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ABC Syringe

Project Leader David Swann Organisation University of Huddersfield Designed By David Swann Project Location India and beyond Project Website - Name of nominating Icsid Member organisation Royal College of Art

Please describe the project and the challenge it intended to address

This innovative two-year study has developed an effective innovation strategy to combat the reuse of disposable syringes within a curative context for low resource settings. We have designed a transformative syringe technology that makes invisible risk, visible.

35 proposals met the required performance specification put out in a request in 1986 from the World Health Organization (WHO) for an immunization syringe that could not be used more than once, -giving rise to the auto-disable (AD) syringe. An AD syringe is purposefully designed to lock upon full injection delivery rendering it unusable. While the AD syringe has now become a prerequisite tool for mass and routine immunization programmes funded by the World Health Organisation and UNICEF (95%), their routine use for a significant proportion of skin and curative injections has yet to materialize (5%). In this context, economic cost is a perceived as a major barrier that has inhibited their widespread use for curative purposes.

In 2008, the WHO calculated the global burden of disease from unsafe medical injections. In total, unsafe injections led to 1.3 million deaths, 340,000 HIV infections, 15 million Hepatitis B Virus (HBV) infections, 1 million Hepatitis C Virus (HCV) infections, 3 million bacterial infections and 850,000 injection site abscesses. These blood-borne infections accounted for 14% of all HIV infections, 25% of HBV infections, 8% of HCV infections and accounted for 28 million disability adjusted life years (a metric of the years of life lost to death and disability from AIDS, acute hepatitis, liver cancer and fatal sepsis). Despite its emergence almost 27 years ago the AD syringe has had made little impact on the prevention of unsafe injection practices, keeping prevention of unsafe injection practices WHO’s research priority no.5.

“Research Priority No.5-Unsafe injection practices: Up to 40% of injections are given worldwide with syringes and needles reused without sterilization. In some countries this proportion is as high as 70%. Future research should focus on understanding the epidemiology and burden of disease transmitted through unsafe injection practices and developing strategies to improve practices that are acceptable and affordable.”

History has demonstrated that achieving absolute safety through one syringe solution is illusionary. Our research identified two deficiencies with current technologies designed to deter unsafe practices: affordability and a difficulty determining sterility when no packaging is present. We have developed a super-frugal innovation that improves the safety performance of any injectable device: disposables, AD syringes and pre-filled syringes. To achieve our objective we have synthesized theories of risk perception and chromism to make invisible risk, visible. Our design hypothesis is “to utilise persuasive design to visually communicate with absolute certainty the safety status of the device.”
Visual communication is critical as human behaviour can have a significant effect on risk outcomes. People often surrender decision-making to those who know more or individuals who are in a position of trust so visual cues are essential to empowering people to participate in the decision making process.

To achieve our proposed innovation unites two proven technologies: colourimetric inks and modified atmosphere packaging (MAP). MAP is a popular technology used by food processing industries to minimize product deterioration and to extend the shelf life of food products. Inside a nitrogen-filled blister pack our syringe label remains deactivated. Exposure to air (by opening or pack failure) activates an o-crestholphthalein coated label which rapidly absorbs carbon dioxide found in the atmosphere. This provides a window for the syringe to be used in a procedure before a dramatic colour transformation take place - changing from colourless to red in 60 seconds. The recolouration inhibits the operability of the syringe and serves as a visual warning of prior use to both literate and illiterate patients.

What are the objectives of the project and are the outcomes same as those originally intended?

The primary objectives of the ongoing research are to:

- Reduce clinical errors/ adverse events caused by the reuse of disposable syringes in a curative setting
- Improve clinical compliance
- Contribute to the UN Millennium Development Goals 4, 5 & 6

However, two factors influenced our strategic approach following stakeholder engagement: design for accelerated impact and commercial adoption. Guided by Peter Evans, Former Head of WHO Procurement Worldwide we sacrificed our original intention to develop a totally new syringe. We soon discovered that introducing any physical design change to an existing syringe would entail a more than 10 year Food and Drug Administration (FDA) regulatory process costing £1 million. Economic and regulatory factors sharpened our thinking. We tactically confined our strategy to a colour-changing label that could be applied to any production injectable: auto-disables, pre-filled and especially those disposable ones that continue to dominate the market (71%- 25 billion units). For a label application, a streamlined 3-month FDA approval process is now achievable. With immediate effect our revised strategy attracted the high-level advocacy needed to achieve impact on a global scale: Marc Koska OBE, Founder of the Safepoint Trust, the World Health Organisation and UNICEF.

While our innovation clearly demonstrated tangible benefits for patients, to leverage future adoption by manufacturers we would need to equalize these benefits. Our research identified a practical testing problem of determining the integrity of sterile blister packages for medical device manufacturers. While theoretically it is feasible to test 10,000 packs for sterility, it is impossible to test 1 million. FDA compliance states an acceptable level of failure for invasive devices is 0.25%. Therefore the integrity of packaging barriers plays a critical role in delivering safe treatments. Consequently, by articulating the labels value as a package integrity monitor for any sterile medical package it has caught the attention of major corporates.

