Home-use Device Recalls: What You Need to Know to Mitigate Risk and Protect Patients
Overview
When a medical device is subject to a recall, manufacturers are responsible for informing their affected customers—healthcare providers, retailers, and distributors—to prevent use of the device in a manner that could cause harm. Unfortunately, for the growing number of patients being cared for in the home, the recall process is far less reliable, since there is seldom any direct communication between manufacturers and home care patients.
Without clear, understandable information, patients cannot accurately assess the health risks and may harm themselves by continuing to use an unsafe device, or by inappropriately stopping use of a device.
The communication of home-use devices recalls is a growing concern, and the Number 1 topic on ECRI’s Top 10 Technology Hazards for 2023.
Join ECRI’s panel of experts for a discussion about increasing concerns surrounding home-use device recalls. We’ll discuss actionable recommendations on how to reduce risks and meet challenges.
Learning objectives
During this live lab webcast, we’ll explore:
- Challenges associated with home-use device recalls
- Solutions to better support patients with recalls in home care settings
- How device manufacturers are working to mitigate risks
Register to view the recording
Agenda & Speakers
Jason Launders
Director of Operations, Device Evaluation, ECRI
Jason Launders has been at ECRI since 1998 and is currently the director of operations for the Device Evaluation group. Jason’s primary responsibility is managing ECRI’s laboratory-based evaluations of medical technologies. Jason holds a masters degree in Medical Physics and spent his earlier time at ECRI evaluating a wide range of diagnostic imaging technology such as: CT, MRI, PACS, and Digital Radiography. Today, he is responsible for developing the content of evaluations to ensure they meet the needs of our clients.
Rob Schluth
Principal Project Officer I, Device Evaluation
Rob Schluth is a project leader focusing on content development and program management for ECRI's Device Evaluation group. During his 25 years at ECRI, Rob has contributed to hundreds of the organization's device evaluations, problem reports, and guidance articles spanning a wide range of health technologies. Rob currently manages special initiatives for the Device Evaluation team and leads the development of the organization's annual Top 10 Health Technology Hazards report. ECRI's yearly report empowers those on (or near) the front lines of patient care to further the organization's mission of improving the safety, quality, and cost-effectiveness of healthcare across all settings.
Patrice Hughes
Senior Project Officer, Device Evaluation
Patrice Hughes joined ECRI Institute in July 1997. Her primary task is reviewing safety reports related to medical devices and identifying device specific and generic hazards. Investigation of these reports involves communication with device manufacturers to identify affected devices and provide guidance to mitigate the problems. Based on the investigation findings, ECRI published notices that describe the problem and provide recommendations with guidance on reducing or eliminating potential device-related risks. These articles are distributed to ECRI Institute’s member hospitals via a number of the organization’s publications, including the Health Devices Alerts product.
Ismael Cordero
Senior Project Officer, Device Evaluation
Ismael Cordero is a Senior Project Officer at ECRI. Ismael's focus is the evaluation of medical devices used for intensive care and respiratory therapy. Before joining ECRI, Ismael worked in more than 50 countries where he led many training and consultative activities for biomedical engineers and technicians, clinical personnel, and hospital administrators. These activities included collaborations with the American College of Clinical Engineering (ACCE) and the World Health Organization (WHO). Cordero was the recipient of the 2008 ACCE Professional Achievement in Management Award and the recipient of the 2014 AAMI Foundation & ACCE’s Robert L. Morris Humanitarian Award. Ismael holds a B.S. in biomedical engineering technology from Temple University in Philadelphia, Pennsylvania, USA.
Tom Toczylowski
Associate Director, Alerts
Tom Toczylowski is the Associate Director of the ECRI Alerts product, which provides ECRI members with recall and safety notifications to help safely manage medical devices and other products. A proud ECRI employee since 2008, Tom manages a group of writers, editors, and data coordinators who all contribute to ECRI’s Alerts, recall management solutions, and inventory management solutions. Prior to coming to ECRI, Tom spent several years working in molecular research laboratories at Fox Chase Cancer Center and Thomas Jefferson University.