Ireland Launches Device eAlert System, Quality Assessment Tool

To help prevent recurrences of medical device-related adverse events, Ireland has launched a national eAlert system intended for healthcare facilities.

The web-enabled system will help in the selection of a designated person at healthcare delivery organizations to take responsibility for receiving device alert notifications and distributing the information.

“A key component of the medical device vigilance system is the dissemination of information, which may be used to prevent recurrence of an incident or to alleviate the consequences of such incidents,” the country’s Health Products Regulatory Authority says.

The national eAlert system receives a notice directly from the HPRA of all medical device safety notifications. A priority level is assigned to each alert in accordance with the HPRA traffic light system of red, amber and green. Each notification has a response timescale within which the designated person reports to the Health Service Executive’s central Information Communication Technology system on whether the relevant action was completed or not applicable.

Implementation of the eAlert system coincides with the launch of the HSE Medical Device Management Quality Assessment and Improvement Tool.

The tool provides opportunities for service areas to gain an informed picture of the quality of services and practices in relation to medical device equipment. The assessment process allows services to identify gaps in current service provision, develop improvement plans to address these gaps and demonstrate accomplishments achieved in the management of medical device equipment, says Ronnie McDermott, medical equipment management lead at Cavan Monaghan Hospital.

“The QA+I tool will support the collation of information generated from the assessment process whilst enabling the development and monitoring of any associated derived quality improvement plans to progress compliance with the HIQA standards,” he says.

Our 100% Money-Back Guarantee

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic delivery.

$1,085 $885

Bonus

Subscribe to The GMP Letter and save $200 off the regular one-year price of $1,085 — plus receive a FREE copy of our webinar: Choosing the Best Device Sample Size for Verification and Validation:Tools to Safely Speed Your Device to Market — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — You get links to documents that support GMP's articles, such as 483s, warning letters, closeout letters, guidances, FDA notices and many others.

FDANEWS DEVICE DAILY BULLETIN — This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.