Ambulatory Infusion Pumps, Created 17 May 2011.Docx; Approved 24 May 2011

8/17/2019 Ambulatory Infusion Pumps, Created 17 May 2011.Docx; Approved 24 May 2011

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Procedure No. 1861-20110524-01

Acceptance Major Minor

Ambulatory Inu!ion Pump!" #reated 1$ May 2011% Appro&ed 24 May

2011

'!ed (orInfusion Pumps, Ambulatory [16-491]

Al!o #alled#ommonly '!ed InAll patient care areas, homes

)copeApplies to ambulatory infusion pumps. If the pump is used for patient-controlled analesia,

see!use Procedure "o. 4#9 P$A Infusion Pumps

*i!+ ,e&el

%ih

ype Inter&al ime *e/uired&a'or 1( &onths ) %ours&inor ) "A ) %ours

&er&ieInfusion pumps are often used *hen accurate deli+ery *ithin of flo* settin/ is re0uired

o+er lon periods of time. Ambulatory pumps are small, battery operated units, that do not rely

on line po*er or ra+ity for operation. hey are commonly used to infuse antibiotics, analesics,

chemotherapeutic aents, and total parenteral nutrition solutions. 2ome units can be used for

patient-controlled analesia.

here are also disposable, elastomeric de+ices that ha+e a flo* restrictor to deli+er fluid at a

fi3ed, lo* rate. hey resemble a balloon and and ha+e a typical +olume of ) m or 1)) m.hey are fre0uently used to deli+er I5 antibiotics and subcutaneous analesics. lo* accuracy of

these de+ices may +ary bet*een and 1).

e!t Apparatu! and )upplie!" Part!7lectrical safety analy8erPressure meter ≥) psi/

Infusion pump tester - optional) m raduated cylinder 1 m raduations/7lectronic balance ()) rane, ).1 m resolution/2top*atch or *atch that displays seconds m pipette ).1 m raduations/

)pecial Precaution!

Proceduree sure that you understand ho* to operate the e0uipment, the sinificance of each control and

indicator, and the alarm capabilities. efore beinnin an inspection, carefully read this

procedure, the operators manual, and the inspection and pre+enti+e maintenance procedures

recommended by the manufacturer typically included in the ser+ice manual/. :se

the iomedicalenchmar; 2upport Assessment orm to document a maintenance decision that

reflects past e3perience *ith this type of e0uipment and the en+ironment *here it is used. hen


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use the IP& Procedure $ustomi8ation ool to modify this procedure as needed< the proram *ill

enerate a documentation form *ith the correspondin chanes.

:se the disposable accessory e.., I5 tubin set, cassette/ specified for the infusion pump to be

inspected. =isposable accessories should be replaced at least *ee;ly and more fre0uently *ith

hea+y use. :se deassed *ater or, *hen a+ailable, bas of outdated i.e., clinically unusable/ I5

solutions.or settins ≥1 m!hr, flo* accuracy is most con+eniently determined *ith an infusion pump

tester. If an infusion pump tester is not a+ailable, calculate flo* rate by di+idin the +olume

collected in a ) m raduated cylinder 1 m raduations/ by the deli+ery time measured *ith a

stop*atch. or settins less than 1 m!hr, calculate flo* rate by di+idin the mass obtained in a

small bea;er on an electronic balance ()) m rane and resolution to ).1 m/ by the

measurement time. If a balance is not a+ailable, use a m pipette ).1 m raduations/

attached to a +ertical mountin stand and di+ide the +olume collected by the deli+ery time.

>perate the infusion pump on battery po*er durin its entire inspection to chec; that the

battery has been chared and can hold a chare. If a lo*-battery alarm occurs, +erify that the

alarm is properly displayed and then continue the inspection on line po*er. "ote ho* lon the

pump *as operatin on battery po*er and the conditions under *hich the lo*-battery alarm

occurred. ully chare the battery before returnin the pump to use.

ualitati&e a!+!#3a!!i!ou!in 7 Acceptance $hec; for shippin damae< report any damae to the manufacturer, shipper, or ser+ice

orani8ation, and arrane for repair or replacement.

$hec; that the infusion pump is suitably constructed to *ithstand normal hospital use and

abuse. or instance, a unit *ith +entin on the top of the housin or poorly protected or sealed

controls and indicators may be prone to fluid entry.

73amine the e3terior of the infusion pump for cleanliness and eneral physical condition. 7nsure

that plastic housins are intact, that all assembly hard*are e.., scre*s, fasteners/ is present

and tiht. $hec; that labels and mar;ins are leible.

#3a!!i!ou!in 7 Major

73amine the infusion pump for o+erall condition. he chassis should be clean and free from I5 or

enteral solution residue, especially near mo+in parts e.., thumb*heel s*itches, pump or

controller mechanisms/. Also chec; for dried solution deposits on accessible air-in-line sensors,

pressure sensin mechanisms, and infusion set!cassette loc;in mechanisms. $hec; that labels

and mar;ins are leible.

Mount 7 Acceptance" Major

2cre*s and brac;ets that attach the infusion pump to an I5 pole should be secure and

functionin. If the pump is mounted on a stand or cart, e3amine the condition of the mount. Also

e3amine the pole, stand, or cart.

A# Plu 7 Acceptance

A solidly constructed, ood 0uality plu *ith ade0uate strain relief is acceptable, but the use of a

%ospital ?rade plu identifiable by a reen dot and!or labelin/ *ill eliminate uess*or; and

ensure a plu of acceptable construction 0uality. @iht-anle plus are unacceptable for pumps

that are mo+ed fre0uently. A ood 0uality t*o-pron plu is acceptable for double-insulatedde+ices. @eplace the plu or ha+e the supplier replace it if it is not %ospital ?rade or other*ise

suitable. %ospital ?rade molded plus are acceptable.

73amine the A$ po*er plu for damae. Attempt to *ile the blades to determine if they are

secure. 2ha;e nonmolded plus and listen for rattles that could indicate loose scre*s.

If the pump or its I5 pole has electrical receptacles for accessories, e3amine them by insertin

an A$ plu into each and chec;in that it is held firmly.


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A# Plu 7 Major

73amine the A$ po*er plu for damae. Attempt to *ile the blades to determine that they are

secure. 2ha;e the plu and listen for rattles that could indicate loose scre*s. If any damae is

suspected, open the plu and inspect it.

If the de+ice or its I5 pole has electrical receptacles for accessories, inspect them by insertin an

A$ plu into each and chec;in that it is held firmly. If accessories are plued and unplued

often, consider a full inspection of the receptacle.

,ine #ord 7 Acceptance

7nsure that the line cord is lon enouh for the infusion pumps intended application< an

e3tension cord should not be re0uired. A lenth of 1) ft [B m] is suitable for most applications,

althouh 1# ft [. m] has been suested for operatin room e0uipment./

he cord should be of suitable 0uality and current-carryin capacity. %ard 2er+ice 2>, 2, or

2>/, Cunior %ard 2er+ice 2C>, 2C, or 2C>/, or an e0ui+alent-0uality cord should be used.

5erify that the pump has ade0uate protection aainst po*er loss e.., from accidental

disconnection of a detachable po*er cord, disconnection of the po*er cord from the *all, or

depleted battery if a battery-po*ered pump is not plued in/. 70uipment ha+in a detachable

po*er cord should also ha+e ade0uate capture de+ices, cleats, or channels to hold the cord in

place. If these are absent, re0uest that the supplier pro+ide suitable means of securin the cord.

5erify that the infusion pump has ade0uate alarms or indicators for line-po*er loss and battery

depletion and an ade0uate battery-charin indicator.

,ine #ord 7 Major

Inspect the cord for sins of damae. If damaed, either replace the entire cord or, if the

damae is near one end, cut out the defecti+e portion.

