Human factors engineering initiative likely to result in guidance, says UK expert

Regulatory guidance is likely to be needed in the area of human factors engineering for healthcare products, including devices, and the UK's Medicines and Healthcare products Regulatory Agency is exploring the best way forward. Amanda Maxwell spoke with UK devices regulatory expert John Wilkinson to find out more

A new group has been set up in the UK to look at the regulation of human factors engineering (HFE), following a lively UK MHRA meeting at the end of February. Its aim is to reach tangible outcomes to improve the safety of medical devices, which are becoming increasingly complex, John Wilkinson, MHRA director of devices, told Clinica.

Devices are becoming more challenging not just for the trained medical staff that use them, but also for patients and carers who increasingly have to make use of such technology in non-hospital settings. Human factors engineering involves designing and producing products that take into account the skills of the intended user and the environment in which they can be used to maximise safety and consistency.

This increase in self-management brings both huge opportunities and huge risks long-term, Mr Wilkinson noted.

The initial drivers that have encouraged the MHRA to bring together people interested in this field are an increased awareness of the issue of usability, especially given the focus on this in the proposal for a new EU Medical Devices Regulation, and also the new EU medicines Pharmacovigilance legislation.

The latter has brought the MHRA's overall vigilance responsibilities into sharper focus, Mr Wilkinson explained. The agency has expanded into drug administration areas such as those involving pumps, syringe drivers and similar device products, and is certainly not just focused on the reporting of adverse drug reactions.

This is a good area where we can demonstrate our cross-cutting strengths, Mr Wilkinson said, referring to the application of strengths in the devices world to inform the regulatory decisions in the medicines sector, and vice-versa

He added that medical mobile applications are another overlap area where the MHRA is making good headway through the same thought leadership initiative. “We have been looking at who the key people are in the system, who understands the potential challenges and how people can work together to drive the UK regulatory initiative,” Mr Wilkinson said.

Successful meeting

The late February meeting was an opportunity to bring together interested parties and experts and to create focus groups in the field of HFE. This was a first step in exploring what initiatives may be needed in this area to ensure that the sector is keeping up with the rapid technological development in the way both drugs and devices are used, Mr Wilkinson explained.

There were some 80 participants at the meeting, including those with clinical backgrounds, such as academics and NHS employees, as well as industry and regulators. The general level of interest in this area is rising, Mr Wilkinson said, and there are already sufficient groups working in this area that may be able to take the lead on HFE meetings, taking some of the organizational weight off the MHRA. The MHRA would then actively participate in such groups.

There are some “great examples of manufacturers doing extremely well in this area, but they are probably quite rare,” Mr Wilkinson said.

Mr Wilkinson has long been a proponent of good communication as a vital cornerstone in progress and said that he hoped that by bringing interested parties together, that this will lead to efficient collaboration involving those who can make progress happen.

The starting point is to have a good understanding of the issues that need addressing, and then proposing how to address them.

Mr Wilkinson is not aware of any further major debate at the European level on this matter. It will only be at the point when we have something positive on the table that we will engage our European partners and the International Medical Device Regulators Forum (IMDRF), he said.

He added that this matter would only be likely to be placed on the European agenda once the MDR is adopted, and when it is possible to identify the regulatory gaps.

“Once the legislation is fixed, it will be necessary to map the work program so it is implemented and we have a comprehensive set of guidances to go with it,” the devices director said, adding that there will be quite a few other areas where such work will be needed.

Pinpointing HFE design shortfalls

With HFE being a cross-cutting area, users (patients and professionals) may be demotivated when they need to make incident reports because of the challenges in assessing where to send the report when a product is part drug, part device.

Yet many of these reports will be key to highlighting HFE issues and continuous improvement in design.

“We are looking at how to make reporting easier,” Mr Wilkinson said. “We are discussing the harmonization of reporting portals into the agency.”

“If an incident occurs in the hospital you do not want to discourage reporting because of the complexity and choices of different portals. Good reporting systems should help people through the process, and [] the information that results from such systems needs to be channelled to the people who are interested and can make use of that information.”

Inevitably, he noted, there will be more and more overlap between adverse incident reporting and management on the drug and device sides, and the agency needs to address any problem issues to make analysis of the problem factors simpler.

Where an adverse incident is related to a human factors issue rather than purely a technological issue, then the MHRA has a role in feeding that back to the manufacturer, Mr Wilkinson said.

There may be various outcomes in such circumstances:

1)the MHRA takes regulatory action because the device is not working as it should;

2)the MHRA works with professional bodies and the NHS to mitigate the circumstances which are due to clinical practice issues; and

3)the MHRA provides feedback to the manufacturer to explain that this is an opportunity to improve design or training

The MHRA is committed to doing more of this sort of collaborative work in both the drug and devices areas, Mr Wilkinson concluded. “No one is more conscious than me about the differences between drugs and devices,” he noted, but “by overplaying the differences, drug and device communities can miss some of the opportunities”.