Author: Kristen Ci
Come visit us at booth #611 October 26-29th, 2015 See our popular liquid to gas oxygen transfilling system. Financing options are available for our liquid to gas oxygen transfilling system and our OxyGo. Check out our NEW OxyGo POC on display in our booth with FREE demos! Get a FREE copy of our Home HealthCare TODAY magazine, with extra savings inside! Get all of your required training in ONE DAY with Applieds FDA/DOT Seminar! During our popular regional seminars you will learn the most current FDA/DOT requirements, oxygen safety, proper equipment handling, what to expect during an accreditation inspection, HazMat Security Awareness, and much more! FDA requires documented, continuing training annually. With Applieds regional training seminars you will now get an official serialized certificate of training, automatic reminders to complete training next year, and the resources to take home with you for citing requirements. For more information on our FDA/DOT seminars click here! We
A Servomex is a paramagnetic oxygen analyzer. It is used to tell you what your gas identity is and the strength/purity of that gas. A Servomexs accuracy is 0.1% Oxygen and has been validated by ORSAT apparatus to USFDA Pharmacopoeia 23. Oxygen is magnetic! Oxygen is attracted to a strong magnetic field most other gases are not. This para-magnetism is used to obtain fast, accurate measurements. If your oxygen analyzer reading is 99.5%, then your oxygen is between 99.4% and 99.6% pure. Why cant I use my handheld analyzer when testing the identity and purity of my gas? A handheld analyzer uses fuel cell sensors which are much less accurate 3.0%. This means that your 99.5% oxygen could be anywhere from 96.5% and 100% pure (possibly not Oxygen USP)! Therefore, the FDA has specified using a paramagnetic analyzer, such as a Servomex.
Applied Certified Training helps you avoid DOT fines and delivery vehicle impounds. Failure to follow DOT requirements can result in fines of $2,100 or more!
OxyGo Portable Oxygen Concentrator (POC) Wins Harvard Business School (HBS) Award OxyGo POC Wins HBS Business Idol at the Owner President Management Course (OPM #49) Westlake,OH, June 24, 2015 - One hundred sixty (160) CEO/Business Owners from 34 countries competed for the coveted Harvard Business School Business Idol Awards in May, 2015. The OxyGo POC won first place based on improving the quality of life for patients and strategy serving patients through Applied Home Healthcare Equipments network of DME providers. Dave Marquard, CEO / Owner of Applied said Winning the first place award for OxyGo was an outstanding team effort of HBSs OPM Study Group #47 team. The team was made up of CEO / Business Owners from Australia, Brazil, Germany, India, Namibia, the U. A. E. and the U. S. A. For more than twenty-two years, Applied Home Healthcare Equipment, LLC, Westlake, Ohio, U. S. A., has manufactured and supplied more than 400 innovative products for home respiratory care sold exclusively
Oxygen Labels 101 What Is Required? And By Who? Oxygen drug product labels are governed by 3 different agencies. The FDA because its a drug product, and the DOT and OSHA because it is considered a Hazardous Material that is in transport (DOT) and in the workplace (OSHA). Each agency is a different government entity that has its own requirements. DOT: For example, the oxygen diamond and the proper shipping name (Oxygen, Compressed) appearing on the label is for the benefit of the DOT: They want to make sure that the hazardous material is properly identified during transport in the event of an accident so that first responders can react accordingly. FDA: The FDA wants the label to indicate what the drug product is (Oxygen) so patients and caregivers know what they are administering to people. So while the DOT would mandate Oxygen, Compressed, the FDA does not care that it is the proper shipping name just that it properly conveys the identity of the drug product. OSHA: OSHA requires
It has been 6 years now since the FDA switched to electronic registration. Is it still a requirement to register every year? YES! In fact the FDA is still inspecting transfillers, and anecdotally we have seen an increase in inspections in our industry. It is very important that you make sure you are registered at the appropriate time. When you are getting ready to register or renew with the FDA, remember these tips: 1. Be sure to check your DUNs number. Your transfilling site address must match the address on file with DUN and Bradstreet. 2. If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated. 3. If you are no longer filling at a specific location it is recommended that you remove the location from the FDA database. We can help! Click here for more information.
Whether you are managing a large or small business or a department, here are a few business minefields to avoid. People are your most valuable asset Your talented and experienced people are your most valuable assets. Never delay or defer milestones which are important to employees such as their semi or annual review. Even if you have little or no budget for salary or wage review, still schedule and conduct the review on time every time. Employees want to know that you value them. Next, dont forget to praise them in public when they earned it, it makes them stronger and even better at what they are doing. If you have to give constructive criticism, always do it in private. Never, ever forget they are your most important resource. Remember business is a game of margins not volume Examples of rationalizing low margin business include accepting it for incremental business and / or to absorb overhead costs. These are both habit forming and hazardous practices. Your sales force can easily
The DME environment in which reimbursement dollars have been reduced due to many factors, cutting costs has become as important as the number of patients that you serve. When looking for ways to cut costs, one of the easiest ways is to fill your own oxygen cylinders. When you realize that there are many other advantages to refilling your own oxygen cylinders, it becomes a project that no DME should ignore. What are the advantages to refilling your own oxygen cylinders?
