Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious injury or death.
Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets. This is a voluntary action based on information obtained from post market surveillance.
Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.
https://www.sleepnetmasks.com/wp-content/uploads/2024/03/Sleepnet-Press-Release.svg00Leigh Annhttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngLeigh Ann2024-03-13 20:19:302024-05-17 15:16:03Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets due to Potential Interference with Certain Medical Implants
With a focus on customer satisfaction and patient well-being, our service team at Sleepnet is driven by a passion for improving patient care. Understanding the critical nature of our products, our dedicated team operates with precision, efficiency, and a patient-centric approach. Whether it’s routine maintenance, rapid responses to technical issues, or offering guidance, our dedicated service team is here to support patients, healthcare providers, and distributors in delivering the highest standards of care.
We take pride in offering personalized service, ensuring that every customer interaction is individual and meaningful. When you reach out to us, you will speak directly with a knowledgeable representative instead of an automated system. Our commitment to a personalized experience extends beyond a phone call. We ensure that when customers connect with us, they’re speaking to the same person who is familiar with their history and needs, eliminating the frustration of repeating steps with each interaction.
What sets our service team apart is our accessibility and expertise. Our team members possess a wealth of knowledge about Sleepnet products and parts, and this understanding allows us to provide informed answers to customers.
A key aspect of our service is the direct support we offer to hospitals and DMEs. From handling phone calls for new accounts to assisting with set-up, our team ensures a smooth onboarding process. Once a relationship is established, our customers gain direct access to a dedicated contact person, streamlining communication and providing a reliable point of contact.
Our commitment to comprehensive support extends beyond the basics. We assist customers with a variety of situations. In situations where queries require a more technical response, our team goes the extra mile by liaising with Sleepnet’s engineers to ensure accurate and detailed solutions. With a US-based team, our service, engineering, and manufacturing facilities all reside in the same building, making this possible. Whether it’s connecting hospitals with distributors, addressing patient queries, or offering guidance on product usage, our team is committed to going beyond expectations.
Sleepnet’s service team is not just a support function; they are a partner in ensuring that our customers receive the highest level of care, expertise, and personalized attention. To connect with a service representative, contact us or call 800.742.3646.
https://www.sleepnetmasks.com/wp-content/uploads/2024/02/Inside-Sleepnets-Service-Approach.jpg10801080Philippahttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngPhilippa2024-01-19 18:02:012024-04-18 17:04:26Inside Sleepnet’s Service Approach
Finding the right size CPAP mask is essential for effective sleep apnea treatment as well as comfort. Here’s a step-by-step guide to help you find the right size CPAP mask:
Consult Your Healthcare Provider: Before purchasing a CPAP mask, consult your healthcare provider, preferably a sleep specialist or a respiratory therapist. They can provide guidance based on your specific needs and facial features.
Use the Manufacturer’s Sizing Guide: CPAP mask manufacturers often provide sizing guides on their websites. These guides use the measurements you’ve taken to suggest the appropriate mask size. Compare your measurements to the guide and select the size that corresponds to your measurements. You can find Sleepnet’s mask size guides here.
Try On the Mask: If possible, visit a local durable medical equipment (DME) supplier or sleep clinic. They might have various mask sizes available for you to try on. Wear the mask and adjust the straps as if you were using it at home. This can give you a better sense of how comfortable the mask is and whether it fits properly.
Consider Different Styles: CPAP masks come in different styles, such as nasal masks, full-face masks, and nasal pillow masks. The right style for you depends on your breathing habits, comfort, and any specific requirements you have. Make sure to try different styles to see which one suits you best.
Check the Fit: A well-fitting CPAP mask should create a seal without causing discomfort or leaks. The mask should fit snugly but not too tight, and the cushion should seal comfortably around your nose or nose and mouth. It shouldn’t leave marks or cause pain.
Adjustable Masks: Some CPAP masks have adjustable features like headgear straps, forehead pads, and nasal cushion sizes. These can be beneficial for fine-tuning the fit.
Consider a Mask Fitting Service: Some CPAP suppliers offer mask fitting services where they assess your needs and help you choose the right mask size and style.
