Not all off-brand products are created equal.
Some may work perfectly fine, to be sure. Generic equivalents to name-brand drugs, for instance, are often just as effective as their counterparts while costing less. Tap water doesn鈥檛 really taste any worse than the pricey stuff in bottles.
Others purport to be as good 鈥� but in practice just aren鈥檛. Despite looking the part, they don鈥檛 taste quite as good or work quite as well. In those cases, you may end up getting what you pay for: reduced performance and unexpected disappointment.
In emergency care, that鈥檚 the case with capnography sampling lines. Lines validated for use with monitors that have from (Oridion) provide accurate, reliable monitoring of end-tidal CO2 across a range of EMS and emergency department uses. Others鈥� sampling lines can be used with Microstream-enabled monitors but may be less accurate, less comfortable and susceptible to breakage.
When you鈥檙e providing essential medical care, that鈥檚 no small matter.
鈥淯sing validated consumables with the technology they鈥檙e intended to be used for is really how you鈥檙e going to get optimal performance from the monitoring equipment,鈥� said Shayna Jackson, Medtronic鈥檚 principal field marketing manager for Microstream capnography. 鈥淣ot doing that may have consequences like erroneous readings that could potentially impact how you care for your patient and the clinical decisions you make.鈥�
THE RISE OF THIRD-PARTY CONSUMABLES
That鈥檚 not just marketing talk 鈥� data backs it up:
路 A compared the accuracy of 16 capnography sampling lines from seven manufacturers used with a portable bedside capnography monitor. Investigators evaluated tensile strength, rise time and end-tidal CO2 (EtCO2) accuracy as a function of respiratory and supplemental oxygen flow rates. They found that 鈥渄ue to increased rise time and decreased EtCO2 accuracy, not all nasal cannula sampling lines provide reliable clinical data when cross-paired with a commercial capnography monitor.鈥� Many of the tested lines lost accuracy when respiratory rates increased or the patient received supplemental oxygen. Monitor-matched , however, provided consistently accurate results.
路 A compared the EtCO2 accuracy and oxygen delivery of three EtCO2/O2 nasal sampling cannulas with a bedside capnography monitor. It found Medtronic鈥檚 Microstream Advance line was least affected by a flow-rate increase from 2 to 4 LPM 鈥� the others saw reductions in mean EtCO2 values.
Medtronic鈥檚 new Microstream Advance capnography sampling lines have more going for them than validation for use with Microstream-enabled monitors. Patients will most notice an improved, softer tubing that鈥檚 more comfortable on the face, as well as a neutral scent for those sensitive to smells.
Medtronic
The rise of these third-party consumables traces back to 2017, when a key patent held by Medtronic 鈥� for its signature gold-ring filter line recognition system 鈥� expired. This let other manufacturers start making compatible, similar-looking consumables that worked with the same Microstream-equipped monitors.
鈥淏asically, a few of these manufacturers have added a new connector at the distal end of their sampling lines to replicate that ring,鈥� said Sarah Martin, Medtronic鈥檚 global senior market development manager for patient monitoring. 鈥淭hey鈥檙e manufacturing their own sampling lines and replacing this one piece so that when it goes into a Microstream-enabled device, it powers on.鈥�
That might get the job done 鈥� but comes with the above-quantified risks and others too. In January 2023, Medtronic issued a letter to customers reporting increased failure rates and monitor damage due to the connectors on third-party lines breaking off inside monitors. 鈥淯se of a third-party sampling line with a metal ring at the end of the connector imitating a Microstream FilterLine or a Microstream filter line may render the Microstream-enabled monitor inoperable,鈥� the company warned.
Another potential danger is the leakage of fluids or secretions from the line. Medtronic prevents that with a 0.2-micron hydrophobic filter that prevents ingress of moisture into the monitoring device. No evidence has been produced indicating competitors have duplicated this degree of protection.
NOVEL TECHNOLOGIES BENEFIT CARE
Medtronic鈥檚 new Microstream have more going for them than validation for use with -enabled monitors. Patients will most notice an that鈥檚 more comfortable on the face, as well as a neutral scent for those sensitive to smells. On long-term lines, the drying element is placed farther from the face to reduce irritation.
Providers will benefit from several technologies and algorithms unique to Microstream:
路 Smart Breath Detection (SBD) 鈥� This pattern-recognition and filtering algorithm screens out low-amplitude nonbreath exhalations such as talking, crying and snoring to calculate a more accurate respiratory rate. 鈥淭his is really important in EMS,鈥� said Jackson. 鈥淚magine you鈥檙e trying to get readings on a patient who鈥檚 crying 鈥� you have to be able to get accurate information quickly.鈥�
路 Smart Alarm for Respiratory Analysis (SARA) 鈥� SARA averages breath-to-breath variations and recognizes and eliminates respiratory 鈥渘uisance鈥� alarms that aren鈥檛 clinically significant.
路 Uni-junction technology 鈥� This patented design senses the strongest source of breath, permitting sampling from either the nares or the mouth should the patient switch breathing methods, including at low volumes.
路 Molecular Correlation Spectroscopy 鈥� This technology uses a CO2-specific infrared wavelength that鈥檚 highly specific and unaffected by other gases to measure EtCO2 accurately and deliver quality waveforms.
Additional features of Advance lines include a one-piece design to limit failure points; an oral scoop to catch CO2 from the mouth; and kink-resistant tubing that reduces alarms. Oxygen is emitted in a cloud from pinholes around the mouth and nose, while undiluted CO2 is sampled from the nares or mouth. 鈥淢any cannula designs deliver oxygen through one nare and sample CO2 through the other,鈥� said Martin. 鈥淲hen oxygen is directed through one nare, it can be drying to the nasal membranes and be uncomfortable. EtCO2 accuracy can also be affected when sampling from one nare and delivering oxygen through the other, of concern in patients with deviated septum and normal nasal cycling.鈥� Lines are available for short- and long-term use, neonates to adults, and both intubated and nonintubated patients.
These concessions to patient comfort 鈥� not always a consideration for makers of things like sampling lines 鈥� have a clinical benefit. A of the company鈥檚 advanced and original sampling lines in which subjects wore each for 72 hours found the newer model more comfortable with less plastic smell. This, the authors hypothesized, could help improve compliance with long-term use.
鈥淲here the cannula rests against the cheeks, the tubing is softer,鈥� explained Martin. 鈥淚t is also DEHP-free [a popular plasticizer that has raised concern in medical devices], and the inner geometric design makes tubing more kink-resistant, so oxygen flow remains unimpeded.鈥�
SAVINGS MAY BE OUTWEIGHED
In fields like EMS, where there鈥檚 so much need to meet with so few resources, the need to save limited funds isn鈥檛 just understandable but virtually a mandate. But taking the lower-price road isn鈥檛 always the lower-cost option. With third-party consumables, any savings may be more than outweighed by breakage or damage that poses unanticipated repair or replacement costs.
Some services have experienced that the hard way.
鈥淚鈥檝e had customers in the last nine months who have switched to generics because of cost,鈥� said Jay Murnighan, a senior regional manager for . 鈥淭hen a few months later, they switched back. And it鈥檚 because of reasons like damage or the accuracy of the readings 鈥� it impacts the outcomes they鈥檙e looking for.鈥�
Many of those alternative manufacturers, it鈥檚 worth noting, aren鈥檛 in the business of making monitors. 鈥淢any sampling line producers with reflective ring connectors make only the lines,鈥� Martin added. 鈥淭hey may not be tested or validated with a monitor because they don鈥檛 manufacture monitoring technology. Microstream capnography is a complete designed, tested and validated system.鈥�
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