Professional Documents
Culture Documents
Syringe and Disposable
Syringe and Disposable
Syringe and Disposable
Medical Device
Introduction
Bayer Radiology Devices
////////////
CV CT MR MI
Stellant
Mark7 Arterion MRxperion
Salient
Intego
Avanta
Vistron Plus
Spectris Solaris RESTRICTED
Bayer Radiology Devices
////////////
Informatic
s
S&D
RESTRICTED
Bayer Radiology Devices- Syringes and Disposable S&D
////////////
Tubings/ Extensions Single/Double Syringe kits
Single / Multi patient Disposables
85571842 ZY5154 Dual Check Y Tube MEDRAD ZY 5154 Salient Dual Injector (Salient-DW) 50/Box
84303241 TUBE,EXT,DUAL MEDRAD ZY 5152 Salient Dual Injector (Salient-DW) 50/Box
Salient Single Injector (Salient-SW)/Salient-
84303233 TUBE,EXT,SINGLE MEDRAD ZY 5151 S/Vistron Plus/Vistron 50/Box
Salient Single Injector (Salient-SW)/Salient- 50/Box
60728885 SET, PKG, LPDCT 160, RAD, MC MEDRAD LPDCT 160 S/Vistron Plus/ Vistron
SALIENT/VISTRON PLUS SYRINGE WITH Salient Single & Dual Injector (Salient-SW &
84710261 QFT MEDRAD ZY 6322 DW)/Salient-S/Vistron Plus/Vistron 50/Box
86617552 PROVIS,KIT,SYR,ANGIO,150ML,MC,WLD MEDRAD 150 FT-Q Mark V Provis 50/Box
60728699 KIT,DUAL,STLNT,APOLLO,TCON,QFT,MC MEDRAD SDS-CTP-QFT Stellant- D 20/Box
ASSY,FINAL,T-CONNECTOR,6",SSS-LP-60-
60729040 T, MEDRAD SSS-LP-60-T Stellant- D 50/Box
ASSY, PKG, SYRINGE, 200ML, ODYSSEY,
60728621 MC MEDRAD 200 FLS Vistron 50/Box
ASSY,PKG,SYRINGE,TRI-
60728656 PAK,200ML,ODYSY,MC MEDRAD CTP 200 FLS Vistron 50/Box
60728974 SET,PKG,INTEG T/CV,SSIT 96VLD,RAD,MC MEDRAD SSIT 96 VLD Spectris Solaris EP 50/Box
MEDRAD
60728567 KIT,65/115ML,96"CT/CV,MRI, MC SSQK65/115VS Spectris Solaris EP 50/Box
SYRINGE
60729385 KIT,PKGD,MEDRAD,150FT,MK7,MC MEDRAD ART 700 SYR Mark 7 Arterion 25/Box
Medrad ZY5154
Disposable Syringe
¹ Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA. US Food and
Drug Administration. July 30, 2001. https://www.fda.gov/media/71405/download. Accessed 29 Dec ,2019.
- Reprocessing may alter device characteristics, and performance may be compromised as a result.
- Single-use devices do not undergo extensive testing validation and testing for reuse.
- Single-use devices may cause cross-infection due to design (for example, fine bores of tubes).
- Some materials can absorb certain chemicals, which can gradually leach from the material over time.
- Device material may experience stress during reuse and may fail, stretch, or break.
- Inadequately cleaned equipment can carry bacterial endotoxins, which remain after bacteria are killed.”¹
¹ Mansur JM. Reuse of Single-Use Devices: Understanding Risks and Strategies for Decision-Making for Health Care Organizations; Joint
Commission International 2017; available at
https://www.jointcommissioninternational.org/assets/3/7/JCI_White_Paper_Reuse_of_Single_Use_Devices2.pdf
26 CF Approval number : PP-CTP-ALL-0011-1 RESTRICTED
Beliefs to Create
////////////
Made at our facilities in the United States, we have supplied over 300 million syringes to
20,000 hospitals and imaging centers worldwide—testament to the quality and trust
radiology professionals have placed in Bayer syringes.
