Feb 26, 2021

Five tips for managing COVID-19 vaccination programmes

covid-19 vaccines
vaccine tracker
Cloud Computing
John D. Grabenstein
4 min
   Five tips for managing COVID-19 vaccination programmes
Global vaccinologist and Wolters Kluwer Health contributor John D. Grabenstein, PhD, FRSPH, offers five key tips for managing vaccination programmes...

As countries roll out COVID-19 vaccination programmes, they face a daunting task. Coordinating whole-population vaccinations in a short timeframe is an entirely new experience for many health systems, posing an array of new challenges. 

1. Expect systems to evolve

The international vaccine picture is changing daily, with continuous updates on efficacy data, utility against variants, storage and handling tips, new vaccine approvals, and availability of doses. To stay ahead, health administrators need to be nimble, ready to respond to changing circumstances. They need to set up their systems and align their staff with flexibility built in. In this fast-moving situation, expect to hear a lot of untested theories and avant garde ideas. Identify trusted sources that can help you separate sound innovations from unreliable speculation. The Wolters Kluwer Lexicomp vaccine tracker is a good place to stay up to date with the latest developments and status.

2. Track everything digitally

With so much critically important information about vaccines, and given the urgency of vocal demand and constrained supply, administrators need the right tools to manage data flow. Paper or Excel temperature monitoring and storage management tracking is not enough. Cloud-based tools offer important advantages for ensuring information is up to date, aligned and consistently accessible to relevant team members. This approach to vaccine management workflow – especially for multi-site program – will give the best visibility. Do your best to make multi-site systems inter-operable –uniformity will allow staff to fulfil their roles and work more fluidly between sites, avoiding errors. 

3. Streamline & standardise compounding processes 

Applying standardised procedures for vaccine preparation, dilution (if needed), and beyond-use dates will help minimise waste of precious vaccine supply. Each COVID-19 vaccine requires its own specific conditions for preparation, handling, and transport. The Pfizer-BioNTech vaccine is the most complicated, not only because of its ultra-cold storage requirements, but also because it is a liquid concentrate that must be diluted before administration. 

Although other COVID-19 vaccines – such as the Oxford/AstraZeneca vaccine – are liquid and ready to use, there are still specific requirements for syringe filling and time of storage in the syringe. With these differences, make sure your teams follow standard processes for the product(s) they will use. Set aside sufficient time to teach staff how to mix and prepare the vaccine they will use. This will prevent errors and avoid waste. 

Administrators also need to consider if there is adequate training on rotating stock and maintaining the cold chain. How are vaccines transported from one building to another? Be prepared to train again when staff move from administering vaccine A to vaccine B. When it comes to cutting waste, make sure you can be nimble and think on your feet if you have spare stock that will go out of date. Think of the vaccination team in Oregon who got stuck in a snowstorm and decided to give their stock of vaccines to stranded drivers rather than let it go to waste. 

4. Keep up competencies

It’s important for your teams to stay up to date with competencies on screening for allergies, vaccine storage, injection technique, and documentation. There are tools that allow you to electronically identify if and when staff need training (or recertification). This will help you stay on track of competencies, which is particularly important when staff numbers must expand quickly to deliver the vaccine at scale. Bear in mind you could be dealing with a highly varied group, including retired clinicians, health professions students and volunteers. There have been reports about over-bureaucratic demands for accreditation, which slows down the recruitment process. Regardless, some training will always be appropriate: Never neglect needle-stick avoidance and bloodborne pathogens, as well as emergency responses such as adrenaline (epinephrine) and cardiopulmonary resuscitation (CPR). 

5. Data, Data, Data 

It’s essential to gather data on training compliance, doses administered, vaccine inventory, and quality – not only for internal controls but also for external reporting. Systems need to be in place to remind vaccine recipients to return for their second dose, perhaps via email or text message reminders, either that you organize or that public-health agencies make available. The time interval will come from your public-health authority. This isn’t a job for index cards - there’s a lot of tech to do this, so make sure you’re using the right tools optimally.

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Jul 24, 2021

A guide to labelling compliance for medical devices

Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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