ECRI Medical Device Recalls FAQ
A: Please contact your internal Loma Linda ECRI Coordinator Vicki Brown, 909-558-4000, extension 14018, or email vibrown@llu.edu.
ECRI Institute’s Alerts Tracker staff is also available to answer your questions about the information presented in Alerts Tracker system. Please contact us at 610-825-6000 or alertstracker@ecri.org.
A: View Only users receive only the content portion of every alert within a week’s broadcast. FYI users receive both content and tracking portions of Alerts broadcast only in the clinical/professional categories to which they have been assigned. FYI users are not required to respond to any alerts but have the ability to do so should they choose. Alerts Tracker users receive both content and tracking portions of Alerts broadcast only in the clinical/professional categories to which they have been assigned, and are required to respond to all alerts assigned to them.
A: According to the Joint Commission, location conditions and permissible volume specifications for gel ABHR dispensers to be installed in egress corridors are as follows:
- Locate your My To Do List, click on the link
- Click on the Accession No. (example: A22151) of the alert you wish to review
- Review the Alert Details and complete the Alert Tracking status portion of each alert
- You may “check” several check boxes and click View Selected to view multiple alerts
A: Yes, if you have alerts in your My To Do List or My New Assignments you need to respond to each one to clear them from your assignment list.
A: Yes. Click on the print ICON in the top left corner of the Alert screen. This will generate a new window, with the Alert displayed as a PDF document. Save the PDF version of the alert, and include it in your e‐mail as an attachment.
A: From the Health Devices Alerts index page, select those alerts that you are interested in viewing by clicking the check boxes adjacent to each.
Click Print View Selected, and a PDF of the alerts you selected will be created. You will notice a Table of Contents in the PDF that includes the Alert’s Accession No., Title, and Suggested Distribution. To view the alerts, click on a title in the Table of Contents or scroll down to the appropriate page.
A: The Action Notes field can hold 7500 characters including spaces and punctuation.
A: Compare notes and avoid duplication of effort by selecting the Alert Status tab from the Alert display page. Here, you can view the following:
- A list of users to whom the alert was assigned.
- The current status, most recent action taken, and most recent action notes for each user assigned to the alert.
A: If you are an existing ECRI Alerts Tracker user, click on the I forgot my password link located on ECRI’s Home Page (www.ecri.org).
Follow the instructions below in order to generate a new password for your account.
A: ECRI Institute assigns an action priority to each Alert, Hazard Report, and Special Report to guide your response to this information. ECRI Institute recommends that you respond to alerts in priority order, starting with any Critical Priority reports and working down to the reports assigned to Normal Priority. Reports are categorized using the following scheme:
- Normal Priority — Hazards, recalls, or other issues describing problems that, if left unresolved, may cause patient or staff injuries or other health problems, financial losses for the healthcare facility, or equipment damage. Although serious injuries or other significant adverse consequences may be possible, the probability of such consequences is low.
- High Priority — Hazards, recalls, or other issues describing problems that, if left unresolved, may lead to patient or user death, serious injuries or permanent health problems, significant financial losses for the healthcare facility, or severe equipment damage.
- Critical Priority — Hazards, recalls, or other issues describing problems that, if left unresolved, are likely to result in patient or user death, severe injuries or permanent health problems, or other significant adverse consequences.
A: ECRI has four alerts content channels covering medical devices, pharmaceuticals, blood products, and food. The medical devices channel covers a broad range of capital and durable medical equipment and systems, medical/surgical supplies, and products that may not always be thought of as medical devices such as contrast media and clinical laboratory reagents. Each alert posted in the devices channel is tagged with one or more of 50 clinical and professional specialty categories ranging from anesthesia to vascular laboratory. Definitions and inclusion/exclusion criteria for each medical device category is located here.
A: ECRI's healthcare product alerts database includes more than 70,000 recalls, hazard reports, and other safety notices. Tips on how to most effectively search the alerts database is located here.
A: To ensure that you receive the most comprehensive information available about medical device recalls and hazards, ECRI Institute continually monitors a number of resources. These include:
- Member- and manufacturer-submitted recall notices and safety alerts
- Reports of ECRI Institute’s investigations into medical device hazards
- U.S. Food and Drug Administration (FDA) sources, including the FDA Enforcement Report, FDA news bulletins, FDA press releases, FDA Patient Safety News, MedWatch, and the Center for Devices and Radiological Health recalls database
- U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Field Safety Notices and Medical Device Alerts
- Health Canada sources, including MedEffect notices and Medical Device Recall Listings
- Other international regulatory agency sources, including the Irish Medicines Board, the Therapeutic Goods Administration (TGA) of Australia, and the German Federal Institute for Drugs and Medical Devices (BfArM)
- U.S. Consumer Product Safety Commission recall notices
- The Joint Commission sources, including news releases and Sentinel Event Alerts
- Centers for Disease Control and Prevention (CDC) sources, including Morbidity and Mortality Weekly Report
- Various news media sources, including PR Newswire, the Associated Press, Reuters, the New York Times, the Wall Street Journal, and the Washington Post
- Various manufacturer Web sites
A: Please contact Environmental Health & Safety at 909-558-4000, ext. 58150, for more information on ECRI Medical Device Recalls, Hazards and Alerts.
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