LAUNCH OF THE COVID HELP NETWORK: PURCHASING PLATFORM FOR MEDICAL SUPPLIES FOR GOVERNORS, HEALTH CARE CENTER.
What is the COVID Help Network?
As a global manufacturer and distributor of medical supplies and a distributor of pharmaceuticals, COVID HELP NETWORK is an essential link in the healthcare supply chain. Their mission is now more important than ever as they work to quickly obtain critical medicines and supplies, particularly Non-PPE Personal Protective Equipment (PPE) and related products, from their healthcare provider customers who need them .
Press Secretary James Nash, responded in correspondence:
“The COVID Help Network intends to meet the demands of healthcare providers by implementing a universal healthcare platform for medical supplies. This last week Andrew Cuomo commented on the “bidding” between states for vital medical equipment like ventilators. Is this a direct response to the issue raised by the governor?
Does your platform intend to solve the problem [above] or help reduce the impact of the outbreak? I.e. What are your expectations for this platforms impact?” I (Mahim Gupta) asked in response to recent events before the platforms launch in late March.
“To get lifesaving equipment and supplies into the hands of the medical professionals who need them, all levels of government and the business community must step up. The COVID Help Network is one link in that chain. A coordinated federal-state approach to procurement and distribution is another.” James Nash, NGA Communcations Press Secretary, stated.
The Help Network are actively collaborating with suppliers to understand and manage the impact of the pandemic on product supply. They are partnering closely with business groups to respond to challenges across the industry. And They are engaging with customers, leading experts, and government officials to help deliver products where they are urgently needed. Connecting states, their health departments and healthcare facilities with medical device companies and non-medical manufacturers willing to modernize their operations to provide emergency supplies to frontline healthcare workers.
Covid Help Network Verified Twitter:
Their main objective is to protect the health of those who use and benefit from the products The Help Network regulates. The Help Network evaluates information about a product, including relevant research, to assess the benefit / risk profile. The benefits of using a health product should always outweigh the potential risks. Their scientific, clinical and legal experience forms the basis for regulatory actions and decisions. These are also reported by a number of independently appointed national scientific experts who are part of our Advisory Committees.
The legislation differs in each of the areas that The Help Network regulate. This means that their regulatory function is not the same for each product and The Help Network is involved in different stages of the product life cycle. For most products under their mandate, The Help Network is responsible for checking their safety and quality once in use and on the market. For other products, mainly medicines, they also participate in their evaluation before they are commercialized. In addition, they conduct compliance inspections of manufacturers, distributors, and other health product facilities.
The Help Network operate national reporting systems to monitor the products they regulate. This allows anyone who experiences or has knowledge of a safety, quality or effectiveness problem to report it directly to us. Each individual report is expertly reviewed and considered as part of their ongoing product benefit / risk assessment.
The Help Network actively participate at European and global level for all products under their mandate. This also gives us access to the latest product information and safety signs across the ever-evolving healthcare product sector. The COVID HELP NETWORK experts are key contributors to a variety of major regulatory committees and working groups, both here and internationally.
The Help Network seek to ensure that those who manufacture and market health products do so in accordance with legislation. The Help Network inspect the sites and investigate possible violations of the law. When necessary, in the interest of public health, The Help Network take appropriate corrective measures, including legal procedures.
Information and transparency.
COVID HELP NETWORK is committed to providing an effective and efficient regulatory framework that is open and transparent without bias towards any special interest. Such transparency guarantees trust in the quality and independence of their decision-making among all of their stakeholders, including the public, healthcare professionals, government and industry.
- Conflict of interest policy
- Code of conduct
- Privacy notice for the Authority and committee members and experts.
- Declarations of Interest
These provisions are administered by COVID HELP NETWORK in accordance with Irish and international best practice. They provide assurances to governments, patients, and the public they serve that there are no potential conflicts of interest regarding the performance of their regulatory functions, while allowing COVIDHELP NETWORK to have access to the best experts available scientists. Annual disclosures extend not only to the interests of these individuals but also to members of their households.
By understanding the critical need to protect frontline healthcare workers as they care for patients around the world, they are doing everything they can to effectively manage and maintain the supply of EPP products, as well as products without PPE that have potential for increased demand. This is an evolving situation, and they are working closely with the Centers for Disease Control and Prevention to optimize their national network, prioritizing identified “hotspots” in the United States.
The Covid Help Network is managing the manufacturing and distribution of critical inventory for more than 100,000 medical products in unprecedented demand. The COVID-19 pandemic is creating challenges for the entire industry, including expected delays in inventory replenishment for certain products. They are experiencing pending orders and declining inventory levels for certain medical products at rates never experienced before. As a result, customers may experience partial shipments and backorders, and in some cases, products will be out of stock. Local COVID HELP NETWORK representatives will continue to keep customers informed of inventory of specific facilities.
