Presentation
MDD6 - Contextual Inquiry for Short Term Use Enteral Feeding Tube in Early Development Stage
DescriptionUsability engineering and human factors engineering (HFE) are essential for medical devices to ensure patient safety, comply with regulatory requirements, reduce use errors, and support ongoing product improvement. By adopting a user-centric approach and considering the human element in device design, HFE contributes to better outcomes for both healthcare professionals and patients.
The purpose of this contextual inquiry is to visit the actual usage environment of the commissioned medical device, the Enteral feeding tube for short-term use, and investigate the users and the usage environment. This inquiry was conducted in the early stages of the medical device design process to understand usage environment factors, tasks related to usage, and user workflows.
Excluding the planning day, the execution took one day. The inquiry location was the Gastrointestinal Endoscopy Center at Seoul National University Hospital. The interviewee is affiliated with the Gastrointestinal Endoscopy Center.
The inquiry was conducted following the 'IEC62366-1:2015+AMD1:2020 Medical device-Part1: Application of usability engineering to medical devices.' This inquiry involved visiting the actual environment where the medical device, the Enteral feeding tube for short-term use, is being used, observing the usage environment and user interactions with the medical device, and conducting interviews with the intended users. Through this inquiry, environmental factors and tasks related to medical device usage that need to be considered during the design process were identified, as well as the workflow of user tasks. It was confirmed that users can be broadly divided into two groups: healthcare professionals and patients, with doctors primarily identified as the primary users. The workflow of the procedures was summarized as follows: ① Preparation and local anesthesia of the procedure area – ② Verification of the surgical location through endoscopy – ③ Dilation of the opening using a trocar - ④ Insertion of a guide wire – ⑤ Capture of the guide wire using a snare – ⑥ Removal of the guide wire from the endoscope – ⑦ Connection of the PEG catheter to the guide wire – ⑧ Placement of the catheter outside the abdomen - ⑨ Fixation with an external bumper - ⑩ Cutting the catheter and connecting the infusion adapter - ⑪ Disposal of used instruments and debris - ⑫ Regular outpatient follow-up appointments. The medical device is generally used in the Gastrointestinal Endoscopy Center of the hospital. Considering its characteristic of being attachable after removing clothing, the device is worn in a separate designated space. Potential interference factors in the use of this medical device include adapter detachment during patient activities or in the process of patient and caregiver usage while maintaining the post-procedure product. Hazards occurring throughout the procedure include the following: First, the risk of infection: ① Needle or scalpel injuries. ② Patient's bodily fluids may come into contact with the skin and respiratory system of healthcare professionals. ③ Some products, when inserted through the oral cavity, pose a risk of contamination and infection. Second, patient discomfort during skin incision. Third, aspects related to the procedure site: ① Some patients may have difficulty in identifying the exact procedure site, and incorrect placement may result in serious complications due to damage to surrounding organs. ② Insertion of a PEG tube can be highly dangerous if the path is missed. Fourth, aspects related to procedure duration: ① In some cases, the patient may need to hold a mouthpiece while undergoing endoscopy, making it difficult to breathe, requiring a faster procedure. ② Some patients may not be able to open their mouths wide enough to accommodate the mouthpiece. ③ If the patient is uncooperative or exhibits unstable vital signs, the procedure may be impossible or risky. Based on the inquiry, the use-related environmental factors, user responsibilities, and usage scenarios of the Enteral feeding tube for short-term use were identified. This research can provide investigating methods and key insights to companies interested in conducting an Formative evaluation of the Short Term Use Enteral Feeding Tube.
The purpose of this contextual inquiry is to visit the actual usage environment of the commissioned medical device, the Enteral feeding tube for short-term use, and investigate the users and the usage environment. This inquiry was conducted in the early stages of the medical device design process to understand usage environment factors, tasks related to usage, and user workflows.
Excluding the planning day, the execution took one day. The inquiry location was the Gastrointestinal Endoscopy Center at Seoul National University Hospital. The interviewee is affiliated with the Gastrointestinal Endoscopy Center.
The inquiry was conducted following the 'IEC62366-1:2015+AMD1:2020 Medical device-Part1: Application of usability engineering to medical devices.' This inquiry involved visiting the actual environment where the medical device, the Enteral feeding tube for short-term use, is being used, observing the usage environment and user interactions with the medical device, and conducting interviews with the intended users. Through this inquiry, environmental factors and tasks related to medical device usage that need to be considered during the design process were identified, as well as the workflow of user tasks. It was confirmed that users can be broadly divided into two groups: healthcare professionals and patients, with doctors primarily identified as the primary users. The workflow of the procedures was summarized as follows: ① Preparation and local anesthesia of the procedure area – ② Verification of the surgical location through endoscopy – ③ Dilation of the opening using a trocar - ④ Insertion of a guide wire – ⑤ Capture of the guide wire using a snare – ⑥ Removal of the guide wire from the endoscope – ⑦ Connection of the PEG catheter to the guide wire – ⑧ Placement of the catheter outside the abdomen - ⑨ Fixation with an external bumper - ⑩ Cutting the catheter and connecting the infusion adapter - ⑪ Disposal of used instruments and debris - ⑫ Regular outpatient follow-up appointments. The medical device is generally used in the Gastrointestinal Endoscopy Center of the hospital. Considering its characteristic of being attachable after removing clothing, the device is worn in a separate designated space. Potential interference factors in the use of this medical device include adapter detachment during patient activities or in the process of patient and caregiver usage while maintaining the post-procedure product. Hazards occurring throughout the procedure include the following: First, the risk of infection: ① Needle or scalpel injuries. ② Patient's bodily fluids may come into contact with the skin and respiratory system of healthcare professionals. ③ Some products, when inserted through the oral cavity, pose a risk of contamination and infection. Second, patient discomfort during skin incision. Third, aspects related to the procedure site: ① Some patients may have difficulty in identifying the exact procedure site, and incorrect placement may result in serious complications due to damage to surrounding organs. ② Insertion of a PEG tube can be highly dangerous if the path is missed. Fourth, aspects related to procedure duration: ① In some cases, the patient may need to hold a mouthpiece while undergoing endoscopy, making it difficult to breathe, requiring a faster procedure. ② Some patients may not be able to open their mouths wide enough to accommodate the mouthpiece. ③ If the patient is uncooperative or exhibits unstable vital signs, the procedure may be impossible or risky. Based on the inquiry, the use-related environmental factors, user responsibilities, and usage scenarios of the Enteral feeding tube for short-term use were identified. This research can provide investigating methods and key insights to companies interested in conducting an Formative evaluation of the Short Term Use Enteral Feeding Tube.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives