Qimono Closed Safety System

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CLOSED SAFETY SYSTEM IN ADMINISTRATION*

(*CSSA)

ONCOLOGY

Think safe. Work safe. Be safe.

2 CONTENTS INTRODUCTION Health consequences of exposure to cytostatics 3 Warning: risks of contamination 4 CLOSED SAFETY SYSTEM QIMONO 6 essential requirements for a safe connection 5 Securization of the Infusion line 6 Practical advice 7 PRODUCTS qimooctopus 8 qimoprime & qimo 9 qimopump 10 qimo IVset 11 qimoconnect 12 LITERATURE 13

HEALTH CONSEQUENCES OF EXPOSURE TO CYTOSTATICS

In addition to surgery or radiotherapy, chemotherapy is an important pillar in combating cancer. The cytostatics used for chemotherapy belong to the CMR (Carcinogenic,Mutagenic, Reprotoxic) substances. Handling these hazardous drugs require special precautionary measures to ensure safety of hospital staff, along with protection of patients and their relatives. Exposure to cytostatics can be short-, medium- or long-term, and can lead to acute, mild or serious adverse events.

Short term (1)

Skin irritation

Headache

Nausea

Hair loss

Allergic reaction

Necrosis

Medium term (1)

Irritation

Infertility

Higher risk

Miscarriage

Congenital malformations

Long term (2)

Higher risk of leukemia

Increased risk for cancers

DNA change

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WARNING: RISKS OF CONTAMINATION

The greatest risk of widespread contamination is, in preparation and administration of cytostatics

BEFORE : when connecting the cytostastic bag to the main IV Line.

DURING : when infusion line is not closed, with a CSSA, a wrong handling could lead to leakage of cytostatics.

AFTER : when disposing the infusion line, residual drugs may remain in the tubing and thus, despite flushing, expose HCP’s.

Surface contamination before and after introduction of a CSTD

By using a Closed System Transfer Device - CSTD (e.g. Qimono), surface contamination can be reduced by more than 96%. (3)

Study result:

Surface contamination without CSTD (78.2%) can be significantly reduced (2.6%) when using a CSTD.(3)

100 75 50 25

78,2%

2,6%

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Protection is key ! With CSTD Without CSTD

THE 6 KEY POINTS FOR SAFE CONNECTIONS IN ONCOLOGY

Screwless connection

• To eliminate over or under-tightening, misthreading

• To reduce repetitive strain injuries

Connectable to standard Luer devices

• To connect standard Luer slip / Luer lock devices (i.e. : syringes, extension lines, …)

Direct fluid pathway

• To make aspiration and injection easier

• To allow effective flushing

Material resistant to aggressive solvents

• To avoid cracking of medical devices

Barrier against toxic drugs and bacteria

• To protect users from chemical contamination and the drugs from bacteriological contamination

Easy disinfection of both ♀ and ♂ hubs

• To be able to disconnect and connect again devices if needed

Valves automatically close on disconnection

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Flat membranes of both ♀ and ♂ connectors Luer Bayonet & Resistant raw material Straight tube in both Qimo ♀ and ♂ Qimo ♀ universal connection compatible to standard Luer
Luer
Luer Bayonet
1 1 2
4 5 6 2 3 4 5 6
3

SECURIZATION OF THE INFUSION LINE

+ Proximal end Female Luer lock connector Compatible with all male luer lock connectors

Chemo NaCl

+ Safety lock mechanism Secure connection through spinning locking system

+ Bayonet system

Easy to disinfect Automatic membrane closure after disconnection (split septum technology)

+ Distal end Compatible with qimo

+ Famel Luer Lock connector

Compatible with standard Luer systems (syringes, infusion lines, etc.)

Automatic membrane closure after disconnection (split septum technology)

+ Distal end Male Luer Lock connection compatible with Female luer lock connection

+ Proximal end Bayonet system Compatible with qimo & with any Male Luer (lock or slip)

6
QIP
Device Dead Volume Product code Units per box ml qimo 0,35 7210.91 50 Device Flow rate Dead volume Product code Units per box ml/min. ml qimo 105 0,03 7210.02 50 Max. 7 days on the patient or 360 connections
Max. 10 connections