Bayer syringes are an integral part of the total injection system.
As the original designers of the injection systems, Bayer is the only manufacturer that can
precisely identify how the system performs. The syringe is ready to meet the specifications of
the power injection system, which are quite stringent to assure the efficacy of the injection.
Bayer syringes and disposables have advantages in a variety of key aspects—material
quality, manufacturing, injector performance, and a legacy of commitment to patient
safety*.
Aligned performance
Commitment to patient safety Bayer Shenzhen
Material quality
Manufacturing and sterilization processes
Packaging and distribution evaluation
Service-related benefits
And more
Looking at the example of Shenzhen syringe, you can tell
the syringe is not as clear as a Bayer syringe. That’s
because the barrel is molded from a different material
that does not have the same clarity or strength as the
Bayer syringe.
30 /// Power Injectors, Saline and Extravasation /// October 2018 RESTRICTED
Pressure
////////////
Total Resistance
Catheter diameter Contrast temperature
System Catheter length Needle size
Resistance Contrast viscosity Wall resistance
31 /// Power Injectors, Saline and Extravasation /// October 2018 RESTRICTED
Wall Resistance
////////////
32 /// Power Injectors, Saline and Extravasation /// October 2018 RESTRICTED
Pressure in a System
////////////
pressure highest at median pressure
PRESSURE IN output of reservoir 100 psi halfway down pipe
pipe (catheter)
force
0 psi
fluid scatters
(no restrictions)
RESTRICTED
Image: © Bayer 2018.
Pressure
P1 Drop P2 P1 -P2 π (Pressure difference) (radius) 4
Volume
Flowrate =ƒ= =
r R 8(Viscosity) (length)
ƒ Resistance
to flow R Assuming an original flow rate = 100cm3/sec
When all other factors remain constant the effect of individually
changing each of the following factors is shown below
L Double length 50cm3/sec
8ɳL Double viscosity 50cm3/sec
R= Where ɳ = viscosity
πr4 Double pressure
Double radius
200cm3/sec
1600cm3/sec
Source: http://hyperphysics.phy-astr.gsu.edu/hbase/ppois2.html
RESTRICTED
Accessed March 2018
A pressure limit is set to protect the consumables. The injector will use the
minimum amount of pressure it needs to propel the fluid out of the syringe
Pressure The pressure limit must be set for the lowest rate disposable in the fluid
pathway to the patient, such as the connecting tube, extension tubes and
limiting cannula
35 /// Power Injectors, Saline and Extravasation /// October 2018 RESTRICTED
Pressure
////////////
It has been reported that warmed contrast media reduces the rate of contrast
media extravasations2
1. Kyongtae T. Bae , MD, PhD, Intravenous Contrast Medium: Administration and Scan Timing at CT: Considerations and Approaches. Radiology 2010; 256:48-49
RESTRICTED
2. Davenport MS, Wang CL, Bashir MR, et al. Rate of contrast media extravasations and allergic like reactions: effect of extrinsic warming of low-osmolality iodinated CT contrast media to 37°C. Radiology 2012; 262:475-484
Gauge 22 20 18 17 16
Ensure that the cannula selected
is appropriately rated for the examination
OuterØ
0,8 1,0 1,2 1,4 1,7
(mm) Check PSI rating on the packaging
or product literature
InsideØ Check flow rating on packaging or product
0,6 0,8 1,0 1,2 1,4
(mm)
literature and ensure rating stated is ml/sec
and NOT ml/min
Flow rate
31 54 80 125 180
(ml/min)
Injection
1-2 2-4 3-7 8-15 10-20
(ml/sec)
RESTRICTED
Source: Martin Mack, Instut fϋr Radiologie, J.W. Goethe-Universität Frankfurt/M)
RESTRICTED
Image: © BD 2018 Information provided by BD
39 /// Power Injectors, Saline and Extravasation /// October 2018 Please check individual SmPCs for information on flow rate
Pressure
////////////
Consumables
Catheter / cannula
Connecting tubing
Additional products added to the fluid pathway
Decisions Viscosity
in Practice Contrast media
Temperature (iodinated contrast media)
A Recap
Pressure
Automated pressure adjustment
Maximum pressure limit
43 /// Power Injectors, Saline and Extravasation /// October 2018 RESTRICTED
Quality
Home
Why Bayer
Quality
Performance
Confidence
* Data on file
RESTRICTED
Quality
Home Specific materials, packaging, manufacturing processes and sterilization methods were designed and developed to
