RT had the opportunity to discuss market trends and the latest in emergency resuscitation products with Jody McCarthy, director of sales and marketing, VORTRAN Medical Technology 1 Inc, Sacramento, Calif; Stan Peretin, BSRT, national clinical specialist for Ambu USA, Glen Burnie, Md; and Gary Rushworth, BSRT, RRT-NPS, REMTB, product marketing manager for therapy products, Laerdal Medical Corp, Wappingers Falls, NY.
|From left: Gary Rushworth, Jody McCarthy, Stan Peretin|
VORTRAN manufactures and markets a patented line of fully automatic disposable respiratory devices for patients in the hospital and other market segments (EMS, post-acute, and home care). Ambu develops, produces, and markets diagnostic and life-support equipment and solutions to hospitals and rescue services. Laerdal creates and distributes a diverse range of medical products designed for CPR training, airway management, advanced life support training, spinal motion restriction, trauma training, monitoring, defibrillation, and patient simulation.
RT: What are the latest trends in emergency care resuscitation products in the industry? disposable? ergonomics? durability? versatility? new materials, etc?
McCarthy: For the past 30 years, mechanical ventilation has been the ventilation therapy of choice. The mode of ventilation is dependent upon the individual patient and their condition. I think that patient comfort and safety, ease of use, reliability, education, and reasonably priced products are and will remain the driving force of this industry. Critical care clinicians will continue to assist in defining goals for improved product-development processes.
Peretin: The Ambu SPUR-II resuscitator has been changed to a 1.5-liter bag from a 2.2-liter resuscitator reflecting the latest recommended resuscitation guidelines. The SPUR-II is now lighter and easier to use, especially for people with small hands. A new dual swivel has been added to the patient adapter, and the new SEBS material allows for an increased operating temperature range of 0 to 122° F. The Ambu medication port is for drug delivery and is found exclusively on the Ambu SPUR-II. Ambu also has developed a new and improved reservoir bag for the SPUR-II. This heavier-duty version tolerates aggressive handling without compromising its function. An example would be in EMS where a patient is in a motor vehicle accident and has to be removed through a window, and the bag is likely to bump up against glass and/or sharp or rough edges. So from a safety and dependability perspective, it is more reliable. The SPUR-II is smaller and easier to handle over long periods of time. An example would be in the case of a prolonged cardiac arrest where there may be a 45-minute transport to the hospital. Sometimes the user’s hand gets very tired from squeezing the resuscitator over a long period. The Ambu SPUR’s built-in handle prevents the hand from losing contact with the resuscitator, while allowing it to relax between compressions. The SPUR-II handle also allows the clinician to hold onto the bag in sticky, wet, or adverse conditions.
Rushworth: There are a lot of different things in different areas. There are developments in the manual resuscitation market, design changes in the manual resuscitator bag, changes in reusable versus disposable mix, and different styles of masks and patient valves. The next level of change is in what’s referred to as automatic resuscitators. They are usually gas-powered devices that are connected to the patient through a mask or an endotracheal tube. Another area is transport ventilators. These are self-contained units that patients are connected to and that allow rescuers to support the patients’ respiration in terms of rate, tidal volume, and other parameters. Once the patient is connected, [it becomes] a hands-free type of service. RTs adjust these parameters to meet patient needs and provide all the external ventilation.
RT: Tell us about your company’s most recent emergency resuscitation products and why they are innovative for the needs of RTs in emergency care situations.
McCarthy: VORTRAN’s Automatic Resuscitator (VAR) and E-vent Case products provide an inexpensive solution for mass casualty incidents (MCIs). VAR is single-patient use and disposable, which eliminates cross-infectivity, cross-contamination, and equipment-sterilization issues. The E-vent Case is organized for rapid deployment in a ventilator emergency and provides ventilatory support for seven patients simultaneously with the seven-port manifold. The manifold system can be connected to a single or multiple gas supply source such as a wall connection, H tanks, or even medical-grade air compressors. Placed in a hospital or triage area, it provides emergent and short-term ventilatory support. This also allows RTs to maximize their clinical performance [and allows them] to perform other critical functions, especially in clinical-personnel shortages during an initial emergency medical response.
