Skip to main content
Top
Published in: BMC Health Services Research 1/2015

Open Access 01-12-2015 | Research article

How can we improve the recognition, reporting and resolution of medical device-related incidents in hospitals? A qualitative study of physicians and registered nurses

Authors: Julie Polisena, Anna Gagliardi, Tammy Clifford

Published in: BMC Health Services Research | Issue 1/2015

Login to get access

Abstract

Background

To explore factors that influence and to identify initiatives to improve the recognition, reporting and resolution of device-related incidents.

Methods

Semi-structured telephone interviews with 16 health professionals in two tertiary care hospitals were conducted. Purposive sampling was used to identify appropriate study participants. Transcribed interviews were read independently by one individual to identify, define and organize themes and verified by another reviewer.

Results

Themes related to incident recognition were the hospital staff’s knowledge and professional experience, medical device performance and clinical manifestations of patients, while incident reporting was influenced by error severity, personal attitudes of clinicians, feedback received on the error reported. Physicians often discontinued using medical devices if they malfunctioned. Education and training and the implementation of registries were discussed as important initiatives to improve medical device surveillance in clinical practice.

Conclusions

Results from the telephone interviews suggest that multiple factors that influence participation in medical device surveillance activities are consistent with results for medical errors as reported in previous studies. The study results helped to propose a conceptual framework for a medical device surveillance system in a hospital context that would enhance patient safety and health care delivery.
Appendix
Available only for authorised users
Literature
1.
go back to reference Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140:296–302.CrossRefPubMed Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140:296–302.CrossRefPubMed
2.
go back to reference Balka E, Doyle-Waters M, Lecznarowicz D, FitzGerald JM. Technology, governance and patient safety: systems issues in technology and patient safety. Int J Med Inform. 2007;76 Suppl 1:S35–47.CrossRefPubMed Balka E, Doyle-Waters M, Lecznarowicz D, FitzGerald JM. Technology, governance and patient safety: systems issues in technology and patient safety. Int J Med Inform. 2007;76 Suppl 1:S35–47.CrossRefPubMed
3.
go back to reference Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004;170:1678–86. Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004;170:1678–86.
4.
go back to reference Lawton R, McEachan RR, Giles SJ, Sirriyeh R, Watt IS, Wright J. Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review. BMJ Qual Saf. 2012;21:369–80.CrossRefPubMedPubMedCentral Lawton R, McEachan RR, Giles SJ, Sirriyeh R, Watt IS, Wright J. Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review. BMJ Qual Saf. 2012;21:369–80.CrossRefPubMedPubMedCentral
5.
go back to reference Sievanen H. User reporting of medical device related incidents. Med Device Technol. 2003;14:26–9.PubMed Sievanen H. User reporting of medical device related incidents. Med Device Technol. 2003;14:26–9.PubMed
6.
go back to reference Pfeiffer Y, Manser T, Wehner T. Conceptualising barriers to incident reporting: a psychological framework. Qual Saf Health Care. 2010;19, e60.CrossRefPubMed Pfeiffer Y, Manser T, Wehner T. Conceptualising barriers to incident reporting: a psychological framework. Qual Saf Health Care. 2010;19, e60.CrossRefPubMed
7.
go back to reference Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of medical device-related incidents: a systematic review, Systematic Reviews. 2015;4:37. Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of medical device-related incidents: a systematic review, Systematic Reviews. 2015;4:37.
8.
go back to reference Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. Newbury Park (CA): Sage Publications; 1998. Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. Newbury Park (CA): Sage Publications; 1998.
9.
go back to reference Butterfield LD, Borgen WA, Amundson NE, Maglio AST. Fifty years of the critical incident technique: 1954–2004 and beyond. Qualitative Research. 2005;5:475–97.CrossRef Butterfield LD, Borgen WA, Amundson NE, Maglio AST. Fifty years of the critical incident technique: 1954–2004 and beyond. Qualitative Research. 2005;5:475–97.CrossRef
10.
go back to reference Bowen GA. Naturalistic inquiry and the saturation concept: a research note. Qualitative Research. 2008;8:137–52.CrossRef Bowen GA. Naturalistic inquiry and the saturation concept: a research note. Qualitative Research. 2008;8:137–52.CrossRef
11.
