Requirements for the manufacturing and processing of the surgical textiles:
Wednesday, August 12, 2015
Deliverables for the medical practices needs a lot of supervision under the set guidelines. Definitely there can be no substitute to safety as far as surgical or any other medical procedures are concerned.
Following are some mandatory guidelines that any surgical textile manufacturer needs to ensure before delivering the product:
1. It is a must for every manufacturer of surgical textile to fulfil the requirements as laid down by EN 13795 and that there is efficient usability with both the disposable and non-disposable products and with the reusable medical equipments as well.
2. The manufacturing and processing methods used are validated.
3. All the manufacturing and processing steps are well comprehended in the validation.
4. All the manufacturing and related processing methods are suitably determined and approved.
5. The frequency of verification has to be determined during the process; once all the changes that have a decisive influence on the items are made, the process of verification should be determined again to ensure the quality.
6. All the critical specifications included in the manufacturing and processing have to be strong-willed, audited and documented. The type and frequency of the regular monitoring must be detailed and stored.
7. Same way the results of validation process and day-to-day supervision must be documented and saved for further records and pursuance.
8. It is most important to maintain the control over decontamination and disinfection procedures during the manufacturing and processing. Make sure to track the process of sterilization.
9. Confirm that the properties of material used in the manufacturing process are maintained.
Following the above norms will ensure a productive outcome for surgical textiles which will help in maintaining the best of sterile environment for the safety of patients and surgical teams.