How was the community engaged through the life cycle of the project?

The use of precedent case studies, force-field analysis, and dialogues with global networks and specialists captured the complexity of the challenge, sharpened the acuity of our strategic approach and identified an urgent need for a frugal solution that offered unilateral benefits to patients, providers and manufacturers.

We have conducted a simple knowledge and attitude test on the streets of Mumbai to validate our innovation strategy. This comparative test presented participants with a choice. Participants were shown a conventional clear syringe and a red coloured syringe and asked which device they perceived to be most dangerous. In reality both syringes were equally dangerous as they were not sterile. However our persuasive colour change was found to trigger an individual’s innate sensitivity to risk. The results verified our deductive reasoning with 100% of participants identifying the red syringe as a threat to their personal safety with many associating its unfamiliar colouration with drug use or blood.

Marc Koska OBE has described the simplicity of our innovation as 'brilliant'.

Include the society of interest and describe any other relevant stakeholders and partners that were involved or consulted.

We acknowledge that preventing unsafe injection practices is a global challenge and have specifically selected India as the focal point for our project as it is the largest consumer of disposable syringes - annually accounting for 25-30% of global demand. Empirical evidence supports our strategic decision. A 2007 study conducted by the India International Clinical Epidemiology Network, Program Evaluation Network (IPEN) on behalf of the Ministry of Health, Government of India and the World Bank assessed the magnitude and prevalence of unsafe injection practices in formal and informal settings. The key findings of the study that are pertinent are:

- 83% of injections were for curative purposes
- 63% of injections were administered in an unsafe manner
- 32% of injections carried the risk of transmitting a blood borne virus- Hepatitis B, HIV
- 69% of injections delivered in government clinics were deemed unsafe
- The type of injection equipment had a profound effect on patient safety
- The proportion of unsafe injections was 9% higher in villages (66%) than in cities (55%)

Today there is still an urgent need to address the preventable practice of unsafe injections and a growing imperative to develop increasingly frugal technologies for low-income and middle-income countries (Howett, 2012).

The social and economic impact associated with the reuse of single-use medical devices is alarming. It is surprising to learn that this is a challenge not confined to low-resource settings. A United States Government report (2012) recently captured data related to the prevalence of unsafe injection practices and the transmission of blood-borne infections in hospitals. In one instance, the use of a contaminated syringe resulted in 63,000 patients being recalled for testing at a cost of $13.8 million and $30,000 in treatment costs for each infected individual.

Our project has assembled a formidable team who shared a common sense of purpose to take a fresh look at a persistent problem through a design, systemic and a commercial lens, with systems thinking and professional diversity being used intelligently to perfect a technology that combines affordability, patient safety and improved healthcare outcomes. The first secretary Ashish Mehta of Trade & Investment who manages the life science cluster for UKTI-India at the British Deputy High Commission has endorsed the project presented.

Our experienced team currently comprises of:

- Dr David Swann, Reader in Design and Designer of the
ABC syringe, University of Huddersfield
- Professor Andrew Mills, Chair of Materials Chemistry,
Queens University Belfast
- Professor Charles Vincent, Professor of Clinical Safety
Research, Imperial College London
- Peter Evans, Former Head of WHO Procurement
Worldwide and Project Lead for Vaccine Vial Monitor
Programme
- Nicholas Coutts, Former VP, Global Distribution Channel
Strategy for IBM
- Maju Jacob, UKTI and British Deputy High Commission,
Mumbai, Senior Trade & Investment Advisor – Healthcare
Sector (India) and his Healthcare sector team

With Marc Koska OBE, pioneer of the safety syringe and founder of SafePoint Trust providing advisory inputs.

How has this project benefited the community of interest?

Patient safety is recognised as one of the most significant issues facing every healthcare system across the world (Canadian Patient Safety Institute, 2006). Dr David Bates, Chair of WHO’s World Alliance for Patient Safety advocates that there is an urgent need for local relevance as research and patient safety solutions for developed or transitional countries are a low priority in developed nations.

As we have observed the most deadly clinical procedure in the world is probably a simple injection. Every year unsafe injection practices kills 1.3 million mothers, fathers and children. For 25 years the global community has turned a blind eye to effectively a patient holocaust occurring within curative settings. We hope to stir humanity’s conscience through our behaviour changing syringe label to prevent a series of associated violations:

- Reuse of disposable syringes and syringes for curative injections
- Loading disposable syringes with multiple doses and injecting people consecutively
- Reusing the same syringe on more than one patient after changing the needle
- Using multiple-dose vial pierced with a single drawing up needle
- Soaking syringes and needles in sodium hypochlorite
- Flushing syringes with disinfectant or water to clean them prior to reuse
- Discarding syringes into general waste
- The collection and resale of used syringes from landfill

The development of locally effective and affordable solutions is seen as a top priority for all developing and transitional countries (Bates, 2009). We will realise healthcare benefits by prioritising affordability. In India this is a critical factor faced by public facilities that bear the burden of care with demand and GDP spending expected to grow year-on-year from 1% to 8% year on year until 2025. History has shown that even the infallible AD syringe has had limited impact in the curative market due to its price sensitivity- costing 200-300% more than a disposable syringe. Defining levels of acceptable risk and responding to them intelligently necessitates a multi-strategy approach.

