Frequently Asked Questions

Answers to some of our most commonly asked questions. We would also like to help clear up some of the confusion around Personal Protective Equipment (PPE) and its application towards combating COVID-19, so we’ve compiled a list of the most frequently asked questions with answers from leading health authorities such as the World Health Organization (WHO) and the Center for Disease Control (CDC). 

Payment and Shipping

Payment, Shipping, and Delivery

Payment:  For qualifying orders, we are currently accepting a combination of no less than 60% electronic bank transfer (T/T) down payment with no more than 40% Letter of Credit (LC) due to high demand and manufacturer requirements.    

Shipping: Prices listed on our website are ex-factory and do not include shipping. We do offer Cost, Insurance, Freight (CIF) and Free On Board (FOB) depending on customer requirements. Click here for more information on the difference between CIF and FOB.

Delivery Times: Please allow 4 days for processing and 7 days for shipment. 

Ventilators: Of the 7 models we carry, we can supply at least 200 units of each every 30 days. Please contact us for the latest updates regarding current stock and shipping schedules: info@tatrixmedical.com

Government Customers and Bulk Orders

We are working closely with governments around the world to deliver critical medical supplies. If you are here looking for equipment on behalf of a government entity or interested ordering in bulk, please send your details to

wholesale@tatrixmedical.com 

FDA vs CE

All of our products are CE approved for trade in the European Union and 90% are FDA approved for trade in the US. It is important to understand the distinction: 

Key Differences

The FDA approves every step of the process that is required for a medication or surgical device to be used clinically, and it bases its approvals on the outcomes of large clinical trials and strict clinical evidence and outcomes. FDA approval indicates that strict criteria have been met, and that clinical application of a drug or device will be safe and effective.

In the EU, by contrast, the CE Mark applies more to whether use of a surgical device is intrinsically safe for the surgeon, the surgical staff, and the patient. The CE Mark does not determine the safety and efficacy of every surgical procedure that is performed by the device; these factors are rather left to the responsibility of the physicians and surgeons who use the device.

At A Glance

• The CE Mark in the European Union and the FDA approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices.
• Despite the differences in the CE Mark and FDA approval systems, there are no more product recalls in Europe than in the United States.

More Information: 

CE Guidelines in the European Union 

FDA Guidelines in the United States

Ventilators

Invasive Ventilation

Invasive mechanical ventilation can become a lifesaving intervention tactic for  patients with respiratory and breathing difficulties. The term “invasive” is used if it involves any instrument penetrating via the mouth (such as an endotracheal tube), nose, or the skin (such as a tracheostomy tube through a stoma, a surgically-created hole in the windpipe) to serve as an artificial airway.1

The objectives of mechanical ventilation are primarily to provide oxygen, remove carbon dioxide, decrease the work of breathing and reverse life-threatening conditions such as hypoxemia, or insufficient oxygenation of arterial blood, and acute progressive respiratory acidosis, or build-up of carbon dioxide in the blood.1

There are two tubes used for invasive mechanical ventilation:

  • Standard endotracheal tube (ET) – inserted via the nose or mouth, the standard ET provides a secure airway when the balloon on the cuff is inflated and sealed, and is mostly used in adult patients with acute respiratory failure; pediatric patients can benefit from uncuffed ET.2
  • Tracheostomy tube –inserted via a stoma, a surgically-created opening in the trachea, the tracheostomy tube is used for patients who need long-term mechanical ventilation, and exists with cuffed and uncuffed options; cuffed tracheostomy tubes seals the airway to control mechanical ventilation, while deflated cuffs or cuffless tubes may be introduced when the patient is more stable.

Invasive ventilation may be used during acute respiratory failure, weaning and for chronic respiratory failure when non-invasive ventilation is impossible to manage correctly. It can also be used as a means to maintain a patient’s airway during a surgical procedure, such as intubation done in the ICU.

At Tatrix Medical, we provide both invasive and non-invasive ventilators. Our models use the latest technology for the most comfortable and effective therapy.  Discover our latest lineup of invasive ventilators.

References

  1. Tobin M. Advances in mechanical ventilation. N Engl J Medi 2001; 344:1986-1996. 
  2. Khine HH. et al. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia. Anesthesiology. 1997 Mar; 86(3):627-31.  
  3. Windisch, W. et al. Guidelines for Non-Invasive and Invasive Mechanical Ventilation for Treatment of Chronic Respiratory Failure. German Society for Pneumology (DGP): 640-652. 
Non-Invasive Ventilation

Noninvasive ventilation (NIV) supports the patient’s breathing without the need for intubation or a tracheotomy. NIV delivers effective therapy with less risk of infection and improved survival in patients with respiratory failure.