Pharmaceutical distribution and supply
COVID HELP NETWORK is partnering with their suppliers to continually monitor the supply chain implications for products used to treat coronavirus, including pharmaceuticals (brand and generic), seasonal cough, and over-the-counter products for the cold and flu.
Their partners have actively collaborated with pharmaceutical suppliers to understand current and future product supply. Many of their suppliers have confirmed that they are worth several months of Active Pharmaceutical Ingredient (API), used to manufacture their pharmaceuticals and finished dose safety stocks.
As the COVID – 19 situation progresses, they are continually evaluating to determine how they can better manage their inventory. With that, they are balancing urgent needs requests in certain areas of the country while continuing to allocate products to meet existing demand.
How does the Covid Help Network prepare for the unexpected?
They take seriously the important role they play in delivering products and medicines from suppliers to customers. The National Logistics Center is a recognized first-class model for effective and efficient delivery for both suppliers and customers. However, if necessary, they have contingency plans for all of their distribution centers in their network to provide continuous product delivery.
they are working closely with supply chain partners and the federal government, including the Department of Health and Human Services and the Federal Emergency Management Agency, to obtain information, optimize their response, and identify additional sources of critical products. they are also an active founding partner in an industry-wide coalition that is working with FEMA to address supply shortages as quickly as possible.
A primary focus of the joint efforts with the Department of Defense and the Defense Logistics Agency is to accelerate the flow of urgently needed PPE to their serving men and women around the world.
Keeping their employees safe
Protecting the health and safety of their employees and their families is vital. Because they are part of a critical infrastructure industry, their employees report to work daily in distribution centers, supply chain operations, manufacturing sites, pharmacies, and other clinical sites. Their efforts are essential to the health system.
To prevent the spread of COVID-19 and protect the safety of critical front-line employees working at these sites, all facilities are regularly thoroughly cleaned, and they have implemented workplace hygiene practices in accordance with the Centers for Disease Control and Prevention and Global Health Organizational Guidelines. To recognize the important contributions made by these front-line employees, who truly live the mission of COVID HELP NETWORK, we are providing a special incentive to those who must report to a facility to work.
All employees who can work remotely work from home. They have significantly expanded their technology infrastructure to help their employees around the world perform their tasks and continue to support customers, patients, and their front-line associates.
All non-essential travel has been prohibited since the start of the quarantine, and access to their facilities by visitors and external providers has been severely restricted. They also implement policies to ensure that employees who are ill or who have been exposed to COVID-19 are able to take time off, which does not affect their paid days off during the year.
The Heads of Medicines Agencies (HMA) is a network of Heads of Competent National Authorities (NCAs) whose organizations are responsible for the regulation of medicines for human and veterinary use in the European Economic Area. The HMA cooperates with the European Medicines Agency (EMA) and the European Commission in the operation of the European Medicines Regulatory Network and is a unique model for cooperation and shared work in legal and voluntary regulatory activities.
In vitro diagnostic tests
In vitro diagnostics are tests performed on samples taken from the human body, such as samples of mucus from the inside of the nose or the back of the throat, or blood taken from a finger prick or drawn by a phlebotomist. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s general health to help heal, treat, or prevent disease. Patients, like their physicians, depend on COVID HELP NETWORK to ensure that the in vitro diagnoses they use to make medical decisions are accurate, reliable, and clinically meaningful.
On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that there are circumstances that justify the authorization of emergency use of in vitro diagnostics for the detection and / or diagnosis of the new coronavirus. Rapid detection of COVID-19 cases in the United States requires the wide availability of diagnostic tests to monitor the occurrence of this serious and rapidly spreading disease.
Personal Protective Equipment (PPE)
Personal Protective Equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, face masks, respirators, and other equipment designed to protect the user from injury or help prevent exposure to infection or disease.
PPE is commonly used in healthcare settings such as hospitals, doctor’s offices, and clinical laboratories, as well as in veterinary hospitals, food production facilities, and food service settings. When used properly, EPP acts as a barrier between infectious materials (such as viral and bacterial contaminants) and your skin, mouth, nose, or eyes (mucous membranes). The barrier provided by PPE has the potential to block the transmission of contaminants from the blood, body fluids, or respiratory secretions when used properly.
PPE can also protect patients who are at high risk of infection through a surgical procedure or who have a medical condition, such as immunodeficiency, from exposure to substances or potentially infectious material brought in by visitors and workers of health.
When used appropriately and with other infection control practices, such as washing hands, using alcohol-based hand sanitizers, and covering coughs and sneezes, PPE minimizes the spread of infection from one person to another. The effective use of PPE includes the proper disposal and disposal of contaminated PPE to avoid exposing both the user and others to infection.