)train *elie! 7 Acceptance" Major

73amine the strain reliefs at both ends of the line cord. e sure that they hold the cord securely.

(ittin!#onnector! 7 Major

73amine any electrical cable connectors for eneral condition. 7lectrical contact pins or surfaces

should be straiht and clean. $hec; any spill-protection connector caps for sins of damae.

#ontrol!)itc3e! 7 Acceptance 5erify that soft*are setup parameters accessible throuh hidden or ser+ice menus are correctly

set for the appropriate application and are consistent for all similar infusion de+ices.

73amine all controls and s*itches for physical condition, secure mountin, and correct motion. If

a control has fi3ed-limit stops, chec; for proper alinment, as *ell as positi+e stoppin. 7nsure

to chec; that each control and s*itch performs its proper function.

#ontrol!)itc3e! 7 Major

73amine all controls and s*itches for physical condition, secure mountin, and correct motion.

Dhere a control should operate aainst fi3ed-limit stops, chec; for proper alinment, as *ell as

positi+e stoppin. $hec; membrane s*itches for membrane damae e.., from finernails,

pens/. =urin the course of the inspection, be sure to chec; that each control and s*itch

performs its proper function.

9attery 7 Acceptance

=etermine the replacement inter+al for all batteries and document the inter+als/. e sure to

include batteries!cells for cloc;s and!or memory los. =isconnect the battery and determine if

the de+ice still operates on line po*er.

>perate the pump on battery po*er for se+eral minutes to +erify that the battery is chared and

can hold a chare. Acti+ate the battery test function, if so e0uipped. $hec; the condition of the

battery charer, and +erify that battery chare indicators function. Pro+ide users *ith

instructions and!or chec;list procedure to ensure ade0uate battery charin and performance.

7nsure that the battery is fully chared before puttin the pump into ser+ice.


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9attery 7 Major

Inspect the physical condition of batteries and battery connectors, if readily accessible. >perate

the pump on battery po*er durin its entire inspection to chec; that the battery has been

chared and can hold a chare. If a lo*-battery alarm occurs, chec; to ensure that it is properly

displayed and then continue the inspection usin line po*er. "ote ho* lon the infusion de+ice

has been operatin and the conditions under *hich the lo*-battery alarm occurred. ully chare

the battery before returnin the pump to use. Dhen it is necessary to replace a battery, label it

*ith the date.

Indicator!:i!play! 7 Acceptance" Major

=urin the course of the inspection, confirm the operation of all lihts, indicators, meters,

aues, +isual displays, and display bac;lihtin, if so e0uipped. e sure that all sements of a

diital function. &any infusion de+ices automatically chec; indicator and display function *hen

turned on or durin a manually acti+ated self-test./

)el-e!t 7 Acceptance" Major

or units *ith a self-test mode, acti+ate it and determine if the e3pected response is produced.

ime:ate )ettin! 7 Acceptance" Major

5erify that the time and date settins on the unit are correct.

Netor+;irele!! Interace! 7 Acceptance

Assess the potential ris;s and +ulnerabilities to the confidentiality, interity, and a+ailability of

electronic information stored or transmitted by the de+ice or system and ta;e appropriate

pre+enti+e measures. &a;e sure that necessary information, includin de+ice identification,

operatin system, IP internet protocol/ address, is documented in the appropriate lo. As

appropriate, +erify that confidentiality e.., pass*ord protection/ and malicious soft*are

protecti+e includin mechanisms for future operatin system and +irus protection patches and

uprades/ measures are implemented. =etermine if a 5P" +irtual pri+ate net*or;/ is needed.

or *ireless de+ices, ensure that appropriate *ireless security measures ha+e been implemented

and that re0uirements of the healthcare orani8ations *ireless manaement policies ha+e been

met. 5erify that data bac;up processes are acti+ated and +erified.