Noninvasive ventilation supports the patient by:

  • delivering the right inspiratory and expiratory pressures or tidal volumes to support their individual ventilatory demand
  • enhancing alveolar minute ventilation
  • recruiting collapsed alveoli

The benefits of noninvasive ventilation

Where possible, noninvasive ventilation is gaining acceptance around the world as the preferred choice of treatment over invasive ventilation. Suitable for patients in the hospital or the home, noninvasive ventilation:

Makes day-to-day activities easier. Effective NIV therapy can help patients use more of their lung capacity. This in turn decreases the work of breathing, making routine activities easier.

Helps alleviate a range of symptoms. Morning headaches, daytime fatigue and shortness of breath are just some of the daytime symptoms that may occur due to low levels of oxygen or accumulated carbon dioxide. By helping to normalize CO2 and O2 levels in the body, noninvasive ventilation therapy helps relieve symptoms over time to improve the patient’s quality of life.

May reduce time in hospital and prevent disease from worsening. Patients treated with noninvasive ventilation therapy tend to spend less time in the hospital. By ensuring adequate ventilation, NIV patients may be able to avoid respiratory failure. Often prescribed for in-home treatment, NIV therapy is both convenient and effective.

Respirators

What is a respirator?

A respirator is a personal protective device that is worn on the face or head and covers at least the nose and mouth. A respirator is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including infectious agents), gases or vapors. Respirators, including those intended for use in healthcare settings, are certified by the CDC/NIOSH.

KN95 vs N95 vs FFP2

At a Glance

In summary, the N95KN95, and FFP2 standards are basically all the same. They stop 95% of particles >0.3 microns in size. The N95 is the USA Code, KN95 is the Chinese code, and FFP2 is the EU code (this includes the UK)We do have one FFP3 model in our inventory, which has a slightly higher filtration rate of >98%.

Standards

The most commonly discussed respirator type is N95. This is an American standard managed by NIOSH – part of the Center for Disease Control (CDC).

Europe uses two different standards. The “filtering face piece” score (FFP) comes from EN standard 149:2001. Then EN 143 standard covers P1/P2/P3 ratings. Both standards are maintained by the European Committee for Standardization (CEN).

The KN95 (China GB2626-2006) standard is very similar to both N95 and FPP2 and has recently been approved by the Food and Drug Administration (FDA) for use in the U.S. market. 

For more details on each specification, you can read more here

Should I wear a respirator in public?

According to WHO:

  • If you are healthy, you only need to wear a mask if you are taking care of a person with suspected 2019-nCoV infection.
  • Wear a mask if you are coughing or sneezing.
  • Masks are effective only when used in combination with frequent hand-cleaning with alcohol-based hand rub or soap and water.
  • If you wear a mask, then you must know how to use it and dispose of it properly.

Most often, the spread of respiratory viruses from person-to-person happens among close contacts (within 6 feet). Recent studies indicate that people who are infected but do not have symptoms likely also play a role in the spread of COVID-19. CDC recommends everyday preventive actions to prevent the spread of respiratory viruses, such as avoiding people who are sick, avoiding touching your eyes or nose, and covering your cough or sneeze with a tissue. People who are sick should stay home and not go into crowded public places or visit people in hospitals. Workers who are sick should follow CDC guidelines and stay home when they are sick.

What makes N95 respirators different from surgical masks?
  • Infographic: Understanding the difference between surgical masks and N95 respiratorspdf icon
  • N95 respirators reduce the wearer’s exposure to airborne particles, from small particle aerosols to large droplets. N95 respirators are tight-fitting respirators that filter out at least 95% of particles in the air, including large and small particles.
  • Not everyone is able to wear a respirator due to medical conditions that may be made worse when breathing through a respirator. Before using a respirator or getting fit-tested, workers must have a medical evaluation to make sure that they are able to wear a respirator safely.
  • Achieving an adequate seal to the face is essential. United States regulations require that workers undergo an annual fit test and conduct a user seal check each time the respirator is used. Workers must pass a fit test to confirm a proper seal before using a respirator in the workplace.
  • When properly fitted and worn, minimal leakage occurs around edges of the respirator when the user inhales. This means almost all of the air is directed through the filter media.
  • Unlike NIOSH-approved N95s, facemasks are loose-fitting and provide only barrier protection against droplets, including large respiratory particles. No fit testing or seal check is necessary with facemasks. Most facemasks do not effectively filter small particles from the air and do not prevent leakage around the edge of the mask when the user inhales.
  • The role of facemasks is for patient source control, to prevent contamination of the surrounding area when a person coughs or sneezes.  Patients with confirmed or suspected COVID-19 should wear a facemask until they are isolated in a hospital or at home. The patient does not need to wear a facemask while isolated.
How can I tell if a respirator is NIOSH-approved?

