PATI ENT SAFE T Y
Position Statement 2. Explore the evidence, where is it? And make recommendations to suit
A clear lack of central reporting on DERS breaches, trapped errors and CQI reporting means that the impact on patient safety and the potential benefits for DERS may be lost. On balance, from published literature, NAMDET believes that appropriately implemented and used smart pumps (including but not limited to DERS) confer a benefit to patient safety.
Position Statement 3. Does DERS need additional infrastructure and support to allows its adoption? The use of smart pumps is only part of a complex multidisciplinary system; successful implementation, via technology integration, together with continuous management and ongoing review, is required for sustainability, and continuous quality improvement.
Position Statement 4. Should DERS be mandated by the NHS? Health organisations with smart pump (DERS) capability who are not using it must review their own medication error incidences and report to the appropriate safety committee, governance teams and/ or medication safety officer to ensure good governance and drive continuous quality improvement.
Position Statement 5. What role should Arms Lengths Bodies (ALBs) play? NAMDET recommended that the occurrence of serious incidents that involve pump technology (i.e. when DERS software captures potential dose or rate limit breaches or errors) are investigated by NHSE & NHSI/MHRA/HSIB/CQC [i.e. Arm’s Length Bodies (ALBs)/regulators] and the learning disseminated through national bodies to drive the increased use of smart pumps.
Position Statement 6. Can DERS be implemented easily in the UK? When procuring smart pumps, include the expertise and people who will use the technology in the procurement process and future-proof purchases. This may include IT and network specialists, medical device management, MDSO, MSO, clinical governance and risk, clinical end users and the supplier/manufacturer.
As well as highlighting the benefits, NAMDET’s report also pointed out that it is important to remember that the use of smart pumps (DERS etc.) does not prevent all errors, largely due to the human involvement in drug and rate selection involved.9 For example, NAMDET pointed out
that one Trust has 13 different options in the smart pump for acetylcysteine options leading to the possibility of choice (or
MAY 2021
picking) errors. It stated: “Smart pumps are just one piece of the jigsaw and ongoing checks, upgrades and validation will still be required. The ultimate effectiveness of any DERS system is reliant on the pump hardware capabilities, connectivity infrastructure and a multidisciplinary team approach with full engagement of the clinical users, the technical team, risk and governance, pharmacy and of course IT and support services.”9
A risk-based approach to designing and implementing technology
As with all medical devices, infusion pumps are not without risks and the FDA has received numerous reports of adverse events, including serious injuries and deaths.1
These
reports previously led to the publication of a White Paper, as part of an infusion pump
improvement initiative, in April 2010, which highlighted ‘software defects’, ‘user interface issues’ and ‘mechanical or electrical failures’ as the key factors in adverse events. The FDA’s investigation of user interface issues specifically highlighted the following ‘human factors’: l The design of the infusion pump screen confuses the user.
l The infusion pump screen doesn’t make clear which units of measurement the user is expected to enter. For example, the user may enter weight in pounds when the infusion pump requires it in kilograms.
l Pump labels or components may become damaged under routine use – through inappropriate cleaning practices or damage may occur to the print on the pump keys, making them unreadable.
l User instructions or cues for mechanical set-up are not specific or clear enough.
l Inadequately designed alarm functions and settings cause users to miss problems or respond late.
l The infusion pump screen design is ‘clunky’ or confusing to users, causing a delay in therapy. For example, the ‘Start Infusion’ key may be located next to the ‘Power’ key, and a user may turn off the infusion pump instead of initiating infusion.
l Warnings are displayed so often that users come to ignore them.
l Warning messages are unclear. l User manuals are confusing, inadequate, outdated, or unavailable.
l When communicating the critical aspects of the pump’s status, the system does not use user-friendly language or does not give enough information to guide users through appropriate actions.
While the technology has moved on since the publication of the FDA’s White Paper, the lessons learnt from this investigation remain pertinent today. As with all medical devices, there needs to be an understanding of the barriers to adoption, the risks, benefits and challenges around human factors and implementation. In December 2020, the Healthcare Safety Investigation Branch (HSIB)11
published its findings from an
investigation into the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals.
The investigation was launched after one
NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl, a powerful pain medication. 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. The investigation focused on the barriers to implementing the
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