Quality Requirements For
Medical Textiles, PPES / Face Masks

As per a notification released by MoH &FW vide S.O. 648(E), PPE kits are considered as a medical device, in pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). CDSCO notification dated 03 Sep 2020 listed out 24 devices as Personal Protective Equipment’s.

Some examples of PPE include :

• Face shield,

• Face Mask (Disposable, Surgical, N95),

• Gowns (surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns)

• Gloves (Latex surgical gloves, Non-latex surgical gloves, Nitrile gloves, Examination gloves)

With the increase in the demand for PPEs, it is necessary that manufacturers lay adequate emphasis on the selection of raw materials as the quality of finished device is heavily dependent on these raw materials.

Although PPEs are used for personal protection, they themselves may cause adverse reactions. Adverse reactions that are commonly reported are acne, skin rash and contact dermatitis which may arise from some components (adhesives, rubber straps or metal clips) of the N95 mask. Skin reactions to gloves included complaints of dry skin, itch, and rash. Type I immunoglobulin Emediated natural rubber latex hypersensitivity is an important, often undiagnosed, occupational health hazard for healthcare workers, especially in those with high exposure.

Biocompatibility tests (ISO 10993) for PPE / Medical Textiles

One of the quality parameters that certify a medical device as safe is its property of being biocompatible.

Biocompatibility tests are recommended for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. US FDA Guidance document issued on 04 September 2020 states that the term “human body” refers to either patient tissues or the clinical practitioner. Therefore "masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility."

Testing for biocompatibility considerations should be performed on the device in its final and finished form.

As per ISO 10993-1:2018, majority of PPE devices are classified as Surface Contacting Devices with contact duration lesser than 24 hours. Below is a snapshot of the testing requirements for surface (Skin, Mucous membrane, Breached/compromised surfaces) contacting medical devices based on their contact surface and the following biocompatibility tests are usually recommended for PPEs. The principle behind each of these tests and the results they produce is briefly discussed below:

• Cytotoxicity test (ISO 10993-5:2009)
• Irritation/ Intracutaneous reactivity test (ISO 10993-10:2010)
• Sensitization test (ISO 10993-10:2010)

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