Trial Period: Many CPAP suppliers offer a trial period for masks, during which you can return or exchange the mask if it doesn’t work well for you. Take advantage of this trial to ensure the mask is comfortable and provides the right fit. Sleepnet has a 30-day Comfort Guarantee if you are not satisfied with your Sleepnet mask.
Remember that finding the right CPAP mask might take some trial and error. It’s crucial to find a mask that fits comfortably and effectively treats your sleep apnea. Regular follow-ups with your healthcare provider can help you adjust and optimize your CPAP therapy as needed.
https://www.sleepnetmasks.com/wp-content/uploads/2024/02/How-to-Find-the-Right-Size-CPAP-Mask.jpg10801080Philippahttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngPhilippa2024-01-18 17:56:162024-04-18 17:04:55How to Find the Right Size CPAP Mask
Finding the right non-invasive ventilation (NIV) mask size for your patient involves careful evaluation, guided by both expertise and prompt action, to ensure an optimal fit and the most effective therapy. Below, you’ll find a step-by-step guide to help you choose the correct NIV mask size and get the best fit for your patients.
Assessment
First, determine the type of mask (e.g., full face or nasal) required. If needed, measure your patient’s face using appropriate tools and guides. Assess the distance between critical points like the bridge of the nose and the bottom of the chin, as well as the width of the nose.
Refer to Sizing Guides
Many mask manufacturers provide sizing guides that correlate facial measurements with the appropriate size. Check the mask’s packaging, user manual, or the manufacturer’s website for these guides. You can find Sleepnet’s size guides, instruction manuals, and videos here.
Consult Manufacturer Guidelines
Each NIV mask manufacturer may have specific guidelines for sizing. Review the manufacturer’s recommendations to understand how they correlate facial measurements to mask sizes.
Try Different Sizes
Depending on the patient’s measurements, having a few different sizes is a good idea. Start with the size that aligns with the measurements and have the next size up and down. Note that once a mask is opened or used, it must be disposed of. To help address fit issues, Sleepnet offers several masks with Custom Fit Technology. This unique feature allows users to mold, shape, and bend their NIV masks to match the unique contours of a patient’s face. The result is a personalized and snug fit that not only enhances comfort but also ensures an optimal seal.
Fit and Comfort Evaluation
Have the patient try on each mask size and assess the fit and comfort. The mask should create a secure seal without causing pressure points or discomfort. Ensure it covers the nose and/or mouth adequately and the patient can breathe comfortably. Additionally, tighten and adjust the headgear correctly.
Check Seal and Leaks
While the patient is wearing the mask, start the NIV device and observe for air leaks. A proper fit will minimize leaks and ensure effective therapy. Adjust the headgear and mask straps at all adjustment points if needed.
Patient Feedback
Ask the patient for their feedback. Are they experiencing any discomfort? Do they feel any air leaks? Their input is crucial for finding the most comfortable fit.
Document and Communicate
Keep thorough records of the mask type and size that best fits your patient. Documentation is helpful for future reference and helps to ensure consistent therapy.
Regular Reevaluation
Over time, a patient’s facial structure or preferences might change. It’s important to periodically reassess the mask fit and comfort to ensure continued effective therapy.
Remember that finding the right size NIV mask is crucial for the patient’s comfort and adherence to therapy. Additionally, each manufacturer’s mask may have different designs and sizing criteria, so it’s essential to follow the specific guidelines provided by the mask manufacturer.
Sleepnet, a leading manufacturer of CPAP and NIV masks, offers innovative Custom Fit Technology across many of its products. This unique feature allows users to mold, shape, and bend their CPAP (continuous positive airway pressure) and NIV (non-invasive ventilation) masks to match the unique contours of their face or their patient’s face. The result is a personalized and snug fit that not only enhances comfort but also ensures an optimal seal.
How Custom Fit Technology Works
Sleepnet’s Custom Fit Technology is designed to be user-friendly and accessible. The mask is made from a flexible medical-grade material that responds to gentle manipulation. Users can easily shape, bend, and mold the mask along the sides, top, and bottom. The mask retains its customized shape, allowing users to achieve a consistent and secure fit.
