Development and content validation of a competency-based assessment tool for penile prosthesis surgery

Area of Science:

• Urology
• Surgical Safety
• Medical Device Technology

Background:

• Inflatable penile prosthesis (IPP) surgery requires precise execution to minimize complications.
• A standardized method for assessing surgical competency in IPP procedures is needed.

Purpose of the Study:

• To identify potential hazards in the inflatable penile prosthesis (IPP) surgical procedure.
• To develop and content-validate an IPP intraoperative competency-based assessment tool (PPAT).

Main Methods:

• A multi-institutional prospective observational study utilizing Healthcare Failure Mode and Effects Analysis (HFMEA).
• A multidisciplinary team (MDT) approach for risk assessment.
• International content validation of the developed assessment tool via meetings and seminars.

Main Results:

• HFMEA identified 41 key failure modes within the 11-stage IPP procedure.
• High-risk steps included corporal dilatation, prosthesis sizing, and reservoir placement.
• The final PPAT comprises 13 processes and 27 sub-processes, validated internationally.

Conclusions:

• HFMEA effectively identified critical steps for developing the IPP assessment tool (PPAT).
• The PPAT, confirmed through international validation, can assess trainee competency in IPP surgery.
• Further validation is needed to assess learning curves for the IPP procedure.