Top Ten Reasons Why Electronic Medical Products Fail Safety Testing

From design flaws to incorrect documentation, electronic medical products fail safety certification for a number of reasons. Some of the most common errors we see can be detected and corrected before final assessment, making for a faster and less expensive test program.

We asked our experts to share the ten most frequent failure modes they see: 

Incorrect Symbols and Marking of Equipment During a product’s design phase, it is vital to follow the standard’s guidelines on appropriate markings, as these are critical to classifying the safety of the product for the end user. A growing number of medical devices do not have the proper symbols and markings on the exterior and interior of the device. As these are outlined in IEC 60601-1, it’s important that they are used correctly while conforming to the requirements of IEC 60878.

Incorrect Instructions For Use User instructions are considered part of electronic medical products when a test house receives a product – and like the product itself, they must be inspected. Common sources of user instructions failure include

• No explanation of symbols
• Inadequate wording for indications of use, or overly-complicated instructions
• No troubleshooting guide
• Non-itemized accessories and consumables not itemized
• Name, address and contact details of the manufacturers
• Intended use of the device and contraindications

Lack of a Risk Management File (RMF) A major change to the previous version of IEC 60601 is the manufacturer’s responsibility to mitigate risks to medical product safety. To do so, it is important to have a complete documented history and traceability of any risk analysis, and the way in which these risks are mitigated in the RMF using recognized methodology. 

This file also needs to consider risks arising from the use of the device (usability) and from the software. Usability is increasingly important, as medical product design needs to show that the operator/end-user needs have been considered in its safe operation.

Insufficient Cleaning, Disinfection and Sterilization If a product has insufficient creepage/clearance distance, or if enclosures are not designed to adequately prevent liquid ingress, insufficient cleaning or unsatisfactory disinfection and sterilization can result. These defects also allow moisture to enter the product, resulting in non-compliance.