Benefits of Custom Fit Technology
Personalization: One of the key challenges faced by CPAP and NIV mask users is achieving an effective seal. Sleepnet’s Custom Fit Technology addresses this issue by empowering users to take control of their CPAP and NIV mask’s fit. It also helps patients with asymmetry in their faces or patients that have gained or lost significant weight. This technology enables users to shape and mold the mask to fit their individual facial structure, resulting in a tailored and comfortable fit that minimizes leakage and pressure points.
Enhanced Comfort: Traditional CPAP and NIV masks often come in standardized sizes, which may not cater to the unique shapes and sizes of individuals’ faces. This can lead to discomfort and reduce mask effectiveness. Sleepnet’s Custom Fit Technology eliminates these issues by allowing users to customizeand maintain their mask’s shape. The ability to adjust the soft-shell mask’s fit on all sides ensures that it remains securely in place without adjusting the headgear and preventing leakage.
Improved Seal: An essential factor in the effectiveness of a CPAP or NIV mask is the seal it creates. An inadequate seal can lead to unwanted leakage and decreased comfort. Custom Fit Technology ensures that the mask adheres perfectly to the contours of the user’s face, creating an effective seal. This enhances the user’s experience.
Conclusion
Sleepnet’s Custom Fit Technology represents a continued commitment to innovation in CPAP and NIV mask design and functionality. By allowing users to tailor their CPAP and NIV mask to their unique facial contours, Sleepnet has improved the user experience with enhanced comfort, improved seal, and a personalized fit. Sleepnet’s Custom Fit Technology is here to provide a customized solution for customers.
Mojo® 2
The Mojo® 2 provides a personalized fit with maximum comfort. Our patented AIR°gel cushion and Custom Fit Technology allows the user to mold the Mojo® 2 for an individualized fit. The unique soft-shell of the mask allows for optimal flexibility, allowing the user to adjust the mask to the unique contours of their face.
iQ®2 & Phantom®2
The iQ®2, a lightweight moldable mask and the Phantom®2, a moldable low-profile mask, both can accommodate most facial structures. Sleepnet’s patented Custom Fit Technology allows each user the ability to accommodate various facial structures, and changes in weight and facial asymmetry.
MiniMe® 2
In collaboration with leading children’s hospitals, Sleepnet offers the MiniMe® 2 Nasal Pediatric mask. It is available in four sizes and two 5-point adjustment headgear options. The Minime® 2 offers new levels of flexibility by using Custom Fit Technology and a patented AIR°gel® cushion providing pediatric patients the ultimate fit and comfort.
About Sleepnet
We believe in building products that help people lead healthier lives. Our passion for innovation is at the core of everything we do, laying a foundation for creating new ideas and building better products. As a company with BAA-compliant products, we are experienced manufacturers focused on developing best-in-class products that improve the health and well-being of our customers. For more than 25 years, Sleepnet has manufactured gel masks and respirators built to help customers breathe easier. Our products include Continuous Positive Airway Pressure masks, Noninvasive Ventilation masks, Pediatric masks, and Respirators. With comfort and safety top of mind, we proudly design and manufacture our products in the United States.
M90173 Rev A
https://www.sleepnetmasks.com/wp-content/uploads/2023/11/Custom-Fit-Technology.jpg10801080Leigh Annhttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngLeigh Ann2023-11-13 08:51:102024-04-18 17:06:05Sleepnet’s Custom Fit Technology
In the face of increasing needs due to illness and chronic disease, demand for comfortable yet effective respiratory masks has never been higher. Traditional respiratory masks, often used as non-invasive (NIV) or Continuous Positive Airway Pressure (CPAP) masks, have served as essential tools for advancing human health, but they often come with discomfort and limitations that hinder long-term usage. Enter AIR°gel® technology – a revolutionary advancement that combines comfort with a superior seal, addressing the shortcomings of conventional masks and offering a new level of user experience.
Understanding AIR°gel®Technology
AIR°gel® technology is a cutting-edge innovation developed by Sleepnet that aims to enhance the comfort and effectiveness of respiratory masks. It involves the incorporation of a gel-like material into the mask’s design, which conforms to the contours of the wearer’s face, creating a secure and comfortable seal. This not only ensures a snug fit but also minimizes air leakage around the edges, which is a common issue with traditional Liquid Silicon Rubber (LSR) masks.
