Kushal Kadakia

Nov 19, 2024 | acpjournals.org | Kushal Kadakia |Harlan M. Krumholz

Get full access to this articleView all available purchase options and get full access to this article. Supplemental MaterialReferences1. Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med. 2014;174:1781-1787. [PMID: 25265047] doi: 10.1001/jamainternmed.2014.41932. Egilman AC, Kesselheim AS, Krumholz HM, et al. Confidentiality orders and public interest in drug and medical device litigation.

Aug 12, 2024 | jamanetwork.com | Kushal Kadakia |Joseph S. Ross |Yale Collaboration

At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?

Feb 15, 2024 | healthaffairs.org | Kushal Kadakia |Vinay K. Rathi |Sanket S Dhruva |Maryam Mooghali |Claudia See |Joseph Ross | +1 more

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a request from Congress, initiated by Senators Durbin (D-IL) and Blumenthal (D-CT), to review FDA’s oversight of device recalls in the wake of the far-reaching and ongoing recall initiated by Philips Respironics, which affected 15 million devices.

Feb 6, 2024 | statnews.com | Kushal Kadakia |Joseph Ross |Vinay K. Rathi

Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure machines, known as CPAP or BiPAP depending on their design, are sophisticated medical devices that have been used for decades by patients with sleep disorders like obstructive sleep apnea.

May 15, 2023 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Joseph S. Ross |Kushal Kadakia

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022 For medical devices, the US Food and Drug Administration (FDA) designates the highest severity recalls as Class I, indicating a reasonable likelihood of serious adverse events or death occurring with use.1 For example, HeartWare Ventricular Assist Device System (Medtronic), which provides circulatory support for end-stage heart failure, was recalled multiple times between 2013 and 2022 for risks...