ReadyMax®, Inc., a manufacturer and distributor of medical, hearing and vision PPE products, receives FDA registration to import medical devices.
SPARKS, NEVADA, USA, July 22, 2020 /EINPresswire.com/ — ReadyMax®, Inc. has received an FDA Medical Device Initial Importer registration for various personal protective equipment (“PPE”) products, including medical and surgical facemasks, face shields, surgical gowns, infrared thermometers, sterile gloves and other medical devices. The FDA registration allows ReadyMax® to import medical devices from foreign-based factories registered with the FDA. ReadyMax® is a developer, manufacturer and distributor of various PPE products including medical, hearing and vision devices and holds numerous international patents on products it has developed. ReadyMax® sells its products through US and international wholesale distributors and direct to government, hospital and institutional buyers.
Commenting on the new registration, ReadyMax® Sales and Marketing VP Chris Jelinek said, “We are very pleased to have received the FDA registration which allows us to expand our medical device product offering. Our broad range of PPE products provide head-to-toe protection in many applications including medical, commercial and industrial environments”. ReadyMax®, Inc. is a Sparks, Nevada-based developer, manufacturer, and distributor of Personal Protective Equipment. The company’s products include medical devices, and hearing, and vision protection, including its patented SoundShield® safety glasses with built-in retractable hearing protection. The company holds numerous international utility patents on products that protect workers in medical, construction, industrial and recreational activities.
To help prevent the spread of COVID-19, the CDC (Centers for Disease Control and Prevention), in addition to hygiene and social distancing, now recommends the wearing of a mask in public. This post will focus on the types of masks available.
Face masks come in an assortment of styles, there are three general types of masks:
Respirator Masks (N95, KN95, FFP2, and other designations)
Cloth masks can be made at home or purchased from a wide assortment of vendors. They can help lower the spread of disease from asymptomatic carriers. That means you. Cloth masks will help prevent you from spreading viruses to other people, they are not effective at preventing the spread of viruses to you. The masks should be cleaned after every use. Care should be taken when removing the masks to not touch you nose mouth or eyes. Please remember to wash you hands after removing the masks.
Surgical masks are disposable masks that come in a variety of different styles and grades. They are designed to cover your nose, mouth, and chin. A typical mask is a flat rectangle with folds, a metal strip across the top, and elastic bands to either loop behind the ears or head. The folds allow for the mask to comfortably expand from your nose over your chin. The metal strip is designed to form a better over the bridge of your nose. Surgical masks that are U.S. Food and Drug Administration (FDA) cleared conform among other things with synthetic blood fluid resistance, bacterial filtration efficiency (BFE) and flame resistance. Listed BFE ratings typically are from 90% to 98%. Masks may be non-Sterile or Sterile depending on the intended usage. In addition to fluid resistance, surgical masks provide the wearer with protection against large droplets, splashes, or sprays of bodily or other hazardous fluids. The masks also help prevent the wearer from spreading infection to others. Due to the loose-fitting nature of the masks, they do not provide the wearer from protection from inhaling smaller airborne particles.
Respirator Masks most frequently known as N95 Respirators or N95 Masks. N95 represents the testing and certification issued by the National Institute of Occupational Safety and Health (NIOSH). This respirator is designed to filter 95% of particles greater than .3 microns, including viruses and bacteria. (Other countries test and certify masks with similar standards. During the current Corona Virus emergency, the FDA has issued several Emergency Use Authorizations (EUA) allowing the usage of imported masks for medical needs. These designated masks include China KN95, EU FFP2, AS/NZ P2, Korea First Class and Japan DS FFR).