All employees at Applied Home Healthcare Equipment are encouraged to donate their time and participate in community service throughout the year. This year, Applieds community service days start off with a lot of fun at the Buckeye Regional FIRST Robotics Competition. Each year FIRST presents a new robotics competition scenerio with twists and nuances for every high schoolteam involved. Then each team receives a kit with parts, and has 6 weeks to build a robot based off of their interpretation. The competition is designed to build self confidence, knowledge and life skills while motivating young people to pursue academic opportunities. Jason volunteered from our company to be one of the judges for this exciting event where high school students, from 56 schools across the country, designed and built robots for the competition. He enjoyed the experience of working with the students and their teams and was able to share his stories and suggestions. Great job to Jason and all the students
Are your cylinders stored according to state and FDA regulations? Oxygen cylinders must be stored properly in order to prevent contamination, keep unauthorized personnel away from cylinders, and to prevent them from being damaged which can cause serious injuries. Take our mini storage audit below to find out if your cylinders are being properly stored: Storage Checklist Yes/No QCU initials Notes Cylinders are stored safely so they can not fall and cause injury or property damage Cylinders can be nested, or stored in carts or racks to keep them from toppling over Storage of oxygen is at least 10 feet away from source of open flame and 20 feet from combustibles Required under NFPA or UCC regulations. Check your state and local fire marshal for requirements in your area. Cylinder storage are clearly designated / signed, (ex, Full, Empty, Quarantine) FDA requirement to help prevent unapproved cylinders or cryogenic vessels from being distributed. DOT and
OSHA, FDA and DOT haveguidelines developed forprecautionary labels for use onoxygen cylinders and cryogenicvessels. These are to be used toidentify the contents, warning ofprincipal physical and healthhazards, and providing appropriateprecautionary information.It is the responsibility of the company(s)that fills, stores, delivers, handles anduses the gas to ensure that the labelcomplies with applicable governmentregulations. Heres a break down of whats required - by regulatory agency. OSHA: The Newest Changes OSHA has adopted GHS.GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide to standardize the labeling and safety data sheets (SDS) for chemicals. Because there are so many chemicals and hazardous substances used world wide, GHS is used to make everyone safer by creating a universal system. The GHS is not a regulatory body in and of itself, but rather a set of standards that regulatory bodies can adopt to create a uniform
Make money despite competitive bidding Everyone knows that the DME market has become much more challenging over the last several years with reimbursement reductions, competitive bidding being implemented, increased audits and regulations by regulatory agencies, along with other factors such as a nationwide recession. These factors have made it more difficult to remain profitable for many DME companies. The following are some suggestions that can help you save money. Consider refilling your own oxygen cylinders. By investing in a transfilling system you can then purchase oxygen in bulk from a supplier rather than having the supplier fill all of your individual cylinders. This can usually provide you with at least a 50% cost savings and often can be as much as a 100% reduction in your cost of oxygen. You also wont need as many cylinders as part of your inventory. There are many transaction cost savings that can be gained when transfilling. Train customers to change their habits. The traditional
Drivers, respiratory therapists, warehouse personnel, and others who handle compressed gas cylinders should do so using the proper equipment to ensure safe movement of the cylinders. Compressed gas cylinders are pressure vessels that are capable of becoming propelled objects (think rockets!) if the contents are suddenly exhausted, either by mishap or accident. The rapid discharge of gas can happen if the cylinders are dropped and either the valve or other part of the cylinder becomes damaged or broken. If a cylinder is dropped and takes off, it can cause injury, property damage or worse. To prevent cylinders from being dropped, use carriers, bags, or carts when handling and moving cylinders, particularly multiple cylinders. Do not try to carry a large number of cylinders under your arms. One wrong move or trip can result in the cylinders being dropped and potentially damaged. Carriers can be constructed of several types of materials. The durability of the carrier is often reflected in
A compliant PAP patient is a happy PAP patient, and as many in the homecare industry know, reimbursement is heavily related to compliance. Two easy ways to help boost compliance rates are to ensure a proper mask fit, and replace masks, filters and tubes as often as possible. Ensuring a good fit The mask is everything. If a mask is uncomfortable, leaks or otherwise ill fitting, the patient will not use the CPAPmachine. Some tips for fitting are to ensure the machine is set to the prescribed flow during fitting, as the change in pressure can change fit. Furthermore, its wise to have the patient lie down and move in their common sleep positions. Youll be able to better anticipate any issues or problems. Masks should be snug enough to prevent leaks, but not so snug as to leave marks on the patients face. Replace Equipment Often If providers replace the masks and tubing as often as is allowed by reimbursement schedules, not only can providers earn more yearly revenue than from the
