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The Roundtable: Defibrillator Equipment

This month, TechNation consulted with the experts to find out the best purchasing and maintenance strategies for defibrillator equipment.

Fri Jan 11 2013By TechNation Magazine

 

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.

The Uni Pulse from Rigel Medical The Roundtable: Defibrillator Equipment

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.

Read full article in the Jan. 2013 issue of TechNation Magazine.

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