The gel material used in this technology is soft, flexible, and hypoallergenic, making it suitable for extended wear. It is engineered to maintain its shape and elasticity over time, ensuring consistent performance and a lasting seal. It also helps to minimize sores and irritation often caused by long-term wear.
Benefits of AIR°gel® Technology
Enhanced Comfort: One of the most significant advantages of AIR°gel® technology is the unparalleled comfort it provides. The gel molds to the user’s face, reducing pressure points and minimizing discomfort caused by tight straps or rough edges. This comfortable fit encourages longer wear times, which is crucial for individuals who need to wear a respiratory mask for extended periods.
Reduces Marks & Irritation: AIR°gel® significantly reduces marks and irritation caused by long-term wear and movement. While other masks may leave painful sores, the soft gel in Sleepnet masks minimizes skin inflammation and discomfort.
Better Seal & Fit: Proper fit is vital for the effectiveness of any respiratory mask. AIR°gel® technology helps create an airtight seal, which prevents leaks. This feature significantly enhances the mask’s efficiency and reduces health risks. AIR°gel® masks provide a snug fit that adapts to individual contours, accommodating a broader range of face shapes and sizes.
User Compliance: Uncomfortable masks often lead to users adjusting or removing them, which compromises their health. With AIR°gel® technology, users are more likely to adhere to mask-wearing protocols due to the increased comfort and minimized irritation.
AIR°gel® technology marks a revolutionary leap in the field of respiratory mask design, addressing comfort and protection in a single package. By creating a custom fit, minimizing leakage, and enhancing overall wearability, this innovation has the potential to improve the efficacy of respiratory masks across various hospital and homecare settings.
https://www.sleepnetmasks.com/wp-content/uploads/2023/09/Air-Gel-Technology-for-Respiratory-Masks-Revolutionizing-Comfort-and-Protection.jpg10801080Leigh Annhttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngLeigh Ann2023-09-07 15:41:442024-04-18 17:06:43Air Gel Technology for Respiratory Masks: Revolutionizing Comfort and Protection
Ensuring Excellence: The Importance of Quality Control in Manufacturing Respiratory Masks for CPAP and NIV devices
By: Skylar Carr
Introduction
After the Industrial Revolution and the emergence of mass production, it became crucial to establish clearer definitions and exert greater control over the quality of products. Initially, the main objective was to ensure that production met engineering standards during the final stages of product development. As manufacturing processes became more intricate, the discipline of quality control and standards evolved to manage process variations and produce products of superior quality (American Society for Quality, www.asq.org, Accessed 7/10/2023).
According to the American Society for Quality, “Quality control (QC) is defined as a crucial component of quality management that focuses on meeting quality requirements. While quality assurance pertains to the way a process is executed or a product is manufactured, quality control primarily concerns itself with the inspection aspect of quality management” (www.asq.org, Accessed 7/10/2023).
Quality control plays a vital role in every aspect of manufacturing. When it comes to producing critical healthcare products like CPAP (Continuous Positive Airway Pressure), NIV (Non-Invasive Ventilation), and pediatric masks, it is paramount. At Sleepnet, we understand the significance of quality control in ensuring the safety, reliability, and effectiveness of our respiratory masks. In this article, we delve into the essential role of quality control within manufacturing and shed light on how our company maintains rigorous quality standards to provide exceptional products to our customers.
Why is Quality Control Important?
Ensures Customer Satisfaction: Quality control guarantees that the end products meet or exceed customer expectations. Our quality standards build trust and confidence in our brand by ensuring customers receive reliable and quality respiratory masks for their sleep therapy and ventilation needs.
Compliance with Regulatory Requirements: Adherence to regulatory standards and guidelines is crucial in the healthcare industry. Quality control requirements ensure that products meet the necessary regulations, providing peace of mind to both distributors and end-users.
