People can die or suffer life-long effects from a tubing misconnection. Standards have been developed to address that problem, but some of the devices launched may have introduced more concerns.
Patients depend on tubing and syringes to deliver the fluids and medications needed to keep them alive during an illness. They also depend on medical staff to properly connect the tubing and syringes. However, tubing misconnections happen, probably much more than we realize because there is no mandatory reporting of these incidents. What we do know is that the problem is significant enough to cause safety concerns across all populations of the health care sector.
The concerns surrounding tubing misconnections came into the public eye almost a decade ago after a New York Times article highlighted a pregnant mother suffering from dehydration, according to Suzanne Staebler, NCC president and policy consultant. The hospital put in a PICC line as well as a line for tube feedings, but unfortunately, she was given food in her IV, which killed both the fetus and the mother.
Call for standards
It was clear there was need for standardization and non-interconnectability between feeding tube and syringe connectors. “The International Organization for Standardization (ISO) has established the ISO 80369 series of standards to reduce the likelihood of tubing misconnections,” explained Klaus Hoerauf, vice president of Global Medical Affairs-MDS at Becton Dickinson. The ISO 80369-3 is a worldwide connector standard for enteral applications, with either “male” or “female” syringes. The female syringe, also known as ENFit®, while compliant with ISO 80369-3 to help address tubing misconnections, may create unintended risks in other areas, like accuracy of dosing. That’s especially troublesome with critically-ill patients. Fortunately, there is another ISO option, a “male” syringe that can be considered by manufacturers to address tubing requirements and maintain the current standard of care.
The safety of critically-ill patients requiring enteral feeding depends on consistent, accurate medication-dosing and clean, hygienic conditions. Depending on the medication and the patient, the implications to the patient may be severe — a small-dose variance in these fragile patient populations can have a significant impact. “For a baby that weighs 500 or 600 grams, dosing variability could be life altering,” stated Staebler.
The ENFit female syringe features a new “cup” design at the tip which is wider, increasing dead space (syringe tip volume), which may lead to inconsistent medication delivery. To achieve consistent oral medication delivery with the female syringe system it is recommended that additional accessories and processes be followed, adding complexity to the process. The other ISO design option, a male syringe to be known as RightFit also addresses tubing misconnections. Because it complies with the same design principles (tapered tip minimizes dead space) as today’s current male oral and enteral syringes, it is not anticipated to introduce any new risks. It’s important that there is awareness of two ISO options and that there will be a choice other than ENFit®.
What can people do?
Both male and female designs in the ISO can be developed by all manufacturers looking to comply with ISO 80369-3. The female syringe may help address most tubing misconnections, but it may also expose patients and users to unintended risks as a result of its design. Patients and relatives need to be advocates for safer tubing methods. They can educate themselves on the incidents of tubing misconnections and the different design options and potential challenges. Don’t be afraid to ask nurses and doctors about what is supposed to happen during feedings.
“It is vital that all industry players, patient stakeholders and the global health community are aware of the differences of the ISO options,” said Hoerauf. Then they can take action to ensure patients and caregivers have access to products that are safe and of the highest quality.
Sue Poremba, [email protected]