Timestrip will be discussing blood temperature monitors at ISBT Barcelona. The 38th International Congress of Blood Transfusion takes place in Barcelona, Spain this month.

Blood transfusion medicine experts from all over the world will convene from 23-27th of June.

Visit booth F87 at ISBT Barcelona

If you are attending, come by our stand F87. You will be able to see our blood temperature indicators being demonstrated, as well as learn about new blood bag monitoring solutions.

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.

Timestrip will be attending the 29th Regional Congress of the International Society of Blood Transfusion (ISBT) in Basel, Switzerland from 22nd - 26th June 2019

See our blood temp indicators

We will demonstrate our Timestrip® Blood Temp 10 and Timestrip® Blood Temp 6 at the exhibition. We will be at Booth U106, Hall 4.U, please drop by and get a sample of our Blood Temp indicators to take away with you.

Our Blood Temp irreversible blood bag temperature indicators monitor temperature compliance in blood bags. They are especially relevant for monitoring blood temperature during transit from the highly controlled environment of the blood bank to use or store in a different destination, such as a hospital.

ISBT is a society in the field of blood transfusion, transplants, science and medicine. It facilitates knowledge about transfusion medicine to serve the interests of donors and patients.

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

Tenet Healthcare is a healthcare services company is using Blood Temp 10 temperature indicators to monitor blood transportation. PDC Healthcare surveyed the company on their experience with the indicators. The survey reported the blood bag temperature indicators helped them significantly improve blood transportation quality control and workflow efficiency.

The Blood Temp 10 indicators helped Tenet Healthcare comply with regulatory guidance by having auditable proof blood core temperature was maintained when being returned to the blood bank.

Read the full case study below:

Tenet Healthcare Blood Transportation Case Study

Riverside Health System is a healthcare non profit that is using Blood Temp 10 temperature indicators for blood temperature compliance. PDC Healthcare surveyed the organization on the efficacy of the indicators. Their survey reported the blood bag temperature indicators helped them significantly improve blood transportation quality control and workflow efficiency.

In turn, the real time temperature monitoring increased patient safety and quality of care was improved.

Read the full case study below:

Riverside Health System Blood Temperature Compliance Case Study

For more information on PDC Healthcare click here.

For the full survey on TechValidate click here.

PDC Healthcare surveyed Decatur Memorial Hospital about the benefits of using Blood Temp 10 indicators. Their survey found the blood bag temperature indicators used to measure blood core temperature helped the hospital improve the quality of care and significantly improve blood transportation quality control to comply with the FDA regulatory guidelines.

Read the full case study below:

Decatur Memorial Hospital Blood transportation Case Study

For more information on PDC Healthcare click here.

For the full survey on TechValidate click here.

Time and Temperature Indicator maker Timestrip launches the Timestrip® Temperature app, a new tool that provides a visual audit trail of its temperature products.

Frame
Zoom
Focus
Snap

Using the App simply involves taking a photo of a Timestrip® label with a smartphone.

If the Timestrip® has a new style serial number, the App will recognise the serial number and allow you to register it on the system.

You can then take a follow on scan where you can enter its activation state (inert, activated or breached), storing this data with essential time and location information in the cloud.

If the Timestrip® has an old style serial number you can still use the app in the same way but you'll need to manually enter the serial number. The App is free to download from the Google Play store with an iOS version to follow shortly.

High tech low cost

The App is the latest innovation from Timestrip, which revolutionised the field of cold chain management with its unique Irreversible Time and Temperature Indicator labels (TTIs).

Recognised by the World Health Organisation and the US FDA as an essential tool for the cold chain management of blood and food products, TTIs provide data as to whether a blood or food product is safe to use. Timestrip’s irreversible TTIs make this crucial safety information unambiguous and instantly visible.

Like having a hundred permanent digital data loggers

The main benefit of Timestrip’s irreversible TTI labels is that they give essential cold chain management information on individual units of processed products. This deals with the main shortcoming of digital data loggers, which are mostly used for containers of transported and stored products.

