• Capital

  • Evaluating existing and new technologies … including strengths and limitations in context of the intended applications

  • Identifying existing technologies that should be scheduled for replacement or upgrade due to obsolescence or condition

  • Planning for installation, integration with other medical & information systems

  • Contributing to cost-benefit, life-cycle cost, and ROI analyses

• Services

  • Evaluating future need for services … adding services to meet developing needs and phasing out services for which there is little or no demonstrable benefit

  • Planning for transition from existing to future services (e.g., acquisition of skills, resources, education of clients & staff, implementation schedules)

• Assessing need for
  • new, beneficial technologies
  • replacing equipment due to condition, obsolescence, etc
• Participating in Request for Proposal (RFP) preparation
• Reviewing of proposals/bids and conducting technical evaluations
• Preparing of life-cycle cost & ROI analyses and recommendations
• Coordinating installation, incoming inspection and training (for users & service personnel)

• Adopting a Standardized Nomenclature
• Providing document trails regarding condition, use and servicing … including files for service reports (including 3rd party), hazard/recall reports, operator/service manuals (or their locations)
• Preparing capital budgets & upgrades schedules
• Standardizing on “best of breed”
• Facilitating integration between devices & systems
• Conducting risk analyses and facilitating risk mitigation efforts (including disaster planning)
• Establishing real financial value of medical technology assets 

• Identifying medical devices that are to be part of the Equipment Management Program using criteria that address
  • criticality
  • function
  • physical risks associated with use
  • equipment incident (e.g., service history)
• Scheduling maintenance \ facility rounds
  • inspection & PM only those devices that benefit from this service … and at a reasonable frequency
  • conducting inspection rounds when “spot checks” are more effective than specific device inspection & pm
• Corrective maintenance
  • Identify best service resource (consider quality, timeliness & cost)
  • Monitor service process & document
• Analyzing & evaluating maintenance data
  • Identifying “problem” devices/systems that may be candidates for replacement (i.e., excessive service calls)
  • Identifying inadequate/inappropriate service (i.e., excessive calls for same/similar problems)
  • Identifying need for user education (i.e., numerous service calls with no problem found or where damage caused by operator)
  • Identifying need for inspection & pm changes (i.e., calls that might have been avoided by more frequently scheduled inspection & pm)
  • Identifying need for less frequent or no scheduled maintenance (i.e., no problems found during routine inspections & pm)

• Identifying sources of information (FDA Enforcement Reports, HD Alerts, etc)
• Assigning responsibility, creating effective information flow and document process, findings and follow-up

• Clinical staff (e.g., device users)

  • General

    • When & how to obtain CE assistance (e.g., repair services)

    • Procedures for addressing incidents involving medical devices

    • General medical device safety … performing pre-use inspections & operational checks

  • Specific Device

    • General indications & contraindications for use

    • Operating procedure

    • Basic troubleshooting

    • Back-up plans in case of equipment failure or unavailability

• Technical staff

  • Identify professional roles & levels of staff (CE, Sr BMET, BMET) along with associated responsibilities

  • Encourage professional development, continuing education, and professional certification for engineers & technicians and document

  • Document technology related continuing ed &  training for technicians

Incident investigation
Investigating/reviewing all “incidents” where medical technology either did cause or could have caused injury or compromised diagnosis/treatment:

• Conduct Failure Mode Effect Analysis (FMEA) / Root Cause Analysis (RCA)

• Recommending

  • Change in process, policy/procedure

  • Additional education

  • Change in technology

• Reporting to Safety Committee, Risk Management, Quality Review

• Adopting a quality management system (e.g., ISO 9000, Six Sigma, Malcolm Baldridge, or similar) that will facilitate identifying:
  • performance criteria for technical systems and processes
  • target goals and objectives (benchmarks) associated with use of technology
  • methods for achieving those goals and objectives
  • techniques for measuring progress toward goals and objectives (e.g., metrics)
  • a process for analyzing and improving effectiveness of methods used to achieve goals and objectives
• Implementing a risk management program including:
  • an assessment program that identifies risks by evaluating the implications of failure of technical systems and their related processes on patient health, patient/staff safety, and the financial well-being of the organization
  • a mitigation program that prioritizes identified risk and provides methods for reducing them to an acceptable level
  • providing root cause analysis (RCA), failure mode effect analysis (FMEA), investigation, and reporting support when technology and technical processes are involved in adverse outcomes or incidents
  • identifying contributing causes
  • proposing recommendations to prevent reoccurrence