Development of a Medical Device in Response to a Fatal Self-Injection of Non-prescribed Opioids: A Case Report.

Patients who inject drugs (PWID) pose unique challenges in their medical care due to risks of increased infection and overdose. There are no known commercially available devices to prevent patients from self-injecting non-prescribed substances into vascular access devices (VADs). A patient in the emergency department (ED) of a midsized suburban hospital self-injected an opioid in the ED restroom after the placement of a vascular catheter by the nursing staff as part of her ED care. Despite precautions taken for a patient with a known opioid use disorder (OUD) and a history of self-injecting non-prescribed substances into VADs, the patient suffered a self-induced fatal overdose. PWID are at significant risk of self-injection when requiring intravenous medications as part of their medical care. This case highlighted the need for formal reporting for patients who self-inject non-prescribed substances into VADs. It revealed a lack of medical devices to help providers ensure that PWID cannot access their medical devices when intravenous therapy is indicated.

Evaluation of the Functionality in an Emergency Department Setting of an Intravenous Protection Device to Prevent Self-Injection.

Background: The United States has an opioid abuse crisis that has been increasing exponentially since 2013. In 2021, there were 220 deaths each day from opioid overdoses in the United States alone. Patients suffering from addiction often present to the emergency department (ED) anticipating that an intravenous (IV) catheter will be placed. This catheter is then accessible for patients to self-inject illicit drugs while under medical care or elope from the facility with the IV in place to self-inject. The misuse of medical IV access is a potential source of prolonged hospitalizations and fatal overdoses nationwide. On two separate occasions, patients were found dead in our ED bathroom after overdosing by accessing their IV site for self-injection. These events prompted the development of the IV SafeLock prototype. The IV SafeLock is designed to prevent intravenous access by the patient while allowing access by specified providers to administer medications. This study aims to investigate prototype usability and functionality by nursing staff in the ED. Methods: A prospective study was performed with twenty ED nurses in a clinical trial to use the IV SafeLock in the clinical setting. Each nurse was given two months to complete an evaluation of 20 patients requiring IV access. They used the IV SafeLock on infusion ports and Intermittent Needle Therapy (INT) access sites. A Likert scale was used to measure the ease of function and use of the IV SafeLock. Results and conclusion: The nurses felt that the IV SafeLock was easy to use and achieved its function of protecting the intravenous access site from self-injection. The IV SafeLock prototypes used in the trial were easy to use and functioned as intended most of the time. The IV SafeLock can be used by nursing staff in a clinical setting to help prevent self-injection. Clinical Trial Registration: NCT05695183 enrolled 01/12/2023.