Netor+;irele!! Interace! 7 Major @e+ie* measures ta;en to ensure protection aainst the potential ris;s and +ulnerabilities to the

confidentiality, interity, and a+ailability of electronic information stored or transmitted by the

de+ice or system and +erify that pre+enti+e measures are still acti+e. or e3ample, are

pass*ords bein applied correctly, ha+e operatin system and +irus protection patches and

uprades been installed, is the de+ice still operatin on a 5P" +irtual pri+ate net*or;/ and are

*ireless security measures still in place. 5erify that data bac;up processes are acti+ated and that

data can be retrie+ed from bac;ups.

Alarm! 7 Acceptance" Major

&any infusion de+ice alarm capabilities can be chec;ed 0ualitati+ely. he follo*in procedures

include tests for the most common alarm conditions. $hec; the instruction manual to see ho*

the alarm should *or;. Dhen an alarm occurs, chec; to see that both audible and +isual alarmsare acti+ated and that flo* stops or is reduced to a ;eep-+ein-open rate e.., ≤ m!hr/.

$onfirm appropriate alarm +olume, as *ell as the operation of any +olume control.

Audible )inal! 7 Acceptance" Major

>perate the de+ice e.., press rate s*itches/ to acti+ate any audible sinals. $onfirm

appropriate +olume, as *ell as the operation of the +olume control, if so e0uipped.

pen :oorMi!loaded Inu!ion )et 7 Acceptance" Major

$hec; this alarm durin setup and operation.


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(ree-lo Pre&ention Mec3ani!m7! 7 Acceptance" Major

urn the po*er off *ith the infusion set primed and loaded in the de+ice. Dith all tubin clamps

open, a full fluid container, and the tubin hanin to the floor, +erify that no fluid flo*s out of

the distal connector.

If the de+ice incorporates a mechanism that automatically closes the set or re0uires the set to

be manually closed before it is remo+ed from the de+ice, +erify the operation of this mechanism.

cclu!ion 7 Acceptance" Major

If the de+ice deli+ers from an e3ternal fluid container, +erify upstream occlusion detection by

acti+atin infusion *ith the tubin clamped 'ust belo* the container. 5erify operation

of do*nstream occlusion detection by acti+atin infusion *ith the infusion sets distal connector

capped.

Inu!ion #omplete 7 Acceptance

2et the total +olume to be infused to a lo* +olume e.., 1) m/ and operate the pump at a

hih-flo* settin. An end of infusion alert should be triered and the rate should drop to a;eep-+ein-open rate typically ≤ m!hr/.

,abelin 7 Acceptance" Major

$hec; that all necessary placards, labels, and instruction cards are present and leible.

Acce!!orie! 7 Acceptance

5erify that all necessary features and accessories e.., sensors, tubin/ ha+e been supplied *ith

the infusion pump. A copy of the operators and ser+ice manuals electronic or hard copy/,

includin schematics, should be shipped *ith the e0uipment. &anuals should be filed in the

central e0uipment file and clinical instructions should be ;ept in the patient care area for easy

access by clinicians.

uantitati&e a!+!


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raduated cylinder until at least 1) m is collected. @ecord the time inter+al and +olume

collected, and calculate the deli+ery rate in m!hr.

or flo* settins G1 m!hr, use an infusion pump tester if it is capable of measurin this flo* or

a 1. m +olume. >ther*ise, use an electronic balance to ra+imetrically determine pump

accuracy by *eihin a small bea;er co+ered *ith a film of plastic *rap to minimi8e e+aporati+e

losses/ before and after collectin a mass of at least 1. . $on+ert the mass to +olume 1

%(> H 1 m< 1 !m can be used for most other test solutions [e.., normal saline], althouh

the mass per unit +olume of some fluids may differ sinificantly/. =i+ide the calculated +olumeby the collection time in hours e.., 1. m ÷ 1 hr H ).1 m!hr/.

If an electronic balance is not a+ailable, use a small lenth of rubber hose to connect the

infusion set to the base of a +ertically mounted, raduated m pipette resolution to ).1 m/.

