Clinical Issues-May 2020

Area of Science:

• Medical Device Management
• Surgical Procurement
• Quality Improvement

Background:

• Special-order implants present unique procurement challenges due to their custom nature.
• Traditional procurement methods may not adequately address the risks associated with these specialized items.
• Ensuring timely and accurate procurement is vital for patient safety and surgical outcomes.

Purpose of the Study:

• To apply Failure Modes and Effects Analysis (FMEA) to the process of special-order implant procurement.
• To identify potential failure modes within the implant procurement workflow.
• To develop strategies for mitigating identified risks and improving the overall process.

Main Methods:

• A cross-functional team conducted an FMEA on the special-order implant procurement process.
• Potential failure modes were identified, and their effects analyzed.
• Risk Profile Numbers (RPNs) were calculated to prioritize areas for improvement.
• Interdisciplinary teamwork was central to the FMEA process.

Main Results:

• Key failure modes were identified, including issues with communication, documentation, and lead times.
• The FMEA process highlighted critical control points in the procurement pathway.
• RPN scores indicated specific areas requiring immediate attention and process refinement.
• The study demonstrated the value of interdisciplinary collaboration in risk assessment.

Conclusions:

• FMEA is an effective tool for systematically improving special-order implant procurement.
• Implementing FMEA can lead to reduced risks, enhanced efficiency, and better patient care.
• Continuous risk assessment and interdisciplinary teamwork are essential for optimizing implant procurement processes.