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AmSECT’s Recommendation on MCS Devices

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jimreagor View Drop Down
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  Quote jimreagor Quote  Post ReplyReply bullet Topic: AmSECT’s Recommendation on MCS Devices
    Posted: Jan 24 2012 at 4:49pm
Each state is different in it's licencing of allied health care professionals. You would have to check the state in which you are interested. This information can be found on your states licencing board website. Many scopes of practice found in licences have statements which have been broadly interpreted to allow other AHPs to manage these patients. However, there is no question that the perfusionist is the most qualified to provide support to these patients. This is another reason why licensure is important. But that is another topic.

Effective utilization of staff is always an issue. It is not common to have a perfusionist bedside for a patient on a VAD. However, a perfusionist should certainly be on call to assist and advise on any issues associated with the support system. As for ECMO I believe perfusionists should either be bedside or a better scenario is for the perfusionist to setup, initiate, and troubleshoot in addition to providing supervision for other properly trained AHPs which monitor the patient on support.

As MCS has evolved the postoperative management has fallen to the VAD coordinators, some of which are perfusionists but most of which are RNs and NPs. This is advantageous in the case of the NPs who have prescribing authority and can manage the patients medications. In a multidisciplinary system these AHPs should rely upon their perfusion staff for technical support for the device.

Perfusionists are the only AHPs formally educated and certified in this field and as such, in my opinion,should supervise the utilization of all MCS and ECLS systems in all areas of the hospital including the cath lab, ICU, ER and of course the OR and be on call to provide troubleshooting and technical expertise for outpatient and other device related issues.

Jim Reagor
Jim Reagor
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  Quote racine Quote  Post ReplyReply bullet Posted: Jan 24 2012 at 10:23am
Is there a list of states that allow nurses or 'others' to manage the use of MCS, ECMO or VADs postoperatively  without perfusionists in house or is that unheard off?  What would be the best case scenario once the patient is transferred to ICU/CVSU after patients are stabilized?  Does the perfusionist stay inhouse or within call range? 
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  Quote jimreagor Quote  Post ReplyReply bullet Posted: Jun 03 2011 at 12:32pm
The AmSECT MCS Committee has been investigating the impact and safety issues concerning the newer generation of mechanical support devices. The committee has drafted a response letter that has been approved by the AmSECT leadership and will be submitted to industry and regulatory agencies. While we support the innovation of this new technology as a means to improve patient viability and decrease mortality, it is clear that the best trained and most highly skilled medical specialist to operate these devices and provide the highest level of safety is a Perfusionist.

Below is AmSECT's position statement as published in AT.

Jim Reagor


UPDATE: Mechanical Circulatory Support Committee Recommendation on Portable and Percutaneous Extracorporeal and Mechanical Circulatory Support Devices

Chair: Mark Lucas
Co-Chair: James Reagor
Ron Matheis
Tom Rusk
Gary Grist

Portable extracorporeal cardiopulmonary life support (ECLS) devices are increasingly gaining the attention of mainstream medicine. On the surface such attention could only be expected to benefit patients with occurrences of acute respiratory failure or acute myocardial infarction. As perfusionists, we know the advantages and disadvantages of these devices, which we operate routinely to rescue patients who may otherwise decompensate and die before the proper treatment can be effected. Device manufacturers realize the untapped markets for these advanced products and pursue bringing mechanical circulatory support (MCS) devices to the mainstream. There is a great risk that the future operators of these devices may not include perfusionists and will not have the background or experience to safely manage these devices and patients. The recent introduction of percutaneous mechanical circulatory support devices to cardiac cath labs have shown the direction that these newer generation of portable ECLS devices will most likely take.

AmSECT President Susan Englert has already stated (AT, Jan-Feb11), that the merit of using MCS devices such as portable heart-lung machines in broader clinical applications certainly exists. Heart disease remains the leading cause of death in the United States with lung disease the third leading cause. Consider that mortality caused by acute cardiogenic shock is estimated at 50-70% even with current therapeutic paradigms including inotropes and IABPs. While some heart failure and respiratory failure patients are treated with immediate transplants, the limited availability of donor organs often requires MCS devices as a bridge to transplant, bridge to decision or as destination therapy. The use of Extracorporeal membrane oxygenation (ECMO), has developed into a specialized, multidisciplinary effort with steadily improving results for respiratory failure. Perhaps wider availability of cardiopulmonary rescue devices would decrease patient morbidity and mortality. But also, perhaps not; if the device operator is insufficiently prepared to manage acutely ill patients supported on the device or to be able to respond to device emergencies that could be disastrous.

Over the past several years, the MCS Committee has been working to provide resources for MCS knowledge and create standards and guidelines for training and competency in current and emerging circulatory assist technologies. As part of these efforts, the committee has evaluated publicly available information on the newer generation of devices and has determined that a qualified perfusionist should be involved directly, as a primary consultant or in a supervisory capacity in the operation of all such devices to provide the highest degree of patient safety. Perfusion practice has more than fifty years of knowledge and experience in extracorporeal support and a proven record of safety . The following letter has been approved by the AmSECT Board of Directors for publication in AmSECT Today and for release to all device manufacturers. The purpose of distributing this letter is to open dialogue with device manufacturers on the qualifications of device operators and clearly establish the organization’s position regarding perfusionist involvement.


AmSECT’s Recommendation on Portable and Percutaneous Mechanical Circulatory Support Devices

The American Society of Extra-corporeal Technology (AmSECT) is the world’s largest professional society of cardiovascular perfusionists. AmSECT seeks to foster improved care, safety and outcomes for patients supported with extracorporeal devices. Perfusionists are the only medical professionals whose scope of practice expressly includes the utilization of extracorporeal devices to support patients in a variety of clinical circumstances. Perfusionists are qualified through CAAHEP-accredited educational programs and certified by the American Board of Cardiovascular Perfusion.

It is AmSECT’s position that optimal patient care and safety must not be compromised. Mechanical Circulatory Support (MCS) devices which are a variation on or are substantially equivalent to current systems operated by perfusionists are beginning to be utilized by other health care providers. AmSECT has charged its Mechanical Circulatory Support Committee with providing knowledge, guidance and insight into MCS devices.

The MCS Committee continues to evaluate the available information regarding the current and pending generation of devices. Upon deliberation, the MCS Committee finds that safe and effective operation of these life-sustaining systems requires that a qualified perfusionist directly participate in or supervise their use. The introduction of such life support devices into the clinical setting without the involvement of a properly trained cardiovascular perfusionist will jeopardize safety and subject patients to substantial and unnecessary risk of injury. AmSECT strongly recommends that a perfusionist qualified by formal education and possessing clinical expertise be utilized directly or in a supervisory capacity throughout the implementation, operation and management of all MCS systems.

We welcome any questions and further discussion of our concerns and position on this matter.

Respectfully,


The American Society of Extracorporeal Technology

January 13, 2011
Jim Reagor
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