Title:KNOWLEDGE, ATTITUDE, AND PRACTICE OF MATERIOVIGILANCE AMONG THE HEALTHCARE PROFESSIONALS IN A TERTIARY CARE HOSPITAL – A QUESTIONNAIRE BASED STUDYIntroduction:The term medical device is defined as “An instrument, machine or apparatus that is used in the prevention, diagnosis, alleviating, treatment of a disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose1. It includes a wide range of products both therapeutic medical devices and diagnostic medical devices like ventilators, hemodialysers, pacemakers, infusion pumps, Catheters, MRI scanners, Orthopaedic implants, In-Vitro Diagnostic (IVD) devices, Heart rate monitors, Ultrasound scanners and probes, Medical imaging systems1,2. “Materiovigilance” means close surveillance of any undesirable occurrence resulting from a medical device by means of having a monitoring system in place which comprises identifying, collecting, reporting, and estimating undesirable occurrences and reacting to them or safety corrective actions after their Postmarketing phase 3.Materiovigilance Programme of India (MvPI) was established by Ministry of Health & Family Welfare, Govt. of India on 06th July 2015 at IPC, Ghaziabad by DCG(I) to supervise the safety of medical devices in the country. The Indian Pharmacopoeia Commission (IPC) functions as National Coordination Centre for MvPI. Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST) will be function as National Collaborating Centre4.

The post-market surveillance, by the Materiovigilance Programme of India (MvPI) will improve the safety of patients and also reduces the occurrence of the incidents. Furthermore, most of the instruments are continuously monitoring medical devices of patients’ health 3, 4.Objectives:1)     To assess the knowledge, attitude on Materiovigilance, and their practice on reporting on Medical Device Adverse Events (MDAEs).2)     To Access the willingness of the medical professionals to adopt a standardized nationwide reporting system to avoid preventable medication errors due to medical devices6. 2) Methodology:A.   Study design: Prospective, Interventional.

B.   Study method: Questionnaire based study.C.   Study place: Saveetha Medical College and Hospital, Thandalam, Chennai.

D.   Study duration : 2 monthsE.    Study population: Clinicians, Healthcare professionals, Biomedical engineers, clinical engineers, hospital technology manager, pharmacists, nurses, Medical device operating technicians working in Saveetha Medical College and Hospital, Thandalam, Chennai.F.    Selection criteria: This study is a questionnaire?based study. The study participants consisted of all the practising clinicians, Healthcare professionals, Biomedical engineers, clinical engineers, hospital technology manager, pharmacists, nurses, Medical device operating technicians who gave their informed consent and who were working at the hospital during the study period. G.   Data collection procedures: ·        Self made questionnaires prepared with twenty relevant questions to the topic and will be distributed to the participants.

·        The questionnaire includes 1) Age 2) Sex 3) Designation 4) Name of the department ·        The questionnaire will be validated by eminent professors of Saveetha Medical College Hospital.·        Study participants will be asked to tick only one of the options in the column. After prior briefing about the study, sufficient time will be given to the participants to complete the questionnaire. H.   Quality control, confidentiality: The confidentiality of the study will be maintained by not revealing their names and the result will be used only for the research purpose for the future benefit of the society. The questions in the questionnaire can be answered without any external influence. The records of this study will be kept private.

I.       Plan of analysis/ statistical tools: Statistical analysis will be done using SPSS statistical analysis software. Percentage wise distribution of various parameters employed in the study will be analysed.J.       Ethical considerations: Study will be conducted after obtaining prior approval from Institutional Ethical Committee. The participants will not be forced to participate in the study and there will not be any remuneration or extra benefit provided to them. The confidentiality of the study will be maintained by not revealing their names and the result will be used only for the research purpose.

  Conclusion:Materiovigilance is as such a complex science in itself, demanding support of many disciplines including clinical medicine as well as clinical engineering/biomedical engineering, capacities existing in our country to promote a safer and reliable use of medical devices for the maximum protection of patients well being as well as heath care providers5,7.Implications:1)    To create awareness among health care professionals to capture and record suspected medical device-associated adverse events like death or serious deterioration in state of health, serious injuries and disability.2)    To assess the compliance of the health care professionals towards a nation – wide system for patient safety monitoring.3)    To analyse the benefit-risk ratio of medical devices.

4)    To generate evidence based information on safety of medical devices and generate medical device alert to regulator/healthcare professional.5)    To support CDSCO in the decision-making process on use of medical devices.6)    To communicate the safety information on use of medical devices to various stakeholders to minimise the risk.References:1. Definition of the Terms ‘Medical Device ‘and ‘In vitro Diagnostic (IVD) Medical Device , Global Harmonization Task Force , 2012 http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf#search=2.

Gupta P, Janodia MD, Jagadish PC, Udupa N. Medical device vigilance systems: India, US, UK, and Australia. Medical Devices (Auckland, NZ). 2010;3:67.3. Mirel S, Colobatiu L, Fasniuc E, Boboia A, Gherman C, Mirel V, Muresan D.

Materiovigilance and Medical Devices. In International Conference on Advancements of Medicine and Health Care through Technology; 5th–7th June 2014, Cluj-Napoca, Romania 2014 (pp. 101-106). Springer, Cham.4. Materiovigilance Programme of India (MvPI) homepage on the internet Updated on June 02, 2016.

Available from: http://ipc.nic.in/index1.asp? EncHid=&lang=1&linkid=82&lid=548.5. Rehn C, Bousquet C, Derain L. PS-095 Analysis of materiovigilance bottom up alerts related to medical perfusion devices.6.

Galgon RE. Understanding medical device regulation. Current Opinion in Anesthesiology. 2016 Dec 1;29(6):703-10.7. Gupta SK.

Medical Device regulations: a current perspective. Journal of Young Pharmacists. 2016 Jan 1;8(1):6.