This month, TechNation consulted with the experts to find out the best purchasing and maintenance strategies for defibrillator equipment. Responders include John Backes, Associate Director of Rigel Medical; Annette Fasnacht, Senior Director of Marketing at Zoll Medical Corporation; Marc Lawrence, President of Progressive Medical International; Matt Spencer, President of DXE Medical, Inc.; and Steve Ziegenhagen, owner of Gopher Medical, Inc.
What are the biggest trends right now in the defibrillator market?
JOHN BACKES: It would seem that the main trends remain unchanged, although the way solutions are currently being delivered goes hand-in-hand with innovation.
The most critical issues relating to cardioversion remain: response times to treatment – both access to and the availability of defibrillators – alongside treatment success rates, better interpretation and subsequent treatment during cardioversion, and making it easier for people to operate defibrillators safely and correctly, essentially making them more fail-safe.
Innovation provides inventive ways of delivering cardioversion through the development of new shock waveforms. We have gone from sinusoidal waveforms in the early experimental days through the use of monophasic (DC) waveforms to current technology, which is based on the biphasic waveforms.
Triphasic waveforms are also available, although presently there is no independent clinical data available to provide clear evidence of the clinical benefits of these in contrast to the clear benefits of biphasic over monophasic.
Most modern defibrillators offer additional features such as pacing and vital signs monitoring (SPO2, NIBP, temperature, ETCO2, ECG, etc.), so we are seeing increasing ‘value added’ innovation through advancements in all aspects of vital signs monitoring. Some manufacturers are able to provide innovative solutions through the inclusion of such things as post-shock support. Advice about CPR (cardiopulmonary resuscitation), including rate and depth of chest compressions, is an example of this.
ANNETTE FASNACHT: For ZOLL it is the adoption of CPR feedback along with defibrillation capability. With over 75 percent of in-hospital events presenting with non-shockable rhythms, high-quality CPR is critical to achieving good outcomes. In 2002, ZOLL began putting Real CPR Help on its AEDs. Today, all ZOLL defibrillators coach rescuers to the correct depth and rate. Manual defibrillators also include coaching for release, perfusion and idle time. We also offer a filter (See-Thru CPR) that removes the artifact created by compressions, so rescuers can determine if there is an organized rhythm developing. This helps speed time to therapy and return to CPR post-shock. It is not sufficient for defibrillators to only deliver a shock.
CO2 monitoring is a Class I recommendation by the American Heart to verify endotracheal tube placement and is increasingly being used to guide resuscitation. Defibrillators that can provide end tidal are increasingly being purchased, as handheld devices cannot integrate with the code record. All ZOLL ALS units offer an option for end tidal.
The other key feature is readiness testing. The ZOLL R Series performs a daily self-test of over 45 key factors which help to ensure readiness, without the need to solely rely on a manual test. But even more important, the results of this test can be transmitted wirelessly to a dashboard in clinical engineering, where staff can see the state of readiness of all the defibrillators in the fleet at a glance. The dashboard even reports the reason for a readiness failure, and biomeds can often troubleshoot and return to readiness with a phone call rather than visit the unit.
Wi-Fi is playing an increasingly more important role for ZOLL as well. We use it to report readiness, download defibrillator case records for debriefing and record keeping, and shortly will be able to automatically link to EMR.
MARC LAWRENCE: Over the last 10 years there have been two significant trends. The first trend was the placement of AEDs in nonmedical commercial applications. The second has been the evolution of defibrillators, which historically were resuscitation devices, becoming multi-parameter medical devices with a defibrillator component.
I expect the placement of public access AEDs to grow. Several factors will influence this trend, including broader public acceptance and training in the use of AEDs, lowering entry cost of purchasing an AED, and the recognition that their deployment will increase with aging of the population.
With respect to ALS devices, I expect that additional parameters to be continually integrated. Specifically, ALS defibrillators will merge with complimentary modalities to become complete resuscitation devices. These modalities will include infusion, ventilation and CPR compression features.
MATT SPENCER: There are two relatively new devices in the market that have made quite a splash: Lifepak 15 and Zoll X Series. The durability of the Lifepak 15 and the size of the X Series have definitely taken pre-hospital defibrillation to a new level. The main trend we see, however, is a strain on capital budgets needed to upgrade to newer devices. This is causing organizations to hang onto their equipment longer.
EVE ZIEGENHAGEN: Over the past few years now and with the standard of care changing constantly, OEMs have been forced to manufacture and develop an easier to use, smaller and more transportable defibrillator and offer more integrated physiological parameters, such as 12 lead ECG, ETCO2, etc. Also, with EMR systems becoming a standard, OEMs are revisiting the ability to export data. Allowing the export of data to such systems will play a critical role in the manufacture of all defibrillators moving forward. The accuracy and reliability of this data are paramount for delivering high quality patient care throughout the health care facility.
