BMUS/ AXREM Advice & Guidance for Ultrasound Manufacturers

26 June 2020

Advice and Guidance for Ultrasound Manufacturers Visits for Servicing & Maintenance, Demonstration, and Installation. This advice and guidance is written to support both ultrasound service providers and equipment manufacturers in the demonstration, installation and maintenance of ultrasound equipment whilst safety precautions during the COVID-19 pandemic are in place.

It is recognised that the procurement, maintenance and servicing of equipment is essential to ensure service continuity in the long term. Visiting representatives from manufacturers are required to ensure this process is fair and equitable and does not disrupt service delivery and patient flow. It is legitimate to have representatives present in order to expedite the procurement process before, during or after clinical evaluations but on an invitation only basis.

Visiting staff are considered to be key workers to ensure the continued safe use of ultrasound equipment. Customers are advised to support manufacturers in ensuring these key workers are able to visit clinical sites where no alternative option is available.

The aim of this document is to ensure safe working practices for both on-site employees and visiting staff / engineers.

In the first instance manufacturers should refer to their own company procedures and adhere to the guidance provided by their employer.

Each individual service provider (the customer) will need to undertake their own risk assessment for their own local needs and risk with an awareness that the risk may vary as the COVID-19 infection rates fluctuate.

General Principles for all visiting applications staff in a clinical setting:

• Departments should provide appropriate means of recording the presence of manufacturer representatives, and should refer to this, should any track and trace event occur.
• All manufacturer representatives to ensure that they are set-up with the NHS track and trace app when it is available.
• Visitors should not enter areas of higher risk, e.g. red/amber zones except under exceptional circumstances.
• Where on-site demonstration or applications is required, the visiting staff will need access to PPE appropriate to the case mix. All appropriate PPE to be provided by the customer.
• Visitors must change clothes between home and clinical sites / between sites. Appropriate garments, ideally disposable scrubs should be provided by the manufacturer. Where this is not possible the customer will be required to provide the visitors with scrubs to avoid wearing of own clothes in the clinical setting.
• Visitor numbers must be kept to a minimum with only one applications person within the site at any one time. Any visitor will need to spend minimal time in the clinical environment and ensure social distancing is maintained where at all possible.
• In order to reduce the risk of cross-infection, it is advised that the electrical safety testing of ultrasound equipment, wherever practicable, is undertaken within the clinical department itself in close proximity to where the equipment evaluation is being undertaken.

Servicing & Maintenance visits

• All equipment requires a decontamination certificate prior to being attended by the visiting engineer.
• Where possible, all staff need an area to work in that meets social distancing regulations; if possible lone working is advised.
• If attendance within a clinical setting is necessary visiting staff will need access to PPE appropriate to setting. Appropriate PPE to be provided by the customer.

Demonstrations 

• Where possible consider on-line / webinar demonstration of equipment. If this is not possible, demonstration of equipment to key members of the customer team may need to be considered with possible non-clinical sites visits rather than demonstration on patient cohorts.
• Patients should give their consent to have their ultrasound performed on a demonstration machine with a third party in the room.
• Any equipment used in a clinical setting for demonstration will require pre and post demo decontamination certificate. Cleaning must be undertaken by a trained member of staff and ideally but the clinical department using the equipment.

Installation 

• It is advised manufacturers develop e-learning packages to demonstrate key features of their equipment, set up procedures and other applications for customers to do on site themselves.
• Remote login and support advised to assist with restricted access set up.
• Where possible, the manufacturer to install required presets and measurement packages off-site pre delivery.

This guidance is not exhaustive and it is recommended that processes are locally agreed between customer and manufacturer representatives / engineers prior to any site visits. Individual customer bases may benefit from seeking advice from their local infection control or clinical engineering departments.