staysafe

.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

A New Connection System

WHY?

PD Foundations India May 2011

Status Double Bag System

Solution bag

Disconnect System with Flush before fill

Complex handling steps Difficult to learn
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 6 10

7 2 8

Peritoneal cavity

5 9

11 3 4

Catheter

Abdominal wall

Drainage bag

PD Foundations India May 2011

CAPD System development

Andy.Disc
non disconnect system w/ flush before fill PVC bag material

staysafe
safe disconnection - PIN guided handling - DISC Biofine material

PD Fresenius Medical Care 2011 Foundations India May 2011

Clinical Meeting 2011

The stay.safe CAPD System

Disconnect system with a mandatory flush before fill Reduced number of steps-Improved handling

DISC

1. Connection 2. Open clamp 3. Turn knob 4. Turn knob

5. Turn knob 6. Disconnection

Drain Flush Inflow Closure

PD Foundations India May 2011

The stay.safe Procedure

Connect to disc

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 staysafe PIN technology eliminates 1,460 risk steps per patient year compared with conventional PD systems

PD Foundations India May 2011

CAPD risk step analysis with PIN

PIN

Less 50 %
PD Foundations India May 2011

Delivering PD therapy in a safe & convenient way

The staysafe 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

What is Biofine?
Biofine is a polymer constructed exclusively from hydrogen and carbon atoms It is PVC-free and plasticizer-free

DEHP

Biofine
PD Fresenius Medical Care 2011 Foundations India May 2011

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.

Biofine
Free from plasticizers an chlorine
No exposure to patients Clean incineration to H2O + CO2

High material demand

Less material demand

Less waste load

Double waste load due to need for higher material use

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) Sterilization process entire system undergoes sterilization at 121C Superior barrier to water evaporation inner bag not wet
Incinerated Biofine generates only carbon dioxide and water

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

Good water vapour barrier perfect material for bags preserving better the PD solution

PD SOLUTION: Electrolytes
mmol/L 134 0.5 103.5 1.25 or 1.75 35 5.5 1.5%, 2.3%. 4.25%

Sodium Magnesium Chloride Calcium Lactate pH Glucose

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 staysafe 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 staysafe 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 staysafe around the globe enabling convenient travelling.

PD Foundations India May 2011

Thank you for listening!!!

PD Foundations India May 2011