ensure the highest quality of each Bayer syringe kit.*
Why Bayer
Quality
Performance
Designed for Bayer injector
Confidence
Strict vendor qualification: Each supplier has been carefully chosen,
audited and certified to provide materials that completely adhere to our
chemical composition and purity specifications
* Data on file
RESTRICTED
Quality
Home Specific materials, packaging, manufacturing processes and sterilization methods were designed and developed to
ensure the highest quality of each Bayer syringe kit.*
Why Bayer
Quality
Performance
* Data on file
RESTRICTED
Quality
Home
Key communication objectives
Why Bayer
Nothing is more important than your patients’ safety. Bayer syringes play an integral role in safely delivering
Quality
imaging fluids to your patients. Every product is made from reliable components to help you provide high
Performance quality care.
Confidence
Confirmed biocompatibility:
Our product development process and material sourcing procedures adhere
to internationally recognized biocompatibility standards, ensuring the
safety profile of your syringes.
* Data on file
RESTRICTED
Quality
Home Medical-grade materials
Why Bayer Specific medical-grade material, are selected via a strict vendor qualification
process to ensure optimal injector performance and patient care.
Quality
Declaration of harmful materials in generic syringe manufacturer IFUs
Performance
“7. Since the connecting tube in the accessories of the product is made
Confidence of PVC, clinical medical staff shall pay attention to its possible toxicity Wego Stellant syringe IFU
to high-risk population (newborns, male before puberty, pregnant
and lactating women), and try to choose alternative products as
much as possible. PVC material contains DEHP plasticizer, which
has significant toxicity on the reproductive system of male mice as well
as significant effect on the expression of apoptosis gene in liver tissue of
rat. All drugs that react with PVC materials shall not be used.
According to the domestic and foreign research data, clinical medical
staff shall note that tube containing PVC may interact with the drugs
infused, resulting in change in efficacy of the drugs. Therefore this
product is contraindicated for infusing drugs incompatible with PVC. The
accessory connecting tube of this product is contraindicated for infusing
paclitaxel drugs and liposoluble drugs.”
Yesomed
RESTRICTED
Quality
Home Confirmed biocompatibility
Our product development process and material sourcing procedures adhere to
Why Bayer
internationally recognized biocompatibility standards, ensuring the safety profile of
Quality
syringes.
Performance
Bayer’s SD engineering group includes AAMI Certified Industrial Sterilization Specialists.
Confidence
These are certified experts in e-beam and gamma sterilization, who ensure that our products and
processes are sterilized according to the latest industry standards and techniques.
All manufacturing and packaging processes adhere to ISO 10993 and ISO 11607 standards,
respectively. ISO 11607 may be a differentiator, because Bayer’s sterile packaging and distribution
processes go above and beyond industry standards.
Each piece of material that we add to our line has to be approved by our biocompatibility team so that
anything that contacts the fluid path, which is critical to patient care, will be clean and appropriate for
medical use.
For every improvement or change made to our line, we do multiple levels of validation and verification,
both for quality and for software to verify that every change is repeatable, and that the line can be
made consistent.
* Data on file
RESTRICTED
Quality
Home
Why Bayer
100% inspection for particulates
Quality
Bayer thoroughly inspects each and every syringe barrel for particulates.
Performance That reduces patient risk and provides an additional level of patient safety.
Confidence
* Data on file
RESTRICTED
Quality
Home
Silicone application
Why Bayer Our US-based manufacturing facilities produce syringes to extremely tight tolerances.
The volume of silicone coating inside the syringe barrel is precisely controlled. This
Quality facilitates optimal device performance and accurate fluid delivery.