Risk Mitigation: Quality control helps identify and mitigate potential risks or defects in the manufacturing process. By identifying issues early on, manufacturers can implement corrective actions to prevent further problems, minimize product recalls, and protect end-users from adverse effects.
What is Sleepnet’s Quality Control Process?
Material Selection: An important step in the quality control process is carefully sourcing and selecting materials during the product design and development phase.We design and manufacture our products in the United States with US and globally sourced components that meet or exceed industry standards to ensure the integrity and durability of our masks.
Manufacturing Processes: Our manufacturing facilities employ robust processes that adhere to strict guidelines and best practices. From precise molding techniques to advanced assembly procedures, we prioritize quality through rigorous training and adherence to best-in-class manufacturing protocols for medical devices.
In-Depth Testing and Inspections: Our masks undergo comprehensive testing and inspections to maintain the highest standards. This includes evaluating structural integrity, ensuring proper seal and fit, and verifying compliance with regulatory requirements.
Continuous Improvement: At Sleepnet, we continuously strive for excellence. We routinely collect and analyze data looking for ways to improve our products, processes, and customer experience.
Certifications and Compliance: Our commitment to quality is demonstrated through certifications, such as the ISO 13485 certificate, which is a quality management certification. As well as being compliant with domestic and international standards, our masks ensure that they meet the highest quality standards set by international regulatory bodies.
Conclusion
Quality control is the backbone of Sleepnet’s manufacturing process, especially when producing critical healthcare products like CPAP, NIV, and pediatric masks. We dedicate ourselves to delivering exceptional products that meet the needs of our customers and adhere to the highest standards through rigorous material selection, robust manufacturing processes, comprehensive testing, and continuous improvement. By prioritizing quality control, we aim to produce best-in-class products that exceed our customers’ expectations.
About Sleepnet
We believe in building products that help people lead healthier lives. Our passion for innovation is at the core of everything we do, laying a foundation for creating new ideas and building better products. As a company with BAA-compliant products, we are experienced manufacturers focused on developing best-in-class products that improve the health and well-being of our customers. For more than 25 years, Sleepnet has manufactured gel masks and respirators built to help customers breathe easier. Our products include Continuous Positive Airway Pressure masks, Noninvasive Ventilation masks, Pediatric masks, and Respirators. With comfort and safety top of mind, we proudly design and manufacture our products in the United States.
https://www.sleepnetmasks.com/wp-content/uploads/2023/08/The-Importance-of-Quality-Control-in-Manufacturing-Respiratory-Masks-for-CPAP-and-NIV-devices.jpg10801080Leigh Annhttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngLeigh Ann2023-08-14 08:20:392024-04-18 17:07:18Ensuring Excellence: The Importance of Quality Control in Manufacturing Respiratory Masks for CPAP and NIV devices
In hospital and intensive care unit (ICU) settings, patients often require non-invasive ventilation (NIV) masks to support their respiratory needs. While these masks are crucial for patient care, they can sometimes lead to skin breakdown and discomfort, particularly around the nasal bridge. In response to these problems, Sleepnet, a leading provider of medical devices, developed a revolutionary technology called AIR°gel®. All Sleepnet masks utilize AIR°gel®, which helps to mitigate skin breakdown, offering enhanced comfort and protection to patients.
Sleepnet’s AIR°gel® Technology
AIR°gel® is an innovative gel technology developed by Sleepnet. Designed with ergonomics in mind, it provides a cushioning effect that adjusts to the shape of the patient’s nasal bridge. This customized fit ensures optimal contact and dissipates the pressure exerted on the skin, significantly lowering the risk of skin breakdown and related complications.
