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Leading product safety lawyer voices concerns over syringe driver safety

Product liability lawyer troubled by reports that unsafe syringe drivers may have been in use

Posted on 19 August 2018

A leading product safety lawyer belives the government should open an inquiry into the safety of syringe drivers after media reports suggested that the threat to life from such devices had been ‘ignored’ during the Gosport Hospital inquiry.
According to reports, a whistleblower from the Gosport inquiry panel suggested that the inquiry ‘buried’ evidence of cheap, faulty syringe drivers which may have caused the death of thousands of patients treated in UK hospitals. 
Michelle Victor from the product safety and consumer law team at Leigh Day said it was ‘deeply troubling’ that despite numerous warnings relating to the safety of the pump devices, they remained in circulation in the NHS until 2015. 
Following the scandal at the Gosport Memorial Hospital in which the inquiry suggested over 450 people could have had their lives shortened through a systemic failing in the prescribing of opiates, the hospital withdrew more than 100 syringe drivers from use. 
The Sunday Times reported that concerns about the faulty pumps were raised but this information was ‘buried’ by the inquiry panel. 
Approximately 40,000 Graseby MS 16 A MS 26 pumps are reported to have been in circulation in UK hospitals up until 2015. 
The Graseby MS-Series syringe driver pumps meant that medics did not need to administer the opioids manually, helping to save time. 
However, various concerns were raised that the Graseby MS-Series devices did not meet the Global Harmonisation Task Force for medical devices (GHTF) "Essential Principles of Safety and Performance of Medical Devices" guidelines. 
These guidelines represent International minimum requirements for the safety and effectiveness of medical devices. Medsafe who are responsible for the regulation of medicines and medical devices in New Zealand reported the following problems with the models:- 
  • The visually similar MS16A and MS26 models have a 24-fold difference in infusion rate. Confusing the two has resulted in multiple serious adverse events
  • The device does not use standard measuring units requiring a calculation to set the flow rate, thus introducing the risk of error.
  • The pump lacks a stop button.
  • The rate can be changed while the pump is in operation.
  • There is no protection against misloading of the syringe, air entrainment, tampering or siphoning.
  • The occlusion response characteristics of this pump are very poor.
  • The pump does not retain a record of operation
  • Some models feature a "prime" button which provides maximum infusion rate when depressed. There is no limitation on the number of times this may be activated nor a record of activation. Serious adverse outcomes have resulted from inappropriate use.1 

In particular, it has been reported that the syringe pumps used may have administered up to a day’s dose of opioid within a one hour duration potentially resulting in an overdose. 
The devices stopped being supplied to hospitals in New Zealand as early as October 2007 and as a result of safety concerns they were banned altogether from use in New Zealand and Australian hospitals. 
When administered in overdose form, opioid drugs which are ordinarily used to help alleviate severe and chronic pain and to help a patient become more comfortable, can cause symptoms including impaired breathing and respiratory problems which, if not treated immediately, may lead to death. 
Michelle Victor, Partner in the product safety and consumer law team at Leigh Day said:
“It is deeply troubling that despite such alarming warnings relating to the safety of the MS-Series syringe pump devices being published in 2007, the syringe pumps remained in circulation in the UK until 2015. 
“The welfare of patients is paramount. When we are admitted to hospital we expect to be cured and cared for, if the medical devices then used in our care cause a further threat to life, this is wholly unacceptable.
“We would call on the Government to open a new and thorough inquiry into the safety of these devices to learn from the mistakes of the past.”

1.  R Allman for Medsafe, ‘Discontinuation of supply of Graseby MS16A and MS26 syringe drivers’. Wellington, Medsafe 23 November 2007, on 25/06/2018 (accessed 25/06/2018).

This article was updated on 17.08.18. First published 25.06.18