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Software Controls...
In 1990, a Canadian medical device company with an excellent reputation accidentally caused the death of several Americans as a result of some last minute, uncontrolled software changes to a radiation therapy treatment system. The patients died over a period of a week or so from a radiation therapy treatment system. The realization that the device was causing those deaths - required several weeks and the deaths of more patients to pinpoint the cause.

Right before the weekend, a well meaning programmer responded to user complaints and hastily sent this fix to several radiation therapy treatment sites. This quick fix modified the design of proprietary software to solve a minor timing problem. The change was implemented on a casual basis - WITHOUT any procedural or documentation controls of the design. The problem was that ...If an operator typed information through the keyboard too fast, the program caused a FATAL fault. If an operator typed information through the keyboard slowly the program functioned correctly and the therapy treatment was as expected. Unintended effects were not anticipated. This software modification to the software in the field had not been properly retested.

This failure demonstrated a fact that shocked the FDA- that a failure in the software could have equally undesired effects, as could the hardware. Prior to this as part of the review process, software was treated as a nuisance. No more.

Since that occurrence, The Safe Medical Device Act enforced by the U.S. Food & Drug Administration has required that software be treated with equal prominence to hardware at every occasion. This equal prominence includes items such as: parts lists, revision control, specifications, testing, documentation, etc. If you want to delay your submission and generate many questions for additional information, just design controls on software and treat software with cavalier disregard. Watch how the FDA deals with you.

The Safe Medical Device Act requires a control systems {refer to design controls} to accumulate and track all adverse reactions to a device or device deficiencies. This act requires:

The manufacturer to maintain a central repository to collect all adverse reactions so appropriate remedies can be implemented. Hospitals must report adverse reactions to medical devices directly to the FDA.

Although these reporting requirements are not part of a determination of substantial equivalence of a device, the FDA requires under the category of safety that all 510(K) submission must demonstrate this capability as part of a 510(K). copyright by Compliance Consultants, Stamford, CT USA, September 2001