Skin Breakdown in NIV Mask Users
“Noninvasive ventilation refers to the delivery of assisted ventilatory support without the use of an endotracheal tube. Noninvasive positive pressure ventilation (NPPV) can be delivered by using a volume-controlled ventilator, a pressure-controlled ventilator, a bilevel positive airway pressure ventilator, or a continuous positive airway pressure device. During the past decade, there has been a resurgence in the use of noninvasive ventilation, fueled by advances in technology” (Mayo Foundation for Medical Education and Research. https://www.mayoclinicproceedings.org/action/showPdf?pii=S0025-6196%2811%2964786-1. Accessed 7/24/2023). “However, there are potential problems with its clinical application and the development of skin breakdown” (International Wound Journal. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7950763/. Accessed 7/11/2023). Patients who rely on NIV masks for breathing support may experience skin breakdown due to several factors. Prolonged mask use as well as inadequate mask fitting can cause pressure ulcers, irritation, redness, and even tissue damage. “Moisture and heat develop on the surface of the skin beneath the mask, which alters the skin surface and increases the potential for skin breakdown. Repeated adjustment of the NIV mask to maintain adequate ventilation can contribute to friction and shear on the surface of the skin,” (RT Magazine. www.rtmagazine.com. Accessed 7/11/2023).
Consider the following scenarios where skin breakdown occurs in NIV mask users:
Scenario 1: Pediatric Patient
Emily is a 7-year-old child admitted to the pediatric ICU due to respiratory distress caused by pneumonia. The medical team decides to provide non-invasive ventilation (NIV) using a mask to support her breathing. Over the course of several days, Emily’s skin begins to show signs of breakdown around her nasal bridge due to prolonged use of the NIV mask.
Despite the medical team’s efforts to adjust the mask and provide additional padding, Emily’s delicate skin becomes red, irritated, and even starts developing pressure ulcers. This condition causes significant discomfort and pain for Emily, leading to increased agitation and difficulty cooperating with the necessary treatments. The skin breakdown becomes a concern for the medical team as it can delay the healing process and hinder Emily’s overall recovery.
Scenario 2: Elderly Patient
John, an 80-year-old patient, is admitted to the hospital’s intensive care unit after experiencing acute respiratory failure. To facilitate his breathing, the medical team decides to administer non-invasive ventilation using a mask. As the days go by, John’s skin, particularly around his nasal bridge, begins to deteriorate.
His skin becomes increasingly fragile due to aging and the prolonged pressure exerted by the NIV mask. Despite the medical staff’s attempts to reposition the mask and provide cushioning, John develops skin breakdown with areas of redness, blistering, and even open wounds. The skin breakdown not only causes physical discomfort for John but also increases the risk of infection and delays his recovery.
In both scenarios, skin breakdown in NIV mask users highlights the importance of finding effective solutions to minimize this issue. Sleepnet’s AIR°gel® masks mayplay a crucial role in preventing skin breakdown, offering a cushioning effect that reduces pressure on the skin and adapts to the unique facial features of pediatric patients like Emily and elderly patients like John. By incorporating AIR°gel® technology, medical professionals may be able to enhance patient comfort, promote skin integrity, and support a faster recovery process.
The Benefits of AIR°gel®
The primary objective of AIR°gel® technology is to protect the skin and the nasal bridge that is in contact with the mask, minimizing irritation and increasing overall comfort for patients. Here are some key benefits offered by Sleepnet’s AIR°gel® technology:
Enhanced Comfort: The gel’s cushioning effect creates a soft and gentle interface between the mask and the skin. It helps distribute pressure evenly, reducing the likelihood of discomfort and pain associated with extended mask use.
Skin Protection: By reducing pressure on the nasal bridge, AIR°gel® helps mitigate the risk of skin breakdown and pressure ulcers. It acts as a barrier, minimizing friction and shear forces that can compromise skin integrity.
Optimal Seal: Sleepnet’s commitment to ergonomic design ensures that the mask fits comfortably and securely on various facial shapes and sizes, providing a reliable seal and optimal functionality.
Sleepnet strives to deliver effective, innovative, and cost-effective products that prioritize customer satisfaction. By integrating AIR°gel® technology into their NIV masks, Sleepnet addresses a crucial concern in patient care, offering a solution that promotes comfort, reduces the risk of skin breakdown, and enhances overall well-being.
Skin breakdown in patients who wear NIV masks is a significant concern in hospital and ICU settings. Sleepnet’s AIR°gel® technology represents a breakthrough in addressing this issue, providing a cushioning effect that minimizes pressure on the skin and nasal bridge. With a focus on comfort and protection, AIR°gel® technology ensures that patients receive the respiratory support they need without compromising their skin integrity. Sleepnet’s commitment to customer satisfaction through effective and innovative solutions reinforces their position as a leading provider of Continuous Positive Airway Pressure masks, Noninvasive Ventilation masks, Pediatric masks, and Respirators.
