},{"key":"R12-4-20240903","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1055\/a-1195-1945","article-title":"Materiovigilance: Concept, structure and emerging perspective for patient's safety in India","volume":"70","author":"Hoda","year":"2020","journal-title":"Drug Res (Stuttg"},{"key":"R13-4-20240903","first-page":"1","article-title":"Ensuring medical device effectiveness and safety: A cross \u2013 National comparison of approaches to regulation","volume":"69","author":"Kramer","year":"2014","journal-title":"Food Drug Law J"}],"container-title":["Indian Journal of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_818_22","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:13:25Z","timestamp":1787166805000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_818_22"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023]]}},"URL":"https:\/\/doi.org\/10.4103\/ijp.ijp_818_22","relation":{},"ISSN":["0253-7613"],"issn-type":[{"value":"0253-7613","type":"print"}],"subject":[],"published":{"date-parts":[[2023,5]]}}}