This article explores how NHS professionals can effectively manage medical devices with a focus on safety and compliance.

By aligning with the structured framework provided by MTS Compliance Assure, healthcare organisations can address critical areas—Governance, Inventory Management, Training, Procurement, Maintenance, and Cyber Security—ensuring that their practices meet MHRA guidelines and enhance overall patient safety and operational efficiency.

Governance

Effective governance in medical device management is often challenged by the absence of executive-level KPIs, limited compliance visibility, and a lack of formal quality systems and audits(2). These gaps hinder adherence to MHRA requirements and the implementation of a robust Medical Device Management Strategy.

As the regulatory landscape evolves, especially with the rise of Internet of Medical Things (IoMT) and increasing cyberattacks—81% of UK healthcare providers faced attacks in 2022(3)—updating governance policies is crucial.

To improve medical device compliance, healthcare organisations should focus on:

• Enhanced reporting and monitoring by developing comprehensive KPI standards and evidence-based reporting.
• Establishing a Medical Devices Group with clear terms of reference and appropriate representation from procurement, finance, and clinical stakeholders to ensure a structured framework for quality processes.
• Aligning policies with service delivery and appointing a director or board member responsible for medical device management.

The benefits of these improvements include increased transparency and accountability, as proper documentation and monitoring of processes enhance organisational oversight.

Improved governance also boosts patient safety by highlighting investment needs, such as training, and ensuring devices are maintained on a risk-based schedule.

Furthermore, regular audits help mitigate risks while aligning equipment procurement with departmental feedback ensures that devices meet operational and strategic needs(2).

Inventory Management

A typical general hospital manages 8,000-15,000 items of equipment, and Strickland et al. argue effective inventory management is vital for “better patient outcomes, operational and financial sustainability, and improved care(1).” However, challenges like fragmented inventories, inconsistent naming, and poor documentation complicate compliance and reporting, often leading to costly, redundant service contracts, especially for high-risk devices(4).

To improve medical device inventory management, healthcare professionals should implement a centralised and robust asset management system as the foundation for effective device management.

Introducing a managed equipment library ensures that necessary equipment is available when needed, while a Radio Frequency Identification (RFID) solution can maximise utilisation and reduce inventory. It's crucial to link inventory management data with overall equipment asset management systems and review all Original Equipment Manufacturer (OEM) and maintenance contracts across the hospital(2).

Moreover, maintaining accurate device records and re-labelling equipment for GS1 compliance, a global standard for supply chain management and data exchange, ensures precise identification and tracking of medical devices, enhancing patient safety, regulatory compliance, and supply chain efficiency.

The benefits of these improvements include compliance assurance through regular audits, reduced risk of device shortages, and enhanced decision-making by providing critical data on equipment lifespan. A centralised approach ensures resources are focused on high-risk items, improves efficiency, and supports continuous quality assurance through standardised processes(2).

Maintenance

Over 40% of equipment is already beyond its recommended and extended life, a situation exacerbated by several challenges.

The availability and capital funding contributes to many hospitals lack of finance to replace equipment. Poor inventory management makes it difficult to locate devices, while the lack of scheduled preventative maintenance and an administrative backlog in updating service records further complicate the issue. Workforce shortages and inconsistencies in service frequencies can compound these problems(1).

Improving maintenance helps ensure patient safety by keeping equipment functional and reliable. Addressing the maintenance backlog is critical to mitigate risks from overdue services and to establish formal evidence for performance reporting, and focus on patient safety.

You could consider:

• Implementing robust Planned Preventative Maintenance (PPM) based on risk and manufacturer guidance.
• Clearly labelling maintenance dates to ensure devices are serviced on time.
• Integrating and effectively managing external maintenance contracts to reduce the high costs associated with multiple service agreements.
• Utilising existing equipment.

The benefits of these improvements include extended equipment life cycles, reduced costs, and minimised downtime through proactive maintenance. Regular, systematic maintenance enhances device reliability and performance, contributing to operational sustainability. Furthermore, maintaining accurate records and KPIs ensures compliance and readiness for Care Quality Commission (CQC) inspections(2).

Procurement

A typical hospital will have upwards of 300 individual maintenance contracts(1), so procurement of medical devices faces challenges like fragmented spending and poor planning, especially for non-capital items. This disjointed approach complicates equipment replacement, leading to inefficient use of NHS funds. The procurement is often spread across multiple departments with no centralised plan and cost.

Poor procurement strains finances and affects clinical outcomes. Enhancing these processes ensures spending is focused on critical, high-risk items, addressing backlogs and aligning with strategic goals.

You could consider gaining third-party support for managing medical devices that streamline operations and reduce costs, delivering Cost Improvement Programme (CIPs) targets and patient safety.

According to MHRA guidelines, external providers offer several advantages, including:

• Predictable costs
• Customisable response times
• The ability to specify equipment downtime

Third-party support is often cheaper than manufacturer services and consolidates management by reducing the number of external organisations involved(5).

Training

Effective training is critical for the safe and efficient use of medical devices, yet many organisations face significant challenges. The absence of centralised training records makes assessing and documenting staff competency difficult, leading to inconsistencies across departments. More resources are needed to ensure proper management and recording of training activities which can be centralised and stored electronically.

Rapid technological advancements, the integration of patient-connected technologies, and the high incidence of user errors drive the urgency for improvement. Since no Trust can replace all equipment simultaneously, staff must quickly become competent with new technologies while maintaining their skills on current and ageing equipment(2).

You could consider:

• Conducting a thorough training needs analysis to document competency levels for specific devices.
• Centralising training records to maintain a single source of information on training needs and competencies.
• Establishing dedicated training resources and aligning the training policy with service delivery to help ensure that staff are well-prepared.
• Auditing and reviewing training effectiveness, to help ensure that users are properly trained.

The benefits of these improvements include significantly enhanced safety, reduced equipment downtime, and increased operational efficiency. Standardised training processes ensure consistent knowledge across the organisation, minimising risks and ensuring clinical users are fully competent in the safe and effective operation of medical devices, ultimately protecting patient wellbeing(2).

Is your medical device management as efficient as it could be?

Streamline your processes and ensure compliance with MTS Compliance Assure. Our tool transforms MHRA guidelines into six actionable pillars—Governance, Inventory Management, Maintenance, Training, Procurement, and Cyber Security—enabling you to confidently assess and enhance your medical device management.

Discover where your Trust stands. Use MTS Compliance Assure to identify key areas for improvement, prioritise action, and elevate your operational efficiency.

Contact us to see how MTS Compliance Assure can help you achieve excellence in medical device management, ensuring patient safety and regulatory compliance across your organisation.