Authors (including presenting author) :
Leung L(1), Chow HY(1), Au Yeung SH(1)
Affiliation :
(1) Central Sterile Supply Department & Theatre Sterile Supply Unit, United Christian Hospital
Introduction :
Packaging is one of the steps in the reprocessing cycle of medical devices. Currently, flat pouches and reels are used to package instruments in Sterile Services Department (SSD). The staff members used to check the sealing integrity of heat sealers for peel reels by visual inspection daily and by seal check and ink test weekly.
Apart from using packaging materials which conform to ISO 11607-1 “Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems”, the sealing process also has to be validated in accordance with ISO 11607-2 “Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes”. The process validation of cleaning, disinfection and sterilization of medical devices has been conducted in SSD since 2012. However, the sealing process has not been validated regularly. To help maintain the sterility of the packages, it is essential to carry out the process validation for the heat sealing process.
Objectives :
To ensure the sealing process of peel reel is under control and produces optimally sealed sterile barrier system.
Methodology :
An advanced practice nurse (APN) of SSD was assigned to coordinating all process validation of the existing reprocessing equipment. She acquired the skills to perform different validation tests by the training in some international or overseas organizations. Before carrying out the tests, a validation plan was established, which provides a guidance of:
•performing validation of packaging processes including installation qualification, operational qualification and performance qualification
•writing a validation report with formal approval
•process control and monitoring
•revalidation
The sealing processes of all existing heat sealers have been annually validated in accordance with ISO 11607-2 and the Germany’s “Guideline for the validation of packaging processes according to ISO 11607-2”. The samples of worst-case scenario have been tested. The critical parameters, such as sealing temperature, pressure and speed, have been validated. The integrity of seal seam has also been inspected.
Training was given to all nurses and patient care assistants. They were instructed how to monitor the critical parameters and the integrity of seal seam by routinely conducting seal check and ink test, which prove the sealing process consistently meet the predetermined specifications.
Result & Outcome :
The sealing processes of all existing heat sealers have been annually validated by the APN since 2018. Moreover, the suppliers are required to carry out the process validation for new heat sealers during the commissioning. When the warranty ends, the annual performance qualification is carried out by the APN.
The process validation of sealing process is coordinated by an enrolled nurse now with the guidance and supervision of the APN.
No nonconformity of sterile packaging has been found since 2018.
All processes are conformed to ISO 13485 “Medical devices — Quality management systems”.