Performance
Confidence Silicon is the lubricant inside the Bayer syringe that allows for smooth and exact
movement of the plunger which is the key component of the syringe
Not enough silicone may result in a lower flow rate which can affect contrast
delivery which can affect images, which can lead to additional scans and more
exposure to radiation
If the application is not precisely controlled, then silicone can be over- or under-
applied, impacting fluid delivery performance and the well being of patients.
Automated precision Bayer’s automated process precisely applies a micro-
layer of silicone for consistent and accurate injection performance under clinical
pressures.
RESTRICTED
Performance
Home
Syringes that are not custom designed and manufactured by Bayer for your Bayer system can
Why Bayer impact the performance of your radiology suite and commitment to patient care.
Quality
Performance
Lab tests performed with non-Bayer syringes found
Confidence instances where the syringe is technically incompatible
with the Bayer MEDRAD® injector.
Non-compatible syringes can fail, resulting in injector
downtime and patient rescheduling.
Non-compatible syringes may deliver the incorrect dose,
requiring rescanning or rescheduling.
Bayer cannot guarantee the performance of your injector
with generic syringes and disposables.
RESTRICTED
Performance
Home
Syringes that are not custom designed and manufactured by Bayer can impact the performance of
Why Bayer the radiology suite and commitment to patient care.
Quality
RESTRICTED
Performance
Home
Service warranty strategies
Why Bayer
Service warranties may be voided if it is determined that the injector malfunction
Quality
was caused by the use of non-Bayer disposables.
Performance
Confidence Service warranties may be void for injectors that malfunction due to generic syringe use. When generic syringe use leads to
contrast fouling of the injector head, the injector head must be replaced and the customer may be charged full price for the
replacement head. Figure 1 to the right shows an excerpt of the relevant Terms & Conditions in Canada’s DirectCARE Basic
service agreement and policies, showing that damage caused to the injector by non-Bayer disposables may not be covered
under the service warranty.
RESTRICTED
Confidence
Home
Can I use generic syringes with your injector?
Why Bayer
Quality
We don’t recommend using non-Bayer/ non-MEDRAD® syringes with
Performance our injector.
Confidence Our Bayer product families are designed and manufactured to work
as a system, and we rigorously invest into our product design.
Every component plays an important role in ensuring the highest
level of performance and reliability of your product.
When choosing contrast and saline syringes, you need to consider:
particulate, biocompatibility, application of silicone and compatibility
with injector equipment.
Only a validated syringe from a trusted supplier like Bayer can give
you the peace of mind you need, and that your patients have come to
expect.
* Data on file
RESTRICTED
Confidence
Home
Can I use generic syringes with your injector?
Why Bayer
Quality
RESTRICTED
Confidence
Home Can you meet the price of syringes that I’m being quoted for generic syringes?
Why Bayer Ensure the customer is making an informed comparison. Discuss the quality of our consumables with the
customer and how they are designed, tested, and warranted as a total system.
Quality
Bayer has a number of clinically proven injection systems on the market in various
Performance
modalities. In CT alone, Stellant is the 8th generation injector
Confidence Bayer is a reputable and reliable company that is focused on meeting customer
needs in Radiology. If something were to go wrong, we have a dedicated team to
make it right for you. If you are considering an alternative supplier, what kind of
proven performance and approach to customer care has this supplier
demonstrated to you?
As a healthcare institution, you are committed to the highest level of quality when it
comes to supplies that you use on your patients. How do you manage the transition
between suppliers of materials?
For new suppliers of quality materials that you use in majority of your radiology
procedures, how do you qualify new suppliers in your department?
What role do you think BAYER can play in the operational efficiency of your
department?
What are your active initiatives in the hospital regarding outcome of care and
quality measures? What impact do you believe quality, proven suppliers have on
those measures?
RESTRICTED
Confidence
Home
Why Bayer
External content pieces
Quality
Confidence
PP-M-STE-ALL-0021-1 RESTRICTED
RESTRICTED
Thank you
RESTRICTED