From a potential cybersecurity risk for some insulin pumps to health equity issues with pulse oximeters, here are four medical device updates the FDA has published as of Sept. 15:
1. The FDA said it will meet Nov. 1 to discuss the potential issues with pulse oximeters, which recent studies have found to be less effective for patients with darker skin colors. The agency first acknowledged the problem early in 2021.
2. Baxter recalled more than 500,000 solution sets used to deliver chemotherapy drugs after the company received dozens of complaints about the product leaking. This is a type 1 recall, the most serious type, because the leaking could expose healthcare workers to hazardous drugs or delay treatment for cancer patients.
3. The FDA updated its recommendations for healthcare workers for Medtronic's recall of nearly 400,000 endotracheal tubes, which has received two reports of deaths related to the issue.
4. There's a potential cybersecurity risk for Medtronic's MiniMed 600 Series Insulin Pump System because the product has wireless communication components that can be compromised. There have been no complaints related to the issue.