Home Resources Blog September 2023

Making health the focus on World Patient Safety Day 2023

15 september 2023
5-minute read

Sunday 17th September 2023 marks World Patient Safety Day, an initiative led by the World Health Organization.

NQA Regional Assessor Tam Rowell explains where ISO 13485 (Medical Devices Management) comes into play – and the top five clause requirements for patient safety.

A snapshot of World Patient Safety Day 2023

As the name suggests, World Patient Safety Day was introduced back in 2019 for one reason: to improve patient safety.

On 17th September every year, the World Health Organization calls upon countries and international partners in every corner of the world to put patients first.

Patients, families, caregivers, communities, health workers, healthcare leaders, policymakers… World Patient Safety Day involves those across the medical space.

NQA fully supports this initiative, ensuring patient safety in the B2B world with a leading standard.

All about ISO 13485 (Medical Devices Management)

ISO 13485 (Medical Devices Management) is the go-to standard for medical professionals and organisations worldwide.

The latest version was released in 2016, with a goal to keep healthcare professionals and customers safe.

How? By ensuring that medical devices:

  • Stay compliant with relevant laws, regulations and customer needs.

  • Follow specific manufacturing, installing and servicing requirements.

ISO 13485 is typically aimed at medical device manufacturers, component manufacturers (contract), distributors and responsible personnel – anyone with a vested interest in the medical space.

While ISO 13485 isn’t mandatory, it can help open new global supply chains and partnerships.

The similarities between ISO 13485 and ISO 9001 (Quality)

ISO 13485 follows the same process model approach as ISO 9001 (Quality). Here’s a basic definition of the ‘process model approach’:

Defining and managing processes and their interactions achieving the intended results that align with the organisation’s quality policy and strategic direction.

If an organisation achieves ISO 13485, they maintain patient safety through an ISO 13485 quality management system.

Don’t know much about quality management systems? Get up to speed with ISO 9001 (Quality).

Which ISO 13485 requirements focus on patient safety?

All the clause requirements of ISO 13485 are important, for various reasons.

However, in true World Patient Safety Day spirit, here are the requirements relating to patient safety in particular:

Patient safety requirement #1: Safety through design

The Medical Device Directive (MDD) and Medical Device Reporting (MDR) require organisations designing a medical device to perform a risk/benefit analysis.

This analysis helps the organisation determine whether the potential harm the device can cause is worth the risk compared to the potential benefit.

ISO 13485 also calls for a risk assessment process for ‘product realisation’, which covers design. The standard points to ISO 14971 (Application of risk management to medical devices) for guidance on identifying the risks a patient may face.

Risk assessment top tips

  • Complete the risk assessment early to make sure that patient safety is at the forefront.

  • Regularly review and update the risk assessment to minimise new, unacceptable risks.

    • Involve a multidisciplinary team with the reviews and updates (‘living document’).

  • Use a scoring system that covers the severity, occurrence probability and detection likelihood.

    • Score each risk and state the controls that need to be put in place.

    • Determine a residual risk score to identify if a) more work is needed and b) new risks have been introduced by mitigating actions.

Patient safety requirement #2: Traceability

Every material that goes into a medical device should be readily traceable to the source.

To better understand why, let’s run through a potential scenario…

A supplier contacts you about a particular batch of material. They have just discovered a flaw that may cause a medical device to fail – a danger to the patient and/or user.

Your ISO 13485 quality management system allows you to identify which batches are affected and where those batches have gone. From there, you can quickly and effectively recall the medical device to avoid possible danger to the patient and/or user.

Traceability top tip

The level to which you can trace materials should be based on the risk.

For example, implants require a file of batch information for:

  • Each individual device

  • Its specific components

Patient safety requirement #3: Inspection for release

With robust inspection processes in place, you can identify and prevent ‘bad products’ from being released.

An indication that your ISO 13485 quality management system works as intended?

The level of internal non-conformities identified during inspections
Significantly higher than product-based complaints received from customers

This demonstrates that more ‘bad product’ is identified internally compared to what you release.

Inspection for release top tips

  • The strongest processes are when operatives with no involvement in product manufacturing (i.e. an independent) perform the inspection.

  • Every inspection should include:

    • Batch records assessment

    • Traceability information

    • The product’s physical properties and test results

  • The following should be documented and retained as records:

    • Identity of the inspector

    • Identity of the inspection equipment

    • Inspection measurement results

Patient safety requirement #4: Response to incidents

Sometimes things go wrong. When this happens, it’s vital for the ISO 13485 quality management system to:

  • Determine what and why the incident(s) occurred.

  • How to prevent the incident(s) from taking place again.

Response to incidents top tips

  • Potential incidents must be identified quickly (via complaint, post-market surveillance (PMS) and vigilance processes).

    • These processes should also feed into recall/regulator reporting processes at the first given opportunity.

  • Incident results and potential fixes need to be fed to the design team.

    • To update the risk assessment / possible methods to control or mitigate the risk.

  • Also consider positive and general feedback gathered, as this can be valuable for:

    • Improving patient experience via implemented design features and/or processes.

    • Retaining positive aspects of the product during future design changes.

Patient safety requirement #5: Management responsibility

When it comes to patient safety, the responsibility lands at the feet of top management.

For this reason, it’s crucial to actively involve top management in the operations of the ISO 13485 quality management system.

Management responsibility top tips:

  • Participate in management reviews

  • Monitor performance data

  • Hire sufficient staff for operations to continue

  • Train staff effectively and thoroughly

  • Be prepared to make the right decisions

…all to keep patients safe – and not just on World Patient Safety Day, but every day of the year!

Final thoughts from NQA

World Patient Safety Day is a significant event, bringing together the day-to-day necessity of patient safety and ISO standards.

NQA is proud to award ISO 13485 (Medical Devices Management) to organisations committed to patient welfare.

Explore the ISO standard for medical device management via our ISO 13485 product page.

Want to learn more about certification with NQA? Get in touch with a friendly expert today!