May 17, 2020

Royal London Hospital: Designed for operational effectiveness

brand new hospital building
state-of-the-art hospital
21st
Admin
3 min
The new Royal London Hospital fully operational in 2012
The first phase of a £1 redevelopment and expansion of The Royal London Hospital officially opened in March this year culminating in one of the m...

The first phase of a £1 redevelopment and expansion of The Royal London Hospital officially opened in March this year culminating in one of the most complex hospital moves ever undertaken. The state-of-the-art hospital, globally recognized as a leader in pre-hospital and trauma care, boasts of advanced features including specialized ventilation systems to keep air 100% fresh,  control infection and reduce noise.  The move to the new, 17 storey hospital, which is located next door to the old hospital site accessed from Whitechapel Road or Stepney Way, involved moving 3,000 staff,  patients and some 11,000 boxes.

Most exciting move ever made

It has been hailed as one of the most complex hospital moves ever undertaken. Chief Executive Peter Morris said, “This move into our new hospital, which for the first time brings our clinical teams together under one roof, gives us a once-in-a-generation opportunity to provide a health legacy to a community with some of the most challenging health needs anywhere in the developed world.” Mr. Morris also said, “I am incredibly proud of what our staff has achieved in reaching today’s milestone, which marks a new and exciting chapter in the Royal London’s history.”  The new hospital has replaced a number of now demolished old buildings with a coherent structure, purpose-built to support the delivery of 21st century clinical care.

The architecture of the new hospital building

The world’s most acclaimed architectural design company HOK was selected as the architect for the project by Skansa. The new hospital features a cluster of inter-connected contemporary glass buildings, including two 18 storey towers and one 10 storey tower. The 727-bed hospital has 6,000 rooms, 52,000 pieces of new furniture, loose equipment, 28,000 towels, 3,000 pillows and 12,000 keys. The tallest part of the building is 284 sq ft, the same height as Big Ben. The building has used 7,000 km of metal reinforcement (the distance between London and Miami), and 175,000 tonne of concrete. Royal London Hospital is a completely sealed building and the windows do not open. The building is completely ventilated with 100% fresh air as a way to reduce noise and control infection. The 17-storey building took about five years to complete at a cost of £650 million. It has been designed with inputs from nurses and doctors to provide the best healing environment for patients.

World-class services and facilities offered at the Royal London Hospital

The new hospital has been designed to best manage patient, visitor and staff foot traffic. The hospital has been recognized worldwide as a leader in pre-hospital and trauma care. The new hospital programme is replacing many of the current ageing buildings with state-of-the-art healthcare facilities. The Royal London Hospital provides emergency care with a resident Emergency Department consultant available 24 hours a day. It also offers renal and urology services, and maternity facilities. Maxillofacial surgery is the Trust’s major specialties. The hospital’s eight maxillofacial consultants can now practice this surgery in state-of-the-art operating theatres.

Glance into the history of the hospital

Royal London Hospital is a part of the Barts Health NHS Trust. It was founded in September 1940, and was initially named The London Infirmary. In the year 1748, the name was changed to The London Hospital. Again on its 250th anniversary in the year 1990, its name was again changed to The Royal London Hospital. In May 1741the hospital was moved to Prescott Street and remained there until 1757.

The Royal London Hospital enjoys the best reputation and is successfully well-known for its expertise in clinical areas.

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
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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