Staff Priority for Ventilators? ... Yes?

Today’s posting addresses the issue of providing preferential access to ventilators for health care workers in a pandemic. This is a somewhat touchy subject from an ethical point of view. Any opinions expressed here are strictly my own, but I will try to provide a rational basis for any opinions that I do express. If you disagree with my opinion, (or agree) you can leave a comment below and we can discuss it. If you think this is an important discussion, please post a link to this post ( http://panvent.blogspot.com/2008/06/staff-priority-for-ventilators-yes.html ) in other discussion forums. I should declare that I am a health care worker myself, and that could be a considered a conflict of interest in this discussion. Nevertheless, I hope you hear me out.

The May 2008 article in Chest journal DEFINITIVE CARE FOR THE CRITICALLY ILL DURING A DISASTER
(available at http://www.chestjournal.org/content/vol133/5_suppl/)
and ALLOCATION OF VENTILATORS IN A PUBLIC HEALTH DISASTER published in Disaster Medicine and Public Health Preparedness Vol 2/No1, recommends that health care workers do not receive any preferential treatment in a pandemic. Many other planning documents recommend the same. I have a great deal of respect for these documents and the people that wrote them. The authors of these documents are trying to make plans that will save as many lives as possible during a pandemic using the limited resources that they expect will be available to the health care system. They try as much as possible to stay within traditional ethical guidelines, but insist that the principle of doing the greatest good for the greatest number of people is the primary principle and this should override values based on the traditional ways of delivering health care.

The principal rationales for not providing health care workers with preferential access to ventilators are these:

1. Fundamental ethical principles demand that there is no discrimination in access except for survivability criteria. Discrimination based on age and health status is acceptable because this allows the triage team to identify which individuals are more likely to have an increase in survivability by having access to the limited supply of health care.
2. It is unlikely that a health care worker that is given preferential ventilator access during a pandemic will recover in sufficient time to be able to come back to work and help others before the pandemic is over.
3. The triage protocols demand that certain persons be given authority to decide who gets access to medical treatments in limited supply. The public must trust that these persons will make decisions based on the pre-established rules and sound ethical principles. If the public believes that the decision makers are giving preferential access to people that they personally know, it may undermine this trust.

Discussion of Point #1
I believe that the principle of non-discrimination except for areas where it improves overall survivability is very valid and should be pursued. Where the argument for not favoring health care workers may fail is that it considers the availability of healthcare in a pandemic to be a zero sum game; that whatever is available at the beginning of a pandemic is all that will be available. They state this explicitly when they say that whatever is used to help health care workers will not be available to help the general public. This is may not be entirely true, as I will outline in point 2.


Discussion of Point #2
Now it may be so that once stricken, the health care worker as an individual may not be able to contribute a positive benefit to the pandemic care effort, but it is wrong to look at health care workers strictly as individuals. Health care is a team effort. The work that must be done by health care workers during a pandemic is not the routine of the non-pandemic. Society will demand that health care workers place themselves (and possibly their families through indirect exposure) at greater personal risk than the general public, and will demand that they work under more severe and hazardous working conditions and longer hours than they normally do.

It is essential that health care workers are motivated to not only work under these conditions, but to provide the most and best quality work they can. Staffing level is one of the key issues identified as a major limiting factor in being able to provide the maximum care to save as many people as possible in a pandemic. One way to get staff to work more would be to impose stringent laws and use force to draft anyone able to provide health care to work whether they want to or not. This would not be good way to get maximum efficiency from all workers and most plans do not recommend it. The workers must be motivated to provide the very high level of performance expected from them during a pandemic.

The health care worker component of a pandemic shortage is not a zero sum game. Some conditions will encourage healthcare workers to go to greater lengths to provide the most that they possibly can, and other conditions will cause them to retreat from working into a place of self preservation. It is not as straightforward either as being that worse conditions cause more people to retreat. Many people will work very hard in poor working conditions and even in situations of great risk if they feel their cause is just. Military organizations understand this, and place a great value on maintaining morale, group cohesion and supplying a valid reason for soldiers to contribute their maximum effort.

