Sumitomo (SHI) Demag recently supplied a 75 tonne IntElect all-electric injection moulding machine to Avenue, a Nolato Company, in Sligo, Ireland. The investment supports the growth in the company’s healthcare division, providing dedicated capacity to mould precision parts during the product development phase. With demand for its medical device injection moulding and tool-building services increasing, Avenue recently installed a new 100 sqm ISO Class 8 cleanroom area.

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With a large proportion of Sumitomo (SHI) Demag’s Irish customers in the medical market in Ireland, we last year opened a service and support office in Limerick, Ireland. This was to support its installed base of predominantly all-electric machines, providing on-the-ground preventative and reactive machine maintenance and troubleshooting support.

Among other things, the importance, utility and enhanced safety offered by prefilled and labelled medication syringes is emphasised, as well as the use of aids such as colour-coded medication trays that can help the anaesthetist correctly organise the syringes before and during anaesthesia. Neither prefilled syringes nor these coloured aids are yet in widespread use in the UK NHS.

The IntElect machine met Avenue’s brief for a small footprint machine for carrying out test runs during the development phase of projects.

The global medical injection moulding market size was valued at $1.38 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% between 2020 and 2027. Much of this is being driven by advances in the home healthcare sector and an ageing population, which WHO predicts will double by 2050.

For example, when parts are being produced on multi-cavity tools, like pipettes, robots are programmed to remove and place the components into cavity-assigned racks. This means that if an issue with cavity 1 arises, the rack containing all corresponding cavity 1 parts can be isolated and the rack recalled, with all the production information stored in the MES.

Gerard Henn, Avenue’s general manager, said: “All medical programmes are lengthy as it can take two to three years to obtain approvals from the authorities, so there are many months of testing before a component or mould is ready to be scaled up to mass production.”

Darren Herron, UK national sales manager at Sumitomo Demag, analyses the injection moulding market and what is driving new developments for medical applications.

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Establishing an Irish office is also part of a post-Brexit insulation strategy that will moderate any potential concerns Irish moulders may have about dealing with a UK machinery supplier. A permanent in-country service and support base will facilitate timely spare parts sourcing and trading in euros without incurring hefty exchange fees. We firmly believe that Ireland’s talent base and this supportive infrastructure will continue to make Ireland very attractive to inward investment, especially in medical and biotechology R&D.

Plastic moulding continues to be used for many medical applications, including manufacturing implantable medical device components, test tubes, beakers, casings and housings for laboratory and medical equipment, drug delivery components and surgical equipment. With demand for medical devices at an all-time high across hospitals and laboratories thanks to COVID-19, this has had a positive impact on market growth.

This creates some complications in relation to the CE marking process on medical devices as the UKCA (UK Conformity Assessed) mark will replace the longstanding CE mark for goods, including medical devices, sold within England, Wales and Scotland. As there’s no hard border in Ireland, the CE mark still applies there.

The machine’s small footprint is down to the use of its own motors and drives. The model also has wide tie bar spacing and high clamp force for its size, allowing the use of larger moulds than would normally be accommodated by a 75-tonne machine.

To enhance patient safety, there’s a drive towards using new and more innovative regulated materials with a better flow and high impact strength to mould components. The EU Medical Device regulations came into force 26 May 2021, following a one-year extension due to the pandemic. In Vitro Diagnostic medical device regulations (known as IVDR) become effective 26 May 2022. In the UK, the market is currently regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The authors say: “’First do no harm’ is what doctors strive for. We hope that these guidelines provide useful points for anaesthetists’ individual practice, while acknowledging that patient safety also relies on supportive systems within their hospitals.”

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Advanced batch tracking, contact-free inspection using cameras, and highly automated assembly are among the latest developments to meet the medical device market’s precision and quality control requirements. Traceability is not just about mandatory information and supply chain tracking. Real-time traceability is about being able to call up data and verify the exact settings used on the injection moulding machine when that individual plastic part was made, making connectivity to a Management Executive System (MES) vital.

This guidance has been produced by the Association of Anaesthetists in response to requests from members in view of continuing incidents of medication errors and patient harm. It ties in with the World Health Organization (WHO) 3rd Global Patient Safety Challenge 'Medication Without Harm', which was the theme of the WHO World Patient Safety Day September 2022.

The authors explain: “Peri-operative medication safety is complex. Avoidance of medication errors is both system- and practitioner-based, and many departments within the hospital contribute to safe and effective systems. For the individual anaesthetist, drawing up, labelling and then the correct administration of medications are key components. These guidelines aim to provide pragmatic safety steps for the practitioner and other individuals within the operative environment, as well as short- to long-term goals for development of a collaborative approach to reducing errors. The aim is that they will be used as a basis for instilling good practice.”

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The authors say that labelling errors have been noted in around 1–1.25% of peri-operative medication administrations and medication substitutions in 0.2% of administrations during anaesthesia, although precise figures are lacking as research studies use different methodologies. It is important to acknowledge that every practitioner is open to error and that the risk can increase over time during a case, especially in the presence of specific factors that diminish performance such as fatigue. The authors say: “Understandably, there is considerable emphasis on medication errors. However, it is also important to give appropriate recognition to the fact that in virtually all cases the correct medication is given by the correct route, at the correct time. Good practice should be highlighted; in most cases there is a consensus on what this looks like.”

The guidance, which was now published in Anaesthesia (the journal of the Association of Anaesthetists), has been written by a working party of UK anaesthesia experts that include Dr Mike Kinsella, Honorary Consultant, Department of Anaesthesia, University Hospitals Bristol and Weston, Bristol, UK and Chair of the Working Party.