Page 215 - Safety Risk Management for Medical Devices

194 Safety Risk Management for Medical Devices

Listening systems should be established and tuned in to various sources of informa-
tion. Examples of potential sources of information are as follows:
• manufacturing/production
• product service/repair
• returned product investigations
• customer service
• field service/customer visits
• clinical studies, e.g., postmarket clinical follow-ups
• customer complaints
• limited market releases
• product demonstrations
• databases such as MAUDE or EUDAMED
• legal department
• regulatory agencies, competent authorities (e.g., Field Safety Notices, Safety Alerts)
• suppliers
• distributors
• published literature on your device or similar competitive devices
• social media

Surveillance should include the applicable standards, such as ISO 14971. Changes
to safety related standards may require revisions to your risk management procedures
and risk management files.
The frequency of monitoring and trending of collected information should be
established and documented. It is advisable that the frequency of data monitoring be
based on the risk of the device. The higher the risk, the more frequent is the moni-
toring. For example, data monitoring may be executed monthly, quarterly, or yearly.
It is important to define the criteria for assessing the collected data. For example,
you may trend the monitored data using established statistical methods and set up trig-
ger criteria when trended data exceed predetermined thresholds.
One of the most important sources of customer feedback is complaints. Monitoring
of this source of information is critical to the proper tracking and management of product
field performance. In addition to providing insights to potential safety risks, complaint
monitoring could provide valuable information on customer experience and product per-
formance. This information could benefit product design teams to improve product
design for better performance, safety, and customer satisfaction.
Some of the sources that were mentioned earlier, feed information to the manuf-
acturer. Manufacturers passively receive the information from them and react to the infor-
mation. An example is customer complaints. Other sources must be proactively searched
for information, e.g., published literature or MAUDE database. Regulatory bodies
increasingly look for more proactive postmarket surveillance of medical devices.