The US military is known as being one of the finest fighting organizations in the world. They do not rely only on just having the best equipment, but also focus on getting the maximum that they can from their people. One of the ways they do this is by saving every captured or injured soldier that they can. The principle is best stated in the Ranger Creed of “No Man Left Behind”. (See http://www.yaleherald.com/article.php?Article=532 for a discussion of this.) Each soldier is willing to risk his life to save his fellow soldier, even in the face of extreme odds, because he knows that the other would do the same for him. This cohesion and dedication then translates into a high degree of effectiveness for the many other things a soldier is asked to do.

Now look at two scenarios, handled in different ways and what could be the possible outcomes. Both scenarios start the same way. A pandemic strikes; workers are worried for their safety, but feel a sense of duty and commitment to work. Most show up for work, but are not sure about volunteering for extra work. Some are distrustful that their employers are doing everything they can to protect them and stay away from work. They talk about this a lot at breaks. One of the nurses gets sick and needs a ventilator. The other staff believes she got sick from caring for a pandemic patient.

In the first scenario the nurse is refused a ventilator so that it can be given to another person. The other staff worries that they too may get sick and believe that not enough will be done for them. More staff now stays home from work. The hospital can now care for less patients than they could before due to staff shortage.

In the second scenario the nurse is put on a ventilator. Other workers volunteer extra hours to make sure she is well looked after. Some workers that initially stayed home now also come to work. They have greater trust that they will be looked after if they get sick and also wish to be available if any more of their coworkers get sick and need help. The hospital can now care for more patients than they could before.

It is interesting that the second scenario works even if the nurse does not survive. It is the fact that they were able to try to save her that is important.

Discussion of Point #3
The public may accept that health care workers will go to great lengths to care for their own. We accept this from other groups that put themselves in danger in order to protect us. Two examples are police and firefighters. When they go to great lengths to save one of their own, or in the case of police to obtain justice for the death of one of their own, the public does not complain that they are now providing a lower level of service to the rest of us. We accept this, and even demand it. When it was found out by the public that many injured Iraqi war veterans were poorly treated the public demanded that conditions improve. The same happened for many police and firefighters injured in 9/11. The public respects the risks that people place themselves in for the public good and demand that they receive the best care possible when they are hurt in the line of duty.


Conclusion
I would like to believe that I would do everything I can to help in a pandemic crisis regardless of risk to myself, and I think most people feel this way. I just can’t be sure that everyone will actually act so magnanimously when a crisis actually occurs. A lot can be learned from studying staff reactions during the SARS crisis in Toronto when some people felt that the hospitals involved did not provide adequate information and protection to staff working with SARS patients. I understand that the critical care system is a public trust and that the health care workers cannot arbitrarily use these resources preferentially for themselves. The triage plans that have been published take a much more pragmatic approach to the allocation of scarce resources such as ventilators in a crisis such as a pandemic. These plans are willing to forgo systems that are currently used such as first come, first served, in favor of allocation systems that will save the most people possible. Perhaps they should study how staff will actually behave in a pandemic system, and adjust the plans accordingly if it could in fact save more total lives.

Clarence Graansma



P.S.
Maybe this is the place for the Pandemic Ventilator. Maybe if healthcare workers volunteer extra hours to look after their own in a pandemic and even build their own ventilators…

The Cost of Efficiency

Modern hospitals have become much more efficient than they were in 1957 or 1968 when we had our last pandemics. Today, hospitals are run more like a business than they ever were. Even non profit hospitals and hospitals in countries with socialized medicine or single payer systems have had to run more efficiently. This is not entirely a bad thing. Hospitals have had to become more efficient as the ongoing improvements in health care technology became more readily available. Many more high tech health options are possible today, and they are generally more expensive. We treat heart disease, cancer, trauma, premature birth and organ failure much more aggressively than we did 40 or 50 years ago. We can also routinely save or extend more lives than we did back then. Efficiency is how we afford it.

To make hospitals more efficient we utilize space, supplies and staffing as much as we can. We do not have empty rooms. If too many rooms are unused we close wings and convert them to outpatient departments or offices or close some hospitals. We do not let equipment sit idle, we buy just what we need and rent some extra to get us over the peaks. We use just in time supply systems to reduce excess inventory and waste. We hire fewer full time staff and use temporary staff or pay a bit of overtime here and there to handle the peaks. The average length of a hospital stay has been dramatically reduced.

