Purchasing for Patient Safety

Research Theme: Healthcare Design

The research aim is to apply a systems-based approach to using procurement to leverage design for patient safety. By extracting the information both used and provided by designers, measures of a medical device that characterise its safe use will be defined and used to construct a model/framework to be used by purchasers.

Motivation

Despite numerous reports and research in the area of patient safety, citations of incidents have not decreased significantly[2]. While attempts have been made to provide guidance to designers on how to design for patient safety[1, 3] many industries in the UK still exhibit an ad-hoc approach to design[4] and there is little pull from buyers to encourage the use of such approaches. Part of the problem is that current purchasing procedures do not have the guidance necessary to identify what measures of a medical device affect the safety of devices in the user context.

Objectives

  • Develop an understanding of the current procurement processes for medical devicesDefine the measures of a medical device that determine patient safety, to develop a model/language of requirements to be used by purchasersDevelop a procurement system that also advocates patient safety and involves all stakeholders in the system

Method

The framework of the project will be built into the model proposed by the Design for Patient Safety Initiative[1] which provides a design-led approach to improving services across the NHS. Plans include an extensive literature review, close collaboration with PASA and NPSA, pilot studies with three NHS trusts and surveys with medical device companies.

Findings

Some of the problems in the current procurement process identified through informal interviews and literature research include[6]:

  • Remoteness of the user from both the manufacturer/designer and purchaser
  • Lack of influence of national procurement strategy on local strategy
  • Limited training of procurement staff
  • Limited evidence base for quality of products
  • Lack of need-driven procurement
  • Barriers caused by current purchasing drivers (e.g. immediate cost-driven decisions)
  • Abundance and variety of stakeholders within the purchasing process

Details

The framework of this project involves using the model for improving patient safety shown in the figure opposite, taken from the publication from the Design Council on Design for Patient Safety[1]. The aim is to contribute to the knowledge base by understanding the current procurement system and gathering information on medical device-related errors that could contribute towards understanding patient safety from a device-in-use point of view. It has been shown that regulation standards alone do not ensure the safety of devices in the user context[5] and clearer definition of terms such as 'affordability', 'efficiency', 'safety', 'usability' and 'operability', to name a few, are needed for defining patient safety. Therefore the above knowledge will feed into defining the requirements that articulate measures of a product that determine its safety. These requirements will be the basis of a model (or 'product') to be used by purchasers to provide guidance on criteria to look out for ensuring patient safety when choosing devices. Additionally, such procedures need a procurement system that advocates patient safety in which to operate, as an essential part of the greater medical system.

Acknowledgements

Support provided by:

Support for this project was provided by the EPSRC.

Selected Publications

  • DH, Design Council. Design for Patient Safety: A system-wide design-led approach to tackling patient safety in the NHS. London: Department of Health Publications; 2003.
  • MHRA. Adverse Incident Reports 2005: Department of Health; 2006 March 2006.
  • FDA. Design control guidance for medical device manufacturers: CDRH; 1997.
  • Martin JL, Craven, M P, Norris, B J. MATCH: A new industry-focused approach to medical device development. In: al. Te, editor. International Conference Healthcare systems Ergonomics and Patient Safety; 2005; Florence, Italy: Taylor & Francis, London; 2005. p. 294-297.
  • Clarkson J, Alexander K, Bishop D. Observations in medical device design, Part I - current practice. Cambridge: Cambridge University Engineering Department; 1999.
  • Warrington J. The reality of supply - An agency perspective [Presentation]. Hampshire: NHS Purchasing and Supply Agency; 2002.