Non-invasive ventilation (NIV) masks are a type of respiratory support used to treat patients with breathing difficulties. They provide mechanical ventilation without the need for intubation, which is the insertion of a breathing tube into the patient’s airway. NIV masks help to treat a wide range of respiratory conditions, including chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), pneumonia, and more.[1] As hospitals and medical professionals move away from intubation due its risks, the demand for NIV masks continues to grow.
How do NIV masks work?
NIV masks deliver pressurized air or oxygen through a mask placed over the patient’s nose and/or mouth. The pressurized air helps to keep the patient’s airway open, allowing them to breathe more easily. The mask stays in place with straps that wrap around the patient’s head, and healthcare staff adjust pressure levels to meet the specific requirements of each patient.
What types of NIV masks are available?
There are several types of NIV masks, which include nasal masks, full-face masks, total face masks, pediatric masks, cannulas, and nasal pillows. The type of mask medical professionals select depends on the patient’s condition and individual preferences. Nasal masks cover only the patient’s nose, while full-face masks cover both the nose and mouth. Nasal pillows are small, cushioned inserts that fit into the patient’s nostrils.
What are the benefits of NIV Masks?
One of the benefits of NIV masks is that they are non-invasive, meaning that they do not require the insertion of a breathing tube. Using an NIV mask reduces the risk of complications associated with invasive treatment, such as infections or lung damage which occasionally arise with intubation. NIV masks are also generally more comfortable for patients than invasive treatments, and they potentially reduce the time a patient spends in acute care.
NIV masks are utilized in diverse settings such as hospitals, long-term care facilities, and homes. Within hospital environments, they are commonly used in the intensive care unit (ICU) to offer respiratory support to patients who are critically ill. In long-term care facilities, NIV masks help manage chronic respiratory conditions. In the home, NIV masks function as respiratory support for patients with COPD and other chronic diseases.
While NIV masks are generally safe and effective, it’s important to note that there are potential risks associated with their usage. These include skin breakdown, pressure ulcers, discomfort, and mask leaks. This is why it is important for patients using NIV masks to be closely monitored by healthcare professionals.
NIV masks are a vital tool in treating respiratory conditions. They offer a non-invasive way to provide mechanical ventilation to patients without requiring intubation. NIV masks are generally safe and effective, but patients should be closely monitored for potential complications. If you or a loved one has a respiratory condition, talk to your healthcare provider about whether NIV masks might be a suitable treatment option.
Does Sleepnet offer NIV masks?
Sleepnet specializes in manufacturing respiratory masks, including NIV masks designed to provide comfortable and effective respiratory support for adult and pediatric patients. Sleepnet offers multiple NIV mask options, each with unique features that meet the needs of various types of patients. For more information on Sleepnet NIV masks, go to https://www.sleepnetmasks.com/respiratory-masks/.
This article explains the Buy American Act (BAA) and how to comply with BAA standards.
What is the Buy American Act?
The Buy American Act (BAA), enacted by Congress in 1933, requires Federal Government Agencies to procure products produced or manufactured in the United States[1]. Specifically, the law “requires federal agencies to apply a price preference for domestic end products and use domestic construction materials for covered contracts performed in the United States.”[2]
History of the Buy American Act (BAA)
President Herbert Hoover signed the Buy American Act on March 3, 1933, on his last day in office. Initially, the Buy American legislation was partly inspired by “Buy British” marketing campaigns and the fact that many U.S. government agencies and projects were purchasing foreign products. The legislation also came about after the Great Depression, and it aimed to protect American jobs for large government-sponsored projects like the Hoover Dam.[3]
Additional Related Legislation
Since 1933, due to its control over federal Spending, Congress authorized several laws in addition to the BAA that restrict federal agencies from purchasing foreign products, with various exceptions:
The Trade Agreements Act of 1979 (TAA) (19 U.S.C. §§ 2501-2581), allows agencies to waive the BAA in certain instances. The TAA also allows specific eligible products from designated countries to be considered alongside offers from U.S. companies for certain types of federal acquisitions that exceed explicit monetary amounts.