We no longer have any excess capacity left. We designed it that way. Any hospitals that resisted this change in the past were closed and branded inefficient. This efficiency has a cost though. Our efficient health care systems could no longer handle a pandemic even of the type seen in 1968. Pandemics require far more resources than the ordinary ebb and tide of daily business. Too much efficiency can be deadly.

Quick Review of “Definitive Care for the Critically Ill During a Disaster”

This week the report from the “Task Force for Mass Critical Care Summit, January 26–27, 2007” was published in CHEST. The series is titled “Definitive Care for the Critically Ill During a Disaster”. It consists of five separate articles subtitled:

• Summary of Suggestions From the Task Force for Mass Critical Care Summit
• Current Capabilities and Limitations
• A Framework for Optimizing Critical Care Surge Capacity
• Medical Resources for Surge Capacity
• A Framework for Allocation of Scarce Resources in Mass Critical Care

I quickly read through all these papers this week. I will review each of them in more detail in upcoming postings. You can get all five of the published articles for free at this location. Thank you CHEST for supplying these articles for free. If you are involved in pandemic planning, I urge you to download these papers and read them. They offer many suggestions and solid frameworks for planning your response to a mass critical care incident.

The publishing of these papers has generated a few news reports this week. Most of the newspaper articles were sensational, focusing mainly on the list of classes of people that would be excluded from care. Here are a couple of news links. AP, Globe and Mail.

When you read these news articles you would think that the summit meeting was all about denying care. When you read the actual papers you will see that the summit was really about providing the best care possible under various worsening and even the nearly hopeless conditions that could possibly occur. The sensational articles referred to the list of recommendations of who would be refused care in the most severe crisis. This list was merely a suggestion, and the authors state in the papers that there must be an ethical discussion of these issues by non medical professional people to determine whether society will accept these criteria.

The papers do not focus only on pandemic planning, but stress that plans must be flexible enough to account for many different types of mass casualty incidents. The included charts list nearly every type of incident and the appropriate responses. Still the main focus is on pandemic preparedness. Short of a nuclear war, a severe pandemic is probably the incident that would most stress the existing critical care infrastructure.

Some of the papers I have read before these on pandemic planning were very complex and tedious to follow. Many other papers focus on the numerous problems, give many “what if “ scenarios and concentrate a lot on how little we know. These papers focus more on how to get to a solution rather than moaning about the hopelessness of it all. The planning goals are focussed on three main areas; stuff, staff, and space. Essentially they say you have to have enough of each. If you are well prepared in two areas and short in the third, you are still limited by that area. They focus less on trying to predict the severity of any incident and more on how hospitals can maximize their ability to respond.

Stuff is things like ventilators, medications, PPE and other medical supplies. Staff is the number of staff that are not affected by the event plus the number of addition personnel that can be trained and used as well as how much you can increase the number of patients existing staff can care for. Space is the suitable areas that can be used to provide complex critical care.

In a nutshell, they recommend that facilities aim to increase by a factor of 3, the amount of critical care (including ventilators) they can provide, and also stockpile enough supplies to last about 10 days, with perhaps some additional buffer, and to ensure they can maximize their staffing and space to make this possible. I think these are very good recommendations. They are very similar to the recommendations I posted on the BMG website last year. I also suggested that facilities try to increase their ability to manage ventilated patients by up to a factor of 3 in one of my posts last year.

They warn that manual ventilation will not work. They are very skeptical that sharing ventilators among several patients will work with real patients that have ARDS. They provide an extensive list of requirements that facilities should look for when purchasing ventilators for surge capacity, but acknowledge that is unlikely that anyone will actually buy that many ventilators ahead of time. They also provide a much shorter list of the minimum requirements for a ventilator in suggestion 3.2:

(1) be able to oxygenate and ventilate most pediatric and adult patients with either significant airflow obstruction or ARDS
(2) be able to function with low-flow oxygen and without high-pressure medical gas
(3) accurately deliver a prescribed minute ventilation when patients are not breathing spontaneously
(4) have sufficient alarms to alert the operator to apnea, circuit disconnect, low gas source, low battery, and high peak airway pressures

The pandemic ventilator should be able to meet those short list minimum requirements.