How will the market for defibrillators evolve in the next five years? How will that affect service of the equipment?
BACKES: In general, all manufacturers have been able to make defibrillators increasingly successful and safer to use by people. The challenge going forward is to make them more widely available, and this will happen when defibrillators become more cost effective.Safety and performance will continue to remain a critical issue, too. A quick search on the Internet provides well documented failures surrounding the safety and performance of automatic electronic defibrillators (AEDs). Although manufacturers provide built-in check procedures, these are not always sufficient to warn the user in advance; problems with equipment more often than not will only surface when cardio version is required – of course, this is far too late and patients’ lives will be placed at even more risk if equipment doesn’t work.No doubt manufacturers will be able to address some of these concerns and perhaps even consider letting their users have remote (wireless) access using public (WiFi) hotspots to monitor AED status.
However, the necessity for testing defibrillators will remain, no matter what level of self-testing is incorporated into future defibrillator technology. A good example of this is the car industry, where innovation has generally increased the reliability of automobiles dramatically. Most modern cars are fitted with several self-test and alarm features, but this hasn’t eliminated the need for regular check-ups in the garage or by the owners. Wear and tear is difficult to monitor, and visual damage always requires human interpretation.
Last but by no means least, battery self-testing is difficult without applying a load, ensuring there will always be a need to test the function of the battery under ‘real-life’ conditions; i.e., a shock has to be provided and the energy this creates has tobe measured.
FASNACHT: The uncertainty in health care and the economy over the past few years has lead to many defibrillators in hospitalsbeing kept longer than the typical fiveto seven-year life cycle. This may lead to more maintenance required for the older units remaining in service, but we also project more new units coming into service over the next five years as hospitals replace aging equipment or realize that the function of defibrillators has evolved (CPR and use of end tidal CO2 monitoring) and seek to improve patient outcomes with newer technology.
LAWRENCE: The evolution of defibrillators will be quite different based on application. The AED will become more deployed in commercial non-medical application, and the corresponding acquisition cost will fall. As the population ages, I suspect the market will demand an inexpensive home model. They will become as common as fire extinguishers.
With respect to ALS devices, defibrillator manufacturers will have to embrace the need to transition defibrillators from emergency response devices to therapy products with corresponding reimbursement schedules. Zoll is currently offering this with a wearable defibrillator called Life Vest.
Defibrillators will become more complex based on modality expansion. As manufacturing technology improves the defibrillation will become a component of multi-measurement and therapy device, which will feature two-way communication to comply with growing EMR needs.
As defibrillators integrate more modalities, they will become more CPU based. Technicians will need to address multiple parameters beyond PM/Cal/Safety test of previous defibrillators. Repair will involve more component replacement. As communication technologies increase on defibrillators, many service requirement may be conducted remotely via the Internet by the manufacturer or remote technician, which could reduce support cost to the defibrillator owner.
SPENCER: We don’t see a big expansion in the EMS market over the next five years, but the constant turnover of older equipment being replaced by new in both hospital and pre-hospital markets will remain. The tightening of budgets will require some providers to continue using older devices. Those devices will require service, which provides additional opportunities to show value to your customer base.zIEgENHAgEN: We expect to see more integrated technologies with other OEMs. I believe manufacturers of defibrillators will work with manufacturers of cardiac equipment to develop connectivity paths to cardiac central monitoring systems. Also, many health care facilities will be eliminating monophasic defibrillators and upgrading to the newer, more advanced biphasic technology. This will have an immediate impact on biomed departments. As monophasic equipment is replaced by new technology, biomeds will have an increasingly difficult time accessing the remaining supply of monophasic defibrillator parts that they need to continue to support and repair their inventory of monophasic defibrillators.
What are some of the biggest challenges of purchasing and maintaining defibrillators today?
BACKES: This comes down to ensuring you get value for money. Understanding the need of your (expected) patients or members of the public in case of AEDs is important in making the right purchasing decision. After sales, service and product longevity are certainly important factors, which directly impact the cost of ownership, while finding the right solution requires trying out different manufacturers and their models.
But what is too often overlooked by many organizations is ensuring that members of staff – and the wider public – really understand the workings and dangers of using defibrillators. Training and making sure people understand the warning signs and hazards of equipment misuse are probably the most critical things to consider here because while defibrillators are undoubted lifesavers, in the wrong hands, or if not properly maintained or operated, they can easily become serious safety hazards for users.
