Table 2.

Recommendations to improve Medical Device Reporting (MDR) and the Manufacturer and User Facility Device Experience (MAUDE) database

	Limitation	Recommendation	Owner
Event coding	Impossibility to identify patient harms and root causes associated with specific FDA device problem codes.	FDA patient codes and FDA investigational codes (methods, results and conclusions) publicly available in MAUDE.	FDA
Patient exposure	Lack of information about frequency of device use does not allow to estimate patient exposure.	The manufacturers could make their distribution/sales data available to the Health Authorities, upon request.	Global Health Authorities (including FDA), Manufacturers
Root cause identification	For the majority of reports the suspect sample is not available and cannot be evaluated by the manufacturer. Identifying the root cause of the event is especially difficult if the device in question has not been identified and directly evaluated by the manufacturer.	Global adoption of UDI: in order to identify the device and link the device to a serial number, UDI needs to be present on the device and readily accessible in the medical record. More guidance and training for the healthcare professionals on the importance of sending the device with all the adequate information (including UDI) to the manufacturer for evaluation, if the suspect device is explanted.	Reporting facilities, FDA, Manufacturers
Timely reporting	The MAUDE advanced search interface is updated monthly, and the search page reveals the date of the latest update. The FDA tries to include all reports received before the update, but the inclusion of some reports may be delayed.	More guidance and training on the importance of timely reporting should be provided to the different stakeholders involved in the complaint handling process.	Reporting facilities
Report source	Most of the MDRs from MAUDE come from spontaneous reports received from the manufacturer. This type of report may be associated with reporting bias.	Healthcare provider reports directly to the FDA need to be strongly encouraged via training and regulatory guidelines. Enriching the FDA MAUDE PMS data with data from medical device registries. In order to be able to link the registry data with the manufacturer reports data, common standardized dataset including UDI should be created.	FDA
Scope	MAUDE only includes FDA‐reportable complaints. If the complaint does not meet the FDA reporting criteria, the complaint will not be in MAUDE. MAUDE only includes complaints associated with medical devices that are marketed in the United States. If the medical device is not marketed in the United States, the complaint will not be in MAUDE.	Exchange of PMS data (including FDA‐nonreportable complaints and trend reports for FDA‐nonreportable complaints) between different Health Authorities. Development of a global repository to store global PMS data for medical devices.	IMDRF, Global Health Authorities (including FDA)

Abbreviations: FDA, Food and Drug Administration; PMS, PostMarket Surveillance; UDI, Unique Device Identifier.