We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byBryanna Chanley
Modified over 2 years ago
© Safeguarding public health MHRA Adverse Incident Centre IT system developments Roy Saunders November 2007
Roy Saunders © The advantages of reporting online Why our IT system developments are so important to us – and to you
November 2007 Roy Saunders © Adverse Incident User & Manufacturer Reports Risk Assessment Data input Investigation Action AITS Adverse Incident Tracking System Medical Device Alert for (Immediate) Action CA notification Other regulatory action incl. Safeguard action One-liners Device Bulletin Other advice e.g. wall posters Monitor and trend Education tools: manufacturers and users & manufacturer and user actions
November 2007 Roy Saunders © Adverse incident reports: Sources
November 2007 Roy Saunders © Do you personally (i.e. under your own name, and in your role as a Liaison Officer), submit medical device adverse incident reports to the MHRA? (select one option) A. Yes B. No Q1
November 2007 Roy Saunders © If you do submit reports yourself, do you use the MHRA’s online adverse incident reporting system? (select one option) A. Yes B. No – I didn’t know there was one C. No – I don’t have access to the internet D. No – I choose not to report online Q2
November 2007 Roy Saunders © Online reports 2006 - 68% of total user reports submitted online
November 2007 Roy Saunders © Advantages of online reporting - speedy - accurate - different forms for different devices - automatic acknowledgement & ref no. - paperless
November 2007 Roy Saunders © Advantages of online systems - improved communications
November 2007 Roy Saunders © - improved communications
November 2007 Roy Saunders © Advantages of online systems - improved communications “ cc” function in online form use of email
November 2007 Roy Saunders © We are increasingly using email as the means of communicating with incident reporters. Would you prefer to receive all communications from MHRA: (select one option) A. via email? B. by post? C. by fax? Q3
November 2007 Roy Saunders © Advantages of online systems - improved communications “ cc” function use of email - electronic links to other reporting systems - greater visibility of investigation progress
November 2007 Roy Saunders © If you (MDLOs) were able to log into a private, secure area where you could send reports directly to our incident database. What information about your ‘live’ incident reports would you like to be able to find out there? A. confirmation that report is on database? B. date and outcome of incident report risk assessment? C. dates of correspondence with device mfr? D. date device mfr’s response received? E. date and outcome of concluded incident investigation? Q4
November 2007 Roy Saunders © Next steps - consultation & feedback - IT project life-cycle scoping design & development testing & implementation But in the meantime…
© Safeguarding public health Roy Saunders November 2007 Report online www.mhra.gov.uk
© Safeguarding public health Roy Saunders November 2007 Any questions?
1 14 October 2003medXchange© Private & Confidential Dental Implant Register & Patient Dental Profile.
Dakota State University.
Essentials of Incident Reporting. An Incident (or Near Miss) is: “any unexpected or unintended event … that leads to (or could have led to) harm, loss.
Peirsonpatterson,llp eDisclosure Solution ppdocs.com.
SQIN CIP November Supplier Quality Incident Notification Supplier Access via the Internet INITIAL This will be sent out when a.
ITS eRAM eResearch Animal Management Overview Presentation.
© Safeguarding public health Implementing Medical Device Regulation and Maintaining Patient Safety Name Nicola Lennard Date October 2011.
Online Access Request Process June 20, 2007 University of Michigan Administrative Information Services Online Access Request Process Amie Robison Presented.
London & Zurich Plc User Guide. Service Benefits Full on-line management of client accounts Paperless direct debit – no signatures required Standing orders.
Electronic marking of students assignments Carlton Wood 5 th July 2013.
User Guide. Service Benefits Full on-line management of client accounts Paperless direct debit – no signatures required Standing orders fixed not.
Incident Reports and field Safety Corrective Action ( FSCA) Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics.
Trainee Revalidation on SOAR An overview of the online processes.
Scarlett Gibb NIH Office of Extramural Research Office of Electronic Research and Reports Management Interim Chief, eRA User Support, Training & Documentation.
