PD Foundations India May 2011
stay•safe®
….safe and convenient for all
PD Foundations India May 2011
Current Challenges - PD Programs
• Patient compliance
• Technical failure
• Peritonitis
• Adequacy
Increasingly, CAPD is the therapy selection not only used for the young & technically skilled persons, but also for the elderly and those
who may have multiple pathology and cognitive dysfunction.
PD Foundations India May 2011
Risk Steps in A PD Exchange
• Connection of delivery system to catheter
– touch contamination
– detachment, leakage
• Control of direction of flow of PD fluid
– inadequate flushing
• Closure of the catheter
– Leakage
– touch contamination
PD Foundations India May 2011
Points to Consider when Developing a New PD System
• Prevention of peritonitis
– Flush before fill
– Reduced risk of touch contamination
• Ease of Training
• Compliance & maintenance of the correct daily routine
• Ecological factors
• Biocompatible factors
• Cost
PD Foundations India May 2011
WHY?
A New Connection System
PD Foundations India May 2011
1. Connection
2. Clamp inflow line
3. Break breaking-cone of drainage
bag
4. Break-cone of pt connector
5. Open clamp Drainage
6. Close clamp
7. Open inflow line Flush
8. Clamp drainage line
9. Open clamp Inflow
10. Clamp Y-line Closure
11. Disconnection
1 7 8
1 0
2 6
5 1 1
9
4
3
Solution bag
Peritoneal
cavity
Catheter Abdominal
wall
Drainage bag
Status Double Bag System
• Disconnect System with Flush before fill
– Complex handling steps
– Difficult to learn
PD Foundations India May 2011
© Fresenius Medical Care 2011
Clinical Meeting 2011
CAPD – System development
Andy.Disc • non disconnect system
• w/ flush before fill
• PVC bag material
stay•safe®
• safe disconnection - PIN
• guided handling - DISC
• Biofine® material
PD Foundations India May 2011
DISC 1. Connection
2. Open clamp Drain
3. Turn knob Flush
4. Turn knob Inflow
5. Turn knob Closure
6. Disconnection
The stay.safe CAPD System
• Disconnect system with a mandatory flush before fill
• Reduced number of steps-Improved handling
PD Foundations India May 2011
Connect to disc
The stay.safe Procedure
PD Foundations India May 2011
Improved Patient Handling
• Less steps
• Central control disc
• Regulation of solution flow
• No clamps
• No breaking of frangible pins
PD Foundations India May 2011
Reduced Risk Of Contamination
PIN
• Easy to learn automatic inline closing of the patients catheter extension before disconnection providing extra safety and less handling for the patients
Disinfection/Betadine Cap
• Integrated disinfection ensures PIN is disinfected
Organizer
• Reduces touch contamination
• Makes exchange possible with 1 hand
PD Foundations India May 2011
Closed Disconnection
• The stay•safe® PIN technology eliminates 1,460 risk steps per patient year compared with conventional PD systems
PD Foundations India May 2011
PIN
CAPD risk step analysis with PIN
Less 50 % Risk
PD Foundations India May 2011
Delivering PD therapy in a safe & convenient way
The stay•safe® system has been specifically designed to help patients with their daily self-care CAPD treatment in a safe and convenient way. Operating errors are essentially excluded.
• This innovation has resulted in improved safety levels, patient compliance and excellent clinical results
PD Foundations India May 2011
PD Foundations India May 2011
© Fresenius Medical Care 2011
What is Biofine®?
• Biofine® is a polymer constructed exclusively from hydrogen and carbon atoms
• It is PVC-free and plasticizer-free
DEHP
Biofine ® PVC
PD Foundations India May 2011
Biofine®
25.000 t 1.000Trucks
25 m
PVC (Polyvinyl Chloride)
• Contains plasticizers and chlorine Exposure to patients Incineration w/ toxins,
such as HCL, dioxins, etc.
• High material demand Double waste load due
to need for higher material use
Biofine® • Free from plasticizers an
chlorine No exposure to patients
Clean incineration to H2O + CO2
• Less material demand Less waste load
PD Foundations India May 2011
Biofine™
• A high tech material
– 60 % thinner saving raw material
– Biodegradable
– Multilayer foil contains no glue
PVC Biofine™
Less material =
Lower environmental burden
PD Foundations India May 2011
Biofine™
• More ecological life cycle (production usage and disposal) – Incinerated Biofine® generates only carbon dioxide and
water
• Sterilization process – entire system undergoes sterilization at 121ºC
• Superior barrier to water evaporation – inner bag not wet – Good water vapour barrier– perfect material for bags
preserving better the PD solution
• Contains no PVC – No absorption or adsorption of plasticizers
• Environment friendly – from production to usage and disposal
• Requires less material (60% thinner than PVC) = less waste
• Easy to recycle • Excellent clarity allows patients to inspect the bags
PD Foundations India May 2011
PD SOLUTION: Electrolytes
mmol/L
• Sodium 134
• Magnesium 0.5
• Chloride 103.5
• Calcium 1.25 or 1.75
• Lactate 35
• pH 5.5
• Glucose 1.5%, 2.3%. 4.25%
PD Foundations India May 2011
Colour Coding
• Color coding of DISC
– 1.5% - yellow (CAPD 2)
– 2.3% - green (CAPD 3)
– 4.25%- red (CAPD 4)
PD Foundations India May 2011
Bag Sizes
– 2L
Calcium concentration
– 1.25mmol(17, 18, 19)
– 1.75mmol(2, 3, 4)
Glucose concentration
• staysafe 17, 2
– 1.5% glucose
• staysafe 18, 3
– 4.25% glucose
• staysafe 19,4
– 2.3% glucose
PD Foundations India May 2011
Heating
• Recommended Thermosafe heater
– Microwaving not recommended
PD Foundations India May 2011
Summary
• Since 1996 stay•safe® has become established as a proven and reliable system.
• stay.safe offers a state of the art double bag CAPD system that incorporates a flush before fill
– Disc and PIN technology improves patient handling
– Reduction in the risk of touch contamination
• The stay•safe® system is made from a non-PVC material called Biofine® which is free from plasticizers and is environmentally friendly.
• Available globally - patients can enjoy the benefits of stay•safe® around the globe enabling convenient travelling.
PD Foundations India May 2011
Thank you for
listening!!!