Our strategy is to introduce into the market a super-frugal additive technology that delivers a superior disposable syringe for an additional £0.008. In the longer term, it is our ambition that on a global scale it becomes a mandatory requirement for ALL production disposable syringes to embody our discriminative feature; explicitly exposing for the first time procedure uncertainty and the risks associated with human behaviour that results in unsafe injection practices to occur.

What metrics are used to track the impact of the project?

We proclaim that the addition of an intelligent label can have immeasurable significance. Our initial impact estimation based upon extrapolated data and tacit knowledge of our team has identified (applied to a traditional disposable syringe) that our intervention will have prevented 700,000 fatal injections, saved 6.5 million live years and $130m in direct medical costs by Year 5 in India alone. Demonstrating that even the slightest presence of design substance can educate and empower:

"Teaching about the perils of reuse of syringes is a fundamental part of medical training and yet, throughout the developing world, reuse continues to be a generally accepted practice. Part of this is because the patient, and the medical professional, are used to the reuse of syringes and there is no immediate feedback that something is wrong. The product you have described, an indicator showing prior exposure to air and therefore non-sterile, is to my knowledge unique."

Peter Evans, Former Lead for WHO Procurement Worldwide & WHO Project Lead: Auto-Disable Syringes (2013)

As the project advances we intend to perfect clinical, engineering and design performances/ specifications to ensure regulatory compliance; conduct a comprehensive technology evaluation study with key users and opinion makers; produce a batch demonstrator that proves repeatability and design robustness for clinical/ market trials. Concurrently we shall continue to work closely with the Safepoint Trust and their LIFESAVER programme, the WHO and UNICEF. High-level project support ensures that the project’s focus is deeply aligned to the UN’s Millennium Goals.

How will winning the Prize raise awareness of the project and further its impact?

We have had used our design intelligence to conceive a frugal design intervention that resonates far beyond its immediate remit with the potential to touch all humanity.

Gandhi once articulated,

‘In a gentle way we can shake the world’.

We passionately believe that the gravitas associated with winning the prestigious Icsid’s World Design Impact Prize will enable us to shake the world together, and bring global visibility to one of the world’s most neglected, elusive and complex design challenges.

Briefly describe the challenges the project currently faces

The sheer scale of the design challenge has necessitated a different methodological approach to evaporate barriers and corporate resistance to change. Unlike many conventional design projects a rigorous engagement process from the very outset was required to establish confidence and high-level advocacy. Without traction with key stakeholders, no project, no matter how innovative the design is doomed to fail. We have also modelled our implementation strategy on the WHO’s Vaccine Vial Monitor project involving UNICEF and PATH. A vaccine vial monitors (VVMs) is an ink label affixed to the vial that visually identifies over time when the vaccine is damaged by heat. Today VVMs are a prerequisite performance requirement for all vaccines procured by the WHO and UNICEF. Peter Evans who was deeply involved in the development and success of the VVM project is a member of our project team, and can provide detailed insights regarding commercial concerns: validation, logistical, liability and regulatory considerations. We have achieved traction to enable us to advance the projects towards our goal of achieving world design impact.

Please include any other relevant information you would like to share

The WHO has recognised the pertinence of our design innovation to global health. Denis Maire, who works for the World Health Organization's health systems and innovation taskforce, said our ABC Syringe could help to make injections safer.

"Anything that can contribute to decrease the reuse of syringes is worth considering and cost is certainly a major factor," he said. "The great advantage of this concept is that not only health care workers but also patients can have a visual appreciation on the safety status of the device. In my view this could be a good deterrent for practitioners to reuse."

A new global mandate is presently being prepared by the WHO in conjunction with Safepoint Trust that seeks to homogenise the production, safety and quality of future WHO-certified AD syringes and injection devices for safety. A wide range of technologies are encompassed in the mandate, and our colour-changing label is included as part of this programme.

The WHO also seeks to raise awareness of the pressing need for appropriate design solutions through its compendium of innovative health technologies: Medical devices and eHealth solutions for low-resource settings. This annual publication serves as a showcase for emergent innovative medical devices that are not yet widely available in under-resourced regions. Our behaviour-changing syringe is shortlisted for inclusion into the 2014 compendium.

To protect the future commercial value of our intellectual property we have registered our innovation with the World Intellectual Property Office. Our go-to-market strategy will initially target all syringe applications- a $43 billion market delivering 35 billion syringes per year. To build commercial confidence, market leverage and the required production infrastructure, we will work closely with Marc Koska OBE, who is also a Director of StarSyringe; an organisation that presently licenses his AD syringe intellectual property to a portfolio of syringe manufacturers that includes: Becton Dickinson and Hindustan & Medical Devices- India’s market leader (60%) with distribution network of 4000 dealers supplying 2.5 billion syringes per year.

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