European blood safety directives set standards of quality and safety for the collection and testing of human blood and blood components, which these button dataloggers may help meet
The blood safety directives 2002/98/EC and 2004/33/EC became law in Europe on 8 February 2005.
Member states have the choice to retain existing national arrangements for nine months thereafter, and the directives are due to be adopted into UK domestic law in November 2005 in the form of the Blood Safety and Quality Regulations 2005.
After this time, any person who knowingly sells or supplies blood or any blood component which is not labelled in accordance with the requirements of this regulation will be guilty of a criminal offence.
The Directives set standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, together with their processing, storage and distribution when intended for transfusion.
All blood donations (whole blood and blood components) will have to be traceable 'from vein to vein', that is, from donor to patient.
Article 14 of 2002/98/EC states that: "Member States must ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components, thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof ...
The system must unmistakably identify each unique donation and type of blood component".
Annex III in the Directive lists nine criteria for labelling the blood including its storage temperature.
At present the supply of blood is managed on a monopoly basis by the four UK Blood Services and Hospital Blood Banks run by NHS Trusts and private hospitals.
They are responsible for the collection, testing, storage and distribution of whole blood and blood components.
The UK Blood Services operate under guidelines agreed and promulgated by their Joint Professional Advisory Committee (JPac).
Hospital blood banks operate under guidelines issued by the UK Health Departments and professional bodies.
In 2003 the UK Blood Services issued more than three million units of blood and blood components.
The annual report of the chief medical officer 2003 stated that: "The quality and safety of blood and blood products in the UK is among the best in the world...
Nevertheless, the use of blood, like most medical procedures, can never be risk free"." Most of the requirements of the new directives are already being met but Brian Turner, managing director of data logging specialist Signatrol, believes stricter temperature monitoring will be essential to ensure compliance with the new regulations.
"If blood and blood products are allowed to go outside the stipulated temperature bands, the effects can be fatal.
"Unfortunately there is no way of knowing what conditions the blood has been subjected to in the supply chain if continuous temperature monitoring has not taken place.
"Both higher and lower temperatures outside the recommended limits can cause the blood to be unsafe and, although the regulations give storage temperature limits, there are currently no statutory guidelines relating to temperature excursions.
"It would appear that currently hospitals follow the '30 minute recommendation' suggested by the Blood Transfusion service, whereby any transfusion should be started no more than 30 minutes after the blood has been removed from storage at between 2 and 5C.
They advise that if it is not used within that time limit then it should be returned to the blood bank and suitably marked".
There are two key issues involved with keeping temperature records.
One is accurately measuring the temperature, the other, ensuring data is stored in a format which is secure, easy to file and straightforward to access.
These records need to be an integral part of other data storage systems allowing full traceability and, with the new regulation stipulating that all records must be kept for a minimum of 30 years, this presents an onerous task for personnel.
Brian Turner is confident his company is well placed to play a small yet important role in the implementation of the new directive.
"We already have experience in this area, having worked with the MOD for almost ten years, providing portable temperature loggers for monitoring the transportation of blood products around they world.
"We are also involved with monitoring the storage conditions of vaccines and, although this is not currently subject to EC legislation, we expect that to change sooner rather than later.
"Measuring and recording the temperature of blood and blood products during storage and local movement within a specific hospital is relatively straightforward.
"However ensuring a continuum of measurement when products move outside to different locations can be more difficult.
"Current blood transportation methods are routinely checked to ensure the packaging methods maintain the blood within the required temperature limits, but this statistical approach may not be deemed adequate for the new regulations.
"In this case the temperature profile of each and every box would need to be logged throughout its journey to be sure no temperature excursions have occurred".
Signatrol is working closely with third parties to provide a comprehensive portable blood temperature logging solution which can be used in both a practical and compliant manner.
The company believes its tiny SL50 data logging button is cost effective enough to be used in all transportation boxes, both externally and in hospitals.
At the start of a particular blood journey, the button can be issued from either a PC or a small hand held reader/checker, each with its own unique identifier.
Ideally, the system would be automated so there would be no user intervention at all.
The software would be polling the reader looking for a button present and, once one is attached, the data would be backed up and the logger issued.
At a preset delay time after issue, the logger starts to record temperatures at fixed intervals and monitors for alarm conditions.
Any two consecutive readings outside the acceptable band will result in an alarm flag being set.
Alternatively the button can be issued from a hand held device.
Only buttons that have had their data read and stored, and are therefore 'empty', can be issued for another mission.
At the destination, the button is placed into a small hand held reader, which stops the mission and flashes an LED indicator the colour of which varies depending upon the alarm condition: green - no alarm detected; red - alarm detected.
The LED will also flash red if the mission has exceeded a preset time.
The button is then returned to the issuing station where that data are downloaded and saved in a database.
An immediate notification of an alarm condition, if present, is highlighted on the screen.
The data can also be read from a remote station via the network, so that it can be included in an overall recording system supplied by others.
The temperature data is stored as a record, along with additional information including date and time, issuer and receiver ID, button serial number and alarm status.
Any system must be foolproof and simple to use, especially in emergency situations.
As Brian Turner concludes: "We have developed our own flexible and powerful Windows based software which features a single platform across all our logging products.
"This offers significant advantages especially for handling data from different applications across multiple sites and different users.
"We have also developed FDA compliant software for use with electronic signatures.
"This approach means that data can be accessed and shared nationwide."
