ISO 14971 Fundamentals - Using standardized terms for more accurate risk analysis

Using standardized codes and terms for potential harms helps you in more accurately estimating and evaluating risks, and in responding more quickly to safety signals.

Do you use a standards harms table in your risk management process?

If not, you are likely to face challenges in accurately estimating risks during the pre-market phase and evaluating them for changes during the post-market phase.

According to the International Medical Device Regulators Forum (IMDRF), widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory authorities.

In the guidance document IMDRF/AE WG/N43FINAL:2020(Edition 4)¹, they also list these specific benefits for both manufacturers and regulatory authorities:

• Improved accuracy of capturing and reporting of medical device related adverse events

• More effective evaluation of adverse events

• Signal detection and trend analysis through advanced querying

• Consistency in reporting across different jurisdictions

• Increased accuracy and reliability of information shared between regulatory authorities

Regulators in the US and the EU have adopted the use of standardized codes for adverse events reporting. FDA Form 3500A and the MIR form in the EU, both required the use of codes. Increasingly, these codes are being harmonized to facilitate real-world data analysis through standard queries.

In this premium article, we will describe the current industry practice and explain why it makes sense to adopt a standardized terminology for patient harms and device malfunctions. In a future article, we will share a simple method to create a standards harms table you can use consistently throughout the risk management process.

Let’s dive in.