Monday, May 13, 2019

   Sources of Medical Device / Equipment Field Use / Quality History

   Ques (heavily redacted) :  I am a South African medical doctor. I have been tasked by the         
   radiology department of one of our hospitals to do a review of medical diagnostic ultrasound 
   systems, specifically if there are studies looking specifically at the quality of the procured equipment 
   from the start.  I came across one of your articles and thought you may have some insights... 

Ans:  I'm not sure what article you're referring to, and the full nature of the assignment with which you've been tasked.  But, it sounds like you are to set up a system to review the quality of ultrasound products the hospital is considering purchasing.  If so, here's some approaches / suggestions: 
1.  ECRI Institute:
     I haven't looked at them for many years, but they used to provide analysis like the U.S.'          
     Consumer Reports, but on medical products;
2.  The U.S. FDA:
     The FDA maintains a MAUDE (Manufacturer's and Users Device Experience) database,
     which lists products that have been voluntarily reported to have problems (adverse events) in
     the field that could or did cause serious injury or death.  It's not complete, but it can provide
     an idea of field / use issues facing families of products cleared / approved by the FDA.
     You have to get the product's regulation number, by searching the US Federal Register, 21 
     CFR 800-series, and use that number in the MAUDE database.  You can also  search it by 
     common name / description, or manufacturer.  
     New US and EU labeling requirements -- UDI, GUDID (a database), are new but should 
     ultimately provide similar data globally.
3.  Only purchase products from companies following a quality management system, US FDA 
     CGMPs, 21 CFR 820 for devices / equipment, or ISO 13485 / EU MDD / MDR for   
     CE-marked equipment in Europe.  These companies are periodically inspected as to 
     adherence to those respective QMS', which means the equipment meet applicable
     standards / requirements, and were built / documented to required QMS law.

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