Patient monitor

Discussion in 'The Projects Forum' started by anhdtvt, May 22, 2009.

  1. anhdtvt

    Thread Starter New Member

    May 22, 2009
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    Anyone knows how to test the specifications of a patient monitor (accuracy, sensitivity, .... )? As I understand, the patient simulator will generate input signals for the patient monitor, but how do we know if the specs are all correct? how do we know the accuracy is 3bpm for example? Thanks!
     
  2. beenthere

    Retired Moderator

    Apr 20, 2004
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  3. KMoffett

    AAC Fanatic!

    Dec 19, 2007
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    We used calibrated simulators. They gave us standard waveforms (I, II, II, aVr, aVl, aVf, and V leads), pulse rates, and amplitudes. It all depends on what parameters you want to verify... and whether in the field or on the bench.

    ken
     
  4. jpanhalt

    AAC Fanatic!

    Jan 18, 2008
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    Regulation of medical devices varies by country. If you are in the USA, look up FDA 510(k) validation. There is a distinction between bedside testing, monitoring on-patient (e.g., ekg or pulse oximeter), and laboratory testing. Here is a reference to the FDA's validation requirements: http://www.fda.gov/cdrh/ode/parad510.html

    This all assumes that what you will be monitoring is well established in medical practice, so all you need to do is show equivalency to existing methods. If what you are going to monitor is new, validation is much more complex and requires additional clinical assessment and correlation at a minimum.

    John
     
  5. CDRIVE

    Senior Member

    Jul 1, 2008
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    Besides everything that's been stated thus far, the simulator itself needs to be certified by a credited calibration lab. This is odd though because any health facility would or should know this.
     
  6. anhdtvt

    Thread Starter New Member

    May 22, 2009
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    Thanks guys for answering my question. However, it is still not clear how I could check the specs of the patient monitor. Suppose I purchase a BM3 Bionet patient monitor and already have BC Biomedical PS2200 simulator. What do I need to do to check/test the performance of the monitor??? For example, the specs page shows the Heart Rate Accuracy of 3bpm, how I could know it is 3bpm?

    I would appreciate if anyone happens to know links/ documents explaining about this process.
     
  7. jpanhalt

    AAC Fanatic!

    Jan 18, 2008
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    In what country are you? It would be a waste of time going through the US FDA requirements, only to find that you are in Sweden or somewhere else.

    FDA has validation requirements for purchased, approved or cleared devices, modified devices, and new devices. Given a specific device and purpose one can dig through the FDA literature and other regulatory bodies (e.g., JCAHO) to get ideas of what validations need to be done. In my experience, those requirements will state what needs to be validated; however, it will not give a step by step procedure for doing that. The manufacturer of an approved or cleared device is expected to provide the bulk of the step by step information, which was likely submitted as part of the 510(k) process.

    The simple answer to your hypothetical is to contact the manufacturer and get its validation procedure. If you are the manufacturer, then you need to hire someone familiar with the process who has appropriate qualifications.

    John
     
  8. CDRIVE

    Senior Member

    Jul 1, 2008
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    Amen to that! In a hospital the Bio-Med Electronics dept is responsible for the maintenance end testing of such devices. If you're a credited health care provider they will test it for you and bill you for the service.
     
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