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A Story with a message *
Healthcare during pregnancy and childbirth needs more attention and resources.
The key is to prevent avoidable harm.We suggest a system solution to the problem of retained swabs.
Never events’ are not common but are 'red flags' of weak systems with inadequate design solutions.
iCount is a design solution which makes it easy to do the right thing
A Simple Intuitive Cost-Effective Solution to Prevent Surgical Items Accidentally Left Behind
Patent published UK IPO and WIPO
Safer by Design
Did You Know ?
557 swabs were accidentally retained after childbirth and surgery
(NHS England reported data 2012-22 and underreporting is known)
The solution is a simple proprietary docking device, with an option of being a smart device with a AI - electronic medical records integration
Retained swab never events - rare, but not as rare as you may think...
An active Map of retained swab never events reported to NHS England. Evidence is in the Resources section - NHS trust board minutes/CQC reports
The red cross signs indicate deaths where the retained swab was a direct or contributory cause of death
Our team have started working on an AI and computer vision- technology to integrate the solution with the digital space and Electronic Medical Records
The second round of simulation testing with the near-final product has been done and the results are reassuring (Oct 2023). The first iCount has been designed and will be introduced in maternity - vaginal deliveries as the proportion of retained swabs/sponges is higher.
We are pleased welcome Professor Brennan to our advisory board
We have been supported by Medlink Midlands
and East Midlands AHSN for design, development,
clinical evaluation through grant support
Winners of 'Collaboration of the Year' and
highly commended in the 'health and wellbeing' category at the Staffordshire and Keele University
'Breaking the Mould' awards celebrating Promising innovations
#KeeleBTMAwards Dec 2020
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Winners of the 'RCOG Sir William Gilliatt award' in the poster category at the RCOG World Congress 2021
Winners of the 'One to Watch' MedilinkBusiness awards 2022
York Health Economic Consortium, an independent, reputed organisation has done a detailed cost-benefit analysis. Although these events are not common, the litigation, legal costs associated, morbidity and staff cost amount to several million per year. We intend to make it available at a sustainable and cost-effective price which is much lower than the economically justifiable, cost-neutral price as demonstrated by this analysis. This will bring significant cost savings to the NHS.
Innovate UK Smart grant, Biomedical catalyst grant winners
Patent granted February 2022 - UKIPO (first filed 2018)
IP strategy applied on a regular basis.
New IP filings 2022 for all iterations
Patent granted Sept 2023 -
EU
iCount system eases the method of calculating measured blood loss rather than relying on estimated blood loss, as recommended by the ACOG and the RCOG
We believe in Co-design and Co-production
A Usability study was done in High Fidelity Simulation Clinical environment (2020) by MDTec-NIHR, University hospital Birmingham showed positive feedback leading to design changes and prototype iteration. Business Bridge, Keele University provided the initial 'Seed funding' for prototype development.
When Patients, Carers, Nurses, Midwives, Doctors, healthcare service managers, Engineers, Research academics, Business developers, Universities, Funding bodies, Technology development organisations come together....Amazing things happen
Patient Public Involvement (PPI) done by NIHR Surgical MIC, Leeds (2020)
Some of the comments from the healthcare service users were :
"It is shocking that surgical swabs are still left behind in this day and age. The first case series was reported in 1884. We thought that we should have overcome this problem by now"
"It would be good to have a failsafe engineering solution rather than just rely on counting which is susceptible to human error."
Patients and healthcare service users provided some excellent suggestions for user-centric design, integration into the current workflow and about raising awareness about patient safety
We used these for developing a systems engineering approach
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*Although the story is based on real stories, names and situations have been changed.Any resemblance to real persons is purely coincidental
The Challenge
Over 100 retained surgical items every year in England
The USA -over 3000 every year. Canada -around 160 every year.
Thousands of these incidents over the world happen every week.
The commonest item left behind is a ‘surgical swab or sponge’.
(published NHS England/Improvement data)
Effects are pain, infection, re-operation, psychological trauma, inability to bond with the baby, long term discomfort and rarely, death. Retained swabs are called surgical "Never Events" which should never really happen.
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iCount is a registered trademark (UK Intellectual property Office) with patent published (UK IPO) and with complete freedom to operate
Our Collaborators and Supporters
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US Institute for Clinical Systems Improvement. Health care protocol 9:
prevention of unintentionally retained foreign objects during vaginal deliveries (2009) mentions in its detailed report “For as long as the medical community has been assisting women in performing vaginal deliveries, we have had the risk and misfortune of unintentionally retained foreign objects. Many measures have been instituted to mitigate the likelihood of an unintentionally retained item, but unfortunately, they continue to occur.
National reports references:
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1. Healthcare Safety Investigation Branch(HSIB) is the first in the world to carry out independent healthcare investigations to improve healthcare at the system level.Their recent report highlights a common ‘Never Event’ that leaves women at risk of harm after childbirth.Click here - HSIB report puts a spotlight on the recurrent problem of retained swabs after childbirth.
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2. Surgical Never Events. NHS Improvement (2018). Learning from 38 cases occurring in English hospitals between 2016 and 2017.
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3. UK NHS National Patient Safety Agency. Rapid response report NPSA/2020/RRR012.Reducing the risk of retained swabs after childbirth and perineal suturing.
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4. WHO Safe surgery Guidelines - Safe Surgery saves lives (2009) recommend checking and documenting whether the count is correct but recognises the dual error of leaving an item inside the patient and a counter-balancing discount resulting in a 'false correct' count.
WHO encourages using alternative methods for tracking and counting surgical swabs.
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5. The Organisation for Economic Co-operation and Development (OECD) Surgical Safety indicators - retained surgical swabs.
Measuring Patient Safety: Opening the Black Box (2018).
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6. Reducing the risk of retained swabs after vaginal birth. British Medical Journal 2010;341:c3679
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7. US Joint Commission report: Preventing unintended retained foreign objects
https://www.jointcommission.org/assets/1/18/retained_foreign_objects_faqs.pdf
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8. The Australian Commission on Safety and Quality in Health Care (the Commission)- Sentinel events list- retained swabs
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9. The New Zealand Health Quality and Safety Commission, New Zealand. Retained vaginal swabs following childbirths- problem and prevention strategies.Sentinel events. Dec 2015.
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10.Spotlight on patient safety. Minnesota Department of Health. Focus on retained foreign objects- vaginal sponges which contribute significantly to…. www.health.state.mn.us/patientsafety and similar reports from each US state.
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11. Care Quality Commission.Inspection Single Assessment Framework MATERNITY. Swab Count audits. pg11
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11. Reducing the risk of retained swab after perineal suturing, Malaysia Guidelines 2019.
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