Measuring surgical safety during minimally invasive surgical procedures: a validation study

Area of Science:

• Surgical Safety
• Minimally Invasive Procedures
• Medical Device Implementation

Background:

• Surgical safety can be compromised during the introduction of new surgical devices and technologies.
• Existing safety measures are insufficient for detecting hazards during these implementation phases.
• The study aimed to assess surgical teams' ability to measure safety during new intervention introductions.

Purpose of the Study:

• To evaluate the effectiveness of a new Surgical Safety Questionnaire in identifying potential safety concerns.
• To determine if surgical teams can measure surgical safety during the implementation of new interventions.
• To validate the questionnaire against objective measures like video analysis of surgical flow.

Main Methods:

• A Surgical Safety Questionnaire was developed for postoperative completion by three surgical team members.
• Potential safety concerns were defined by specific questionnaire response ranges.
• Questionnaire validity was assessed by comparing its results with video analysis of surgical flow disturbances in 40 laparoscopic hysterectomies.

Main Results:

• A potential safety concern was reported by surgeons (16%), scrub nurses (9%), and anesthesiologists (9%).
• Concerns regarding device preparation, functioning, and usability were reported in 37.5-47.5% of procedures.
• Procedures with reported safety concerns showed significantly longer surgical flow disturbances (9.3% vs. 2.9%).
• New instruments or devices were associated with a higher incidence of reported safety concerns (51.2% vs. 23.1%).

Conclusions:

• Potential safety concerns are heightened during procedures with significant surgical flow disturbances and when new instruments or devices are used.
• The Surgical Safety Questionnaire is a validated tool for evaluating and maintaining surgical safety.
• The questionnaire is particularly useful for ensuring safety during minimally invasive procedures, especially when introducing new interventions.