StaySafe

PD Foundations India May 2011

stay•safe®

….safe and convenient for all


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.


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


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


WHY?

A New Connection System


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


© 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


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


Connect to disc

The stay.safe Procedure


Improved Patient Handling

• Less steps

• Central control disc

• Regulation of solution flow

• No clamps

• No breaking of frangible pins


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


Closed Disconnection

• The stay•safe® PIN technology eliminates 1,460 risk steps per patient year compared with conventional PD systems


PIN

CAPD risk step analysis with PIN

Less 50 % Risk


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



© 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


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


Biofine™

• A high tech material

– 60 % thinner saving raw material

– Biodegradable

– Multilayer foil contains no glue

PVC Biofine™

Less material =

Lower environmental burden


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 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%


Colour Coding

• Color coding of DISC

– 1.5% - yellow (CAPD 2)

– 2.3% - green (CAPD 3)

– 4.25%- red (CAPD 4)


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


Heating

• Recommended Thermosafe heater

– Microwaving not recommended


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.


Thank you for

listening!!!

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