P.S.
My son Jeff is taking his own pandemic ventilator design “Norman” to the Canada Wide Science Fair in Ottawa this week. I will have a more detailed report on “Norman” next week. I think you will be impressed with the work Jeff has done. I am.

Are the Ventilator Numbers Real?

Last week I wrote about why there is a need for a pandemic ventilator and used facts, numbers and statistics from various sources to support my statements. Whenever I write an article, I generally compose it, then go back to a list of articles and websites I have saved to validate what I have written. Most of the information is easy to validate, but I always find it difficult to come up with verifiable numbers. Often I see the same number used in many reports and assume that it must be correct. It may be though, that everyone is just referencing the same inaccurate source.

The numbers for US ventilators and usage I used last week are ones that I have commonly seen used in other places. I got a good comment on the article that suggested that the actual number of ventilators may be lower, and that usage rates may also be a bit lower as well. I have had some concern with the inability to obtain good solid numbers.

When I reviewed the Ontario Health Plan for an Influenza Pandemic, I noted that the per capita numbers of ventilators for Ontario was significantly lower than the US numbers. Ontario has a comprehensive socialized medical system that treats everyone needing care, and I have never heard of anyone being refused the use of a ventilator in Ontario that required one. I checked the pandemic plans for the region where I live and also the hospital I work at, and the number of ventilators is pretty close to what you would expect from the numbers in the OHPIP report based on population. The utilization rates though are usually pretty high, and it is not uncommon for a hospital to borrow vents from other hospitals if they run short.

The 105,000 number for the number of ventilators in the US for the US population size is 4 times as many as the ratio in Ontario. It is hard to believe that it should be so different. Even the 70,000 number quoted by the comment last week seems high by this criteria.

I think that every pandemic plan should explicitly state how many ventilators they have, and what the utilization rates are. They should also have a good idea of how much they believe that they can extend the capacity of their staff to handle additional ventilated patients if the additional ventilators were made available. Proper planning requires that they know the present status, calculate how much they can extend their capabilities, and compensate as much as possible for any shortfalls in staff or equipment. I have seen very few plans that give figures for all these variables. If they do not have good numbers to base the plans on they are really just guessing.

WWSEF Science Fair Results

Below is the pandemic ventilator prototype "Norman". Norman was built by one of our developers in his automation and robotics class.

This prototype is named “Norman” after Norman Burn. Norman Burn was the Chief Technician at the Department of Anesthesia at Newcastle. Norman Burn built many of the very first positive pressure ventilators. Some of his “home made” ventilators were used during the polio epidemic in Britain in 1947. (link here)

This developer is a high school student and has contributed to the Pandemic Ventilator Project right from the beginning. He has added many insights to the design of the project and did all the PLC programming for "Max" as well as his current prototype. He entered "Norman" in the Waterloo Wellington Science and Engineering Fair.


The Pandemic Ventilator at the Science Fair


He won 3 awards at this Science Fair:

• Silver Medal in the Senior Engineering Division

• The University of Ontario Institute of Technology Innovation Award for demonstrating the most innovative development, adaptation or use of technology in a science project.

• An Award of Merit
  

In addition to the awards, his project has been accepted to participate in the National Canada Wide Science Fair to be held in Ottawa Canada from May 10 to May 18th 2008.

We congratulate him on his hard work and dedication.


Receiving the Silver Medal Award
for Senior Engineering



Receiving the University of Ontario Institute of Technology
Innovation Award for Demonstrating the Most Innovative Development,
Adaptation or Use of Technology in a Science Project




Receiving the Award of Merit

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Correction

It seems there was an error made at the awards ceremony. Instead of the silver medal he was awarded, he was supposed to have received a gold medal and several university and college scholarships. So, we congratulate Jeff on his gold medal award. Here is a link to the official site.

Here are the awards he was supposed to have received:

• Award of Merit,
• Gold Medal, Senior Engineering,
• University of Ontario Institute of Technology Innovation Award,
• Conestoga College Entrance Scholarship,
• University of Guelph Entrance Scholarship,
• University of Waterloo Entrance Scholarship.
• Wilfrid Laurier University Entrance Scholarship.
  