Thanks to the new Timestrip® App, extra key information around cold chain management is added with the safe storage of status, time, journey and location data, which can be accessed at any time via the app or via a website. A digital data logger can be lost or damaged and all its data can be wiped clean. The Timestrip® App however safely stores this data in the Cloud.

Data logger functionality at a fraction of the price

Timestrip UK CEO Reuben Isbitsky says: "I am very excited about our first App, which brings Timestrip TTI labels very close to data logger functionality, at a fraction of the price.  While a key benefit of Timestrip products is that they do not need external infrastructure to read and interpret, using the optional Timestrip Temperature App to scan them, adds enhanced functionality, easy audit trail and provides the customer with a permanent record of the history of the product’s journey."

Interview with Reuben Isbitsky, founder of Timestrip UK Limited, which has just received FDA clearance for its 10°C Non-reversible Blood Transit Temperature Indicator.

Beyond its primary use as a temperature monitoring device, what from the user’s point of view are the key advantages for users of Timestrip 10°C nonreversible temperature indicators for blood products over other temperature monitoring products?

First and foremost, ease of use. Unlike other temperature monitoring devices, Timestrip 10°C irreversible blood temperature indicator can be stored at ambient temperature. It doesn’t need to be stored in a refrigerator and also doesn’t need to be refrigerated for at least 24 hours prior to use.

Moreover, until the button on the Timestrip 10°C is pressed, the device remains totally inactive. There is no risk of accidental activation because of the heat generated by warm fingers. All parts of Timestrip 10°C can be handled by warm hands without this leading to accidental activation. This naturally translates into significant cost savings over extremely sensitive temperature monitoring devices that need to be discarded when accidentally activated.

Ease to use temperature indicators

With Timestrip 10°C, there’s no complicated four-minute instructional video with many caveats. All you need to do is take the blood bag out of the cooler, put it down, take the Timestrip, peel off its protective under-layer, press the activation button and stick it on the blood bag. That’s it.

We’ve also built into Timestrip 10°C a fail-safe activation indicator that tells the user that the Timestrip is ready to use and working. This is unique in the market. No other indicator has this feature.

Lastly, we put huge emphasis on ease of readability. With Timestrip 10°C, if there’s a temperature breach, the indicator will turn from white to blue. Thus, if the indicator on the Timestrip has any hints of blue in it, the user knows for a fact that there’s been a temperature breach.

We don’t want there to be any confusion caused by problems of refracted colours from misleadingly coloured components of temperature monitoring devices indicating that a temperature breach has occurred, when in fact none has. This only leads to uncertainty, which at best means more costs to users because of unnecessarily discarded, but otherwise properly functioning monitoring equipment, and at worst viable blood is unnecessarily discarded.

Blood is an extremely precious commodity and no one wants to be using an unreliable temperature monitoring device that leads to throwing away good blood. As one of our users in Europe says: “Blood is life.”

Interview with Reuben Isbitsky, founder of Timestrip UK Limited, which has just received FDA clearance for its 10°C Nonreversible Blood Transit Temperature Indicator.

 What does FDA clearance of Timestrip 10°C mean for your company?

It’s major milestone. Product-wise, we've been deemed and certified as having a medical device that has an accuracy level of ± 0.5°C and is suitable for transporting whole blood. FDA clearance for Timestrip 10°C will allow us to market this product for this specific application.

And for our business, it marks a very important turning point. We started off as a time indicator company, which evolved into a temperature monitoring business, that is now a high-end medical device and healthcare business.

Moving forward, our business model will be to configure new products for specific and invariably speciality uses. We’re also going to be expanding our range of products for specific uses to enable the safe transportation of the different components of whole blood as well, namely platelets, plasma and frozen blood products. This will go a long way to maximizing the usability of all these components. For instance, even properly transported and stored whole blood only has a shelf life of 35 days, but plasma can be frozen and has many uses.

Lastly, for markets outside the US FDA clearance gives our product enormous credibility. Although FDA clearance cannot be enforced outside the US, in fact for many markets such as Saudi Arabia and India, it is used as an indicator of credibility and for tendering processes is even a prerequisite.