The MDA have opted not to advise on the specific therapy category for individual pump models. They have listed therapy category "A" criteria performance parameters and important safety features.

Most of the recently evaluated pumps largely conform to category "A" but in my opinion none of them are full compliant. It largely depends on what features on the pumps are clinically used. e.g. if you don't use fast acting drugs, give boluses or are not concerned about start-up delays then the choice of pump model is wider.

In the attached spreadsheet I have attempted to highlight and categories deviations from "A" criteria.

I would appreciate fellow forum contributors feedback.

Bill

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<TABLE WIDTH="90%" align="center" BORDER=0><TR><TD width="33%"></TD><TD width="33%"></TD><TD width="33%"></TD></TR><TR><TD colspan="3" align="center"><font color="#0080C0">Category "A" Therapy Infusion Pumps with associated deviation warnings</font>
All the Syringe and Volumetric Pumps assessed in the recently published MDA Evaluation No. 02110 largely conform to therapy category "A". The tables below highlight any deviation from the criteria.</TD></TR><TR><TD colspan="3">

<font color="#0080C0">Therapy Category "A" Critical performance parameters:- </font></TD></TR><TR><TD> </TD><TD colspan="2">Good long-term accuracy.</TD></TR><TR><TD> </TD><TD colspan="2">Good short-term accuracy.</TD></TR><TR><TD> </TD><TD colspan="2">Rapid alarm after occlusion.</TD></TR><TR><TD> </TD><TD colspan="2">Small occlusion bolus.</TD></TR><TR><TD> </TD><TD colspan="2">Able to detect very small air embolus (volumetric pumps only).</TD></TR><TR><TD> </TD><TD colspan="2">Small flow rate increments.</TD></TR><TR><TD> </TD><TD colspan="2">Good bolus accuracy.</TD></TR><TR><TD> </TD><TD colspan="2">Rapid start-up time.</TD></TR><TR><TD colspan="3">

<font color="#0080C0">Important safety features in descending order ofimportance:-</font></TD></TR><TR><TD> </TD><TD colspan="2">Anti-free flow device in administration set</TD></TR><TR><TD> </TD><TD colspan="2">Free-flow clamp in pump when door opened</TD></TR><TR><TD> </TD><TD colspan="2">Provision against accidental modification of settings</TD></TR><TR><TD> </TD><TD colspan="2">Two distinct actions to change rate</TD></TR><TR><TD> </TD><TD colspan="2">Two distinct and/or simultaneous actions to initiate bolus</TD></TR><TR><TD> </TD><TD colspan="2">Syringe barrel clamp alarm, door open alarm or equivalent</TD></TR><TR><TD> </TD><TD colspan="2">Syringe plunger disengagement alarm or equivalent</TD></TR><TR><TD> </TD><TD colspan="2">Patient history log</TD></TR><TR><TD> </TD><TD colspan="2">Volume infused display</TD></TR><TR><TD> </TD><TD colspan="2">Technical history back-up</TD></TR><TR><TD> </TD><TD colspan="2">Battery back-up</TD></TR><TR><TD colspan="3">Syringe pumps are the preferred choice for lower volume and low flow rate infusions.

Volumetric pumps are the preferred choice for medium and high flow rate and large volume infusions.
Most volumetric pumps will perform satisfactorily at rates down to 5 ml/h.

All neonate infusion pumps require to conform to Therapy Category "A".

Based on Medical Device Agency (MDA) Device Bulletin Infusion Systems MDA DB2003(02) March 2003, and Evaluation No. 02110 April 2003


</TD></TR><TR><TD bgcolor="silver">Deviation from "A" criteria:</TD><TD bgcolor="yellow">Yellow card = Caution.</TD><TD bgcolor="red">Red card = Warning.</TD></TR><tr><td colspan="3">

<table width="100%" border="1"><TR><TD colspan="3" align="center"><font color="#0080C0">Syringe Pumps</font>
Deviations from "A" Category </TD></TR><TR><TD bgcolor="silver" width="26%">Manufacturer & Model</TD><TD bgcolor="yellow" width="37%">Yellow Card</TD><TD bgcolor="red" width="37%">Red Card</TD></TR><TR><TD>Alaris Asena CC </TD><TD>Time to alarm on occlusion = 6min. </TD><TD>Constancy index at 1 ml/h = 13min</TD></TR><TR><TD>Alaris Asena GS </TD><TD>Start-up time = 7 min. </TD><TD> </TD></TR><TR><TD>Arcomed SP6000</TD><TD>Time to alarm on occlusion = 7.5min.
Start-up time = 14.5min</TD><TD>Bolus accuracy = -24%</TD></TR><TR><TD>Braun Perfusor Compact S</TD><TD>Occlusion bolus = 0.18ml
Min occlusion alarm = 225mmHg
No technical history log</TD><TD>Time to alarm on occlusion = 30min.</TD></TR><TR><TD>Fresenius Vial DPS-IS</TD><TD>Start-up time = 11.5 min
No technical history log</TD><TD> </TD></TR><TR><TD>Graseby Omnifuse </TD><TD>Time to alarm on occlusion = 7min.
Start-up time = 11.5min.</TD><TD>Bolus accuracy = -20.5%</TD></TR><TR><TD>Medex 3010 </TD><TD>Min occlusion alarm = 200mmHg Start-up time = 19min.</TD><TD>Time to alarm on occlusion = 25min.</TD></TR></table></td></tr><tr><td colspan="3">

<table width="100%" border="1"><TR><TD colspan="3" align="center"><font color="#0080C0">General Purpose/ Volumetric Pumps</font>
Deviations from "A" Category
</TD></TR><TR><TD bgcolor="silver" width="26%">Manufacturer & Model</TD><TD bgcolor="yellow" width="37%">Yellow Card</TD><TD bgcolor="red" width="37%">Red Card</TD></TR><TD>Alaris Signature
Pressure mode</TD><TD>Constancy index at 1 ml/h = 6min.</TD><TD> </TD></TR><TR><TD>Alaris Signature
Resistance mode</TD> <TD>Constancy index at 1 ml/h = 7.5min.</TD><TD> </TD></TR><TR><TD>Arcomed Vp5005</TD><TD>Accuracy + 5.8% at 1 ml/h
Constancy index at 1 ml/h = 8min.</TD><TD>No Anti free-flow device in administration set</TD></TR><TR><TD>Baxter Colleague</TD><TD>Accuracy - 5.2 at 500ml/h
Constancy index at 1 ml/h = 7min.
Min occlusion alarm = 103 - 310mmHg</TD><TD> </TD></TR><TR><TD>Braun Infusomat fms</TD><TD>Occlusion bolus = 0.23ml
Min occlusion alarm = 300mmHg
Air detection = 100ul</TD><TD>Time to alarm on occlusion = 17min.
Constancy index at 1 ml/h = 22.5min</TD></TR><TR><TD>Graseby 500</TD><TD>Time to alarm on occlusion = 8 min.</TD><TD>Bolus accuracy = -14%
Constancy index at 1 ml/h = 19.5min. </TD></TR><TR><TD>Terumo TE172</TD><TD>Constancy index at 1 ml/h = 3.5min.</TD><TD>No Anti free-flow device in administration set</TD></TR></table></td></tr><TR><TD colspan="3">Notes:
Constancy index; The principle is that the constancy index of the pump should be less than or equal to the half-life of the drug used.</TD></TR><TR><TD colspan="3" align="right">WOMD Oct 2003</TD></TR></TABLE>


Bill