Personal Protective Equipment (PPE) are indispensable medical devices as they required to protect health workers and medical practitioners handling patients who are suspected or confirmed as infected with COVID-19 or other such contagious viruses. As such the Indonesian Ministry of Health has issued a Standards book regarding Personal Protective Equipment in Indonesia.
Reflecting the importance of Personal Protective Equipment in Indonesia, the Indonesian Ministry of Health (MoH) Directorate General of Pharmaceutical and Medical Devices has compiled a Personal Protective Equipment Standard Book in Management of Handling COVID-19. This standards book is expected to be a reference for manufacturers in producing Personal Protective Equipment in Indonesia. This book provides information about the different types of PPE used in handling COVID-19 such as:
- Medical/Surgical mask,
- Respirator N95,
- Face Shield,
- Examination Gloves,
- Surgical Gloves,
- Medical Coverall,
- Heavy Duty Apron,
- Waterproof Boots,
- Shoe Cover.
The book also describes the specifications that must be met so that the PPE produced is safe, meets quality standards, and fits the purpose of use as Personal Protective Equipment in Indonesia. This PPE Standard Book can be downloaded here.
Taking the example of Surgical Masks, the standards book states:
- The use of surgical masks is to protect users from airborne particles, droplets, fluid viruses or bacteria
- The frequency of use is single use
- Material for manufacturing surgical masks should be Non-woven Spunbond Meltblown Spunbond (SMS) or Non-woven Spunbond Meltblown Meltblown Spunbond (SMMS)
- Surgical masks are not recommended for direct management of patients confirmed by COVID-19.
- The mask must withstand the penetration of fluids, blood, and droplets.
- The inside and outside of the mask must be easily and clearly identified.
- Mask should have loose fitting on the face
- Masks must be designed so that they are not damaged by the wearer’s mouth
- Has a 98% bacterial filtration efficiency.
- The user can breathe well whilst wearing it (Differential Pressure/ΔP <5.0 mmH2O/cm2).
- The mask has passed the following tests: Bacteria Filtration Efficiency in vitro (BFE), Particle Filtration Efficiency, Breathing Resistance, Splash Resistance, and Flammability tests.
If you have any queries regarding Personal Protective Equipment in Indonesia or our services for medical device registration and representation in Indonesia, please contact us at firstname.lastname@example.org.