Report highlights safety risks of ‘smart’ infusion pump devices


The latest report by the Healthcare Safety Investigation Branch (HSIB) charts the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals.


Smart infusion pumps are the latest generation of programmable devices that administer medication. They are seen as a way of improving safety as the smart functionality aims to prevent underdoses or overdoses. They are equipped with features such as alerts or alarms to help detect problems.


The investigation was launched after one NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl. The patients weren’t harmed as it was swiftly picked up, however, it emphasised the new risks that come with introducing new technology and the potential for serious medication errors.


HSIB’s investigation focused on the barriers to implementing the technology effectively across the NHS, rather than on the technology itself. They examined these barriers through a ‘ten key considerations’ framework which looks at what is needed at each stage to ensure a successful implementation. This covers everything from clarifying why the change is needed to constant evaluation once the system is in place. Using the framework, HSIB’s investigation identified the safety risks that would need to be managed at each stage.


The investigation highlighted the main implementation challenges. This includes:


  • National consistency in drug libraries – smart infusion pumps have an inbuilt dose error reduction system (DERS) which requires the use of a drug library. The investigation found that drug libraries were developed ‘locally’ and that there is no agreed national drug library for use in NHS. They also found that there is no national guidelines or standards on how to implement the
  • Significant changes in processes – introducing the technology requires significant changes to prescribing and administration processes in trusts. The investigation found that procedure and guidance documents often needed updating, and variations in medication practice were ‘locally managed’ and were rarely shared within and between
  • Provision of specialist IT support and infrastructure – substantial IT infrastructure is needed to support the integration of smart pump technology. Software is needed to upload the drug library to smart pumps, download data logs (including any errors detected) and monitor the status of each smart pump. The investigation highlighted that maintaining the required IT infrastructure required specialist staff roles and often a new skill.


The investigation found that the implementation of smart pump functionality would benefit from the use of risk management practices, as requirements are complex and similar to the introduction of a new IT system. Existing NHS Clinical risk standards could provide a basis for both manufacturers and trusts to work together to manage risks.


Scott Hislop, Principal National Investigator at HSIB said:


“The purpose of the investigation wasn’t to endorse or examine the advantages or disadvantages of the technology but to understand why it can be difficult to implement in hospitals and where this might introduce some new risks to patient safety.


“Our investigation identified that these risks have been seen in trusts of different sizes across England. We have worked closely with manufacturers, regulators and national bodies and its clear a system-wide approach is needed to share learning and manage those risks effectively.


“The ten key considerations framework which underpins the report helped us to see where there may have been gaps at a national level and this has been reflected in the safety recommendations we have made.


“Setting out what an effective implementation journey should look like will help NHS trusts to use smart infusion pump technology to its full benefit, reducing the risk of serious harm to patients.”



Medication safety has become a global emergency


The positive impacts of pharmacists in supporting medication without harm are described in a new publication from the International Pharmaceutical Federation (FIP).


The World Health Organization reports that one in four patients is harmed by the care they receive in primary and ambulatory care settings, including harm from medicines. It estimates the global cost associated with medication errors at USD 42 billion per year.


FIP’s new reference document, entitled “Patient safety — Pharmacists’ role in ‘Medication without harm”, provides information about what pharmacists can do to promote patient safety at an individual patient level, as well as at organisational and policy development levels. It includes case studies of best practice from Australia, Canada, Finland, India, the Netherlands, Oman, Saudi Arabia, South Africa, and the USA.


“Medication safety has become a global emergency and many nations are placing it on their national health priority agendas. Regardless of whether pharmacists provide direct or indirect patient care, they all have a role in promoting safe and quality health care,” said Parisa Aslani, professor in medicines use optimisation at The University of Sydney, Australia, and co-editor of the document.


The reference document highlights a need to shift towards a collaborative systems approach that promotes effective risk management and continuous quality assurance. It also points out that “a culture of blame” neither prevents nor mitigates harm, nor does it enable a positive working environment.”


“The common challenges facing pharmacists include increasingly complex medicines, polypharmacy and ensuring optimal transitions of care for our patients in spite of fragmented healthcare systems or models of service delivery. There is also the often-reported issue of being under-resourced and time-poor. We can learn a lot from each other, and this reference paper is a personal and professional challenge to all pharmacists to keep patient safety at the forefront of practice and to take new steps towards safer care. We all are advocates of patient safety. As pharmacists, we are particular advocates of medication safety,” Professor Aslani said.


You can read the full publication here.