Author: Rachel Benway, Product Manager, Reed Tech
Numerous Public Databases
Abundant data is available about medical devices through the FDA including Approvals & Clearances, Adverse Events (MAUDE), Recalls, and Unique Device Identifiers (GUDID). Unfortunately, all these databases are managed and maintained separately, so it’s not a straight forward process to match an adverse event to the same products approval or a recall. The creation and use of GUDID attempts to solve this issue but even when GUDID information is included on recalls and adverse events, it is found in unpredictable locations and formats. Until GUDID is implemented in a more complete fashion we must use other identifiers to match data from one database to another. It is important to be able to create linkages between the database to enable analysis of the devices, comparisons between devices, and to see trends as they are emerging.
Data Research Centralized
Reed Tech built the Reed Tech Navigator™ for Medical Devices application to enable analysis of class II and class III medical devices. It begins by building and maintaining an extensive database of medical device companies and products. We start by identifying all the medical device companies, looking at the FDA establishment registrations and owner operators along with the FDA Approval & Clearance Applicants as these are primary sources. We then use the proprietary LexisNexis corporate affiliations database to help identify ultimate parents, subsidiaries and generally how companies relate to each other.
Next, we evaluate all the Premarket Approvals and Humanitarian Device Exemptions for class III products; and 510(k) clearances along with de novos and the GUDID listings for the class II products. This should give us the universe of class II and III medical devices as long as the manufacturer is following the FDA mandated regulations. Finally, we attempt to match each event to the appropriate products and companies. These events include: FDA Device listings, Adverse Event reports from the MAUDE database, FDA Recalls, Warning Letters, and more.
Cleansing is a high priority for us since the FDA data can be messy and contain varying names for products and companies. We evaluate the event data as it is gathered and avoid duplicates whenever possible. Our data cleansing process also looks for keywords like formerly known as, doing business as, and also known as when dealing with company names. Each of these name variations are saved as a company alias.
Similarly we monitor for products being sold under different brand names which can happen over time or even at the same time. Moreover, we use identifiers whenever possible to match events to products – such as GUDID, premarket submission numbers, and establishment registration numbers along with the brand names, manufacturers, FDA product codes and the Global Medical Device Nomenclature (GMDN).
Medical Device Classifications and GMDN
As of the beginning of April 2020, the FDA has 6,589 medical device classification codes. Whereas GMDN has 23,902 active terms to describe and classify medical devices. GMDN terms in some cases are more specific than product codes and in some cases the opposite. Within Navigator we use these two hierarchies to classify medical devices and find devices of similar types. The application can be searched by FDA product or device type. When someone searches by FDA product code, all devices with that product code are returned so it can be assumed there is some similarity between the devices. If the FDA product code is not known, you can also search by device type which is an open search field that matches the entered terms with GMDN code term names. Any search results can be filtered by a specific GMDN term. Once a set of similar products is selected they can easily be compared to see how each measures up in terms of adverse event types, recalls, device hazards and patient problems.
The use of GMDN provides some certainty that the selected devices are indeed similar and suitable for comparison. Evaluating similar devices is an important part of risk management, competitive intelligence, and regulatory intelligence. It can be especially important to look at similar products when a product is very new or still premarket as little is known about the new device. If the device is still in development, looking at how similar devices have failed can help inform design choices.
There is still a long way to go to track medical devices throughout the life cycle but using the identifiers we currently have is a first step in the right direction.
Reach out to our team to experience Navigator for Medical Devices for yourself: (267)961-0232 or firstname.lastname@example.org.
About Reed Tech
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.
About the GMDN and the GMDN Agency – www.GMDNAgency.org
The Global Medical Device Nomenclature (GMDN) is a list of generic names used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The main purpose of the GMDN is to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety.
The GMDN is used for:
- Data exchange between manufacturers, regulators and healthcare authorities
- Exchange and analysis of market surveillance and vigilance information
- Supporting inventory control in hospitals
- Purchasing and supply chain management
Information in the form of a 5-digit numeric GMDN Code is cross-referenced to a precisely defined Term Name and Definition. For example:
- GMDN Term Name: Scalpel, single-use
- GMDN Code: 47569
- GMDN Definition: A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.