FDA MAUDE / TPLC Integration in CAPTIS™

Medical Safety Databases and their Use in a Clinical Evaluation Report:

As part of the Clinical Evaluation process for a medical device, manufacturers are required to analyze broadly 2 types of data. One, which is held by the manufacturer, and another one which comes from various external sources, including published scientific literature, which can often form the bulk of this dataset. Apart from literature data, several publicly accessible Medical Device Safety Databases are available which can provide valuable post-market data to monitor device safety and performance.

Defined as a part of a medical device manufacturer’s Post Market Surveillance (PMS) plan, complaints with incidents where the device malfunctioned or caused a death or serious injury are to be reported to the country’s regulatory authority, along with any device recalls or safety notices published by the manufacturer. These then subsequently get published on country-specific medical device safety databases as Reports, Recalls, Safety Alerts or Field Safety Notices. In the United States, the regulatory authority Food and Drug Administration (FDA) maintains several Medical Device Databases. The Manufacturer and User Facility Device Experience (MAUDE), Total Product Life Cycle (TPLC), and the FDA Recall databases are some sources to dip into when finding external PMS data on your device. In this post we’ll discuss the our FDA MAUDE / TPLC Integration and how you can benefit from it.

The FDA MAUDE database contains reports of adverse events involving medical devices marketed in the United States. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Incidents in these reports may describe suspected device-associated deaths, serious injuries, and device malfunctions, with a wide range of causes (e.g., from manufacturing to usability issues).

Data can be extracted from MAUDE by three methods:

1. Using the Simple Search to search by single words or phrases
2. Using the Advanced Search to search by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, or
3. Downloading the data and conducting a manual search

1. 1. Variations in the “Brand Name”: Brand Names on MAUDE are not standardized, which leads to variations in the way the brand name for the same device is reported across multiple reports on MAUDE. Consider a device with the brand name XYZ-Plus. MAUDE may have reports for the same device under the following brand names: XYZ-Plus, XYZPlus, XYZ Plus, etc. Also considering possible spelling errors by reporters when submitting these reports to MAUDE, one must search for all possible variations of the brand name when searching for device names with multiple words.
   2. Multiple Product Codes: You can only search for one product code at a time. While this is fine for standalone devices, device systems with multiple components can include multiple product codes, which means multiple searches to cover all device components.
   3. Singular Searching: MAUDE allows you to enter only one product code, brand name or manufacturer name at a time when using the Advanced Search option. This translates to individual searches for each brand name in scope if writing a CER for a device family. Also, considering searches for similar devices and challenges with brand name variations (see #1 above); that’s a lot of searches to be conducted!
   4. Limitations around >500 results: The MAUDE database does not display or allow you to download more than 500 results in one search; MAUDE displays the following error message “500 records meeting your search criteria returned. The results are incomplete – please narrow your search.” To overcome this issue, one can split the date range into smaller pieces, download individual excel exports and stitch the data to get a complete dataset. This requires a level of manual effort and can be a potential source of error.

At Celegence, we understand operational challenges faced by device manufacturers and medical writers alike and use technology to overcome these. Hence, we developed the FDA MAUDE integration feature within CAPTIS.

Celegence’s CAPTIS technology makes an easy task of searching MAUDE and addresses all the challenges mentioned above.

1. Challenge: Variations in the “Brand Name”

CAPTIS Solution: CAPTIS lists all device brand names which have a report against them in MAUDE, ensuring no relevant record is missed out.

2. Challenge: Cannot search for multiple product codesin MAUDE directly.

CAPTIS Solution: Multiple product codes can be configured in the project settings within CAPTIS and you can search for the entire device system in the same search.

3. Challenge: Singular searching; cannot search for multiple brand names/manufacturer names in MAUDE directly.

CAPTIS Solution: Apart from multiple product codes, CAPTIS allows you to select multiple brand names and manufacturer names at the same time. One can save considerable time by searching for the subject device(s), the equivalent device, and similar devices, all in the same search.

4. Challenge: MAUDE does not display or allow downloads of more than 500 results.

CAPTIS Solution: CAPTIS has no limitations with respect to the number of results. One can view and download >500 results in the same search without having to split the date range or download and combine multiple excel sheets.

Fun Fact: One of Celegence’s recent clients had about 58,000 results on MAUDE! CAPTIS saved a considerable amount of time for the medical writing team by eliminating the need to split the date range, download and compile more than 100 excel sheets of 500 results each.

Total Product Life Cycle (TPLC) is a database within the FDA catalogue, which integrates premarket and post-market data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. A particularly useful feature within the TPLC database when doing FDA Product Code searches is the Device Problems table which provides an overall count of all Device Problems reported for a Product Code within the defined time period.

However, TPLC does not provide you an option to export this table in any format. The only way to export this data from TPLC is to manually copy and paste individual line items at a time, which is time and effort consuming.

At Celegence, we developed the TPLC integration feature alongside MAUDE on CAPTIS to eliminate the manual efforts required from medical writers to gather the data they need, saving time and improving their efficiency.

1. CAPTIS allows you to copy and paste the TPLC table with just a click of a button.
2. CAPTIS allows you to configure your TPLC report and to choose the brand names you are interested in. Along with the “Category Total”, CAPTIS provides you “Device Specific” totals indicating the number of reports for your chosen device(s) vs total reports for the entire product code.

3. CAPTIS gives you a ‘results cut off’ feature in the TPLC report configuration. This dynamic feature allows you to define a “cutoff point” enabling you to filter and view only those device problems which have a defined minimum number of reports.

Your medical writing team can benefit from CAPTIS with faster turnaround times for systematic literature reviews and more accurate end-to-end MDR/IVDR documentation support. To learn more and view a comprehensive demo of CAPTIS, reach out to info@celegence.com today or contact us online to connect with a Celegence representative.