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Focus on Patient Safety: Meeting The Latest MHRA Standards

Patient Safety Alert

From 1 January 2018 to 31 December 2022, the Medicines and Healthcare products Regulatory Agency received 18 reports of deaths related to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles, and 54 reports of serious injuries.

The background

Most of these occurred in community care settings, including domestic settings and nursing homes, as well as acute (hospital) environments. With chest or neck entrapment in bed rails listed by the NHS in 2018 as a ‘Never Event’ (incidents that require investigation under the Serious Incident framework), the MHRA circulated new guidance in August 2023 scheduled for implementation on 1 March 2024.

The MHRA raised this issue as a serious patient alert to change practice, with the focus on patient safety, resulting in far reaching requirements in terms of policy, product information and selection, servicing, information and risk assessments.

The objective is to ensure that these ”serious , largely preventable patient safety incidents … should not occur if the available preventative measures have been implemented by healthcare providers”. Bed rails: management and safe use - GOV.UK

The Medequip team response

On publication of the guidelines back in August, the Medequip team immediately swung into action to see how they could help, communicating with contracts across the country to address the actions required to ensure compliance with the safety alert. Medequip’s immediate responsibilities within the alert focused on equipment data, compliance, updating policies and staff training; as well as providing guidance, assurances and support, using a wealth of best practice knowledge collected from the national team.

“The majority of our contracts already had robust risk assessments in place for bed rails, following updates to earlier guidelines established in 2018, with good systems already established in terms of correct policies and frameworks,” explained Fiona Wasdell-Bowyer, who heads up Medequip’s growing team of occupational therapists working closely with clinicians and commissioners across the UK. “The extra challenge has been to incorporate the use of grab rails, bed levers and other equipment, tightening up on compliance, training, understanding and awareness.”

After consulting with the MHRA for initial clarification, the Medequip team also reached out to manufacturers of equipment for updates and compliance assurances at manufacturer/supplier level. Medequip has held, and continues to hold, meetings with contracts with detailed communications and offers of support, bringing in Medequip’s experienced procurement, clinical and SHEQ teams.

The practical issues

With a wealth of knowledge and experience around the fitting and use of this type of equipment, Medequip has compiled a comprehensive bed lever guide to accompany its existing publications on the safe use of bedrails. This guide includes fitting instructions, user guidance, and a pictorial suitability matrix showing different types of bed and the appropriate equipment for use with each.

Alongside this information, Medequip has also produced a detailed measurement guide illustrating vital issues like potential entrapment gaps, as well as a usage guide and full examples of appropriate risk assessments.

Combined with practical assistance like placing physical stickers on all relevant equipment identifying entrapment risks to provide an important visual reminder for families and carers and making additional information cards available to all contracts, Medequip has put robust support in place to reinforce the requirements of the latest MHRA guidelines. Trusted assessor training modules have also been updated to comply with MHRA guidelines and shared widely.

“It is a challenging situation for us and all our contract partners,” confirmed Fiona. “These guidelines require changes to policies, training, reviewing device inventories, implementing documented servicing and maintenance schedules, together with new requirements for contracts around conducting priority reviews for certain patients, risk assessments and regular reviews. In the current climate where budgets and resources are stretched to the limit, these are pressing issues, which are vital for patient safety.”

Future actions

In support of the new guidelines, Medequip continues to supplement the clinical section on its website, ensuring information for prescribers is as accurate and complete as possible. Video and more shareable content are in preparation and will be added to this resource in the near future.

The alert references the need for initial and update risk assessments and ongoing reviews for all those using this equipment in the community, particularly where the equipment or the patient’s clinical condition has changed, as well as at regular intervals.

This presents a massive challenge to resources in the current climate for contracts, requiring thousands of individual risk assessments and ongoing reviews over time. Medequip continues to offer support to contracts across the UK, with the option to provide trained and competent staff to assist with this body of work.

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