Information Management/Technology – Biomedical Technology Needs

Service: Risk Management
Subject: Information Management/Technology
Type: Risk Profiles

Aging, obsolescence, unreliability or lack of biomedical technology to support clinical needs can lead to a negative impact on care, and a potential for an adverse event or equipment failure. The risk of inability to get parts for biomedical equipment where licenses are not being renewed is also identified as potentially contributing to this risk. This document contains information entered by HIROC subscriber healthcare organizations (acute and non-acute) in the Risk Register application to help you in your assessment of this risk.

Ranking / Ratings

  • Likelihood – average score 3.64
  • Impact – average score 4.18 

Key Controls / Mitigation Strategies

Care

  • Early recognition of advanced care needs
  • Regional critical care program
  • Patient transfer algorithms which consider biomedical technology needs
  • Risk assessments

Vendor/Manufacturer Management, e.g. Request for Proposal (RFP), contracts

  • RFP requirement licensed by Health Canada to provide a minimum of one year written notice if requirement parts are no longer available and vendor support for a minimum number of years from date of manufacture
  • Written documentation on agreed to notice period from manufacturer/vendor of intent to lapse license

Maintenance, Audits or Inspections

  • Regular inspections to ensure device is performing as per specifications outlined by manufacturer
  • Checking of scopes to ensure all fibers are intact prior to use. 
    • Vendor completes a review every other year 
  • Semi-annual preventative maintenance
  • Battery and/or accessory testing and checks
  • Electrical safety, calibration, alignment testing
  • Biomedical machinery regular maintenance schedules 
  • Onsite loaner of equipment during service and maintenance checks by vendor

Administrative or Management practices

  • Floor markings for equipment that requires exact positioning to minimize failures or alarms
  • Enterprise assessment management of medical technology including procurement dates, life span expectancy and end of service notifications 
  • Standardized variety of ventilators to account for potential backorders including respective consumables 
  • Development of 5-year capital technology plan to identify financial resources to execute the plan

Monitoring / Indicators

  • % of biomedical devices maintenance checks completed 
  • % of checks for system integrity based on identified timelines
  • % of biomedical technology beyond life span expectancy
  • % checks for parts replacement (i.e. battery)
  • Adverse events and critical incident debrief
  • Coroner’s report recommendations
  • Health Canada Medical Device License confirmation
  • Audit of supplies and accessories to ensure has not expired
Date last reviewed:
This is a resource for quality assurance and risk management purposes only, and is not intended to provide or replace legal or medical advice or reflect standards of care and/or standards of practice of a regulatory body. The information contained in this resource was deemed accurate at the time of publication, however, practices may change without notice.