His project is also entered in the Canada-Wide Science Fair

One Year Anniversary

Today is just over a year since I started the Pandemic Ventilator Project. To commemorate, I have added a new logo pVp to the blog (on the right) and will also use a smaller version as my avatar on discussion boards. Vinnie is nearing completion of the first prototype stage. Not all the features and alarms are yet in place but it is far enough along that it can be seen that this is a very feasible approach.

I have decided to give the other prototype ventilator a name as well. I will call it Max in honor of Maxwell K. Reynolds. He is the man who built those ventilators in Marquette Michigan to help save children from dying in the Polio epidemic when a commercial iron lung was not available.

In many ways I am quite happy with the progress so far. The basic principles of the design have been validated, and it also appears we can build a more advanced version with improved control and alarm capabilities. On the other hand, I expected that the project would have involved more people by now than we currently have. There are really only 3 active developers and a small number of contributors that provide advice, direction and promotion help as well.

The basic development work done so far has been done with no funding. We have purchased all components and equipment on our own. We are reaching the point that if we want to scale up the project to do more testing and be able to increase the number of available units we will have to seek some form of funding source. Everyone working on the project now is either in a full time job or education. The development work is done in our spare time. We really need the help of a professional in respiratory therapy. I have a background in biomedical technology, but I have to learn all the clinical requirements of ventilator therapy as we go along.

I have learned a lot in the last year. I thought my idea of building home made ventilators for use in a pandemic was original, but I have since learned that the same approach was used to save lives in the polio epidemic in the first half of the last century. I thought my weighted bellows idea was original but have come across many designs for older ventilators that also successfully used that principle such as the Blease Manley Ventilator. I thought the idea of building a low maintenance, low cost ventilator that can be serviced by local people in third world countries was novel, but there is a successful precedent for that as well. http://www.glostavent.com/


One idea I hold that I wish were shared by more people is that the use of home built ventilators from a proven design using readily available highly reliable industrial control system components and other common materials is a valid approach to supplying ventilators in a WHO phase 6 pandemic alert. I believe that this is one more way of maximizing the number of lives that could be saved, but not necessarily a complete solution to the ventilator shortage. I have no idea of how I can impress this idea on the people that make the triage plans and allocation decisions for pandemic planning. I have produced this blog, contacted them directly and have made numerous posts in other prominent avian flu pandemic discussion forums. I find it hard to believe they have not heard of this proposal. I have not heard from any high level planner about this. Not even criticism.

Review of - Mass Medical Care with Scarce Resources: A Community Planning Guide

Today I will review another US government planning document. This is from the US Department of health and Human Services (HSS) and the Agency for Healthcare Research and Quality (AHRQ). This one is titled Mass Medical Care with Scarce Resources: A Community Planning Guide, and is available for free at http://www.ahrq.gov/research/mce/ in html and PDF formats. Again, I will be exerpting the ventilator specific sections and making a few comments. The original document is a 181 page pdf file.

This is document has very broad coverage of not only the avian flu threat and pandemics in general but also other mass casualty events. It is a government document and so tends to avoid much discussion of extreme events and generally assumes a pandemic of similar intensity to the 1918 Spanish Influenza as a worst case position. It discusses the ethical decisions that need to be made in the face of difficult choices and provides good background info and principles but generally steers away from making definitive suggestions on what ethical choices to make.

It presents a case study of a Pandemic Flu outbreak and addresses the expected ventilator shortage. They recommend that a triage system be established to decide which patients will get to use the limited supply of ventilators. They also suggest that hospitals may be using manual resuscitation bags to provide ventilation in response to a pandemic influenza. There are also comments about the need to prevent infection of staff by patients on ventilators by using intubation and by having ventilators with an adequate alarm system so that staff do not have to constantly attend patients.

This document, like the one I reviewed last week has a lot devoted to the process of deciding which patients will receive the ventilator therapy and which ones will not and how to be sure this process is very ethical. All of the planning documents I have read so far are similar in this regard. They write about how we will have to have altered standards of care. These altered standards include: waivers of certain legal liabilities for decisions that care providers must make, licensing requirements for caregivers, using drugs such as antivirals and vaccines in different dosage levels than recommended by the FDA in order to stretch supplies, and using physical facilities that would not normally meet the standards required for hospitals.

