An FDA-approved Irreversible Time and Temperature Indicator that ensures that only viable whole blood supplies are used post-transit

The high tech, low cost alternative to electronic dataloggers Delivery of unambiguous safety data FDA approved Ease of use Lower costs Less wastage Low carbon footprint

A critical issue for medical professionals is ensuring the viability of blood supplies once they leave the highly controlled storage environment, such as a blood bank refrigerator or a hospital blood storage facility. This aspect of the so-called blood cold chain is essential for ensuring that these are kept at the correct temperature right up to the time they are administered by trauma units, ERs, operating theatre staff, air/ ground ambulances, and any other situation requiring blood to be transported from storage units out to patients.

During transit, whole blood needs to be kept within a temperature range of 2°C/36^OF to 10°C/50°F. Below this range, there is a risk of freezing with the formation of ice crystals, rendering the blood unusable, while upper temperature breaches create the possibility of blood being affected by an overgrowth of non-specific bacteria, which may have entered the blood unit during collection or component preparation.

Both these situations have serious consequences: the cost implications of a wasted product and/or more seriously, a patient that is put at risk.

To address these issues, Timestrip® has developed its single-use Blood Temp 10 – a high-tech, low cost Irreversible Time & Temperature Indicator that effectively monitors temperature breaches above 10°C/50°F during transit.

No more guesswork

Thanks to its innovative technology, Timestrip® Blood Temp 10 removes this uncertainty by providing clear, unambiguous data as to whether a supply of whole blood is safe to use or be returned to storage.

This is achieved thanks to the smart label’s two indicator windows:

• the first window to indicate if the label has been activated

• the second to indicate if a temperature breach has occurred

Thus, at a glance, medical staff know if a supply of whole blood is not only safe to use post-transit. The smart label also ensures a higher level of quality of the product is delivered by monitoring of temperature throughout transit.

Moreover, thanks to its irreversible feature, once the smart label has reacted to a temperature breach, this cannot be undone. For security reasons, the colour of the label’s indicator window stays permanently changed.

FDA approved … and more

Timestrip® Blood Temp 10 has FDA certification (FDA 510(k) #BK190363) and is manufactured with controls established by a IQC approved quality management system that conforms with ISO 9001:2015 and ISO 13485:2016.

With a temperature accuracy of +/- 0.5°C, this means that the Timestrip® label is designed with reliable and, more importantly, trustworthy technology as assessed by some of the world’s most stringent criteria. Moreover, extra security is assured by every Timestrip® label having its own unique serial number, thus ensuring full traceability.

Checking this list of features brings further benefits to healthcare providers involved in the transportation of whole blood by also ticking the box for local and internal regulatory compliance.

Cost savings

Because Timestrip® Blood Temp 10 ensures that only viable blood supplies are either administered post-transit, or returned to storage, the possibility of precautionary disposal is eliminated. This reduction in waste can have significant cost benefits.

In fact, studies have shown that loss rates without a Timestrip® are around 5%. These are halved with its use. In fact, reducing a loss rate by 9.9% pays for the total investment and a conservative 19.8% reduction doubles the ROI.

The generation of similar positive temperature monitoring outcomes are possible using other products, such as electronic devices. These, however, are far costlier.

Ease of use

Apart from delivering clear, unambiguous data as to whether post-transit a unit of whole blood may be used or returned to storage thanks its innovative indicator windows, the Timestrip® Blood Temp 10 is also remarkably easy to use.

In fact, unlike other whole blood temperature monitoring solutions on the market, Timestrip® Blood Temp 10 is a unique FDA 510(k) medical device that does not require preconditioning. Moreover, it is also CE approved and designed for:

Prior to the transit of a unit of whole blood, a simple squeeze of the label’s activation blister is all that is required for temperature monitoring of a unit of whole blood to begin. Then the label just needs to stuck on the unit.

Squeeze, peel and stick – that’s it!

And the end of transit, Timestrip® technology has also been designed for maximum ease of use:

• until activation, the first indicator window is yellow and the second is white

• upon activation, the first indicator window turns green

• if a temperature breach has occurred during transit, the duration of the breach is indicated by the second white indicator window that proportionately fills up with blue dye

Product Specifications

10°C/50°F monitoring

Irreversible, single use

19mm x 32mm

Field activation

Visual proof of temperature exposure

Advantages over electronic dataloggers

Beyond being less expensive, Timestrip® Blood Temp 10 does not involve a datalogger’s complicated and sometimes cumbersome unit return program that is necessary to make it more affordable. The smart label’s single use indicator makes it the ideal fit for simple, straightforward and effective temperature monitoring.

The Timestrip® also is a super convenient shape: small, flat, with no batteries or any other electronic components to them.

For green credentials, the Timestrip® also outstrips traditional dataloggers in terms of carbon footprint, because the latter eventually needs to be either be thrown away or sent back to source to justify the expenditure.

Lastly, the Timestrip® has the potential of generating more accurate safety data. Indeed, because a container of units of whole blood will tend to use just a single datalogger, inevitably the temperature of ambient air within the container is taken into account, potentially generating less than accurate safety data.

With Timestrip® labels however, every single unit has its own temperature indicator. This means that the possibility of rejecting an entire shipment based on a single result is eliminated.

Whether in a major teaching hospital, a walk-in clinic or a doctor’s surgery, any type of healthcare boils down to two broad objectives: improved patient outcomes and the best possible use of resources.

Although historically reconciling patient health and the harsh realities of budgetary constraints have at times led to difficult choices, the fact is that by integrating technology and innovation into decision making around resource allocation, both objectives can be achieved at the same time.

