Why use error is everyone’s responsibility
Why user error is everyone’s responsibility and how MD-TEC can help you optimise your medical design.
Sinziana Popescu, research fellow from Aston University is heavily involved in medical products development, human factors and usability engineering, being focused on medical product validation and commercialisation at Birmingham’s MD-TEC (medical device testing and evaluation centre). Here, she explains what the centre is doing to help combat adverse incidents in medical devices.
Every year about 98,000 people die in hospitals in the United States and 11,859 in England due to medical errors1, many of which are due to incorrect medical device utilisation by the human operator. These are known in the speciality literature as use errors, being commonly triggered by mistakes (lack of knowledge or training) or skill-based (within automated routines) errors. Interestingly, in spite of the improved access to technology and the booming medical innovations, the UK has seen an increase in the number of adverse incident reports for medical devices2. Human factors engineering (HFE) in healthcare entails more than the ergonomics aspects as it is essential to ensure that the design of the device is safe and suitable for lay users, healthcare professionals or patients. The need for more effective HFE has been echoed with moves from the Food and Drug Administration (FDA) and Europe to encourage medical device companies to complete this type of testing with documented guidance published in the last 2 years (FDA guidance document for applying human factors & usability engineering to medical device and IEC 62366-1:2015 application of usability engineering to medical devices). While the manufacturer is in reality the responsible and accountable party for use errors, a collaborative effort is necessary in order to minimise the occurrence and severity of healthcare errors.
During the medical device development, the manufacturer is expected to perform risk analysis and understand the severity of the potential harm3 that comes from the failure of the medical device, especially in actual use scenarios. Two options are acceptable when aiming to eliminate adverse events: the predicted error does not occur as another process is in place to prevent the error from happening, or the error can occur, but it is mitigated so that it does not lead to an adverse event. Moreover, one should not omit the importance of well-defined processes in healthcare institutions, such as standard operating procedures (SOP) for medical device operation, medical device maintenance as well as error-reporting mechanisms4. Human factors is also addressed in relation to health and safety, the reason for which various hospital departments diverged from Health and Safety and Continuous Improvement working towards both employee and patient safety.
Especially in the case of portable or home-use devices, it is in the patient’s best interest to understand and correctly use the recommended medical devices; this is increasingly becoming common place for medical devices. With increased emphasis on community care identified in the NHS Five Year Forward View and Sustainability and Transformation Partnerships (STPs), the need for easily usable devices is becoming more apparent. While the manufacturer must ensure that the instruction manual is adequate for the average user, the healthcare service provider tends to introduce a Code of Professional Conduct for the employees to adhere to. Lastly but not least, healthcare professionals and carers also have a moral duty to report faults or misuses of the medical device. Moreover, regulatory bodies are trying to promote a common approach for manufacturers in the development of medical devices. With the imposed medical device guidelines (essential requirements) and post-market surveillance systems, the manufacturers are legally required to report safety and performance issues.
Usability testing is key to HFE strategy and it involves representative end users performing, step by step, the tasks required for medical device utilisation in order to reveal strengths and weaknesses of the design. Usability tests can be performed at any design stage - development (formative study) and validation (summative study) - as it enables the device improvement for the intended users, use and environments. The medical device users can be protected from harm only via a robust and reliable user interface, comprising displays, controls, labels, packaging and instructions for use. The profile of human factors in medical device development has significantly increased with change in regulations and expectations to improve the healthcare services. Previously sidelined in favour of technological advancement and health and safety, the benefits of usability engineering are now being realised and the implementation of HFE processes can lead to the advantages outlined below5:
Despite the clear need for improved HFE with medical devices there is relatively little support existing outside of the USA, which can be utilised to realise the advantages of engaging end users in medical device development.
Medical Devices Testing and Evaluation Centre (MD-TEC) supported through funding from the European Regional Development Fund 2014-2020, aims to facilitate the commercialisation process for small and medium size Life Sciences companies* in the Midlands region. Offering access to the Usability / Simulation Suite and R&D expertise, manufacturers can evaluate medical device user interfaces in representative use environments, such as the operating theatre and wards. The implementation of usability into medical products is mutually beneficial to all involved parties, leading to use(r) optimisation and a competitive advantage. In addition, the National Institute for Health Research (NIHR) Trauma Management MedTech Cooperative offers similar support and expertise in this area to deliver improved outcomes for healthcare, patients and industry. For further information visit our website www.md-tec.com or email us on mdtec@uhb.nhs.uk
*Eligibility criteria apply.
References
1 - http://threecircles.eu/tag/mhra/
2 - Medicines and Healthcare products Regulatory Agency Annual Report and Accounts 2015/16
3 - CDRH, Applying human factors and usability engineering to medical devices, Guidance for industry and food and drug administration staff, 2016
4 - Z. Robinson Wolf, R. G. Hughes, Chapter 35: Error Reporting and Disclosure, Patient Safety and Quality: An Evidence-Based Handbook for Nurses, 2008
5 - E. Taylor, S. Hignett,, A. Joseph, The environment of safe care: considering building design as one facet of safety, in Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, pp.123-127, 2014