Ethics, Health & Safety

Biocompatibility and sterilization concerns

Because the adapter interfaces with devices that enter the bloodstream, sterility, and biocompatibility are critical. Our prototype was fabricated using resin-based 3D printing, which allowed rapid iteration but did not meet medical-grade sterilization requirements. The printed material is not biocompatible and has not been validated for sterilization methods such as ethylene oxide, which are standard in clinical use. As a result, prototypes serve as a successful proof-of-concept, but they are not safe for human use in their current form. Future iterations must use medical-grade thermoplastics and undergo proper sterilization validation to meet FDA and hospital standards, ensuring the adapter does not pose an infection or biohazard risk.

Biocompatibility

Biocompatibility is essential for any medical device that comes into contact with internal tissues or fluids. Although our final prototype was not fabricated using biocompatible materials due to resource constraints, we designed the adapter with future clinical translation in mind. Ideal materials for this device would include medical-grade thermoplastics or biocompatible resins that do not trigger immune responses or tissue irritation. These materials must also withstand sterilization processes without degrading or releasing harmful substances. Transitioning to biocompatible materials will be a critical step toward making this adapter safe for patient use in real-world hospital settings.

Patient and clinician safety considerations

Patient and Clinician Safety Considerations were central to our design process. The adapter is intended to reduce risks during emergent transvenous pacing by minimizing back-bleeding, which can lead to blood loss and contamination. The secure fit of the adapter protects the patient from hemodynamic instability while also preventing blood exposure to the clinician, reducing biohazard risk. Additionally, the design minimizes the need to remove and replace vascular access sheaths, which shortens procedure time and limits potential injury from repeated insertions. While our prototype is not made from sterilizable or biocompatible materials, future versions would address infection control and sterility, ensuring the adapter meets clinical safety standards for patients and healthcare providers.