PRACTICAL ADVICE

Set up to secure disconnection of an IV line

Device

code

Other set up

code Units per

qimo 7210.91

Connection to main infusion line

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Product
Units per box qimo
50
qimo
With qimo & qimo attached to the end of the Infusion line and on the patient side, the disconnection is safe. Thanks to automatic membrane closure Alternatively
7210.91
qimo 7210.02
prime 7210.81
qimoprime + qimo 7210.01
Product
box
Infusion line is secured with qimo provided with qimo bonded on qimooctopus connect. 50
Device
qimo 7210.02 qimooctopus 7231.221
Infusion port for additional medication or blood sampling

qimooctopus

Safe double lumen IV extension for continuous infusion, intermittent injection and blood sampling through the lateral side port fitted with qimo

High pressure (240 PSI 16,5 bar)

Bi-directionnal valve with split septum closes at disconnection universal luer for intermittent injection or blood sampling

qimo
Internal diameter External diameter Dead volume Product code Units per box cm ml Lumen 1 Lumen 2 L1 / L2 L1 / L2 L1 / L2 L1 / L2 Non return valve qimo 3,60 / 6,60 1,50 / 1,50 2,50 / 2,50 0,31 / 0,29 7231.221 50 + Non return valve prevents back flow in the IV line
Allow priming of qimo +
Closed safety connector with a locking mechanism that secures the end of qimooctopus
qimooctopus longueur
+ qimoprime
qimo

qimoprime & qimo

Securing your IV lines to protect your personal from cytotoxic exposure

+ Valve à déplacement neutre

Disconnection

When disconnecting qimo from qimo , no blood penetrates the catheter thus preventing catheter tip occlusion & reducting intraluminal germ colonization

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Device Product code Units per box qimoprime & qimo 7210.01 50

qimo IVset

Safety IV set for delivery of chemotherapy by gravity or using Qimono Infusion Pump (QIP)

qimo IV set includes :

qimoprime & qimo to prime the whole set.

1, 2 or 4 female, luer-compatible injection ports

an airvented spike and integrated filter

a Robert clamp

a drip chamber

a roller clamp

* qimo IV set can be supplied with or without Qimoctopus assembled on the IV line tubing.

Qimono

Device Dead volume Number of lateral site qimo IVset 2V-1 27 1 qimo IVset 3V-1 27 2
IVset 5V-1 27 4
qimo
Infusion Pump

qimoconnect

IV bag extension with a lateral injection site for connection to the main infusion line

Available with or without 0.2 μm particle filter Roberts clamp for quick closure qimo to secure distal end of the extension tube.

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Lateral injection site Filter Product code per box 1 No 7221.01 25 1 0,2 μm 7221.011 25

qimopump

Universal adaptor for IV sets

Available with 1, 2 or 4 lateral ports

luer-compatible injection ports

Spike with ventilation

Roberts clamp for quick closure

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Device Lateral ports Dead space (without qimo ) ml Product code Units per box qimopump 2V 1 1,30 7227.101 25 qimopump 3V 2 1,50 7227.201 25 qimopump 5V 4 2,00 7227.401 25

LITERATURE

(1) Connor TH, Lawson CC, Polovich M, McDiarmid MA. Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings: a review of the evidence. J Occup Environ Med. 2014.

(2) Hansen J, Olsen JH. Cancer morbidity among Danish female pharmacy technicians. Scand J Work Environ Health. 1994.

(3) Sylvia B. Bartel, Timothy G. Tyler, Luci A. Power, Am J Health Syst Pharm, 2018

(4) Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings, National Institute for Occupational Safety and Health (NIOSH), September 2004.

(5) ISOPP Standards of Practice: safe handling of cytotoxics - Section 7 Medical devices, International Society of Oncology Pharmacy Practitioners (ISOPP), J Oncol Pharm Pract, 2007.

(6) USP General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings, United States Pharmacopeial Convention (USP), 2017.

(7) Preventing occupational exposure to cytotoxic and other hazardous drugs – European Policy Recommendations, European Parliament, 2016.

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FOR FURTHER INFORMATION, PLEASE CONTACT: questions@vygon.com

The specification shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature.

Contribution from
VYGON – 5, RUE ADELINE - 95440 ECOUEN - FRANCE RECEPTION: +33 (0)1 39 92 63 63 – SERVICE CLIENTS FRANCE: +33 (0)1 39 92 63 81 EXPORT CUSTOMER SERVICE: +33 (0)1 39 92 64 15 www.vygon.com  02/2023DBONCO23644E
Vygon Germany

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