Indeed, thanks to its high tech / low cost Time and Temperature Indicator labels, Timestrip® is able to provide healthcare providers and the pharmaceutical sector with a broad range of practical, user-friendly solutions that:

✔ Ensure product quality

✔ Reduce product waste

✔ Ensure regulatory compliance

✔ Reduce time and temperature monitoring costs

But what does this look like in practice?

Improving quality control and efficiency

Tenet Healthcare is US healthcare provider that faced the challenge of needing to effectively manage how it processed bags of whole blood. On the one hand, it faced the need to comply with local regulatory requirements related to the use of effective temperature monitoring for blood products; and on the other, it had to discard any bag of blood that had been exposed to a temperature above 10°C for more than 30 minutes.

The company needed to be absolutely certain that any unused bag of whole blood was 100% safe to be returned to storage for future use. It had also noted ongoing difficulties in using other blood temperature indicators. Potentially, the latter could lead to doubts about product safety, which in turn would require that bag of blood to be discarded, possibly unnecessarily.

Its use of Timestrip® Blood Temp 10 – 10°C Blood Irreversible Transit Temperature Indicator noted the following advantages:

✔ Improved quality of care

✔ Improved workflow efficiency

✔ Maintenance of quality control during transportation and storage

✔ Support in complying with regulatory guidelines

Cost-effective regulatory compliance

Marathon Distributors is a pharmaceutical and healthcare logistics services provider in Cyprus and is involved in the distribution of pharmaceutical products throughout the island. The main cold chain management issue it faced was around compliance with local and EU regulations, specifically the country’s Law on Human Pharmaceuticals 70(I) 2001 and the EU guidelines on Good Distribution & Manufacturing Practices. These mandated the company to ensure that the pharmaceuticals it delivered were not exposed to a temperature above 8°C for more than 8 hours during transportation.

Although other products helped achieve regulatory compliance, the company began using Timestrip® PLUS™ 8°C 8 Hrs (TP065) Irreversible Time and Temperature Indicators because they were much more competitively priced.

Overall the company reported:

✔ Timestrip Indicators were 50% cheaper

✔ Delivery costs were 50% lower

✔ Delivery times were faster

✔ Positive end-user feedback around ease of use

Easy temperature monitoring for vaccine transport

Cambridgeshire Community Service NHS Trust is a UK healthcare provider in south-east England. Part of its work is the delivery of school-age immunisations to schools in its area. This includes for instance flu nasal immunisations for primary schools and HPV vaccinations and Meningitis ACWY and TdIPV for secondary schools.

For the delivery of vaccines, electric Labcold Portable Vaccine Carriers and pharmaceutical-grade vaccine carriers are used. In order to maintain the efficacy of the various transported vaccines, two different temperature ranges need to be managed: 2°C to 8°C and -25°C to 25°C.

In order to ensure the delivery of viable, unspoiled vaccines, the Trust thus had a requirement for a dual, low-cost solution for use by its delivery teams.

To achieve this, two Timestrip products have been used in each vaccine carrier:

● a Timestrip® PLUS (TP 065) to indicate if the temperature went above 8°C

● a Timestrip® PLUS (TP 217) to indicate if the temperature exceeded 25°C, and if so, for how long

The feedback from the delivery teams has been extremely positive, specifically around:

✔ Easy to read visual data

✔ Ease of use

✔ Reliability

Reliable test kit time data

Clinical Innovations is a US maker of obstetrics devices that wanted to develop a non-invasive test kit for the diagnosis of any rupture of membranes (ROM). Although treatable, spontaneous ROM is a serious medical condition and a major cause of preterm births. Thus, an accurate diagnosis of ROM can be a key factor in determining timely and appropriate medical intervention. Similarly, a false diagnosis of ROM can lead to unnecessary hospitalisation, medication and even induced premature delivery.

Timestrip was able to provide Clinical Innovations with Time Indicators for its ROM Plus® self-contained test kit. These give clinicians the essential and immediate data they need to reduce the dangers of any premature ROM for expectant mothers and their babies.

The test kit uses Timestrip technology with an in-built 20-minute time monitoring indicator that generates the required data within 5-20 minutes, with 5,10 and 20 minutes clearly indicated on the Timestrip. Its key benefits are:

✔ Clear visual data

✔ Ease of use

✔ Improved health outcomes

Hygienic healthcare environment

Beyond pharmaceuticals and blood products, healthcare also involves various types of disposable items that need replacing regularly. Especially for the sick, hygiene in the clinical environment is an essential aspect of patients being able to make a full recovery. Timestrip indicators make excellent cleaning reminders for surfaces, filters and instruments.

Assuming the absence of any complications, catheters for instance need to be replaced every 30 days for Foley catheters and every 60-90 days for silicone catheters. Catheter bags however need to be replaced every 5-7 days. If these items are not replaced at appropriate intervals, opportunities are created for harmful pathogens to develop.

Unsurprisingly, this has also been shown to be the case for hospital privacy curtains. Dr Kevin Shek was the lead study author into the rate of contamination of hospital privacy curtains in a burns/plastic ward. In a report about the study findings in Nursing Times, he said:

“We know that privacy curtains pose a high risk for cross-contamination because they are frequently touched but infrequently changed. The high rate of contamination that we saw by the fourteenth day may represent an opportune time to intervene, either by cleaning or replacing the curtains."

Especially in busy hospital departments such as Accident & Emergency and ICU, hospital privacy curtains can quickly become contaminated with bacteria such as methicillin-resistant S. aureus (MRSA) and Clostridium difficile (C. diff). Thanks to Timestrip® Time Monitoring Indicator panels that change color after a set period of time, clinical staff are alerted when a privacy curtain needs to be changed. They help a hospital achieve:

✔ Best use of resources with a low-cost solution

✔ Compliance with guidelines around frequency of change

✔ Less time needed to monitor when that change needs to occur

✔ Hygienically clean hospital environment for patients