May 17, 2020

Bitcoin Against Ebola: Can Your Virtual Money Provide Relief?

2 min
Bitcoin was founded in 2009 and is a form of digital currency.
The most recent Ebola news has surfaced: Sierra Leone is being placed on a two-week lockdown.

Due to a sudden spike in deaths from Ebola, health care w...

The most recent Ebola news has surfaced: Sierra Leone is being placed on a two-week lockdown.

Due to a sudden spike in deaths from Ebola, health care workers from several local and international agencies are racing to the latest Ebola hotspot, a diamond-mining area in the country.

This latest hotspot is an indication of how long it could take to control the epidemic that started in Guinea a year ago, in an area bordering on Sierra Leone and Liberia, and quickly spread to capital cities in all three West African nations. Since then, the disease has traveled to the United States, Mali, Nigeria, Senegal and Spain.

With an epidemic as large as this, people all over the world are coming up with new and innovative ways to help shut down the crisis. The latest? Using bitcoins to directly fund charities that are fighting the disease.

Bitcoin Against Ebola was created by the Ghana-based remittances service Beam to raise funds for charities fighting the outbreak. The non-profit initiative will act as a conduit for people in other parts of the world to send donations via bitcoin to three charities in Sierra Leone who are providing essential services to communities affected by Ebola.

Build On Books is supporting children who are quarantined alone at home, often when parents have died or have been taken to a treatment center. They visit regularly with food and water and monitor the children’s temperature and check for signs of Ebola.

LunchBoxGift provides meals to patients in Ebola treatment centers who do not have families to bring food in for them. The idea of Memunah Janneh, a Sierra Leonean living in the UK, the organization began by providing freshly cooked meals to poor families forced to go hungry during lockdowns.

Sierra Leone Liberty Group is made up of young individuals who are also supporting Ebola quarantined homes by delivery of soap, disinfectant and gloves, as well as food.

Minimizing Transaction Fees

Once you donate your bitcoins, they will be converted into Sierra Leonean Leones and deposited in your chosen charity’s SMS mobile money accounts. The funds can then be turned into cash or used to pay for goods.

Using this process allows for Bitcoin Against Ebola to charge only 2 percent per transaction, rather than 12 percent like most other money transfer services. Donations can also arrive in as little as 30 minutes and put to use immediately.

Will you be using Bitcoin to put an end to Ebola?

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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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