Peretin: Ambu’s newest resuscitator is the SPUR-II. The Ambu RDIC bag is another uniquely designed product for use in disaster/chemical-type environments. It’s a double wall design. The inner compression part of the bag gives you great feel or feedback and doesn’t require a lot of effort to squeeze, yet it recoils nicely to its original expanded state for the next breath. The outer cover is butyl rubber, which is impermeable and ideal for use in chemical or biologic conditions. The RDIC bag is the only one of its kind designed for use in WMD (weapons of mass destruction) situations. Also, the new Ambu Aura laryngeal mask airways are now approved as a suitable method of establishing an airway in an emergency situation.
Rushworth: The biggest thing that we’re coming out with this year deals with the primary resuscitators and with suction units for airway clearance. For the resuscitators, we have a new disposable line that is geared more toward the American market. The Bag II is a disposable manual resuscitator that’s a bag-mask-valve style. The suction units have different levels, from a freestanding AC/DC model to a middle-range continuous suction unit. And then we have a lower level of manual suctions as well. We’ve improved the types of batteries that they have, extending the length of time that they’ll last, and this fact allows them to be used in remote environments without an AC power source for a longer period of time.
RT: What about future trends/products that your company is working on in resuscitation?
McCarthy: Utilizing worldwide resources, user input, and our key personnel creates a path for our product development process. Our VAR devices are being reengineered to provide more efficient gas consumption, a positive-end expiratory pressure (PEEP) valve, and intrinsic alarm systems in future models. We don’t know to what degree right now, as we’re still in the evaluation stages.
Peretin: There are quite a few projects Ambu is working on for both the hospital and prehospital [emergency medical services] settings. Most of these ideas, unfortunately, I can’t talk about. Regarding what’s needed out there, it depends on who you talk to. Some people insist that new equipment is the answer. That new equipment is needed to control certain aspects of ventilation, and everybody and anybody in the field can adapt to it. In my opinion, training is paramount when discussing what health care providers need. Making clinician- and patient-friendly products has always been the focus at Ambu, not just designing new equipment, because some of the new equipment that’s out there feels different. New products do not always feel natural during use, and one might think the product is not working properly based on how it feels in action.
Rushworth: In the next 5 years, we’ll be looking toward possibly bringing a line of transport ventilators in. Laerdal originally started in the hospital market. About 20 years ago, Laerdal began to focus predominantly on prehospital and fire departments. The biggest thing with our company now is that we are getting back into the hospital market. So we’ll be gearing some of our products more toward hospitals, ICUs, and emergency rooms.
RT: Are there any misconceptions or advice to RTs about the use or care of any of your products?
McCarthy: Yes, many RTs compare the VAR to a full-featured ICU stand-alone ventilator with multiple monitoring features. The VAR is 510(k)-approved, FDA-classified as a “short-term” emergency “non-continuous” ventilator. It is not intended as an “unattended” ventilator. The VARs are not designed to be or intended for use as full-feature ventilators or for long-term mechanical ventilatory support. However, they have proven to be useful in a variety of clinical settings and under austere conditions.
The VAR devices do have limitations, such as pressure limitations for patients that have pathology associated with decreased chest wall or lung compliance. Knowing the performance characteristics of the VAR models is essential for safe and appropriate clinical implementation. VORTRAN has been consistent in addressing these concerns or misconceptions through training, publications, and our network of dealers.
|Visit our online Buyer’s Guide to learn where you can find resuscitation equipment.|
Peretin: Ambu puts an actual directions-for-use (DFU) pamphlet in with every resuscitator bag. It’s a mini instruction booklet written in multiple languages. If you have questions, you can refer to the booklet as a quick reference. The DFU covers details from recommended flow rates and tidal volumes for each size resuscitator, to the design of the bag and how it works. The pamphlet also discusses the need to do a quick product function check and walks you through the process to allow each clinician to understand and feel comfortable with each Ambu product.
Rushworth: The biggest thing with any of the devices is that they need to be used by trained personnel. These personnel need to be cognizant of the operations of all the devices. One of the things we see coming back to us from a risk-management standpoint is failure to use the devices correctly. They’re FDA Class II devices. They inherently have a hazard associated with them, depending on the device. Those devices are regulated by the FDA, so they need to be under the auspices of a physician for use and they need to be used by a trained practitioner. Someone not cognizant of that can overventilate and underventilate the patient by delivering too much or too little air and cause the patient to deteriorate. Also, failure to clean and assemble the equipment according to specifications can be an infection-control hazard and can lead to malfunctions of the bag during critical situations.
Tor Valenza is a staff writer for RT. He can be reached at [email protected].