No one sees the fact that we could alter the standards required for ventilators so that we could double or triple the supply of ventilators available in a short period of time. The plans set forth by the Pandemic Ventilator Project will allow this to happen. I have written letters to many of the authors of government planning documents and told them of our plan and invited their feedback or support. I even sent a letter to one of the authors of this document; John L. Hick, M.D in March of 2007. I have never received any reply from them.
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Here are the excerpts related to ventilators:


EMS in an MCE: Expected Shortages and Needs
In the case of an MCE, many health care resources at the local and regional levels will be overwhelmed or eliminated. Those EMS response agencies that are able to remain operational likely will encounter a demand for services that will outstrip the supply and available resources. EMS systems will confront:

• Personnel shortages.
• Breakdowns in supply chains.
• Lack of coordination and information sharing among diverse EMS providers, public safety, hospitals, trauma center, and public health.
• Breakdown of logistic support for operational sustainability, including such things as fuel shortages; inadequate availability of transport vehicles; and shortages in supplies, equipment, and pharmaceuticals.
• Overloading of hospital emergency departments and associated services such as intensive care capabilities; specialty services such as burn care or decontamination units; and specialized equipment such as ventilators, PPE, or negative pressure rooms.
• Breakdowns in local “burden sharing” strategies (mutual aid agreements) due to overwhelming demand and lack of surge capacity.
• The need to implement modified treatment protocols to meet the extraordinary conditions of the MCE that may be limited to reasonable life-sustaining activities where appropriate.
  

Hospital and Acute Care in the Context of a Catastrophic MCE
The overall goal of hospital and acute care response in an MCE is to meet the reasonable care needs of as many patients as possible while also meeting at least minimal obligations for comfort to each patient.63 In the case of a catastrophic MCE, however, hospitals will not have access to many needed resources (e.g., manual resuscitation bags to provide ventilation in response to a pandemic influenza, supply of antitoxin in the case of mass botulism poisoning). Thus, difficult decisions will have to be made regarding the allocation of available resources.

Inadequate Supplies.
Lack of sufficient supplies, particularly of specialized equipment such as personal protective equipment, ventilators, and negative pressure rooms, will be a challenge for most hospitals.

Ideally, hospitals should be able to follow guidance and decision support tools to make resource allocation decisions (e.g., who should receive mechanical ventilation) that are sanctioned and approved at the Federal level and are distributed by the State. Even with the support of these tools or policies, however, it is the hospital that will have to take on the role of implementing them.

Interstate regional coordination is another means of managing allocation of scarce resources. Interstate agreements and cooperation help promote sharing of assets across State lines. These types of agreements also help ensure consistency of response (e.g., National Capital Region) where inconsistencies between State plans could prove problematic. This level of interstate cooperation is difficult to achieve but is one of the most important ways to maximize resource allocation. The development of national-level clinical decision tools to address commonly limited resources (e.g., dialysis, mechanical ventilation) would be very valuable in helping to facilitate greater interstate cooperation.

Using expert panels or planning groups
At this time, no current predictive model is sufficient to serve as a decision framework for determining the allocation of critical care resources (e.g., ventilators, intensive care therapies). One valuable strategy for examining the allocation of scarce resources, however, is to convene a balanced expert panel that can bring in multiple viewpoints and establish decision making guidelines. The panel must be inclusive of relevant stakeholders who reflect the jurisdictional area and its demographics, in addition to recognizing border issues with adjoining States. The composition, functions, and operational role of these groups must be carefully considered.

Convening An Expert Panel To Address The Allocation Of Scarce Resources: The Example Of New York State
In March 2006, the New York State Task Force on Life and the Law (TFLL), in partnership with the State’s Department of Health, convened a workgroup to consider clinical and ethical challenges in the allocation of mechanical ventilators in a public health crisis. The group includes experts in the areas of law, medicine, policymaking, and ethics. Its goal is to develop clinical and ethical guidance for local health care systems that will promote the just allocation of ventilators in an influenza pandemic. The panel considered a range of policy options necessary to support such an allocation system, including the development of recommendations for laws or regulations in areas including liability and appropriate standards of care. Further information on the TFLL is available at www.health.state.ny.us/nysdoh/taskfce/index.

