The IMDD data is current through October 2018, although not for all countries. The database specifies for each source how current the data is.
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.
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 practice—and 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.
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.
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.
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:
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.
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 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.
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.
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.
A more detailed description about the device. It refers to more specific product information based on its use.
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.
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.
Name of the medical device.
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.
The amount of defective products subject to a recall, safety alert or field safety notice.
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)
Measures taken usually by a manufacturer to address a problem with a medical device. It could include recommendations to patients and doctors.
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.
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.
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.
Additional information provided by the original source
Date associated to the record identified as such in the original data source.
Date that the firm first began notifying the public or their consignees of the recall.
Date when the information related to the event was posted.
Date that FDA determined recall actions were completed and terminated the recall.
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.
A numerical designation assigned by the local authorities to identify specific events in the data.
Reflects the causes of the action taken in regards to a specific product.
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.
The audience the event report is intended to reach.
A numerical designation assigned by FDA to a specific recall event used for tracking purposes
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.
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