Arrow International Inc.

You have failed to appropriately validate the sterilization equipment and process in use. You could not provide documented evidence which established a high degree of assurance that the sterilizers and the sterilization process in use are effective and could consistently produce a product meeting its predetermined sterility specifications and quality attributes. You have failed to appropriately validate the software for the computer controlled sterilizers

The specifications for the software requirements for chambers _____ and _____ were not representative of the software currently in use. The software description document provided to the investigator was dated September 1993. This document failed to describe the intended functions of the computer software in terms of the inputs, processing, and outputs for each program element. There have been at least ten revisions made to the software between its installation in March 1995 and April 1996. There was no documentation available of any revisions made since April 1996. Neither Arrow nor the software manufacturer could provide information as to any changes made since April 1996. Although there have been numerous changes to the software, the software requirements have not been updated or revised to reflect the current operating system. Prior to March 1997 these changes had not been the subject of any attempt to validate the software. The significance of each of these changes and the potential impact on the system had not been evaluated

Sterilizer chambers _____ and _____ have been in use since March 1995 and April 1995 respectively. No software requirements testing has been completed on these computer controlled systems as installed. Although some testing was performed in March and April 1997 on these chambers, your firm has yet to complete its review of the data generated. The reason given for this failure was that Arrow was still working on the systems prior to initiating validation.

The software test plan which is currently in use to test the sterilizer software included no description of how test cases were developed or how thorough test coverage is to be achieved. There is no assurance that the software test plan currently being utilized is one which will provide complete test coverage. As the software requirements have not been updated since September 1993, assurance of complete test coverage can not be shown. The software test plan in use is not traceable to the current software specifications requirements for the system.

There is no documented correlation between the user requirements, software functional elements, and software verification activities to assure thorough test coverage. The verification activities in the test plan do not show traceability to established software requirements specifications to ensure that the specifications have been met.

We have completed our review of the response to the FDA 483 submitted by Mr. Confer on May 30. We have continuing concerns with the response which will be addressed in a letter to be issued to Mr. Confer this week. FDA has previously brought the need to properly validate sterilizer software to the attention of Arrow. This was discussed in a Warning Letter issued to your firm in August 1994. Your response should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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