In addition, the Department of Defense (DOD) has special requirements for purchasing domestic goods. Specifically, the Berry Amendment requires that “food clothing, tents, certain textile fabrics and fibers, hand or measuring tools, stainless steel flatware, and dinnerware” procured by the DOD be grown, reprocessed, produced, or reused in the United States (10 U.S.C. § 4862). It also provides for a “specialty metals restriction” that ensures that any “specialty materials” to be used in any U.S. aircraft, mobile units, weapons, or weapon system must be produced in the United States (10 U.S.C. § 4863).[4]
What are BAA Standards?
According to Federal Acquisition Regulation 25.003, a product qualifies as a domestic end product if the item is manufactured in the U.S. and more than 60 percent of the cost of all the component parts is also mined, produced, or manufactured in the U.S. (this pertains to products that are not iron and steel products). The guidelines for domestic end products increased to 60 percent on October 25, 2022, further increases to 65 percent in the calendar year 2024, and 75 percent in the calendar year 2029. If products are not available that meet the new standards or the cost is unmanageable, agencies are allowed to fall back to 55 percent until December 31, 2029.[5]
Complying with BAA Standards
Under the Buy American Act, federal government contractors are required to submit a certificate affirming that they adhere to the BAA standards described above. The specific language and format of this document are required and detailed in the Federal Acquisition Regulation (FAR) (48 C.F.R. §§ 25.1101(a) and 52.225-2.[6] Information on federal contract listings and data can be found at sam.gov (https://sam.gov/content/home).
Sleepnet believes in building products that help people lead healthier lives. As a company that offers BAA-compliant products, we are experienced manufacturers focused on developing best-in-class products that improve the health and well-being of our customers. For more than 30 years, Sleepnet has manufactured gel masks and respirators built to help customers breathe easier. Our products include Continuous Positive Airway Pressure (CPAP) masks, Noninvasive Ventilation (NIV) masks, Pediatric masks, and N95 Respirators. With comfort and safety top of mind, we proudly design and manufacture our products in the United States.
Find out more:
To learn more about Sleepnet masks, visit www.sleepnetmasks.com or email .
[1] United States Government (2023, March 15). 41 USC Ch. 83: BUY AMERICAN. Office of Law Revision Counsel United State Code. Retrieved March 28, 2023, from http://uscode.house.gov/view.xhtml?path=/prelim@title41/subtitle4/chapter83&edition=prelim
[2] United States Government (2022, November 8). The Buy American Act and Other Federal Procurement Domestic Content Restrictions. Congressional Research Service. Retrieved March 28, 2023, from https://crsreports.congress.gov/product/pdf/R/R46748
[3] Reinsch , W. A., Hoffner, J., & Caporal, J. (2020, April 10). A World in Crisis: Will Buying American Help or Hurt? Retrieved March 28, 2023, from https://www.csis.org/analysis/world-crisis-will-buying-american-help-or-hurt
[4] United States Government (2022, November 8). The Buy American Act and Other Federal Procurement Domestic Content Restrictions. Congressional Research Service. Retrieved March 28, 2023, from https://crsreports.congress.gov/product/pdf/R/R46748
[5] U.S. Government (2022, March 7). Federal Acquisition Regulation: Amendments to the FAR Buy American Act Requirements. Federal Register. Retrieved March 28, 2023, from https://www.federalregister.gov/documents/2022/03/07/2022-04173/federal-acquisition-regulation-amendments-to-the-far-buy-american-act-requirements
[6] U.S. Government (2022, October 1). Buy American Certificate. Acquisition.gov. Retrieved March 28, 2023, from https://www.acquisition.gov/far/52.225-2
https://www.sleepnetmasks.com/wp-content/uploads/2023/04/CPAP-Product-Shortages-1.png10801080Leigh Annhttps://www.sleepnetmasks.com/wp-content/uploads/2023/10/Sleepnet.pngLeigh Ann2023-04-28 10:37:372024-04-18 17:20:05What does it mean to be BAA Compliant?
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