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  • Writer's pictureTeam Hoodin

New feature for PMS & Vigilance intelligence

The latest addition to the Hoodin platform is the feature Data Feed for vigilance. Now, you may set up a data monitoring feed on databases such as FDA Maude, FDA Recalls, Bfarm (GE) and MHRA (UK) to retrieve a complete view of your products in a way that reaches the EU MDR / IVDR requirements.

In a few simple steps you will get a full report in just 15 minutes. The report may contain 18 months history of data from each of the adverse events, recalls and incident report databases. Once you have started your data monitoring feed, you will get updated figures and data every day.

These are the three simple steps to get a thorough PMS and vigilance monitoring up and running:

1 - Select the databases to have included in the monitoring feed

You may monitor FDA Maude, FDA Recalls, Bfarm and MHRA. For each created data monitoring feed, you may monitor one or many of these sources.

2 - Select monitoring terms / phrases per source

Due to differences in how one may monitor data and information per source, the input for monitoring queries are several and as a user you may use one or many of the input forms to create the exact feed and data you wish to retrieve.

For all sources, you may monitor them with an open search phrase.

For FDA Maude and FDA Recalls, you may monitor by use of product code

For FDA Maude you may monitor by use of the following inputs; Brand Name, Distributor, Device name, Manufacturer and Model number.

3 - Create your report

Within just a few minutes you will get the results from your monitoring feed and after creation the data monitoring feeds will be updated each day.

From the overview, where you will see high level data per term / phrase and source, you select a wanted time frame and also select what phrases and sources that you wish to add to a report.

Once the report is created, you will get two csv-file (excel sheet) that contains the following data:

Data sheet

Adverse event data sheet

The data sheet contains a compilation of the number of hits per phrase and source. You will from the data sheet also see what type of event each hit was registered as. Types are; Malfunction, Injury, Death, Others.

Information sheet

Advers event descriptions

The larger file is the event related information sheet. From the information sheet you will get a thorough and in depth description per hit (reported event). The information types are:

  • Event description

  • Link (URL) to each report

  • Publish date

  • Brand related (for monitoring product codes)

  • Reported device problem

  • Patient problem

  • Event type

A complete suite for vigilance / PMS

Besides the data monitoring feed feature in Hoodin, you may also monitor literature (+ 100 databases), clinical trials, regulatory updates (all major markets / legal health authorities). For those who really wish to keep an eye on market feedback (positive or negative) you may also monitor social media.

With Hoodin in place for vigilance and PMS monitoring, you have the most complete suite in place to have a smooth PMS and vigilance process in place. Besides vigilance and PMS, there are templates to monitor technical standards, market information and much more.

Besides the monitoring features, Hoodin is designed to make insights actionable. This means that you may easily share the retrieved information with peers in a safe and easy to manage manner.

Book a meeting with one of our experts to learn more and receive a 14-days trial

Got questions? Feel free to contact us HERE


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