Thursday, August 12, 2010

Is an IVC filter as safe as a thermometer ?

According to FDA ,it is !

The FDA has classified and described over 1,700 distinct types of devices and organized them in the Code of Federal Regulations (CFR) into 16 medical specialty "panels" such as Cardiovascular devices or ENT devices. The devices are classified into class I, II, or III.

class I, II, or III, depends upon the degree of regulation necessary to provide reasonable assurance of their safety and effectiveness. The class into which a device is placed determines the requirements that must be met before a manufacturer may distribute the device.
Class I includes  devices with the lowest risk and Class III includes those with the greatest risk.
Given these, lets look at some commonly used devices and their classification.

Class I - tongue depressor, gown, manual stethoscope, nasogastric feed tube, lead jacket used in radiology. 

Class II - EKG, EEG, clinical thermometer, IVC filter, x-ray machine, electronic stethoscope, iv canula, blood pressure cuff, left & right heart catheters, low energy DC defibrillator (that we use), trancutaneous cardiac pacer, occult blood test kit.

Class III - implantable pacemakers, heart valves, intra aortic balloon pump, hip joint prosthesis.

These are some examples. Looking at the list, it does not make much sense to have such a broad classification, as a occult blood test kit and a defibrillator has to go through the same process of approval before being released in the market!

Now with reports of adverse events with IVC filters (Arch of Int Med 2010), may be FDA need to consider altering their classification system,as this does not serve the purpose of classifying the devices according to their use and risk profile.
Does anyone have an explanation for this?? 


  1. Who coes up with the classification criterias??

  2. These classifications were made in 1976 in an effort to regularise the medical devices.Now we have a lot more devices than 1976, and this classification may need to change.

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