UK e-Health Week-20 April 2016 Child Protection – Information Sharing (CP-IS) Val Nugent SRO CP-IS NHS England Cathy Sheehan Clinical Lead CP-IS NHS England.
1 It’s 2 am… do you know where your policies are?.
Powerful Student, Finance, and Human Resources Administrative software exclusively for K-12 schools – public and private. Family Access.
Project Progress Tracking Advantages –Automatic request for reporting. –Uniform Reports available in a central location. –Management at all levels can.
PROACTIS: Supplier User Guide Invoicing. Introduction Why PROACTIS Invoice Management Invoice Notification Viewing an Invoice Acknowledging invoices Accepting.
Steps to setup parent account to Go Green. Go Green The Go Green initiative is a set of features that allows schools to send electronic notifications.
Tell me about my Personal Health Record Contains your personal health information Combines medical information from your insurance claims with health.
Animal Tracking Component Private and State Animal Tracking Databases (ATD) Animal Trace Processing System (ATPS) National Animal Identification System.
Sponsored by. NTBs SMS and Online Reporting and Monitoring System NTBs.
A Product of Copyright © ANGLER Technologies AURA – Quality Compliance Monitoring & Process Management System.
Web Order Approval A convenient, time-saving way to approve your organization’s online purchases What is Web Order Approval? A variety of approval settings.
EIRB Training IRB Committee Member A Paperless IRB System.
16 February, 2003medXchange Private & Confidential 1 Implant Register & Patient Implant Profile for: Orthopaedic, Cardiovascular, Diabetology.
Practical Implications of Electrical Product Safety Regulation in Ontario International Consumer Product Health and Safety Organization Sixth International.
Your Guide. Table of Contents Welcome to MyChart…………………………….…..3 How to Sign Up………………………………… MyChart Homepage (navigating through MyChart)……...
© Safeguarding public health Adverse incident reporting now and the future, roles and responsibilities Mark Grumbridge.
NHS e-Referral Service Making paperless referrals a reality.
Medical Device Management and the Safe use of Medical Devices within RCHT Janine Webster (Medical Device Training Officer)
Where are States Now? Preliminary Legal & Security Survey Results Jim Whitter National Governors’Association Center for Best Practices January 9, 2001.
Discipline, Crime, and Violence August New DCV Application The DCV application and submission process has been revised beginning with the
Chp 1 Electronic Medical Records Lesson 4: Electronic Medical Records.
AB MEDICAL UK How to book an appointment online. Click the online booking icon, From the website,From the app,
Virtual Health & Safety Management System (VHSMS) A Brief Guide for Head Teachers.
Advanced NEOGOV Workshop November 13, NEOGOV Help & Support Human Resources Division –HRD Consultant ( ) –Terra Ellerbe ( )
Agenda Message Class Update SAIG Transmission Header Changes School Testing Software Developer Feedback.
Agenda The role of MHRA, Hospitals and the Manufacturer Incident Reporting Signal Detection Medical Device Regulation Managing Medical Devices Devices.
SEARO –CSR Early Warning and Surveillance System Module Event-based Surveillance.
Online Booking Instructions. Access the login screen via the link provided or our website.
THE SIMPLE GUIDE: COMPLETING AN INJURY/ACCIDENT REPORT For KPBSD Staff Members.
Coaching Comments are meant to be specific comments and/or suggestions in relation to an indicator or area of leadership team planning (e.g. team meetings,
Application Process USAJOBS – Application Manager USA STAFFING ® —OPM’S AUTOMATED HIRING TOOL FOR FEDERAL AGENCIES.
Member Mail Order Helpful Hints, Reminders and Tools.
LS029_V11 : Know Your Health Trend Convert your $100 wellness benefit into a $750 executive health package The health package is a free benefit, already.
WELCOME to the Business Services and Financial Aid.
© 2017 SlidePlayer.com Inc. All rights reserved.