SORIN GROUP DEUTSCHLAND GMBH ∙ Lindberghstr. 25 ∙ D-80939 München
FAQs for the Heater-Cooler System 3T
Disinfection Process
For your reference, a list of anticipated Frequently Asked Questions (with answers) is provided below. If
you have additional questions, please call the Sorin Technical Services Hotline at 1-800-221-7943 Ext.
6355.
1. When must I follow steps 1-4 in the Field Safety Notice dated June 15, 2015?
Please see the FSN Action Diagram at the end of this document.
2. If the water in my 3T is contaminated (bacterial load above drinking water limits and/or
presence of non-tuberculous mycobacteria), what are my options?
You should contact the infection control manager at your hospital to determine appropriate
actions. Please refer to the instructions provided in the Field Safety Corrective Action dated June
15, 2015. For information about deep disinfection services, contact the Sorin Technical Services
Support Line at 1-800-221-7943 Ext. 6355.
3. What 3T water tests are recommended?
Sorin recommends water testing to confirm:
a. Heterotrophic Plate Count (HPC): is less than 500 cfu/ml (acceptable level according to
US drinking water standard)
b. Non-Tuberculous Mycobacteria: is not detectable in 100ml
c. Coliform bacteria: is not detectable in 100ml
d. Pseudomonas aerginosa: is not detectable in 100ml
4. How frequent are the 3T water tests recommended?
For 3T units that have not been properly maintained, Sorin recommends that the water be tested
immediately and then every two weeks until the water quality is determined to be acceptable.
Water testing can then be performed monthly.
For 3T units that have been properly maintained, Sorin recommends implementing a monthly
water testing schedule.
In either case, testing can be performed quarterly after three months of successful results.
Please consult with your Infection Control Manager to determine what is appropriate for your
hospital.
All water samples used for testing should be collected prior to performing the disinfection
procedure.
5. How were these recommended water tests determined?
To minimize the risk of infection, Sorin Group recommends the water in the 3T should meet
microbiological requirements for drinking-water.
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World Health Organization Guidelines (Guidelines for Drinking Water Quality, Heterotrophic Plate
Counts and Drinking Water Safety) and the US EPA’s National Primary Drinking water standard
were the primary sources used.
Additional or alternative tests may be appropriate as recommended by your Infection Control
Manager or Test Laboratory.
6.
Why did the 3T disinfection procedure change?
Sorin became aware of cases of non-tuberculosis mycobacterium endocarditis or deep infection
following cardiac surgery during which the 3T device was in use. Although the investigation to
date has not determined a causal connection between the heater-cooler 3T device and these
cases, we improved the disinfection procedure to minimize the possibility that the 3T could
contribute to patient infections.
7.
Can sterile water be used in place of filtered tap water?
Filtered tap water is the preferred option. The water filter which we recommend is an immediate
barrier against waterborne micro-organisms for up to 31 days. Sterile water can be used if it was
sterilized by way of filtration. De-ionized, distilled or reverse osmosis water must NOT be used
as it may cause internal device corrosion over time.
8. How should I disinfect the overflow bottle?
Automatic chemical-thermal disinfection in a washer-disinfector at intervals of seven days is
recommended for the overflow bottle. The material of the bottle is polyethylene PE-LD and is
resistant to a temperature up to 102°C and has a broad resistance to chemicals. Please refer to
Section 6.9 of the 3T Operating Instructions. If you wish to purchase a new overflow bottle, the
Sorin part number is 96-410-765.
9.
What topical disinfectant should be used to clean the ports and the outside of the device?
Any common disinfectant spray can be used on the connection ports. To disinfect the outside
surface of the device, disinfectant wipes must be used which do not contain oil, grease or
acetone. Please refer to Section 6.2 of the 3T Operating Instructions for a list of approved
disinfectant tissues.
10. If not in regular use, should the device be stored full or empty?
When not in routine use, the water must be emptied from the device. In addition, disinfection
must still be performed every 14 days. Please refer to Section 6.5 of the 3T Operating
Instructions.