Ventilators and fans
A continuous ventilator is a device intended to mechanically control or assist the patient’s breathing by delivering a predetermined percentage of oxygen in the breathing gas.
The FDA recognizes that the need for ventilators, ventilation accessories, and other respiratory devices may exceed the supply available to health care facilities during the COVID-19 pandemic. Also, this body released a new guide that allows more manufacturers to manufacture fans at this time. The agency is allowing modification of the device and the use of fans for other environments.
- High-acuity, invasive, portable, battery-powered fans
- Sample Models: Puritan Bennett 840, Viasys Avea, Drager Evita, GEinvent, Maquet Servo-I, Hamilton G5, GE Carescape
Nasal swab for covid-19 test kits
Here you can find a Nasal Swab Guide for COVID-19 Test Kits. The tip of the flocked swab should be synthetic fiber (dacron or rayon) and appropriate size for a nasal cavity (OP is too large). The shaft must be narrow and made of flexible plastic. The shaft should have a properly distal breakpoint from the tip of the swab to prevent breakage in the nasal cavity.
Personal protection equipment
There are two types of respirators that are appropriate for healthcare workers in close contact with COVID-19 patients: 1) N95 respirators; and 2) N95 surgical respirators. N95 surgical respirators are the appropriate device in the healthcare setting when protection against aerosols and barriers (i.e., splashes or sterile fields) is required and must be approved by both NIOSH and FFR (42 CFR Part 84) and FDA as a device Class II physician (21 CFR 878.4040).
FDA tests: fluid resistance (ASTM F1862), flammability and biocompatibility. N95 respirators (NIOSH approved under 42 CFR Part 84) are appropriate for healthcare settings where only protection from patient-generated aerosols is required. KN-95 must meet NIOSH and / or EU standards and be CE certified.
Medical (surgical) masks
Surgical masks must be approved by the FDA under 21 CFR 878.4040 as class II medical devices.
- Manufacturing Standard: ASTM F2100 – 19 Standard
- ASTM F2100 Level 1 Standards for Material Quality Apply in Hospital / ICU Settings
- Fluid resistance with synthetic blood: 80 mmHg
- Differential pressure: <4.0mmH2O
- Bacterial Filtration Efficiency (BFE)%: ≥95%
- Submicron Particle Adjustment (PFE)
- Flammability: class 1
Disposable non-sterile patient examination gloves are appropriate for the care of patients with COVID-19.
- FDA Regulated: FDA21 CFR 880.6250 (Patient Exam Glove Powder Free)
- Manufacturing Standard: ASTM D6319 for Powder Free Nitrile Gloves, ASTM D3578 for Powder Free Latex Gloves
Disposable (medical) gowns with elastic wrists
Disposable non-sterile patient isolation gowns are appropriate for the care of patients with COVID-19. Four defined levels of protection tested to comply with ANSI / AAMI PB70:
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, a visitor’s gown, or in a standard medical unit;
- Level 2: Low risk, to be used, for example, during the extraction of blood, sutures, in the Intensive Care Unit (ICU) or in a pathology laboratory;
- Level 3: Moderate risk, to be used, for example, during arterial blood collection, intravenous (IV) line insertion, in the emergency room, or in cases of trauma;
- Level 4: High risk, to be used, for example, during long and intense procedures in liquids, surgery, when resistance to pathogens is needed or infectious diseases (not airborne) are suspected.Una bata quirúrgica está regulada por la FDA como un dispositivo médico de Clase II que requiere una notificación previa a la comercialización 510 (k). Las batas quirúrgicas se pueden usar para cualquier nivel de riesgo (niveles 1-4).
Eye / face protectors
Must comply with ANSI Z87.1 for splash protection
Must comply with ANSI Z87.1 for splash protection
Biohazard bag (regulated waste)
Must meet DOH requirements for Regulated Medical Waste Collection (RMW) under Title 10, Part 70-2.2
Red plastic bag, of sufficient strength
Must meet DOT requirements for RMW transportation under 49 CFR 173.197 (e). Cannot exceed 46 gallon volume, must pass prescribed tests for tear and impact resistance under ASTM D 1922 and ASTM D 1709 respectively. It must meet a tear resistance of 480 grams in parallel and perpendicular planes with respect to the length of the bag and an impact resistance of 165 grams.
- Must meet OSHA requirements under 29 CFR 1910.1030 (g) (1) (i)
- Marked with a biohazard symbol
Needle Disposal Safe (Sharps)
OSHA’s minimum requirements for sharps containers include:
- Puncture resistant;
- Leak proof on the side and bottom; Y
- Labeling (biohazard) or color-coded (red) according to the standard.