Expansion of critical care capacity by placing select ventilated patients on monitored or step-down beds; using pulse oximetry (with high/low rate alarms) in lieu of cardiac monitors; or relying on ventilator alarms (which should alert for disconnect, high pressure, and apnea) for ventilated patients, with spot oximetry checks

Clinical Adaptations represent the allocation of scarce resources or services based on the ethical principles outlined in Chapter 2.
Examples of clinical adaptations include the following:

• Triage of patients to home care, acute care sites, or other offsite locals who would otherwise be treated as inpatients
• Assignment of limited resources (e.g., ventilators, radiographs, laboratory testing) to those most expected to benefit
  

The hospital should be able to follow State guidance regarding clinical triage decisions. If no guidance exists, it will be incumbent on the hospital to have a plan or strategy for bringing together the appropriate personnel who can make the best decisions possible and reevaluate the situation during each planning cycle (e.g., each shift a day). When there is little advance evidence to guide allocation decisions (for example, not knowing how different age groups with pandemic influenza respond to mechanical ventilation), good clinical judgment by experienced clinicians will be the final common denominator to justify resource allocation decisions. The decision making process, based on ethical judgments that include maximizing good consequences across the many while meeting at least minimal duties and obligations to all, should be shared openly with staff members, patients, and the public and should be as consistent as possible across facilities.

One of the key decision points in the delivery of out-of-hospital care at an ACS is the ability to provide oxygen and respiratory therapy, particularly the ability to provide mechanical ventilation. The logistics and expense of sustaining oxygen delivery systems in an ACS setting, however, is extremely complex and prohibitively expensive. The exception to this may be the use of nursing homes and long-term care facilities in the role of alternative care facilities, given their existing medical gas supply.


The Challenge of Supplemental Oxygen
The use of an ACS for patients who require supplemental oxygen is highly problematic from a logistical point of view. Options to supply supplemental oxygen run from a home fill unit (10L/min maximum, less than $1,000) to deployable oxygen generation or liquid oxygen storage and distribution system (multiple patients, high technology, upwards of $480,000). Given the variables of cost, general availability, ease of use and sustainability, the most promising options for supplying supplemental oxygen would be either a bank of 10L/min home fill units or a rack of eight interconnected “H” oxygen cylinders, each supplying 7,000 liters of oxygen for a cost of approximately $13,000. Even this rack setup is severely limited, however, as the eight “H” cylinders could supply only 50 patients at 2 liters of oxygen per minute for 8 hours. This would necessitate three refills per 24-hour period and would require the rapid installation of a rudimentary gas distribution system. Support for ventilated patients would increase the rate of oxygen consumption significantly, further complicating this issue, and most likely would not be possible.

Locations ordinarily used to care for persons with eventually fatal chronic illnesses (e.g., nursing facilities, home health agencies) need to be ready to handle more severe complications. Plans should address the prospect of not transferring patients needing ventilator support if they are too sick to survive but prepared to provide appropriate palliative care services.

Potential shortages of ventilators could be particularly problematic. In the case of such a pandemic, hospitals may not have an adequate supply of reserve ventilators required to treat patients suffering from acute respiratory failure.

Key AARC Ventilator Capacity Recommendations

• Increase human resources to assist respiratory therapists and physicians and have easy-to-use ventilators available in the event the respiratory therapists on the hospital staffs cannot handle the volume and noncritical care professionals must be enlisted.
• Extend ventilator capacity for any mass casualty response, expanding the Strategic National Stockpiling Program by 5,000 to 10,000 ventilators. Additional ancillary supplies for ventilator use also should be stockpiled.
• Develop a distribution plan for ventilators at both the local and national levels.
• Intubation (placing a breathing tube down the windpipe) is recommended for patients suffering acute respiratory failure during a pandemic flu, because ventilation by mask may increase the risk for infection to staff and other patients.
• Prepare for a power outage: each medical center should identify emergency power sources for electricity and compressed gas.
  

Assess surge capacity (beds, ventilators, etc.) to meet expected increased needs during a pandemic

Conduct Just-in-time-training for staff members, including influenza transmission, general information, infection control information, ventilator management, and hospital plans. Training is to be conducted via e-mail, informational posters, and shift briefings.

