Approvals Will Be Harder To Get, But User and Patient Safety Will Improve with New Standards
By Ron Sills, Nerac Analyst
Getting approval for medical devices incorporating electrical components will become more rigorous and costly as a result of recently approved standards that are aimed at ensuring safe devices for both user and patient. Testing labs will surely benefit from the extra testing requirements, but they will have additional responsibilities to ensure that manufacturers have documented appropriate risk assessments. And, end users will have to be trained to understand the risks that manufacturers identify.

Here’s the background. In December 2005, the International Electrotechnical Commission (IEC) published IEC 60601-1, which was followed in 2006 by the American National Standard edition ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance. The FDA recognizes IEC 60601-1 as a consensus standard, implying that compliance ensures an acceptable safety level for a device. While this does not make it a mandatory requirement, it is expected that manufacturers should comply, or provide sound validation and rationale for the use of any other guidelines.

The ANSI/AMMI version is similar to the IEC document with the exception of a few requirements that were modified to meet the U.S. National Electrical Code and the National Fire Protection Association standards.

Risk Management Section Is the Key
While the original edition was published in 1977 and has been used with revisions since then, the newest revision is significant in that it includes a section on risk management and specifies individual safety requirements for user and patient. Risk management is essential to compliance, and the manufacturer must ensure that its risk management system is in compliance with ANSI/AAMI/ISO 14971:2007—Medical devices—Application of risk management to medical devices. This standard also was recently revised and will be issued in May.

IEC 60601-1 also includes provisions for design controls, while allowing the manufacturer the flexibility to ensure device safety according to the risks identified as most critical to the user or patient. The standard requires building in two levels of protection in various areas. In the event that the first level fails, there is a second safety level in place.

Compliance Is Beginning, But There Is More To Be Done
Many device manufacturers have already undertaken measures to ensure compliance. According to the Association for the Advancement for Medical Instrumentation (AAMI), copies of the standard have been selling at a brisk rate. It is expected that compliance will be required by 2009, so manufacturers will have time to plan accordingly. They will look to key industry leaders such as AAMI, consultants, ISO registrars and notified bodies to guide them through all phases of compliance, including documentation into their quality systems.