Alliance Endorses State Right to Repair Medical Device Bills
North Carolina Right to Repair Endorsement (Click to Download)Vermont Right to Repair Endorsement (Click to Download) The Alliance for Quality Medical Device Servicing, consisting of TRIMEDX, Sodexo, Crothall, and Agiliti (the “Alliance”), would like to share our support and encouragement forH.160, the proposed Medical Device Right to Repair legislation that is being considered by the […]
Alliance One-Pager on Medical Device Cybersecurity
Cybersecurity poses a significant threat to our nation’s critical infrastructure, and no sector is impacted more than healthcare. Cyberattacks led by nation-states and other cybercriminals are a regular and growing occurrence. Current headlines depict the detrimental impacts of cyberattacks on patient safety and care and healthcare organizations’ finances. Healthcare is the: · most attacked, · […]
FAQ on Right to Repair for Medical Devices
Over the past several years, some original equipment manufacturers (OEMs) and associated trade associations have made sweeping claims towards the work of medical device third-party service providers. The following fact-based responses to those claims were assembled by the Alliance for Quality Medical Device Servicing. SAFETY: Services provided by third parties are unsafe for patients. In […]
Alliance Remanufacturing Position Paper – April 2023
Cybersecurity of Medical Devices Position Paper
Alliance Position on Right to Repair for Medical Devices
Alliance response to Senator Warner’s policy paper on cybersecurity for the healthcare sector
Alliance Opposition Paper to H.R. 7253, the Clarifying Remanufacturing Act
Alliance Comments to FDA on Cybersecurity of Medical Devices
Division of Dockets Management (HFA‐305)Center for Devices and Radiological HealthFood and Drug Administration5630 Fishers LaneRockville, MD 20852 September 22, 2021 Ref: Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities Docket No. FDA-2021-N-0561 Dear Sir/Madam: This is to submit comments to the discussion paper reference above. I. Introduction of Alliance Before providing […]
Comments on FDA Draft Guidance for Remanufacturing of Medical Devices
Dockets Management Staff Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 September 20, 2021 Docket No. FDA-2018-N-3741: Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff, issued on June 24, 2021 (the “Draft Guidance”) Dear Sir/Madam: This document is to submit comments to the Draft Guidance […]
Accountability in Medical Device Servicing
The care and servicing of medical devices is a subject that rightly commands much attention, particularly as the accessibility and availability of critical medical devices became a focused topic during the COVID-19 pandemic. Some of this attention increased calls for right to repair legislation pending in some states as well as similar legislation introduced in […]
STATEMENT ON FTC REPORT TO CONGRESS ON ANTICOMPETITIVE PRACTICES RELATED TO DEVICE REPAIR
Washington D.C. (May 7, 2021)The Alliance for Quality Medical Device Servicing applauds the Federal Trade Commission’s (FTC) new report to Congress on anticompetitive practices related to repair markets. As the report notes, the FTC found there is “scant evidence to support manufacturers’ justifications for repair restrictions.” The Alliance was pleased to see the FTC recognizes […]