Duck Bags Pre-Moistened Instrument Bags

Using Duck Bags

Duck Bags Pre-Moistened Instrument Bags

Product Validation Report

Project: Duck Bag Testing

Objective: To see if the Duck bags would keep wet soiled instruments hydrated

Date of Test: April 2013

Tested By: Manufacturer

Executive Summary

During this test the half din duck bag was tested. The purpose of this test was to ensure that the duck bag kept wet soiled instruments hydrated for 5 days. The bags were tested in a room with at a temperature of 21.7 degrees Celsius under lights and to ISO15883 standard. We tried to replicate a hospital ward where the bags will be being used.

The outcome of the tests was:-

• Test Started at 1300 11/4/2013
• Load in the bag @ 1500 11/4/2013 After 2 Hours the soil was still moist
• Load in the bad @ 1700 11/4/2013 Soil is still moist. No signs of drying
• Load in the bag @ 1200 12/4/2013 the soil has changed colour but still moist
• Load in the bag @ 0900 15/4/2013 the soil has again changed colour, but when you touch the instruments the blood is still wet on the instruments.
• Load in the bag @ 1300 16/4/2013 the soil is still wet and can still wipe it off with a tissue.

The bag had been fully tested over 5 a five day period and the results proved conclusively that the soil remained moist up to the end of the 5th day.

Testing Details

Procedure carried out by the manufacturer.

1.0 Objective

Half din Duck Bag

• The objective was to carry out a functionality test of the product. This was tested to ISO15883 standard.
• The test temperature was approximately 21.7 degrees Celsius throughout
• We expected to see the Duck bags keep the soiled instruments hydrated for at least 5 days

2.0 Test Protocol

2.2 Equipment

• The equipment used during this testing was a half din duck bag for the test. The instruments were soiled using Edinburgh test soil.
• Inside the bag there was solid instruments inside an open din basket

2.3 Consumables

• Edinburgh Test Soil was used. Batch number 978 with an expiry date of 16/04/2013

2.4 Procedure

• The schedule was designed to test the integrity of the product over a period of 5 days
• The bag was checked at regular intervals over this time period
• The performance was tested by touching the instrument through the bag without opening the bag

3.0 Results

• Load in the bag @ 1500 11/4/2013 After 2 Hours the soil was still wet
• Load in the bad @ 1700 11/4/2013 Soil is still wet. No signs of drying
• Load in the bag @ 1200 12/4/2013 the soil has changed colour but still wet
• Load in the bag @ 0900 15/4/2013 the soil has again changed colour, but when you touch the instruments the blood is still wet on the instruments.
• Load in the bag @ 0900 16/4/2013 the soil is still wet and can still wipe it off with a tissue.

No calibrated equipment was used in this testing.

4.0 Conclusion

After testing the duck bag Medisafe can confirm that the product achieves the results that we expected. All objectives were met and passed by the Duck Bag.

References

Department of Health (2012) Choice Framework for local Policy and Procedures 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care. Part A: the formulation of local policy and choices manual, Pages 57-58.