Service & Maintenance - why is it so important?
Still a relatively 'new' item in a hospital's inventory (having been around a mere 30 years compared with the 80+ years of the patient transport trolley or stretcher), the Mobile Surgery System requires specific service and maintenance.
Such systems used to be called 'Day Surgery Trolleys' - which perhaps gives a false impression. The Anetic Aid QA4™ is essentially an operating table, but on a trolley base - with patient recovery capability built in.
Day Surgery as a concept has gained huge traction in recent years, with more specialisms - from general surgery to orthopaedics - adopting it as the default approach for a wide range of procedures. The benefits of such a short hospital stay for patients (including reduced infection risk, bringing down Trust waiting lists and easing funding pressures) are clear, so that now, the question is: 'What CAN'T be carried out as a day surgery procedure?"
The one-device approach to transport, treatment and recovery for same-day surgery offers even more benefits, including:
Reduced lifting and handling for practitioners - and no manual handling risk for patients
Zero waste of time on transfers - so maximised patient flow / optimum use of theatre time
Ease of procurement, training and storage, as one device accommodates all needs.
With all of these benefits wrapped up in a single, versatile piece of equipment, there are clearly maintenance requirements to ensure optimum functionality and indeed, a Mobile Surgery System such as the QA4, must be considered and maintained in the same way as an operating table.
This is particularly important as all new models are powered: under the Global Medical Device Nomenclature (a system of internationally agreed generic descriptors used to identify all medical device products), the QA4 is defined as a 'Universal Operating Table, Electromechanical.'
As such, it comes under the Medical Device Regulation 2017/745, which states that its technical file documentation, which includes instructions for use, must also include a risk management file stipulating the manufacturer's service requirements - a key mechanism for eliminating risk.
Assessment of risk is also covered by other industry standards governing such equipment: BS EN ISO 14971:2019 and Annex A (A.2) ISO/TR 24971:2020. These standards provide a series of questions to guide the manufacturer in assessing a device's risk - some of which specifically relate to servicing and on-going maintenance.
Anetic Aid's technical team members have been through this process, using the questions set out in the standard. They concluded that a QA4 should be serviced annually by trained personnel, in line with the company's documented process (which contains a 13-point service schedule, including an Electrical Safety Analysis). You can view that document by clicking here: TECHNICAL DOCUMENTATION LINK
Another relevant standard is BS EN 6235:2014 - Medical Electrical Equipment. This states that recurrent test and test after repair of medical electrical equipment should be adhered to - not only as part of an annual pre-preventive service but also following periodical repair.
At Anetic Aid, we offer an annual, pre-planned and manufacturer-backed service plan called AnetiCare - delivering value for money and minimal downtime. Not only do we combine product knowledge with customer care, we also offer the following:
Safety and peace of mind - all our service plans are fully compliant with MHRA 'Managing Medical Devices' and CQC guidelines
Monitoring and auditing - to ensure timely, preventative action to optimise performance throughout a product's life
Cost savings - we offer simple, structured pricing plans
Ease of administration - we liaise with your clinical team, planning service schedules to minimise equipment downtime
Expertise - as a UK designer / manufacturer, we use only original parts, fitted by our own locally-based and fully-trained engineers for a swift 'fix first time' policy
Training - we provide free, certified end-user training programmes on all equipment.
You can discover AnetiCare for yourself here: AnetiCare link
Or if you want to learn more about our QA4™ Mobile Surgery System, click here: QA4 link
To view this document in full, click here: Document download link