go back to reference Sandelowski M. Theory unmasked: the uses and guises of theory in qualitative research. Res Nurs Health. 1993;16:213–8.CrossRefPubMed Sandelowski M. Theory unmasked: the uses and guises of theory in qualitative research. Res Nurs Health. 1993;16:213–8.CrossRefPubMed
12.
go back to reference Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology. 1984;60:34–42.CrossRefPubMed Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology. 1984;60:34–42.CrossRefPubMed
13.
go back to reference Auerbach CF, Silverstein LB. Qualitative data: an introduction to coding and analysis. New York: New York University Press; 2003. Auerbach CF, Silverstein LB. Qualitative data: an introduction to coding and analysis. New York: New York University Press; 2003.
15.
go back to reference Polisena J, Jutai J, Chreyh R. A proposed framework to improve the safety of medical devices in a Canadian hospital context. Medical devices: research and evidence. Medical Devices: Research and Evidence 2014. Polisena J, Jutai J, Chreyh R. A proposed framework to improve the safety of medical devices in a Canadian hospital context. Medical devices: research and evidence. Medical Devices: Research and Evidence 2014.
16.
go back to reference MaRS Discovery District. How medical devices are approved in the US. MaRS Discovery District. 2010. Toronto (ON), MaRS. 11-11-2013. MaRS Discovery District. How medical devices are approved in the US. MaRS Discovery District. 2010. Toronto (ON), MaRS. 11-11-2013.
17.
go back to reference Kaldjian LC, Jones EW, Rosenthal GE, Tripp-Reimer T, Hillis SL. An empirically derived taxonomy of factors affecting physicians' willingness to disclose medical errors. J Gen Intern Med. 2006;21:942–8.CrossRefPubMedPubMedCentral Kaldjian LC, Jones EW, Rosenthal GE, Tripp-Reimer T, Hillis SL. An empirically derived taxonomy of factors affecting physicians' willingness to disclose medical errors. J Gen Intern Med. 2006;21:942–8.CrossRefPubMedPubMedCentral
18.
go back to reference Segal JB, Bridges JF, Chang HY, Chang E, Nassery N, Weiner J, et al. Identifying possible indicators of systematic overuse of health care procedures with claims data. Med Care. 2014;52:157–63. Segal JB, Bridges JF, Chang HY, Chang E, Nassery N, Weiner J, et al. Identifying possible indicators of systematic overuse of health care procedures with claims data. Med Care. 2014;52:157–63.
21.
go back to reference Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. Journal of the American Medical Association. 2005;294:955–8.CrossRefPubMed Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. Journal of the American Medical Association. 2005;294:955–8.CrossRefPubMed
22.
go back to reference Polisena J, Clifford T, Elshaug AG, Mitton C, Russell E, Skidmore B. Case studies that illustrate disinvestment and resource allocation decision-making processes in health care: a systematic review. Int J Technol Assess Health Care. 2013;29:174–84.CrossRefPubMed Polisena J, Clifford T, Elshaug AG, Mitton C, Russell E, Skidmore B. Case studies that illustrate disinvestment and resource allocation decision-making processes in health care: a systematic review. Int J Technol Assess Health Care. 2013;29:174–84.CrossRefPubMed
23.
go back to reference MaRS Discovery District. New partnership to establish Ontario as premier site in pre-market evaluation of medical technologies [news release]. MaRS Discovery District. 12-6-2011. Toronto (ON), MaRS. 1-2-2014. MaRS Discovery District. New partnership to establish Ontario as premier site in pre-market evaluation of medical technologies [news release]. MaRS Discovery District. 12-6-2011. Toronto (ON), MaRS. 1-2-2014.
24.
go back to reference U.S. Food and Drug Administration. Medical Device Epidemiology Network (MDEpiNET). U.S. Food and Drug Administration. 4-22-2014. Silver Spring (MD), U.S. Food and Drug Administration. 1-2-2014. U.S. Food and Drug Administration. Medical Device Epidemiology Network (MDEpiNET). U.S. Food and Drug Administration. 4-22-2014. Silver Spring (MD), U.S. Food and Drug Administration. 1-2-2014.
25.
go back to reference Normand SL, Marinac-Dabic D, Sedrakyan A, Kaczmarek R. Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty. Med Care. 2010;48:S58–67.CrossRefPubMed Normand SL, Marinac-Dabic D, Sedrakyan A, Kaczmarek R. Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty. Med Care. 2010;48:S58–67.CrossRefPubMed
Metadata
Title
How can we improve the recognition, reporting and resolution of medical device-related incidents in hospitals? A qualitative study of physicians and registered nurses
Authors
Julie Polisena
Anna Gagliardi
Tammy Clifford
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2015
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-015-0886-0

Other articles of this Issue 1/2015

BMC Health Services Research 1/2015 Go to the issue