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Irradiation indicators must be used as an aid to differentiate irradiated from non-irradiated blood and blood components.

Rad-Control blood irradiation indicators are registered with the FDA. However, this registration is only to be used within the US by Onpoint’s US distribution partner. All other markets shall follow European regulations where blood irradiation indicators are not classified as a medical product and therefore have no CE marking.

Yes! The intended use of irradiation tags is to check each individual blood product if it was exposed to irradiation.  The KEY question in blood irradiation verification is whether a specific blood bag was inside of the irradiation machine during the irradiation process. Irradiation indicator tags are not intended to check the irradiation machine or any dosage. The basic principle applies: “Check the blood, not the machine”.
If your facility’s protocol deviates from this principle please reach out to your Onpoint contact for further consultation/advice.

An indicator is an aid to differentiate irradiated from non-irradiated blood and blood components. It verifies that irradiation has occurred and should never be considered as radiation dosimeters.  Dosimeters measure the exposure and show which radiation dose was applied.

How to to properly adhere Rad-Control irradiation tags:

• Wipe off any condensation or oil from the blood bag prior to application.
• Apply the tag to a clean, dry surface on the blood bag; avoid any contact with the adhesive
• Keep a portion of the tag on the blood bag label for best possible adhesion.
• Using your thumbs, press down firmly to effectively apply the tags.

  Check out the PDF-file “How to get started in our download section!

All Rad-Control irradiation indicators are equally available and suitable for both Gamma and X-ray irradiation.

Rad-Control Irradiation Tags can be stored at room temperature. Temperature indicator cards indicate overheating at temperatures of 75^o C or above and are therefore not needed for the daily use in blood banks or laboratories.

Our 25Gy tags were systematically tested at extreme conditions (above and below recommendation). If the tags were exposed to temperatures below -4^oC, the indicator function can be fully restored after keeping the labels at room temperature for 24 hours before irradiation. Tags exposed to higher than recommended temperatures work as specified. Only temperatures higher than +50^oC cause irreversible damages to the indicator.

The main purpose of the irradiation indicator is to verify that the blood bag was inside the irradiator and the irradiation had taken place. During irradiation, the indicator colour changes gradually from red to fully black at a minimum of 25 Gy. Although the transition phase tends to be very short, the indicator cannot be referred to as a dosimeter at any time.

Yes, to avoid the migration of potentially harmful substances it is mandatory that the adhesive is certified for blood bags. For current certificates please contact Onpoint directly.

The outcome of the EU Manual on Borderline and Classification in  the Community Regulatory framework for medical devices in its current version is, that “blood irradiation indicators do not fulfil the definition of a medical device laid down in Article 1(2)(a) of Directive 93/42/EEC; therefore they are not considered to be medicals devices”. As a result, Rad-Control indicators are not CE marked.

X-ray machines are being used to screen mail for the presence of hazardous items. However, the dosage is minimal and there is no risk the irradiation indicators will lose their full functionality and purpose.

Rad-Control indicators do not contain any hazardous or environmentally harming components and can be disposed together with blood bags.

A reddish tint can be caused by several factors. The irradiation indicator tags are designed to get black at a minimum of 25Gy. It may be that in some areas of the canister a lower dosage was applied. We recommend consulting the dosage map to confirm the minimum dose. Another reason could be that the tags were inadvertently stored in a refrigerator. This is not harmful but might have an effect on the discoloration. We recommend storing the indicator tags at room temperature. If the tags were in a refrigerator, they should be stored at room temperature for 24 hours to fully restore their functionality. Other reasons could be factors influencing the interpretation of the color as for example the angle of light incidence.
Generally, a reddish tint is no reason for concern as long as there is a clear and unambiguous color change as stated in the IFUs.

Yes, this is typically due to some form of physical damage to the tag during handling. A red line may be visible if the tag is bent, bumped, or scratched. If the major portion of the indicator window turns black, you can rest assured that the blood product has successfully been irradiated.

Using the Rad-Control Barcode makes it technically impossible to double-irradiate the blood product since the irradiation result is entered into the IT system immediately after irradiation. In the case the blood product was irradiated a second time, the data will show that irradiation had already taken place before and the first irradiation result had already been entered into the system.

To verify the irradiation process, the indicator turns into an electronically readable barcode. The criterion for a positive verification is the electronic readability only, not the colour. Therefore, the barcode does not have to turn fully black.

Only after irradiation has the indicator field turned into a barcode. This barcode stands for “ok”. The IT software asks whether the irradiation was performed and the irradiation result “ok” can be scanned and automatically entered into the system.

The imprinted barcode enables a quick identification of the lot code. The barcode indicator however enables the digital verification of a positive irradiation result. This result can now be scanned – there is no more need for manual data entry.

We strongly recommend a touch contact reader, such as the Datalogic Touch 95/60 Pro. Scanning should be conducted from an ideal distance between 0 and 4 cm.

Depending on your current process, the Rad-Control barcode substitutes and optimizes a lot of steps before releasing the blood product, such as handwriting on each indicator (date, user) before irradiation, handwriting in protocol lists, manual entering data of protocol lists into the IT system, manual changing of the status of the product to „irradiated“ in your IT system.

The irradiation result is immediately stored in the system and digitally traceable right after irradiation. Prone to error handwriting and manual entering of irradiation results are not needed anymore and double irradiation is technically impossible.

After irradiation, the electronic verification has to be conducted in two steps:
1. Identification of the blood product
2. Confirmation of the irradiation result.
Only after the change of the status, the data of the next blood product can be processed.

This type of irradiation indicator does not work with a YES/NO information on the irradiation result. Irradiation produces different shades of blue to make it possible to classify irradiation results between a minimum and a maximum value.

Using the Rad-Control Scale helps to avoid to double-irradiate the blood product. In the case the blood product was irradiated a second time, the color will change to dark blue and show that irradiation had exceeded the maximum value and taken place at an unfavorably high dose.