11. Where can I get my water tested?
One option is as follows:
STERIS Isomedix Services
Attn: Annette Eckman
Biotest Laboratories Account Manager
9303 West Broadway Avenue | Brooklyn Park, MN 55445
Mobile: 763-221-0345
Email: [email protected]
Web: www.isomedix.com and www.biotestlabs.com
Samples of at least 100ml are typically required for each water test.
Please note: The use of this lab and their protocol will be solely at your hospital’s discretion.
Sorin will not be responsible for your hospital’s interactions with this lab or test results.
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12. What is the process for collecting and shipping water samples?
The samples are typically sent in collection containers, placed in a cooler with a cold pack and
shipped overnight. Sodium thiosulphate should be added if the water is chlorinated. A test
request form is also normally required. Please contact the laboratory of your choice for specific
instructions.
13. What’s special about the recommended water filter?
The filter used during the validation testing was the Pall-Aqauasafe™ AQINA. It’s a 0.2 micron
filter that removes bacteria from tap water. The Pall-Aqauasafe™ AQ31F1SA contains the
identical internal filtration and is also acceptable for use.
14. What is the difference between the Pall-Aqauasafe™ AQINA and the Pall-Aqauasafe™
AQ31F1SA?
The AQ31F1SA is easier to use than the AQINA as it has a higher flow rate and only requires
one tubing connection to the inlet side. The AQINA requires connections to both the inlet and
outlet. Therefore, when using the AQINA filter, the outlet tubing should be discarded after each
use as it is downstream from the filter.
15. What hardware is required for these Pall-Aquasafe™ filters?
a.
b.
c.
d.
Two (2) "quick disconnect fittings" are required for the AQINA. One fitting attaches on the
outlet side of the filter and one on the inlet side of the filter.
One (1) “quick disconnect fitting” is required for the AQ31F1SA. The fitting attaches to the
inlet side of the filter; the outlet side of the filter is an opening to atmosphere where the water
exists.
Pall supplies a CPC quick disconnect fitting with a 1/2" NPT male connection point to tubing
(Part# TAP1/2MV) and a CPC quick disconnect fitting with a 1/2" NPT female connection
point to tubing (Part# TAP1/2FV). Both of these parts have a "stop" valve inside to hold water
back when disconnected from the filter.
Any adapters needed to connect the 1/2" male or female quick disconnect fittings (TAP1/2FV
or TAP1/2MV) to tubing needs to be supplied by the user.
16. Must a new filter be used every time the 3T is filled with water?
a.
b.
The Pall-Aquasafe™ AQ31F1SA and AQINA filters are validated for up to 31 days use no
matter how much water passes. The 31 day period starts after the filter is opened from its
sterile packaging. The filter should be dated in black marker on the label showing opened
date and 31 day expiration date.
When not in use, the filter should be kept in hygienically clean storage (i.e. a sterile bag).
17. What’s special about the recommended water lines?
a.
b.
c.
The recommended water lines are certified for drinking water systems. They are made of a
Polyethylen (PE) material.
The tubing does not contain plasticizers because they could promote bacterial growth.
The Sorin part number for this tubing (25 meters) is 75-510-218.
Please refer to the internet link below for additional Heater-Cooler System 3T information.
www.sorin.com/3t
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Products and Services Information Guide
Product
Part
Number
Manufacturer
Contact
Contact Information
Tubing Lines (25
meters)
75-510-218
Sorin Group
Customer
1-800-650-2623
Service
Overflow Bottle
96-410-765
Sorin Group
Customer
1-800-650-2623
Service
Water Filter
AQ31F1SA
Pall Medical
Customer
[email protected]
Service
Water Quick
Disconnect Male
Fitting
TAP1/2MV
Pall Medical
Customer
[email protected]
Service
Water Quick
Disconnect Female
Fitting
TAP1/2FV
Pall Medical
Customer
[email protected]
Service
Water Testing
HPC/Non-TB
Biotest Labs
Mycobacteria
Annette
Eckman
Deep Disinfection
Service
H/C Deep
Disinfection
Technical
1-800-221-7943 Ext. 6355
Services
Sorin Group
[email protected]
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FSN Action Diagram
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