FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…

Device History Record

The FDA requires manufacturers to maintain Device History Records (DHR).  Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain.  The Device History Record is meant to be a collection of records containing all…

End of Life Notice – 13.4 Conductivity Standard Solution, 32 oz

Mesa will be discontinuing the sales of the 13.4 mS Conductivity Standard Solution Quarts-32oz (part number 02.0009). Effective immediately. Mesa will continue to sell the 13.4 mS Conductivity Standard Solution Pints-16oz (part number 02.0016). Please speak to your Mesa sales representative or contact Mesa directly with questions at medsales@mesalabs.com for more information. Let’s talk DialyGuard! Talk with…

New Legislation Enhances Kidney Care

The Chronic Kidney Disease Improvement in Research and Treatment Act, H.R. 1130 aims to enhance the efficiency of kidney care, eliminate access restriction to Medicare Advantage plans, and strengthen resolves to treat and avoid kidney disease and ESRD. This legislation adds to efforts that have been made to improve kidney care since 1972, when Congress…

A Brief History – Dialysis

Inspired by an article by John Abel, the first artificial kidney was born in 1943 thanks to the efforts of Dr. Willem Kolff, a Dutch physician. The dialyzer is now revered as one of the foremost life-saving medical technologies in existence, however, his early work was met with many hardships, from hiding the experiment during…

What is the Best Dialysis Treatment?

Currently, doctors recommend one method of Dialysis over the others to treat almost every patient due to treatment mortality rates. However, studies so far have only been observational in nature for their comparison of the treatments available, perhaps creating bias towards one over the other. It may be time to reassess these evaluations and start…