FDA puts highest-risk category on infusion pump recall

Avatar July 2nd, 2013 Posted by Zohar Peretz( ) Recall

Recently the FDA start building new guidance for infusion pumps medical devices. Such product shall require more concern on their RISK assessment. There are in the market different solution for infusion pumps some are fully mechanical and some has embedded hardware and software. 

Those more advanced products requires higher attention on the integration between the system and in that manner to be able to isolate each sub system by its verification and validation procedure as well to include the integration test that treat the product as complete.

Since in some product there are replaceable parts it may come that displacement of those replaceable parts may cause increased flow of the fluid into the patient and in that way put patient in higher risk.

What type of mitigation can be suggested to reduce that risk?

GOBlock® Rapid Recovery System

About the author, Zohar Peretz

Zohar has 18 years of experience in leading software development products, at leading software companies and startups. Using his vast experience in software development, Zohar has identified the need for a holistic solution for R&D departments, and together with Rami and a small development team, they established Orcanos ALM in 2005.

Since then, Orcanos software has evolved to other domains such as quality control and specific industries, such as medical device.

Zohar holds a BA degree in Industrial Engineering.



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