How current is the data?

The IMDD data is current through October 2018, although not for all countries. The database specifies for each source how current the data is.

Should I assume that companies named in the database have acted improperly?

No, medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the IMDD engaged in unlawful conduct or otherwise acted improperly.

Have you performed any transformations to the data?

The data comes from different sources which were not uniform in the presentation of   companies, device names and events. There is not a unique identifier that connects all the devices across countries. A device may have different names in different parts of the world. Model and lot numbers may be present, but it is not a standard practiceand there may also be variations per source. This means that sometimes what seems to be the same name could appear in different ways in this database.

ICIJ did not merge records with similar names, so there may be duplicates. The Event ID, when available, helps to identify unique events per country.

Names could have typos or be misspelled, but this is how they appear in the original databases ICIJ obtained. We did not perform any cleaning or standardization of the names, except to extract information on company and device names that were present in larger portions of text. ICIJ also translated the data into English when the original source was in a different language.

To aid exploration of the data, ICIJ added two additional categories: “Manufacturer Parent Company” and “Product Classification.” ICIJ used U.S. Securities and Exchange Commission filings and Dow Jones Factiva 2017 reports as primary sources to identify parent companies of manufacturers. The field was added for events starting in 2008.

The team also used FDA Device Classification by Review Panels to identify broad categories of medical specialties, such as cardiology and orthopedics, that would use specific devices. This classification was also used for other countries to enhance navigation. It was incorporated into the database doing matches against FDA’s class 1 recalls (a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death). The matches were not done against class 2 and class 3 recalls, which means not all devices outside the U.S. have a Device Classification linked to them.

Because this is a database that connects devices and manufacturers, isolated events with no device and manufacturer name were not included.

How did you link an event to a country?

The country field reflects the source of the data.

There are other entries that also provide country connections. For some sources, the address of the manufacturer that could be from a different country from the data source is present.

The United States data also provides information on whether devices recalled in the U.S. are being distributed in other countries.

Is there information that helps to confirm which version of a device was affected by an event reported in the IMDD?

The field Model / Serial offers more details about the device. It may include: model number, lot number or serial number. There might be variations across countries. The device details facilitate the identification of the product.

I can’t understand some of the terms used in this database. Could you help me with that?

This database contains information about recalls, safety alerts and field safety notices. For more details on these events check the U.S. FDA or local health authorities websites. Links to original sources are provided in the database.

Here are some frequent terms found in the IMDD and definitions provided by local authorities:

Recall

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that a patient must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.

Safety Alert

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Field Safety Notice

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Product Classification

The field identifies broad categories of medical specialties that would use specific devices, such as cardiology and orthopedics. It comes from the U.S. FDA Device Classification by Review Panel and was extended to other countries when needed to facilitate navigation.

Product Code

An identifier assigned to a device category by local authorities. Assignment may change by country. In the case of the FDA it is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time.

Product Description

A more detailed description about the device. It refers to more specific product information based on its use.

Distribution

General area of initial distribution of a product such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

Implanted device

An indicator that the device is placed into a surgically or naturally formed cavity of the human body intended to remain implanted for 30 days or more. It could also be determined by the health authorities from a specific country.

Device Name

Name of the medical device.

Model / Serial

A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Quantity in Commerce

The amount of defective products subject to a recall, safety alert or field safety notice.

Device Class

A risk based classification system for all medical devices. There may be differences between countries. The U.S. FDA classifies devices using the following values:

1 = Class I (low to moderate risk)

2 = Class II (moderate to high risk)

3 = Class III (high risk)

U = Unclassified

N = Not classified

F = HDE (Humanitarian Device Exemption)

Action

Measures taken usually by a manufacturer to address a problem with a medical device. It could include recommendations to patients and doctors.

Event Risk Class

A numerical designation assigned by local authorities to a particular event that indicates the relative degree of health hazard. Not all countries classify events by degree of hazard. There may be differences between the class systems, if they exist.

The most commonly used one includes a numerical designation (I, II, or III):

Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Event level

The level to which an event action has to be undertaken, based on the significance of the risk and the channels through which the goods have been distributed. In Australia the recall action levels are wholesale, hospital, retail and consumer.

Action summary

Short description of measures taken usually by a manufacturer to address a problem with a medical device. It could include recommendations to patients and doctors.

Extra notes in the data

Additional information provided by the original source

Date

Date associated to the record identified as such in the original data source.

Event Initiated Date

Date that the firm first began notifying the public or their consignees of the recall.

Event Date Posted

Date when the information related to the event was posted.

Event Terminated Date

Date that FDA determined recall actions were completed and terminated the recall.

Local Authorities Determined Cause

Local authorities determined general type of event cause. In the case of the FDA, recall cause determinations are subject to modification up to the point of termination of the recall.

Event Number

A numerical designation assigned by the local authorities to identify specific events in the data.

Reason

Reflects the causes of the action taken in regards to a specific product.

Event Status

Reports about the status of an event. In the case of the FDA a recall can be in progress (on-going), completed, terminated or pending.

Target audience

The audience the event report is intended to reach.

Event ID

A numerical designation assigned by FDA to a specific recall event used for tracking purposes

Manufacturer

Company behind the production of a medical device. It is usually the firm that initiates the event.

If you want to learn more about medical devices, you can check here.

Can I download all the data in my computer?

Yes, of course! Follow the instructions in this link. Remember that the ICIJ IMDD is licensed under the Open Database License and contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data.

How do I get in touch with ICIJ?

Contact us if you have any information that you think might be of interest to ICIJ. You can send us an email to contact@icij.org for tips and general questions or contact data@icij.org for data related questions.

If you wish to contact us in a secure manner, follow the instructions in this page, which includes a link to our Secure Drop server.

If you’re a journalist interested in collaborating with ICIJ, please send an email to data@icij.org. We welcome these new offers of collaboration but also ask for your patience, as we may only add a few new partners to each investigation.

This is not easy data to understand. It took great commitment from all of our current media partners to find stories of important public interest.

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ICIJ is a non-profit organization. We rely heavily on charitable foundations and on financial support from the public. We do not take funding from governments. Without our readers’ support, we cannot exist. Recent ICIJ funders include: Adessium Foundation, Ford Foundation, Hollywood Foreign Press Association, Jonathan Logan Family Foundation, Laura and John Arnold, Omidyar Network, Open Society Foundations, and the Swedish Postcode Foundation. Read more about our supporters here.