Device Failure: Clinical and System Reviews, Incident Analyses
Given the broad range of potential causes of device failure, in addition clinical and system reviews to identify latent causes and determine appropriate recommendations.
Occurrences of harm are often complex with many contributing factors. Organizations need to:
- Measure and monitor the types and frequency of these occurrences.
- Use appropriate analytical methods to understand the contributing factors.
- Identify and implement solutions or interventions that are designed to prevent recurrence and reduce risk of harm.
- Have mechanisms in place to mitigate consequences of harm when it occurs.
To develop a more in-depth understanding of the care delivered to patients, chart audits, incident analyses and prospective analyses can be helpful in identifying quality improvement opportunities. Links to key resources for conducting chart audits and analysis methods are included in the Hospital Harm Improvement Resource Introduction.
If your review reveals that your cases of device failure are linked to specific processes or procedures, you may find these resources helpful:
- Canadian Agency for Drugs and Technologies in Health (CADTH) https://www.cadth.ca/
- Canadian Patient Safety Institute
- 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.
- Government of Canada www.Canada.ca
- Health Canada. About medical device problems. Government of Canada. Published January 24, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/medical-device-problems.html
- Medical Devices Regulations (1998) SOR/98-282. Retrieved from https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/FullText.html
- Health Canada. Canadian Medical Devices Sentinel Network. Government of Canada. Published June 26, 2019. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
- Health Canada. Medical device incidents. In: Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report. Government of Canada. Published December 11, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html#a3
- Health Canada. Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report. Government of Canada. Published December 11, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html
- Medicines & Healthcare Products Regulatory Agency (MRHA) Medicines and Healthcare products Regulatory Agency - GOV.UK www.gov.uk
- 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
- Medicines & Healthcare products Regulatory Agency (MHRA). Devices in Practice: Checklists for Using Medical Devices. MHRA; 2014. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/403401/Devices_in_practice.pdf
- National Institute for Health and Care Excellence (NICE) www.nice.org.uk
- National Institute for Health and Care Excellence. Published guidance and advice. NICE Guidance. https://www.nice.org.uk/guidance/published?type=apg,csg,cg,cov,mpg,ph,sg,sc,dg,hst,ipg,mtg,qs,ta
- National Institute for Health and Care Excellence. Introducing techniques and medical devices. NICE Guidance: Local Practice. Published January 2013. https://www.nice.org.uk/sharedlearning/introducing-techniques-and-medical-devices
- National Institute for Health and Care Excellence. Medical Technologies Evaluation Programme. NICE guidelines. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-medical-technologies-evaluation-programme
- World Health Organization (WHO) www.who.int
- World Health Organization. Medical devices. WHO Health Topics. https://www.who.int/health-topics/medical-devices#tab=tab_1