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A Little Good News and Lessons Learned: Progress in Hemodialysis Patient Safety from a New FDA Guidance Document


Posted By: Brendan Faulkner on Jan 26, 2016 in Firm News

FDA hemodialysis guidanceHemodialysis catheters come in various designs, are made of several different materials (polymers), and are distributed by multiple competing companies.  Thus, in any given hemodialysis center, there may be several different intravenous hemodialysis catheters in use among the patient population.  Critically, however, each catheter, because of its material and other characteristics, can only be used with certain site care agents.  For instance, a catheter that may be suitable for use with a particular antibiotic crème may not be suitable for use with an ointment.  This is due to the variations in chemical formulations among commonly available site care agents throughout the world (i.e. Betadine, Hibiclens, Bactroban, etc.). 

Despite this, it may not be uncommon for dialysis centers to use one particular site care agent for ALL catheters, without consideration of whether that agent was approved for each particular device in use at the center.  Even worse, it turns out that not all catheters are tested for all commonly used site care agents before the catheters are sold and implanted in patients.  Given that certain site care agents are known to degrade certain catheter materials over time, both of these practices are frightening.  An intravenous catheter, which provides access to a patient’s blood for hemodialysis, is a patient’s lifeline, and if it fails, the consequences can be catastrophic.

Part of the problem identified seems to stem from shortcomings in the FDA device “clearance” and/or enforcement process, and in part derives from testing and labeling failures by the device-makers themselves in the rush to get new products on the market and maximize profits. 

It was, therefore, encouraging to see the important changes contained in this FDA guidance document concerning the 510(k) process for hemodialysis catheters issued last week: "Implanted Blood Access Devices for Hemodialysis" (PDF)

There are many important recommendations in the guidance document, among which is that “Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.” The recommendation lists the disinfection agents FDA considers to be commonly used, states that testing should include those and perhaps other site care agents, and should simulate the intended clinical use and that those test results should be compared with the predicate devices.  If there are differences between the results, the 510(k) submission should include an explanation as to why this difference supports the substantial equivalence of the proposed device. 

Additionally, the new guidance document recommends that “labeling must identify any disinfecting agents that cannot be used to clean any components of the device,” that “any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter,” or, alternatively, “contraindicated disinfecting agents must be identified by a label affixed to the patient’s medical record and with written instructions provided to the patient.”

Sadly enough, the problem being addressed has been known in the industry and reported in the medical literature for years.  (It is hard not to think they would’ve come sooner were confidential product liability settlements not the norm.)  These new recommendations will save lives. (Clearer, more specific hospital and dialysis center policies and procedures concerning catheter site care would also help, as would improved training on such clinical policies and procedures.)    

The similarity of the discussed recommendations in the new FDA guidance to the issues in a case in which we represented the estate of a woman who died as a result of her catheter’s degradation from repeated application of incompatible site care agents (from failures in testing, labeling, and clinical care procedures) renews our hope that our efforts make the world a safer place.