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
Ease of use
Low carbon footprint
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/36OF
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
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
FDA approved … and more
Timestrip® Blood Temp 10 has FDA
certification (FDA 510(k) #BK190363)
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
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.
generation of similar positive temperature monitoring outcomes are possible
using other products, such as electronic devices. These, however, are far
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:
• quick and easy application
• no prior conditioning by blood storage staff
• temperature breach data delivered at a glance by
medical field personnel.
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
• 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
Irreversible, single use
19mm x 32mm
Visual proof of temperature exposure
Advantages over electronic dataloggers
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.
Timestrip® also is a super convenient shape: small, flat, with no batteries or
any other electronic components to them.
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.
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
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.
adminTimestrip Blood Temp 10: less waste, lower cost, less risk
Timestrip will be attending the 29th Regional Congress of the International Society of Blood Transfusion (ISBT) in Basel, Switzerland from 22nd – 26th June 2019
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
✔ Reduce product
✔ Ensure regulatory
✔ 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
✔ 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.
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
✔ Ease of use
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
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.
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
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
clean hospital environment for patients
adminEfficient, effective healthcare with Timestrip®
Wine has always been a popular drink and
for many the fermented beverage of choice. In most cases whether you prefer Red
or White, or even a Rose, experts and connoisseurs believe that any wine is
best stored and served chilled.
So, you may well ask what is the difference
between a wine served warm, or chilled, and does it really matter if the wine
is warmer than expected, or even hot? Some wines are indeed served hot and are
even used in cooking, but why is it important if it gets hotter than
anticipated before it gets to the consumer?
Well, from an article in WinePair ™ a short time ago it was stated that; wines do change when they are subjected to a high temperature. Firstly, the tannins become ‘more noticeable and wines take on a tangy, astringent character. Instead of a smooth and supple mouthfeel, wines feel rough and more one-note on the palate. Fruit flavors often become secondary to unpleasant acidity. In dry climates, corks shrink as they lose moisture, leading to leaky bottles and a sticky mess.’
This is all well and good, but at above
what temperature would there be any noticeable change to the wine we drink?
Any wine should normally be stored between 55 – 65F (13-18C) and wine should be stored in a cellar, or a wine refrigerator, that maintains this recommended temperature level. And, it is generally noted that the change to the body of the wine begins at 70F (21C), and wines can “cook” as exposure temperatures hit 80F (26C) degrees and beyond. However, an occasional spike won’t decimate a wine, but prolonged exposure — like a week-long heat wave, or full day in the car — can.
Timestrip offers a full range of stock
labels including two that have a temperature breach of 20C and 25C (tolerance
+/- 1C), and Timestrip can also produce a custom and branded label that can be
set to monitor more specific temperature breach limits.
So, in the future be on the look out for
some form of temperature indicator label on the bottle of wine that you buy to
ensure that it has been kept at the recommended temperature to insure you get
the most enjoyment from the wine that you buy and drink.
How Timestrip irreversible time sensitive indicators are used in Germany by Ulmer Wohnungs for their apartment ventilation units to remind tenants that they need to change the ventilation duct filters.
Translation: “In many UWS apartments, ventilation units are installed which permanently ensure fresh and clean air. Only when the filter is clean, do the fans work quietly and use less energy. In our video we show you how to easily change the filter.”
Timestrip can make you a custom Time Sensitive Indicator Label – we create custom solutions that measure time ranging from 1 hour up to 2 years. We are ISO 9001:2015 certified and Timestrip time indicators offer a helpful visual reminder of service and maintenance schedules for consumable components. Accurate and reliable, Timestrips contribute to a more positive experience for the consumer and help ensure optimum performance from appliances that need replacement indicators or service reminder indicators in order to function effectively.
adminTimestrip Irreversible Time Sensitive Labels used by Ulmer Wohnungs for Filter change Reminders