Importance of ppe in healthcare COVID-19 pandemic has taken a critical health and financial cost for the population. As we became familiar with the sickness and how it spreads, reports began rising of healthcare workers getting contaminated.
We were additionally shown the importance of PPE in healthcare in safe-guarding our frontline healthcare workers. A PPE comprises of a body-protection suit, gloves, facemask, eye goggles, hair cover, and foot cover. PPEs in the past were called Hazmat suits and utilized in careful cases with HIV-positive patients and such cases. With the coming of HIV treatment, the cases got less, and consequently the utilization of PPE was not frequent. With the COVID-19 pandemic, PPE has come in the bleeding edge, and it has picked up significance more than ever.
- We provide regulatory consulting for medical devices manufacturing.
- We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.
FDA 510 k Clearance & Premarket Approval for Medical Device
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.
Hospitals now have to ensure that all healthcare personnel coming in direct contact with patients, even in non-COVID-treating centres use PPE; albeit they come in contact with the asymptomatic patients and require quarantine for 14 days or worse if they contract the disease. If proper PPE precautions are not taken then multiple staff members may be required to be quarantined and in some cases the hospital maybe sealed – a trend we have seen across the country.
As we realized what importance of PPE in healthcare PPE is, and its prevention of the disease, there was a sudden global increase in demand for its use across the board, especially for healthcare workers. The national lockdown created logistical issues and some manufacturers faced challenges in transporting the PPEs. Around the same time, the government banned export of PPEs as Indian healthcare workers were grappling with the shortage.
The exponential worldwide demand and inability for the importance of PPE in healthcare equipment manufacturing industry to meet this surge was seen as a business opportunity, and many unscrupulous manufacturers and distributors started reaching out to health institutions offering these kits at exorbitant prices. Masks that were previously available for as low as one rupee are being marketed at many times that cost. Given the urgent need and very short supply, hospitals are left with no choice but to pay over-inflated prices for acquiring them. Though hospitals in a state of urgency are acquiring these kits, the quality of these kits is questionable as they might not be following the BIS standards.
However, as the pandemic continues to progress, a lot of renowned companies from multiple industries have stepped in to help deal with the shortage. These are non-traditional health equipment manufacturers but, given their infrastructure and historical commitment to quality, they can be better trusted with producing quality sanitizers, gloves, masks, PPE, etc., to help with the shortage.
Healthcare personnel in India face a dire situation in dealing with the Covid-19 pandemic with a shortage of quality personal protective equipment (PPE) looming as Indian manufacturers say they don’t know what to produce in the absence of health ministry specifications for them.
Importance of PPE in healthcare
Personal protective equipment (PPE) helps prevent the spread of germs in the hospital. This can protect people and health care workers from infections. All hospital staff, patients, and visitors should use PPE when there will be contact with blood or other bodily fluids.
PPE also helps to protect those at a high risk of contracting infections, such as those with a medical condition, for example immunodeficiency, from being exposed to potentially infectious materials brought in by staff or visitors. All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA\’s regulations and should meet applicable voluntary consensus standards for protection. This includes surgical masks, N95 respirators, medical gloves, and gowns.
The consensus standards and the FDA\’s requirements vary depending on the specific on of Importance of PPE in healthcare. When these standards and regulations are followed, they provide reasonable assurance that the device is safe and effective.
Shortage of proper protection equipment has been one of the reasons for infections among health workers. There have been sporadic reports of doctors/nurses testing positive in India too, increasing the sense of insecurity among medical personnel, many of whom took to social media to talk about the shortage of protective gear. When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes). The barrier has the potential to block transmission of contaminants from blood, body fluids, or respiratory secretions. Though it is encouraging to see everyone stepping in and doing their bit in this time of national crisis, the cost of gloves, masks, and other components of the PPE is still very high.
