Medical devices are required to comply with high standards of safety and reliability. Failure to meet safety requirements can have catastrophic consequences for the health and well-being of patients.
The regulatory safety requirements depend on the medical device classification. Class I devices have the lowest potential to harm patients, and class III devices have the highest. Therefore, safety requirements for class III devices are stricter than class II or class I devices.
Furthermore, early identification of design flaws saves a lot of time and money compared to product recalls and lawsuits.
Therefore, risk analysis should be incorporated into the design process of medical devices.
Another issue that medical device Original Equipment Manufacturers (OEMs) face is the difficulty of maintaining worldwide fleets of medical devices (for example: imaging systems). Logistic support of distributed fleets can be quite expensive.
Maintenance optimization requires a multidisciplinary analysis of the fleet including: failure modes and effects, failure distributions, repair and procurement turnaround times, spare parts demand, and cost associated with spare parts, equipment failures, maintenance manpower, support equipment and transportation.
BQR provides solutions for reliability and maintainability analyses and optimization.
Performance and Risk Management
Hospitals and medical centers provide a wide range of services, each having its own procedure.
BQR’s tools allow you to review the procedures, identify weak points and improve performance and patient satisfaction by:
- Identifying harmful actions
- Analyzing unsafe conditions (Error-prone, process failure)
- Intervening to prevent harm
- Monitoring outcomes that prevent harm