The need for this guide

The Usability Technical Committee 1817 of the Israeli Institute of Standards (SII) sought to adapt the international standard, hoping to recommend it to the SII as the standard for Israeli medical systems, as well as for Israeli customers of medical systems. The committee evaluated the international standard and realized that it describes adequately most of the usability problems typical to ME operation, but does not provide adequate solutions to these problems. Eventually, it became clear that the standard is not adequate for users in medical facilities

The main deficiencies found in the international standard are due to targeting two types of users: the customers and the manufacturers. The difference is in responsibility. When the user of a medical system misses an alarm because of alarm overload, it is the user who is considered responsible, not the manufacturer who failed to optimize the alarm rate. We found that the international standard often avoids providing explicit instructions that could  prevent medical mishaps.

To illustrate the limitation of the international standard, consider the following comment in section 5: ME EQUIPMENT identification marking and documents:

As applicable, the instructions for use shall caution against setting ALARM LIMITS to extreme values that can render the ALARM SYSTEM useless. 

The users of alarm systems cannot afford to focus their attention on the alarms. Typically they are busy doing all sort of tasks related to their job. They are liable to make errors in the setting of alarm limits. Sooner or later they will make an error, and a patient will be the victim. Using today's technology, there is no excuse for the manufacturer to letting the user make such errors.

On the other hand, the equipment can be designed to test the alarm limits and to warn the users when the system becomes useless due to improper limits setting. The manufacturer can protect the system against user mistakes much better than the user. However, the international standard does not require this simple test from the manufacturer. Generally, it does not enforce sufficient protection against alarm mishaps, such as unintentional off position, extreme alarm limits or inaudible alarms.

Other limitations of the international standard regarding the user needs:

  1. Insufficient instructions for how to evaluate the quality of the alarm system,  leaving much room for interpretations. (..\60601-1-8\html\AviEvaluation.htm - עברית)
  2. Insufficient instructions for assuring the quality of the alarms, leaving room for design mistakes (..\60601-1-8\html\AviQA.htm - עברית)
  3. The international standard is difficult to read and comprehend by users, mainly due to its arrangement in terms of features instead of operational activities (..\60601-1-8\html\AviReadability.htm - עברית).