By guest blogger Brendan Gribbons, Regional Engineering Team Manager, Lower Mainland Biomedical Engineering (LMBME)
Lower Mainland Biomedical Engineering (LMBME) and Vancouver Coastal Health (VCH) recently investigated a concerning incidence of intravenous medication over-infusions between July 2018 and April 2019.
An over-infusion is defined as any scenario where more fluid is delivered to a patient than intended. This type of medical device incident (MDI) meets the criteria for mandatory reporting to Health Canada under Vanessa’s Law, effective December 16, 2019.
Large volume infusion pumps are medical devices intended to accurately control the delivery of fluids into a patient’s body. The operator of the device, most often a nurse, programs the pump to deliver a precise volume of fluid at a specified flow rate. Infusion pumps are often used to deliver high-risk medications which make the pump’s reliable performance of utmost importance for ensuring patient safety.
The sentinel incident which instigated the investigations involved an over-infusion of morphine.
The pump involved with the incident was sequestered; however, the morphine tubing set was discarded. The alteration of the infusion setup and inadvertent destruction of evidence limited the extent of investigation that could be conducted. A definitive cause for the over-infusion was unable to be determined.
Following the sentinel incident, BCPSLS developed a special query which improved the ability to identify new PSLS reports that may reflect over-infusion incidents. This query helped with the identification of over forty additional suspected over-infusions from September 2018 to March 2019.
Individual incident investigations were conducted for each suspected over-infusion. The infusion setup in all cases was altered from the “as is” state at the time of the over-infusion. Lack of complete evidence resulted in a root cause not being identified for the majority of incidents.
The LMBME and VCH investigation team reported all over-infusions to Health Canada as well as the manufacturer. Health Canada responded to the high incidence of reports and used their regulatory authority to compel the manufacturer to perform certain actions. The manufacturer also voluntarily partnered with the investigation team to assist with identifying the cause of the high incidence of over-infusions.
The investigation team developed various strategies over the course of the investigations to improve the evidence received from the over-infusions identified and reported by the care providers. These strategies focused on educating clinical staff on the importance of sequestering devices and reporting medical device incidents to Biomedical Engineering. The BC Patient Safety and Quality Council (BCPSQC) supported the development of alerts and distributed communications within BC Health Authorities and nationally.
As a result of these efforts, the evidence gradually improved over the course of the investigations, including smartphone video of the aberrant operation and sequestering in an ‘as is’ state.
In March 2019, new evidence was received from a suspected over-infusion which significantly changed the course of the investigations.
The infusion system was received by LMBME still set-up and running in its original state. The investigation team was able to interrogate the infusion system which led towards identification of an IV tubing defect (see images below) as the root cause for a number of over-infusions staff identified and reported in PSLS.
This tubing defect, identified as a result of the investigations in BC, resulted in a voluntary global recall of over 100 million IV tubing sets. Numerous alerts were generated regarding the uncontrolled flow, including from Health Canada and the manufacturer.
The exemplar (good) tubing set has a uniform wall thickness throughout the entire cross-section of the tube, resembling a Cheerio:
Micro-CT Cross Section of Exemplar Tubing Set
Micro-CT 3D Reconstruction of Exemplar Tubing Set
The incident (bad) tubing set had a non-uniform wall thickness which can cause uncontrolled flow through the infusion pump:
Micro-CT Cross Section of Incident Tubing Set
Micro-CT 3D Reconstruction of Incident Tubing Set
Medical device incidents and Vanessa’s Law
The IV tubing with the dimensional defect was first distributed in August 2018. Within Canada, BC was the only province reporting a high incidence of over-infusions to Health Canada.
The infusion pump implicated in the investigations is used in many other provinces in Canada and the defective IV tubing was distributed globally. It is likely that other healthcare institutions experienced a high-incidence of over-infusions; however, they were either not reported by clinical staff to Biomedical Engineering, or Biomedical Engineering did not report the over-infusions to Health Canada.
If it wasn’t for the consistent and thorough voluntary reporting in PSLS from health care staff in BC, the dimensional defect may have taken much longer to identify, putting more patients at risk!
Under the new Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, such incidents as these over-infusion events will require mandatory reporting to Health Canada and thus provide better data for earlier identification and action on the patient safety risk.
The over-infusion investigation team, including VCH Professional Practice, Risk Management, Patient Safety and Quality and LMBME, would like to express their sincere gratitude and thanks to clinical staff for their patience and courage during the investigations, and for their extra vigilance while providing infusions to patients. Clinical staff’s diligent reporting and sequestering of infusion systems was pivotal in cracking the case.
A large thanks is also owed to LMBME Biomedical Technologists who investigated over 40 suspected over-infusion incidents. Additionally, the LMBME Blue Team at Vancouver General Hospital and the LMBME UBC Hospital Team played a critical role in the investigations through exploring various potential root causes, performing exhaustive device testing and researching technical risk mitigations.
Lastly, thank you to our partners: PHSA Supply Chain for helping to remove the affected sets from inventory, the BC Ministry of Health and Health Canada for their support, BCPSQC for distributing practice alerts across BC, BCPSLS for improving identification and reports, UBC Centre for Hip Health and Mobility for micro-CT imaging and all other organizations that contributed to the investigations.
Brendan Gribbons is a Biomedical Engineer with Lower Mainland Biomedical Engineering. He manages a regional team of four Engineers who support Fraser Health, Providence Health Care, Vancouver Coastal Health and Provincial Health Services Authority. Brendan is the Chair of the Canadian Medical and Biological Engineering Society’s (CMBES) Publications Committee and was awarded the CMBES Early Career Achievement Award earlier this year.
Did you know?
Mandatory reporting to advance Vanessa’s Law comes into force December 16, 2019. This means that hospitals will be required to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of the event being documented within the hospital.
In BC, all health care providers are encouraged to report ADRs and MDIs in PSLS, which will ensure that reports are reviewed, de-identified, and submitted to Health Canada by the 30-day deadline. For more information, visit the Government of Canada website and stay tuned for a Vanessa’s Law eLearning module, coming soon to LearningHub and iLearn.