The NIOSH approval number and approval label are key to identifying NIOSH-approved respirators. The  NIOSH approval label can be found on or within the packaging of the respirator or sometimes on the respirator itself. The required labeling of NIOSH-Approved N95 filtering facepiece respiratorspdf icon  includes the NIOSH name, the approval number, filter designations, lot number, and model number to be printed on the respirator. You can verify that your respirator approvals are valid by checking the NIOSH Certified Equipment List (CEL).

What do I do with an expired respirator?

In times of increased demand and decreased supply, consideration can be made to use N95 respirators past their intended shelf life. However, the potential exists that the respirator will not perform to the requirements for which it was certified. Over time, components such as the strap and nose bridge may degrade, which can affect the quality of the fit and seal. Prior to use of N95 respirators, the HCP should inspect the respirator and perform a seal check. Additionally, expired respirators may potentially no longer meet the certification requirements set by NIOSH. For further guidance, visit Release of Stockpiled N95 Filtering Facepiece Respirators Beyond the Manufacturer-Designated Shelf Life: Considerations for the COVID-19 Response.

Gloves

What type of glove is recommended to care for COVID-19 patients in healthcare settings?

Nonsterile disposable patient examination gloves, which are used for routine patient care in healthcare settings, are appropriate for the care of patients with suspected or confirmed COVID-19.

What standards should be considered when choosing gloves?

Standard specifications for nitrile gloves, natural rubber gloves, and polychloroprene gloves indicate higher minimum tensile strength and elongation requirements compared to vinyl gloves.1,2,3,4

1ASTM D6319-Standard Specification for Nitrile Examination Gloves for Medical Applications

2ASTM D3578 Standard Specification for Rubber Examination Gloves

3ASTM D5250 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

4ASTMD 6977 Standard Specification for Polychloroprene Examination Gloves for Medical Application

Is double gloving necessary when caring for COVID-19 patients?

CDC Guidance does not recommend double gloves when providing care to suspected or confirmed 2019-COVID patients.

How do I put on (don) and take off (doff) my gloves?

Gowns

What type of gown is recommended for with suspected or confirmed COVID-19?

Nonsterile, disposable patient isolation gowns, which are used for routine patient care in healthcare settings, are appropriate for use by patients with suspected or confirmed COVID-19.

What is the difference between gowns and coveralls?
  • CDC’s guidance for Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids provides additional comparisons between gowns and coveralls.
  • Gowns are easier to put on and, in particular, to take off. They are generally more familiar to healthcare workers and hence more likely to be used and removed correctly. These factors also facilitate training in their correct use.
  • Coveralls typically provide 360-degree protection because they are designed to cover the whole body, including the back and lower legs, and sometimes the head and feet as well. Surgical/isolation gowns do not provide continuous whole-body protection (e.g., they have possible openings in the back, and typically provide coverage to the mid-calf only).
  • The level of heat stress generated due to the added layer of clothing is also expected to be less for gowns when compared to coveralls due to several factors, such as the openings in the design of gowns and total area covered by the fabric.
How do I put on (don) and take off (doff) my gown?
  • Check to see if your facility has guidance on how to don and doff PPE.  The procedure to don and doff should be tailored to the specific type of PPE that you have available at your facility.
  • If your facility does not have specific guidance, the CDC has recommended sequences for donning and doffing of PPE.pdf icon
  • It is important for Health Care Providers (HCP) to perform hand hygiene before and after removing PPE. Hand hygiene should be performed by using alcohol-based hand sanitizer that contains 60-95% alcohol or washing hands with soap and water for at least 20 seconds. If hands are visibly soiled, soap and water should be used before returning to alcohol-based hand sanitizer.

If you did not find your answers in the above list, or want more information on any of the topics mentioned, please do not hesitate to reach out to us. We will get back to you within 24 hours.