Excerpt from MDDIONLINE Article – Published on Aug 07, 2023
The consequences of non-compliance in the medical device sector are financially substantial. As of August 1, the FDA has initiated nearly 30 recalls in 2023 alone, each potentially costing over $600 million individually.
The McKinsey Center for Government, known for collaborating with global stakeholders to enhance device operations, estimates that “non-routine” quality-related events like recalls and lawsuits will consistently cost the industry between $2.5 billion and $5 billion annually, reflecting ongoing concerns.
Costs for achieving and maintaining compliance with industry standards are also on the rise. The International Electrotechnical Commission (IEC) 60601-1 standards, applicable to electrical medical equipment, has seen its Version 3.2 recognized by the FDA. This recognition could amplify manufacturer certification expenses, potentially quadrupling the previous estimate of $10,000-$20,000.
The IEC 60601-1 standards focus on electrical medical products, incorporating metrics for validation across markets like the US, EU, Australia, Canada, Brazil, Japan, and Russia.
Achieving compliance involves certification from qualified third-party testing laboratories. This process evaluates devices independently from manufacturers, ensuring adherence to applicable clauses within the established standards. Nigel Syrotuck, a lead engineer at Starfish Medical, suggests in-house testing before third-party assessment to identify and rectify design flaws, potentially speeding up the certification process.
Internal testing methods, like the drop test, contribute to device durability assessment. The IEC 60601-1 has collateral and particular standards aligned with specific device types or functions, contributing to safety and quality.
Clearance and creepage distances are critical components of IEC 60601-1 compliance. They address isolation requirements between device parts operating at different voltages to mitigate risks.
Another relevant standard is the IEC 62353 series, which focuses on recurring testing after the initial certification. While 60601-1 is for development and initial certification, 62353 covers ongoing safety verification, excluding design-related clauses.
To delve deeper into this topic, please read the full article on MDDIONLINE.