Medical device adverse incident reporting in interventional radiology Poster No.: C-0226 Congress: ECR 2014 Type: Authors: Scientific Exhibit N. PARVIZI 1, I. Robertson 2, R. G. McWilliams 3 ; 1 Oxford/UK, 2 Glasgow/UK, 3 Liverpool/UK Keywords: DOI: Interventional non-vascular, Interventional vascular, Experimental, Safety, Education and training 10.1594/ecr2014/C-0226 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. www.myesr.org Page 1 of 7
Aims and objectives Adverse incidents (AI) related to medical devices are often under-reported and have recently experienced a dramatic increase in interest and debate. The Department of Health (UK) issued a review in 2012, which called upon all those involved in delivering care to ensure they improve on AI reporting. 1 Interventional Radiology (IR) is heavily reliant on the use of a wide range of medical devices. The aim of this project was to investigate the current situation concerning AI reporting by members of the British Society of Interventional Radiology (BSIR). BSIR was chosen as IR is a specialty that uses many medical devices and there is a history of collaboration between the BSIR and MHRA. Methods and materials A survey containing questions on the reporting of adverse incidents for new medical devices was conducted of the BSIR membership between November 2012 and January 2013 using Survey Monkey (www.surveymonkey.com). The link was sent to the BSIR membership via e-mail on 9 November 2012 followed by a reminder email on 16 December 2012. The survey consisted of 10 questions on the interventional radiologist's experience of the unexpected failure of medical devices and the approach to the reporting of such AI. In particular, the survey questioned the barriers that existed to reporting and to which organization AI reports were made. The survey also asked what improvements could be made to improve the interventional radiologist's reporting of AI. User error is recorded as an important potential cause of AI involving medical devices, and therefore, questions were asked regarding the interventional radiologist's practice of reading the Instructions for Use (IFU) of medical devices. Results By 7th January 2013, 119 surveys were returned from a BSIR membership of just over 500 members. The number of IFU read in the last year varied from 9% not reading any to 50% reading 1-3. 79% responded that most of the devices they used were straightforward and similar, 61% felt that the manufacturer's representative gave sufficient information when the new device is being used, 24% referred to the IFU in case they ran into a problem and 5% felt the IFUs did not relate to real life. The majority of the members who completed the survey had experienced an AI relating to the use of a device (Figure 1). Around 75% of respondents reported AI locally with Page 2 of 7
only 42% reporting directly to the Medicines and Healthcare products Regulatory Agency (MHRA), which was explained by both a lack of time and a lack of awareness regarding mechanisms of reporting directly to the MHRA (Figure 2). Images for this section: Fig. 1: 80% of respondents had experienced an AI related to an unexpected failure of a medical device in their practice of IR and the frequency of this is shown. Page 3 of 7
Fig. 2: Proportion of respondents who had reported AI directly to the MHRA. Page 4 of 7
Conclusion AI involving medical devices are an important subset of adverse medical events leading to patient morbidity and mortality. Incident reporting is an essential part of system improvement for patient safety. 2 The practice of IR is very dependent on medical devices and involves considerable procedural and medical device innovation. The reporting of AI involving medical devices is advocated by BSIR, the Royal College of Radiologists, and the General Medical Council (GMC) and there is expected to be greater emphasis on this at the European (EU) level. The BSIR has actively promoted improvements in AI reporting in particular at the last BSIR Annual Scientific Meeting. The Royal College of Radiologists document "Standards for the introduction of new procedures and new devices" states that "Should an adverse event occur, this must be reported to the MHRA at the earliest opportunity". 3 The GMC published "Good practice in prescribing and managing medicines and devices" in 2013 which advocates that AI need to be reported to the MHRA. 4 The draft EU Medical Devices Directives proposal (published in September 2012) currently undergoing negotiation, places greater emphasis on improvements in AI reporting and enhancement of patient safety. 5 AI related to the unexpected failure of medical devices have been experienced by the majority of Interventional Radiologists. The majority of these are reported but there is significant confusion as to where and how these should be reported. Improvements in the number and quality of adverse incidents reported requires better education, avoidance of duplication of work, and improved feedback after reports have been made to ensure the delivery of high-quality, safe patient care (Figure 3). Images for this section: Page 5 of 7
Fig. 3: Responses to suggestions that would help improve AI reporting. Page 6 of 7
Personal information References 1. Earl Howe Review, Poly Implant Prosthese (PIP) silicone breast implants Review of the actions of the MHRA and Department of Health 14 May 2012. https://www.gov.uk/government/uploads/system/uploads/attachment_data/ file/152327/dh_134043.pdf.pdf [Accessed 15/02/2013] 2. Jones DN, Thomas MJW, Mandel CJ, Grimm J, Hannaford N, Schultz T, Runciman W. Where Failures Occur in the Imaging Care Cycle: Lesson From the Radiology Events Register. Journal American College of Radiology 2010; 7: 593-602 3. Royal College of Radiologists (RCR) Standards for the introduction of new procedures and new devices. http://www.rcr.ac.uk/docs/radiology/pdf/ BFCR(09)13_Stand_Intro_Proceduresv2.pdf [Accessed 15/02/2013] 4. GMC Guidance Good practice in prescribing and managing medicines and devices. February 2013 http://www.gmc-uk.org/ Prescribing_guidance_Last_ever_final_update_29_4_13.pdf_51867046.pdf [Accessed 16/02/2013] 5. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. EC/2012/0266 http://www.europarl.europa.eu/oeil/ popups/summary.do?id=1225601&t=d&l=en [Accessed 20/02/2013] Page 7 of 7