BB Refrigerator Temperature Verification

[Santa Beauchamp]

We are a Transfusion Service that is  writing to ask for an interpretation of 21 CFR 606.60 with regards to

 

Equipment	Performance check	Frequency	Frequency of calibration
Temperature recorder	Compare against thermometer	Daily	As necessary

 

All of our  storage equipment is monitored with the following:

1. Isensix-NIST traceable 24/7 remote monitoring system with alarms

2. NIST traceable thermometer in liquid located on the interior of the unit (upper and lower for large equipment)

3. Paper continuous trace chart recorders

 

Isensix is checked everyday with a “checkpoint” verification which is described in SOP as reviewing of temperatures, charts and displays to verify that everything is functioning properly and within acceptable temperature ranges.

Weekly all  of these monitoring devices are compared against each other for acceptability criteria.

 

It is our understanding that many blood centers have discontinued the use of the paper chart recorders and depend solely on the electronic monitoring system. Our question regarding the interpretation of this requirement is this:

Do we additionally need to manually read, record and compare the NIST traceable interior thermometer against the paper chart recorder on a daily basis? 

Do we additionally need to manually read, record and compare the NIST traceable interior thermometer against the Isensix reading on a daily basis?