In todays DME environment in which reimbursement dollars have been reduced due to many factors, cutting costs has become as important as the number of patients that you serve. When looking for ways to cut costs one of the easiest ways is to fill your own oxygen cylinders. Then when you realize that there are many other advantages to refilling your own oxygen cylinders it becomes a project that no DME should ignore. What are the advantages to refilling your own oxygen cylinders? Reduce your oxygen cost by 50 100% by buying oxygen in bulk. Reduce the frequency of purchasing cylinders. By transfilling you dont need the cylinders that used to be at your supplier being filled, because theyre being filled in-house. Reduce the number of cylinders in your inventory. Because of the reason listed above your inventory of cylinders doesnt need to be as large when filling in-house. Reduce your dependence upon a supplier. Have 24/7 availability of oxygen. Even in a crisis situation
Are you confused about FDA registration? Dont be! Applied takes the worry out of annual registration for you! The FDA says that any firm that transfers oxygen from one container to another, via gas to gas, liquid to gas, or liquid to liquid; is considered a drug manufacturer by the FDA and is required to register with the FDA every year between October 1st and December 31st of the year. (See 21 CFR 207.21(a)). When you are getting ready to register or renew with the FDA, remember these tips. Your transfilling site address must match the address on file with Dun and Bradstreet, so be sure to check your DUNS number. If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated. If you are no longer filling at a specific location, it is recommended that you remove the location from the FDA database as well. Starting June 1, 2009 the FDA stopped receiving paper submissions for registration. Registration must now be done electronically.
Who? What? Where? When? The FDA requires that training be completed on a frequent and continuing basis. This has been interpreted to mean twice a year. This training must be completed by anyone who can affect the purity of the oxygen. Personnels training in Current Good Manufacturing Processes is required by law (21 CFR 211.25). Some examples of those that must complete FDA training include fillers, drivers, quality control unit, and warehouse personnel. The DOT requires that training be done at least every three years, and within 90 days of the start of employment for new employees. Drivers, loaders, and people in charge of storage of oxygen cylinders for ANY amount of oxygen delivered (1 cylinder to over 1,001lbs), must successfully complete DOT training. This training touches on three areas which include Job Specific Training, HazMat Security Awareness Training and HazMat Safety Training. Training needs to be completed in each area in order for an employee to be considered DOT compliant. Applied
Maintaining Your Oxygen Equipment: 3 Easy Steps FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. Dont forget you need to document all calibration! DAILY Each Fill Day, youll need to calibrate your paramagnetic analyzer. The paramagnetic analyzer (such as the popular Servomex) is NOT the same as a handheld analyzer. It is a sophisticated analyzer that can gauge the purity of your oxygen drug product, and is a required step in filling gas cylinders. You should calibrate your analyzer with special oxygen and nitrogen created for this purpose, and that comes with a valid COA (Certificate of Analysis). Click here to see our calibration gases. ANNUALLY Your filling equipment is used in the manufacture of a drug product, and must be maintained according to the manufacturers standards, or FDA requirements. Heres what we recommend for some essential filling equipment. Gauges and Thermometers Vacuum and High Pressure
GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide to standardize the labeling and safety data sheets for chemicals. Because there are so many chemicals and hazardous substances used world wide, GHS strives to make everyone safer by creating a universal communication system. THe GHS is not a regulation body in and of itself, but rather a set of standards that regulatory bodies can adopt to create a uniform system across the globe. Think of GHS as akin to the metric or imperial system- metric or imperial are not themselves a regulation, but something that regulating bodies adopted. Similarly, GHS has recently been adopted by OSHA, the Occupational Safety and Health Administration of the Federal Government, to standardize hazardous material safety in the US. This means that the way things look on the chemicals you use and the material safety data sheets you see will change. Each company will need to train employees on the key
According to the CGMPs, each manifold filling sequence, each uninterrupted filling sequence, every cryogenic vessel filled, and each storage tank following a delivery is considered a new lot and is required to be assigned a new lot number. For firms filling liquid oxygen for delivery to home patients, each of the large cryogenic vessels or dewars either portable or permanently mounted in a van or a truck are required to be assigned a unique lot number. The assigning of a single lot number for an entire days production is not acceptable. A manufacturing operation, such as the filling of high pressure cylinders on a multi-outlet manifold, is governed by a set of manufacturing procedures or conditions. When these procedures are performed from the beginning to the end of a process they provide assurance that the batch is uniform and consistent. As such, each batch is in itself a separate entity with its filling operations unique to that filling sequence. At the present time, cryogenic