Efficient, effective healthcare with Timestrip®

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

blood transportation compliance

A bag of whole blood with a Timestrip® Blood Temp 10°C

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

Timestrip® PLUS™ 8°C

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.

Timestrip® PLUS (TP 217) 25°C

C

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.

Clinical Innovations ROM Plus with Timestrip
The ROM Plus® test kit with its built-in Timestrip time indicator and activation button

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.

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.

Timestrip produces a broad range of Time Indicators

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

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Operational Risk Assessment in the Logistics, Pharmaceutical & Food supply chains

The big word in the logistics and supply chain “world” is RISK, and a risk assessment being performed, or at least having a mitigation plan in place, is becoming part of many certification requirements, like ISO 9001, and other pending or recently introduced federal regulations.

It will be no surprise, I am sure, when I mention certain facts like – “Where humans are involved in a process there will be errors, and 90% plus of all supply chain errors are human errors”; but how do you avoid these?

Firstly, let me say there will always be Risk not only in the common elements of the supply chain but also and especially with the way that you handle any cold chain or temperature-controlled products.

So how do you manage these risks?

There are 4 common and accepted ways that Risk can be managed, or mitigated:

  1. Risk Avoidance: Changes made to your processes and players that ensures risks are no longer an issue.
  2. Risk Mitigation: Reduce the severity of the loss or prevent the likelihood of the risk from occurring.
  3. Risk Acceptance: Avoidance of a potential risk area is not possible or economically feasible, so it is acceptable and will not impact your business.
  4. Risk Deflection: After the risk has been identified and quantified, transfer that risk to the control of another player or partner in the process – maybe add it as a clause to be addressed in a vendor contract.

So how do you establish a Risk Mitigation Plan?

  1. Review and audit your supply chain to assess where risk does, or may exist
  2. Assess what the impact of these risks may be and create a list with the highest probability items at the top to address first
  3. Define your risk mitigation strategies for the highest-level items and work down the list from High to Low
  4. Implement the strategies and document them.

What else should I do, or know?

  1. Even though your Risk Management plan includes good SOP’s and WI’s make sure that people are adequately trained in these disciplines
  2. Conduct self-audits regularly
  3. The cost of a Cold Chain Monitoring device or solution, is far less expensive than the cost of disposal of a temperature compromised shipment
  4. All Quality Systems and Risk Aversion Plans should have one over-arching goal – Quality of Product and Consumer Safety!!!!

At Timestrip we are acutely aware of all kinds of risks that can exist in all kinds of supply chains from Pharmaceutical to Food and even beyond to special chemicals and laboratory testing time lines.

For a full range of our products please visit our products page

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Timestrip Complete: Q&A

What is Timestrip Complete?

Timestrip Complete is our product that monitors upper and lower threshold temperature breaches, such as 2°-8°C cold chain monitoring for vaccine storage and transport.

timestrip complete 2-8c monitoring

The product is in fact made up of two elements: a Timestrip Plus, which is our ascending indicator that measures, for example temperature breaches above 8°C and the amount of time that they have breached, and a descending temperature indicator called Freeze Check Plus FCP for short that logs breaches, for example, below 2°C.

This is why we’ve called the indicator “Timestrip Complete”: It provides complete monitoring for the 2°-8°C cold chain.

Why was Timestrip Complete developed for vaccine storage and transport?

A vaccine is affected by heat and by freezing and the two critical temperature thresholds for storage and transport are 2°C and 8°C.

It’s time and temperature that’s the critical factor leading to degradation of vaccines.

For freezing, the crucial event is whether this has happened or not. Because vaccines are contained in an aqueous solution (water), when it freezes, it expands and the resulting crystallization can destroy the vaccine

How much does a Timestrip Complete cost?

Under US $4 per unit, and considerably less in volume purchase. It’s the lowest cost solution and easiest to implement to achieve complete 2°C-8°C temperature monitoring. Any other tool that does this job involves using a single-use digital data logger, which start at about US$10 per unit

This totally fits in with our company ethos of providing the easiest, simplest and most cost-effective products for temperature monitoring. Many 0°C or 2°C descending indicator on their own for instance normally costs at least US$2.50, so we know that our sub-US $4 price is very competitive.

How do you use Timestrip Complete?

It can be stored at room temperature, is inert until activated and has a button-like feature that needs to be pushed for activation.

There is an extra measure needed in storage to bear in mind— and this is industry-wide for all descending temperature indicators — is that they are always active.

This means they need to ship to end-users above the temperature they monitor and we achieve this by packing them with heat packs to ensure they never go below 2°C.

On the positive side from our clients point of view, because the ascending indicator can be stored at room temperature, they only need to ensure that our products are kept above freezing.

Similar products present the logistic difficulties of needing to be kept above 2°C and below 8°C, so this is a big advantage

Are there other Timestrip Complete products apart from 2°C-8°C?

Yes, this is a key range which we are looking to grow.  The product also comes as 0°C-8°C

Timestrip Complete 0°C – 8°C and 2°C – 8°C are also used for the storage and transportation of medicine and biologics.

We are now launching a Controlled Room Temperature indicator that has 15°C and 25°C thresholds. These are designed for environments such as food transportation for airlines.

The key message here though is that we have the technology to produce a variety of complete upper and lower level temperature monitoring — and at a very competitive price.

