Significant Risk Medical Devices – General and Plastic Surgery

This chapter deals with the safety profile of commonly used surgical instruments in both the general and plastic surgery domains. Risks are based on their potential implications for patients. Significant risks can have profound and immediate consequences, while nonsignificant risks are those that may not pose immediate threats but can impact surgical outcomes or patient comfort. The difference in risk status of the medical device is determined in accordance with Investigational Device Exemptions (IDE) regulation (21 CFR 812). Devices in plastic surgery domain are further categorized into diagnostic, prosthetic, surgical, and therapeutic devices. An awareness of the scope of use errors as outlined for each of these devices below is important in preventing the occurrence of such errors.