The FDA regulates the production of a sharps container as a Class II medical device that requires 510 (k) premarket notification. Sharps containers must meet DOH requirements for RMW collection under Title 10, Part 70-2.2. Marked with a biohazard symbol, rigid, leak-proof, puncture-resistant, and closable (same as OSHA). Must meet DOT requirements for the transportation of sharp objects under 49 CFR 173.134 (c) (2) (x)
Securely closed to prevent leaks or punctures, less than 18 gallons in capacity when transported on a wheeled rack, and is made of puncture resistant plastic that meets ASTM F2132-01.
Who runs or sponsors COVID HELP NETWORK?
The data handler is COVID HELP NETWORK unless otherwise specified. The data protection officer can be contacted on his website. COVID HELP NETWORK processes personal data in the performance of their regulatory functions to protect and improve animal and public health through the evaluation of the safety, quality and efficacy of health care products. Personal data is processed by HPRA employees, who will ensure the confidentiality of the data.
The legal basis for the processing is that it is necessary for the performance of a task carried out in the public interest or in the exercise of the official authority conferred on the COVID HELP NETWORK and that it is necessary for reasons of public interest in the area of public health. Some processing may take place as it is necessary to fulfill a legal obligation to which the support network is subject. You can find a list of the relevant legislation describing their responsibilities on the website.
Any personal information you provide is made available to other regulatory bodies in Europe, the United States and third countries when necessary to fulfill their regulatory functions. Personal information may also be shared with a third party when you make an online payment to COVID HELP NETWORK.
Regarding the reporting of safety and quality concerns, specific information about who the data is shared and transferred to can be found in the privacy notices for each type of report. All personal data related to their regulatory functions is retained indefinitely.
COVID HELP NETWORK fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality, strictly in accordance with the General Data Protection Regulation 2016/679.
Personal data is only processed for secondary purposes under the following conditions:
- Secondary use is related to the original reason the data was collected and / or is part of the regulatory functions of the HPRA.
- The data is not sensitive personal data.
- The processing of personal data is unlikely to cause harm or distress to the data subject.
- There are no consequences for data subjects after further processing.
- There are safeguards to guarantee the confidentiality and integrity of the data.
What are your rights under the data protection law?
- The COVID HELP NETWORK grants you the following rights regarding the processing of your personal data
- The right to request access to your data
- The right to request that your data be rectified or deleted
- The right to oppose the processing or request the processing of your data will be restricted.
- The right to data portability
- The right to file a complaint with the Data Protection Commissioner.
- COVID HELP NETWORK uses profiling for recruitment purposes.
National brand associations
The Covid Help Network works with many other manufacturers to distribute the critical products they produce. They are in constant communication with these national brand providers who are experiencing many of the same challenges that they are experiencing right now. Like us, these suppliers are expanding their production capabilities to help address customer needs.
COVID HELP NETWORK is a distributor of N95 masks, but is not a manufacturer of N95 masks. Given the shortage of N95 masks, COVID HELP NETWORK is working with a network of industry partners and the federal government to identify additional sources. And, in close collaboration with leading industrial manufacturers of N95, they are distributing options for N95 industrial masks, which the FDA recently licensed for use in healthcare settings. Given the great need for N95 and the limited historical use of these industrial masks on their channel, they are taking advantage of FEMA and federal government recommendations to distribute these masks to critical points in the US. USA For reference, this is a useful resource on how to optimize the N95s.
Who runs the platform?
NGA is taking preventative measures to keep their nation healthy and has implemented guidance from the Center for Disease Control and the Department of Defense regarding social distancing and travel restrictions. Over the next few weeks, all in-person site visits are canceled. If you were scheduled for an on-site visit, their scheduling team should have contacted you to cancel. When appropriate, they will contact you to reschedule the appointment.
Patient Safety Movement Mission: https://patientsafetymovement.org/
This organization is focused on eliminating preventable harm and death in healthcare around the world by creating a sense of urgency and unifying humanity.
- Prioritize safety with patients at the center.
- Promote dignity, compassion and respect in health care.
- Align everyone who influences or is touched by health care.
- Promoting transparency
- Realign incentives for safer care
- Inform caregivers, patients, and families about patient safety.
- Identify preventable causes of patient harm and death, and then freely create and share actionable solutions (Actionable Patient Safety Solutions) to mitigate them.
- Promote the implementation of actionable patient safety solutions (APSS)
The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC that provides educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice of medical technology innovation, playing a proactive role in helping to shape policies that impact the ecosystem. This is accomplished by working with key members of Congress, senior staff from the FDA, CMS, and other agencies, and through grassroots support from their members.
Today, Masimo is publicly traded and employs more than 4,600 people worldwide, with annual revenues of approximately $ 800 million. The license agreements allow Masimo technology to work within monitoring devices from a large number of manufacturers, including Philips, Atom, Mindray North America, GE Medical, Spacelabs, and Zoll. Throughout his journey of more than 25 years, Masimo’s mission – to improve patient outcomes and reduce the cost of care – has remained strong.