What’s been the feedback so far from end-users of these complete temperature monitoring indicators?

Timestrip was involved in supporting anti-rabies work in Malawi with a 0°C-30°C indicator for the transportation and storage of canine vaccine. Rabies is huge problem in Malawi and spoilt vaccines seriously hamper efforts to address the situation.

The bottom line was that this 0°C-30°C product was successful in identifying those doses of canine vaccine that were either spoilt because of ambient heat exposure or from freezing caused by the ice-packs that are used during transportation.

This allowed for a re-stocking with unspoilt vaccines that ensured that the anti-rabies field teams’ efforts were effective and thereby measurably supported the prevention of more cases of rabies in Malawi.

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Marathon Distributors

Marathon Distributors

Company Profile & Environment

Marathon Distributors is a pharmaceutical and healthcare logistics services provider on the island of Cyprus. With an annual turnover of over $40m, it has a 35-38% market share for its range of activities and employs a workforce of just over 40 people.

Its services include warehousing, transportation and distribution and it boasts a state-of-the-art warehouse strategically located on the outskirts of Nicosia (Latsia Industrial Area), just-off the Nicosia-Limassol-Larnaca highway. The warehouse area has a floor space of 2,500m2 and a modern cold storage area with a capacity of 70m3.

For transportation, it operates its own fleet of 18 vehicles — all temperature controlled and GPS monitored — and they cover 100% of the island. The vehicles deliver to pharmacies, pharmacy depots, physicians, hospitals, clinics and clinical laboratories across the island.

Cold chain issues fall under the remit of MD Simone Kapakiotis. Her work covers all aspects for the warehousing and transportation of cold chain products, which are mainly vaccines.

The main regulations that the company needs to comply with are the Law on Human Pharmaceuticals 70(I) 2001 and EU guidelines on Good Distribution & Manufacturing Practices.

The company faces numerous challenges in the sectors it operates in. Firstly, the Cyprus market is of a relatively small size, which stifles its potential for growth. Also, it is a highly regulated environment, subject to numerous stringent EU guidelines. Lastly, the business itself must manage quite high operating costs and low profit margins.

On the plus side however, due to relatively short transportation distances on the island (delivery times are 6 hours at most) and the company’s use of validated cooling containers for the transportation of cold chain products, it never generates any product waste.

Use of Timestrip Indicators

Because of its environment, Marathon uses Timestrip Plus 8°C 8 Hrs (TP065), which monitor temperature breaches above 8°C for periods of up to eight hours. Cold chain issues are of concern during the transportation process.

The procedure followed for using Timestrips is that they are placed in all orders containing cold chain products. These indicate to drivers and customers whether a temperature deviation has occurred during transportation. If no deviation occurs, customers receive orders and sign all the relevant documentation. If however a deviation has taken place, these orders are returned to the warehouse and the company sets in motion a deviation procedure that needs to be followed.

The Timestrip Solution

The main reasons the company uses Timestrip TTIs above other approved TTIs are a competitive price, the reliability of the product, an easy order system and speed of delivery.

Significant improvement has been noted in these areas since the company began to use Timestrips. The product itself is 50% cheaper than other similar products. Also, delivery times are one day faster and delivery costs are 50% lower than before.
Other Benefits

Feedback from Marathon’s customers has been very positive and have enhanced its standing with them. They particularly like that Timestrips are easy to use, easy to read and reliable.

Simone Kapakiotis says: “The use of Timestrips adds to our company’s reputation of being professional and reliable.”

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Monitoring the Canine Vaccine Cold Chain in the Field

Monitoring the Canine Vaccine Cold Chain in the Field

Abstract: The World Health Organisation stresses the importance of maintaining the cold chain for temperature sensitive vaccines. Due to the recommendation for rabies vaccines to be stored between 2° and 8° Celsius and the nature of canine mass vaccination projects, cold chain maintenance remains one of the most significant logistical hurdles project managers have to overcome.

Mission Rabies field teams in Picture4Malawi evaluated the use of adhesive temperature monitors as an alternative to thermometers in both storage fridges and field cooler boxes during the duration of a 4 week mass vaccination drive in April/May 2016.

Two different Timestrip® temperature monitors were used to alert the teams to the critical temperature thresholds of 0°C and 30°C.  As freezing rapidly damages vaccines, each vaccine box containing 10 vials of 10ml vaccine was marked with a monitor that indicates the immediate crossing of the lower threshold through colour change. As damage from high temperatures is related to both the temperature achieved and the time of exposure, to test for the upper temperature limit each cooler box was equipped with a monitor that showed the crossing of the upper threshold over time.

Of a total of 22 vaccination teams participating in the study, 7 teams reported an exposure of the vaccines to temperatures above 30°C for more than 4 hours and on 9 occasions teams reported a temperature drop to 0°C or below.

Picture1

These findings highlight the importance of monitoring the temperature during field campaigns, both due to proximity to ice packs and exposure to high outside temperatures. The use of Timestrip temperature indicators gives early visual clues and raises awareness among the team. However practicability of the temperature monitoring must be taken into consideration and adhesive monitors need to be improved with regards to their setup to make them a valuable tool in field projects.

This abstract was presented at the 28th Annual Rabies in The Americas Conference on 23 October 2017.

Authors: Frederic Lohr, Reuben Isbitsky, Andy Gibson, Alasdair King

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