Surgical N95 Respirators also are cleared by the FDA. The difference between the two types of N95 Respirators is the fluid resistance required by the FDA. N95 Respirators come in a variety of styles some with valves and some without. Those with valves are not cleared by the FDA for use as surgical masks. They will protect the user; they do not protect others from the user. Also, there are higher ratings, these include N99 which block 99% of particles, and N100 which block 99.97% of particles. The most important feature of all N95 Respirators is that a tight fit is required to ensure proper level of protection. Each time a respirator is used the user should ensure a proper seal is created with the mask. It should be noted that beards and stubble can prevent the creation of a tight seal. If the Respirators are used in areas of high exposure, they should be discarded after each use. They should also be discarded if they no longer form effective seals, if the become dirty or wet, and if they are difficult to breathe through.
One other important note. Unless specifically certified, none of these masks provide protection from solids or aerosols that contain oil. Oil certified masks are designated with an R or a P. The R designation indicates resistance to oil. The P designation indicates oil proof. As an example, a P95 mask is one that is oil proof and filters at the 95% level.
Foreign object debris (F.O.D.) is any object, material or substance in a place that it is not supposed to be creating a condition that can cause damage to individuals or equipment. Foreign Object Damage (also FOD) is the damage caused by Foreign Object Debris. While the term ‘FOD’ is most closely associated with the Aerospace industry, it also is present in construction, electronics, environmental, manufacturing and transportation. From the FAA “As defined in AC 150/5210-24, Foreign Object Debris (FOD) Management, FOD is any object, live or not, located in an inappropriate location in the airport environment that has the capacity to injure airport or air carrier personnel and damage aircraft.”
Types of FOD
We’ve all seen litter on the freeway. Whether a bag, piece of tire or bottle, it all can cause damage or accidents and it all is FOD. If you have watched a NASCAR race, you’ve seen the tremendous effort by the cleanup crews to remove both debris and liquids from the track. That FOD can cause even more accidents.
In defining FOD the National Traffic Safety Board includes tools, rags, gloves, parts, pieces of broken equipment, paint chips, metal shavings, birds, and consumer products. Whether it is being ingested in to an engine, cutting a fuel tank, or blowing out a tire, items out of place can create a serious and potentially deadly situation.
The sources of FOD include personnel, the environment, airport infrastructure, support equipment, airplane parts, and other debris.
Effects of FOD
A tragic incident is the case of Air France 4590. While departing Charles de Gaulle International Airport the Concorde ran over a piece of titanium debris from a recently departed Continental DC-10, shredding a tire and slamming rubber debris into the plane’s fuel tank. The subsequent leak and fire caused the plane to crash, killing 109 people in the plane and four people on the ground.
Beyond the rare tragic incidents, the effects on airline industry are huge. The FAA requires the absence of FOD within contained spaces in the fuselage. Inadvertent depositing of materials can cause expensive rework to equipment, slowing down construction and the production lines of manufacturers. In active duty aircraft FOD causes accidents and damage resulting in significant rework or replacement. Whether it is items ingested in to engines or broken equipment that damages tires, these pose potential safety issues and are scrupulously monitored by airlines.
Costs of FOD
The replacement cost of a single 737 engine is in the $6-7 million range. Most of the damage occurs on runways, taxiways and aprons. Lighter damage can lead to flight delays. More serious issues will keep planes out of service and in need of more expensive repair and rework. A plane out of service has large downstream effects including lost productivity from flight delays, missed connections and canceled flights. The FAA estimates that the total costs of FOD to the airline industry exceed $4 billion annually.
On aircraft carriers, prior to beginning flight operations, crews regularly do a shoulder to shoulder sweep of the flight deck to remove all debris. With safety and reliability at a premium, they ensure that FOD is eliminated. Military and civilian ground crews regularly check and remove FOD from runways, taxiways and aprons.
There are measures that can be taken to reduce if not eliminate FOD. Training should engrain in workers awareness and attention to FOD. When working in an area keep track of tools, parts, PPE and waste materials. Tethering gear and equipment helps to keep it organized and prevent FOD. Create checklists of items and verify that all items are accounted for. Signage should be prominently placed in critical areas so that the awareness is reinforced. See an issue, correct and/or report it.