FASNACHT: One of the biggest challenges is freeing up funds to purchase defibrillators, or at least making them a priority in capital purchases. That is why ZOLL has focused heavily on defibrillators as tools to improve resuscitation outcomes. When a defibrillator is viewed simply as a box that delivers a shock once in a while, the need to update technology is pushed down on the priority list. But when hospitals understand the possibilities that surround having a full-featured, comprehensive resuscitation platform, the equation changes. ZOLL developed a financial model based upon Medicare reimbursement rates, which projects that each additional patient who survives cardiac arrest neurologically intact can generate an incremental $50,000 in reimbursement. That is not an insignificant return on a best practice.
We have hospitals that have more than doubled their survival to discharge from a national average of 12 percent to 17 percent. That results in real money to hospitals.
LAWRENCE: The biggest challenge in purchasing defibrillators is budgeting. There is an inverse relationship to increasing device costs and medical provider reimbursements. Independent as well as hospital based biomedical service providers will be compelled to support defibrillators beyond the typical product life cycles of seven to nine years. Technical staff will need to improve skills to sustain operation of existing inventories while preparing to embrace the increasingly technical complexity of next generation devices.
SPENCER: The biggest struggle we see in our industry is the ability to perform ongoing preventive maintenance required for compliance. This responsibility often falls to an individual or team with multiple other duties. Often, necessary preventive maintenance gets overlooked. It is our job to remind our customers that regular PMs are necessary and make sure we coordinate with them in the most effective and efficient way to satisfy their needs.
ZIEGENHAGEN: From our standpoint, one of the biggest challenges health care facilities across the county will be faced with is the new health care plan, which will increase existing financial strain. With tighter budgets, hospitals will have fewer capital dollars available to upgrade older defibrillators or even standardize the units they own now. This will have a big impact on the biomeds and clinical engineers responsible for maintaining their facility’s aging fleet of defibrillators. They will likely be pressed by administration to keep older defibrillator technology running longer.
Please share your advice for people in hospitals that are faced with these challenges.
BACKES: It is important to seek impartial advice on the different applications of defibrillation, and make a sound judgment on what features meet your current and perhaps future requirements. Evaluate more than one make/model and compare your findings with other organizations. Forums are available to do just that. Follow or track the latest developments in the technology, applications and thinking via the FDA website.
Rigel Medical can also provide a free informative booklet on the subject of pacing and cardioversion. This is available on request at firstname.lastname@example.org.
FASNACHT: The best advice I can give is to be aware of the very positive trends in resuscitation outcomes, and work with your supplier to develop a business case for new equipment when the time comes. It is no longer enough that staff put in a capital request and wait to see what happens. Supply chain is looking for reasons to purchase (and not purchase) and to do business with a company. Look at what is available in the market; don’t just buy the latest from your current supplier. If a hospital has not purchased defibrillators for seven to 10 years or even longer, the landscape is very different today, and you owe it to patients and staff to ensure you deliver the best technology has to offer.
We are available to help you assess the current state of your resuscitation program and help put together a comprehensive business case that supports the need for new equipment or upgrades to existing inventory. A sentinel event related to resuscitation very quickly wipes out any savings from keeping an old platform in service.
LAWRENCE: Continually maintain the devices in conformance with original manufacturers’ recommendations. Develop a sourcing for aftermarket parts, accessories or reconditioned parts that will not materially affect device operation or patient safety.
SPENCER: We encourage our customers to schedule not only their next PM, but the next several. Our service department provides this scheduling, complete with 60-day reminders, free of charge to all DXE customers.
Consider purchasing refurbished devices for incremental needs, which will extend asset life cycles. Develop continuing training to support to respond to increasingly complex defibrillators. Evaluate deployment of defibrillators based on application, frequency of use and or projected use, and consider less costly AEDs in low acuity settings. Be aware of future EMR requirements and how next-generation defibrillators comply with those needs. Watch for accessory compatibility across the entire fleet of devices.
ZIEGENHAGEN: The cardiac defibrillator manufacturing industry is highly competitive and is dominated by Philips, Medtronic, ZOLL Medical, Cardiac Science Corporation and other large companies. These are usually midsize to large capital purchases, and each health care facility needs to be prepared to negotiate with their vendor partners. Negotiating is a critical component of purchasing any product. Today, most health care facilities are partnered with some type of group purchasing organization (GPO) for buying power. The OEMs may offer additional discounts by allowing heath care facilities to trade in older or obsolete equipment. Using this leverage to negotiate will get you more competitive pricing, upgrades on software/ hardware and biomedical training.