Alexander O. Everhart

1 month ago | bmj.com | Alexander O. Everhart |Pinar Karaca-Mandic |Rita F. Redberg |Joseph Ross

Research BMJ 2025; 388 doi: https://doi.org/10.1136/bmj-2024-081518 Cite this as: BMJ 2025;388:e081518 Alexander O Everhart, instructor1 2, Pinar Karaca-Mandic, professor3, Rita F Redberg, professor4 5, Joseph S Ross, professor6 7 8, Sanket S Dhruva, associate professor9 10 11 1Division of General Medical Sciences, John T Milliken Department of Medicine, Washington University School of Medicine in St Louis, St Louis, MO, USA 2Center for Advancing Health Services, Policy and Economics...

May 9, 2023 | jamanetwork.com | Vinay K. Rathi |Alexander O. Everhart |Soumya Sen

To the Editor A recent study1 reported that 11% of the medical devices cleared via the 510(k) regulatory submission pathway experienced a class I or class II recall. Even though I share the concerns of Dr Everhart and colleagues1 about unsafe devices, I believe they may have underestimated the recall rate for devices cleared via the 510(k) process. Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

May 9, 2023 | jamanetwork.com | Alexander O. Everhart |Yi Zhu |Ariel Stern |Soumya Sen

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance—Reply In Reply Dr Rathi’s comments describe a fundamental challenge when studying 510(k) medical devices. Researchers can observe individual clearances, but when are devices actually different or new? Changes not related to device design that seem trivial ex ante could affect patient safety ex post.

May 3, 2023 | ajmc.com | Alexander O. Everhart

This study examines the availability of cost-effectiveness analyses for medical devices, both in terms of the number of studies and when studies are published. ABSTRACTObjectives: Academic researchers and physicians have called for greater use of cost-effectiveness analyses in informing treatment and reimbursement decisions. This study examines the availability of cost-effectiveness analyses for medical devices, in terms of both the number of studies and when studies are published.