Dual purpose naso-gastric tubes with ENFit® connectors and the risk of aspiration
Through its core work to review recorded patient safety events, the National Patient Safety Team identified issues regarding a risk of aspiration when nasogastric (NG) tubes designed for a dual purpose of feeding and drainage did not enable adequate drainage of gastric contents (gastric decompression).
Gastric decompression is the removal of stomach content through a tube passed via the nasogastric route. Inadequate decompression of the stomach can mean fluids accumulate, causing abdominal distension, pain, and nausea. This can result in vomiting and risk of aspiration, which can be fatal.
Whilst fine bore NG tubes are used to manage feeding and/or administration of medication, wide bore tubes should be used if gastric drainage (decompression) is needed. Although all feeding tubes must have an ENFit® connector to reduce the risk of misconnection errors (see related Patient Safety Alert), wide bore drainage tubes do not, as the ENFit® connector at the distal end of the NG tube will influence the rate at which fluid can drain.
A Field Safety Notice (FSN) was issued in 2018 relating to NG tubes marketed to support both feeding and drainage, due to the risk that the dimensions of ENFit® connector can adversely affect the rate and volume of gastric drainage, particularly if the stomach content is viscous. The manufacturer updated their instructions for use (IFUs) as a result and removed reference for drainage with the use of these NG tubes.
The team reviewed an incident report describing the death of a patient and a lack of awareness of the limitations of dual-purpose NG tubes. Although this event predated the FSN, a wider search of the National Reporting and Learning System revealed a very small number of cases where a lack of awareness persisted.
In response, MHRA (Medicines and Healthcare products Regulatory Agency) were asked to contact other manufacturers of this type of device to ensure all IFUs were clear about limitations, in addition to ensuring accessory devices (such as drainage bags) were subject to the same advice.
The Clinical and Product Assurance team at NHS Supply Chain were asked to review use of the term ‘drainage’ in ENFit® NG tube descriptors and apply point of purchase information regarding device limitations. We also engaged with British Standards Institute who agreed to consider amendments to the current standard to include more obvious warnings of the limitations of the ENFit connector on drainage devices.
About our patient safety review and response work
The recording and central collection of patient safety events to support learning and improvement is fundamental to improving patient safety across all parts of NHS healthcare. The National Patient Safety Team identify new or under recognised patient safety risks, which are often not obvious at a local level. It does this through its core work to review patients safety events recorded on national systems, such as the National Reporting and Learning System (NRLS), the new Learn from Patient Safety Events service (LFPSE), and other sources.
In response to any newly identified risks, we develop advice and guidance, such as National Patient Safety Alerts, or work directly with partners as in the example above, to support providers across the NHS to take the necessary action to keep patients safe.
You can find out more about our processes for identifying new and under recognised patient safety issues on our using patient safety events data to keep patients safe and reviewing patient safety events and developing advice and guidance web pages.
You can also find more case studies providing examples of this work on our case study page.