Device Failure: References

Canadian Institute for Health Information. Appendix A. In: Hospital Harm Indicator: General Methodology Notes. Canadian Institute for Health Information; 2019. https://indicatorlibrary.cihi.ca/display/HSPIL/Hospital+Harm?preview=/10453027/15564910/Hospital%20Harm%20Indicator%20General%20Methodology%20Notes.pdf

Canadian Institute for Health Information. Implantable Medical Devices in Canada Insights into High-Volume Procedures and Associated Costs. CIHI; 2020a. https://www.cihi.ca/sites/default/files/document/implantable-medical-devices-report-en.pdf

Canadian Institute for Health Information. Hospital Harm Project Data Tables: Hospital Harm Results, 2014-2015 to 2019-2020. Published online 2020b. https://www.cihi.ca/en/hospital-harm-project

Canadian Patient Safety Institute (CPSI). 'If something doesn't feel right, you have to ask the question.' CPSI. Published October 30, 2014. Accessed April 2021.

Canadian Patient Safety Institute (CPSI). Global Patient Safety Alerts. Published n.d. Accessed 2021.

Health Canada. About medical device problems. Government of Canada. Published January 24, 2020. Accessed April 2021. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/medical-device-problems.html

Health Canada, Institute for Safe Medication Practices Canada, Health Standards Organization, Canadian Patient Safety Institute. Educational Support for Mandatory Reporting of Serious ADRs and MDIs by Hospitals. CPSI. Published n.d. Accessed April 2021.

Health Standards Organization. Reporting of Adverse Events in Reprocessing of Medical Devices. HSO Leading Practices Library. Published 2011. https://healthstandards.org/leading-practice/reporting-of-adverse-events-in-reprocessing-of-medical-devices/

Health Standards Organization. The Development of an Interdisciplinary Smart Pump Working Group reporting to Safe Medication Practices for the Management of Parenteral Administration using Smart Pump Technology. HSO Leading Practices Library. Published 2019. https://healthstandards.org/leading-practice/development-interdisciplinary-smart-pump-working-group-reporting-safe-medication-practices-management-parenteral-administration-using-smart-pump-technology/

Institute for Healthcare Improvement (IHI). How-to Guide: Prevent Harm from High-Alert Medications. IHI; 2012. http://www.ihi.org/resources/Pages/Tools/HowtoGuidePreventHarmfromHighAlertMedications.aspx

McLean J, Cribb R. Faulty and unproven medical devices implanted in Canadian patients despite known risks. Toronto Star. Published 2018. Accessed April 2021. https://www.thestar.com/news/investigations/2018/11/25/faulty-and-unproven-medical-devices-from-vaginal-mesh-to-hip-replacements-implanted-in-canadian-patients-despite-known-risks.html.

Medical Devices Regulations (1998) SOR/98-282. Retrieved from https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/FullText.html

Medicines & Healthcare products Regulatory Agency (MHRA). Managing Medical Devices: Guidance for Health and Social Care Organisations. MHRA; 2021. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/965010/Managing_medical_devices022021.pdf

Patients for Patient Safety Canada, Institute for Safe Medication Practices Canada, Canadian Patient Safety Institute. Vanessa's Law Protecting Canadians from Unsafe Drugs Act: Serious Adverse Drug Reaction and Medical Device Incident Reporting. Published online n.d. Accessed April 20, 2021.

Polisena J, Jutai JW, Chreyh R. A proposed framework to improve the safety of medical devices in a Canadian hospital context. Med Devices (Auckl). 2014;7:139-147. doi:10.2147/MDER.S61728

Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review. Systematic Reviews. 2015a;4(1):37. doi:10.1186/s13643-015-0028-0

Polisena J, Gagliardi A, Clifford T. How can we improve the recognition, reporting and resolution of medical device-related incidents in hospitals? A qualitative study of physicians and registered nurses. BMC Health Services Research. 2015b;15(1):220. doi:10.1186/s12913-015-0886-0