=i+ide the collected +olume 1. m, minimum/ by the collection time to calculate the infusion

rate.

o calculate flo* error, use the follo*in formulaF

&ost ambulatory infusion pumps are specified to deli+er *ithin of the flo* settin. "oteF

"eati+e and positi+e flo* error represents underdeli+ery and o+erdeli+ery, respecti+ely.

(lo Accuracy 7 Major E=etermine the flo* accuracy at t*o typical flo* settins ≥1 m!hr e.., 1) and 1)) m!hr/.

:se an infusion pump tester or collect the output in a raduated cylinder. :se a stop*atch or a

*atch that displays seconds to time the deli+ery into the raduated cylinder until at least 1) m

is collected. @ecord the time inter+al and +olume collected, and calculate the deli+ery rate in

m!hr.

o calculate flo* error, use the follo*in formulaF

&ost ambulatory pumps are specified to deli+er *ithin of the flo* settin. "oteF "eati+e

and positi+e flo* error represents underdeli+ery and o+erdeli+ery, respecti+ely./

Ma=imum Pre!!ure 7 Acceptance E1 psi of manufacturer specification

=etermine the pumps do*nstream occlusion alarm pressure specification if a ma3imum

pressure is not specified. or most pumps, ma3imum pressure *ill be e0ui+alent to occlusion

alarm pressure. %o*e+er, it is important to understand *hat is happenin *hen a pumps

occlusion alarm acti+ates to properly measure ma3imum infusion pressure. 7ach pump model is

li;ely to use one of three pressure references for trierin its occlusion alarmF 1/ a sinle fi3ed

pressure, (/ user-ad'ustable occlusion pressures, or B/ occlusion pressures that are

benchmar;ed from operatin infusion pressures. or pumps *ith user-ad'ustable pressure, this

test should be performed at the hihest settin. or pumps that reference occlusion alarms to

increases in baseline operatin pressure, it *ill be necessary to restart the pump se+eral times

after serial occlusion alarms until a ma3imum pressure is obtained. he ma3imum pressure of

most pumps is less than () psi.

$onnect the distal end of the primed infusion set to a pressure meter or use an infusion pumptester if e0uipped to perform this tas;/, and start infusion. =etermine ma3imum pressure and

the time to occlusion alarm acti+ation at t*o commonly used flo* settins e.., 1) and 1))

m!hr/. @estart the pump after each occlusion alarm to ensure that ma3imum infusion pressure

has been attained.

It may be desirable to also measure and record the time to occlusion alarm for future reference.

If this is done, record the lenth and type of infusion set i.e., standard or microbore tubin/

that *as used.

Ma=imum Pre!!ure 7 Major E1 psi of acceptance test pressure


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@eference the pumps ma3imum pressure determined durin acceptance testin. $onnect the

distal end of the primed administration set to a pressure meter or use an infusion pump tester if

e0uipped to perform this tas;/. 2tart infusion at a commonly used flo* settin e.., 1) or 1))

m!hr/ and record the ma3imum pressure. @estart the pump after an occlusion alarm to ensure

that ma3imum infusion pressure has been attained.

Air-in-,ine :etection 7 Acceptance" Major ) to 1)) µ

If the pump has an air detecor, in'ect 1)) µ air into an in'ection port of the I5 tubin *ith a :-

1)) insulin syrine bet*een the fluid container and the air-in-line detector. 1)) µ can be

appro3imated by 1) units from a :-1)) insulin syrine. 2ensiti+ity to air +olumes of less than) µ is li;ely to result in nuisance alarms. &ost pump *ill trier an alarm for ) to 1)) µ air.

Pre&enti&e Maintenance*eplace 7 Major

@eplace the primary battery and!or the cloc;!memory battery!cell, if necessary, and label it *ith

the date.

Note!est Procedure Appro+ed (4 &ay ()11

)y!tem #omponent!)

Ambulatory Infusion Pumps, Created 17 May 2011.Docx; Approved 24 May 2011

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Transcript of Ambulatory Infusion Pumps, Created 17 May 2011.Docx; Approved 24 May 2011