Thursday, July 16, 2020

Considering The Importance Of PPE In Healthcare


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.
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.

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

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 
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Friday, July 10, 2020

Study About Utilization Of Medical Disposable Urine Bags


The medical disposable urine bags or the urine collection device or (UCD) is a device that permits the assortment of urine for examination (as in clinical or criminological urinalysis) or for motivations behind basic end (as in vehicles occupied with long journeys and not furnished with restrooms, especially airplane and rocket). The medical disposable urine bags of the last kind are now and then called piddle packs.
Similar devices are utilized, basically by men, to oversee urinary incontinence. These medical disposable urine bags otherwise called urisheaths or Texas/condom catheters, urinals and hydrocolloid-based gadgets’ clinical dispensable pee packs are joined to the outside of the penile territory and direct pee into a different assortment chamber, for example, a leg or bedside sack. There are a few assortments of outside pee assortment gadgets available today including. 
Reusable products are sheltered to utilize in any event, during the Coronavirus pandemic as long as fundamental cleanliness rehearses are utilized. Single-utilize or disposable products are not inalienably more secure than reusable products as the infection can stay irresistible on the two surfaces for differing time. Either devices or products like reusable or expendable, they can be cleaned with the generally utilized family unit disinfectants, for example, soap and cleanser.
Uncommon UCDs medical disposable urine bags or exists for the assortment of urine tests for ensuing urinalysis. They go from a straightforward plastic cup to expand devices intended to gather explicit volumes or kinds of urine samples at different focuses in the development procedure.

  • Medical disposable urine bags

Penile external catheters /urisheaths combined with medical disposable urine bags are preferred over absorbent products – in particular when it comes to ‘limitations to daily activities. Advantages also include discretion, less water retention at the skin surface, and the potential for 24 hour use.

  • Covid-19 on Medical Disposable Urine Bags

Concern over virus transmission has prodded utilization of single-use plastic products internationally, including individual defensive apparatus, clinical gear and conveyance bundling. The resurgence in the utilization of disposable materials will have negative effect on the earth and sabotage years-long worldwide endeavours to check plastic contamination.

  • Synopsis on Medical Disposable Urine Bags and urine collection device (UCD)

A typical UCD consists of a small container with a dehydrated sponge inside, connected to a tube which in turn is connected to a funnel-like orifice that is adapted to the user’s anatomy.
The user simply holds the funnel near or on their urethral opening and urinates into the tube, with the collected urine saturating the sponge (which may be impregnated with disinfectants and odor-control substances) and filling the container. UCDs are designed to be used in cramped quarters without requiring that the user rise from his seated position in the cockpit. In most cases, the user wears special clothing that can easily be opened to permit use of the UCD.
Apparently, one way life will be different now is the use of disposable urinals. With people looking for ways to avoid public bathrooms, companies that sell disposable pee bags have seen an increase in sales recently. As people look for ways to avoid crowds and germs, some have turned to disposable urinal bags as a way to use the bathroom on the go. The products often use chemicals that turn liquid into an odourless solid that can be stashed and later thrown away.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com


If  You Want Medical Devices Services Consultation For Following.

    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 

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Thursday, July 9, 2020

CDSCO Registration: Wholesale and Manufacturing License

Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India. Every nation in the world has its own dedicated governing body under the ministry of health to look after every aspect of pharmaceutical and medical devices. 

CDSCO Roles

  • Approval of new drugs and clinical trials.
  • Import CDSCO registration & licensing.
  • Licensing of blood banks, vaccines and some medical devices.
  • Amendment to Drugs & Cosmetics Act and rules.
  • Participation in WHO GMP certification schemes.
  • Grant to test license, personal license, NOC’s for export.
  • Testing of drugs by central labs

How Operon Strategist Assist you in CDSCO Application process?

When it comes to CDSCO medical device license process, Operon Strategist is a medical device consulting company. We are makes the lengthy process easy and smooth with the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure. Extensive experience in Regulatory consulting, medical device certification makes Operon strategist best regulatory Consultant. Contact us for all types of medical device consulting services and we will be always there to assist you.

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1.Orthopedic Implants Manufacturing

2.Dental Implants Manufacturing

3.Blood Collection Tubes Manufacturing

4. How to start the Manufacturing of Disposable Syringes?

5. disposable syringe manufacturers

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

  1. Medical Device Consulting 
  2. cdsco registration 
  3. FDA 510k Clearance 
  4. ce mark medical device 
  5. CDSCO Manufacturing License 
  6. CDSCO import license 
  7. TURNKEY PROJECT CONSULTANT 
  8. medical device manufacturing 
  9. iso 15378 certification 
  10. 21 cfr part 210 and 211 
  11. ISO 13485 Medical Device Consultant 
  12. Primary Packaging Turnkey Project Consultant 
  13. Clean Room Design Consultant 
  14. manufacturing site conceptualization 
  15. Market Analysis and feasibility for Medical Devices 
  16. manufacturing plant layout design 
  17. medical device design and development 
  18. DMF file submission guideline 
  19. 21 cfr part 820 
  20. qms certification services 
  21. capa management 
  22. design control requirements 
  23. medical device process validation 
  24. combination product 
  25. continuous improvement program 
  26. Medical Device Compliance & Regulatory Services 
  27. Cdsco India authorized agent for medical device  
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CDSCO Import License for Medical Devices In India

  Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vi...