Open a joint information center (JIC) with the hospital association acting as liaison with all hospitals in the region. The regional coordinating hospital provides updates and solicits baseline availability of ventilators and patient beds.

Respiratory therapy manages ventilators only; other respiratory care services are to be provided by nurses. Floor nurses are to receive training in basic ventilator monitoring, with floor units supervised by a roving ICU nurse to monitor ventilated patients.

Select operating room and procedure room space to be used for additional ventilated patient care.

Set up a triage team (may consist of one critical care and one infectious disease physician, among others) to review conflicting resource needs (e.g., two patients needing a single ventilator) on a case-by-case basis.

Identify a Bed Czar to monitor the bed and “hard” resource statuses (e.g., ventilators), make assignments based on availability, and implement triage team recommendations.
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There is a mention of where to obtain the Sphere Handbook for Humanitarian Response in the original document. The listed website is incorrect. Here is the correct one:
http://www.sphereproject.org/component/option,com_docman/task,cat_view/gid,17/Itemid,26/lang,English

Review of Online Book - Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary

Today I am presenting sections from the online book:

Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary
Stanley M. Lemon, Margaret A. Hamburg, P. Frederick Sparling, Eileen R. Choffnes, and Alison Mack, 2007

I will concentrate primarily on the issues that affect ventilator shortages. This is only a small part of the book. The pdf file runs 250 pages.


This book is available complete for free as a pdf file at:
http://www.nap.edu/catalog/11917.html

Available from The National Academies Press at http://www.nap.edu

This book presents a fairly complete and balanced view of the ethical issues to date regarding pandemics.

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The book begins with a quote from Goethe:
“Knowing is not enough, we must apply;
Willing is not enough, we must do.”

The following excerpts are from the workshop discussion:

Addressing Shortages: Medical Care
While it is widely acknowledged that an infectious disease pandemic is likely to overwhelm the U.S. medical system, the federal government has given scant attention - and even less money - to redressing this situation. “There is a great gaping gap here,” said speaker D.A. Henderson, who criticized government planners for focusing on what he believed to be “fringe things,” such as stockpiling and delivering countermeasures of questionable efficacy, rather than concentrating its efforts on “a problem which we know we are going to have.” He attributed the lack of progress toward addressing this critical and predictable need to poor communication between public health officials and hospital administrators, as well as between HHS and CDC.

Although individual hospitals are attempting to prepare themselves for pandemic influenza by conducting surge capacity trials, Henderson observed that few facilities are prepared to handle a worst-case scenario in which patients could exceed capacity by 30 to 40 percent. He predicted that under those conditions hospitals would begin to turn away patients, including some who desperately need care. In order to accommodate them, Henderson recommended the creation of alternate regional sites staffed by volunteer caregivers. He also noted that plans for medical care during a pandemic need to address such issues as liability, the credentialing of volunteers, nonpaying patients or patients without adequate health insurance, the cancellation of elective surgical procedures, and pandemic associated losses in hospital revenue.

Workshop participants considered a variety of gaps that exist in pandemic preparations at the hospital level. According to one estimate, if an influenza pandemic occurred today, demand for ventilators would exceed supply by nearly 200 percent (Bartlett, 2006)

Addressing Shortages: Global Supply Chains
Another far-reaching concern regarding the U.S. pandemic influenza strategy is its failure to recognize America’s dependence on and interdependence with fast-moving global markets. Forum member Michael Osterholm observed, for example, that the vast majority of medicines in the U.S. are manufactured abroad or made from precursor materials that are manufactured abroad. Furthermore, critical supplies such as oxygen are delivered just in time to hospitals and other end-users and are therefore dependent upon fuel, which is also largely foreign in origin.

Duty to Care
Health-care workers on the front lines in infectious disease outbreaks (e.g., smallpox, Ebola, and SARS) have consistently fulfilled their duty to care for patients even when it has cost them their lives (see Heymann, page 33). Ruderman and colleagues report, however, that during the SARS crisis in Canada, “serious concerns arose . . . about the extent to which health-care providers would tolerate risk of infection,” leading to the anticipation of a potential crisis during a pandemic (Ruderman et al., 2006).


Ethical Guidelines for Clinicians
An influenza pandemic is likely to produce extraordinary shortages in medical care. Hospital resources—both human and material—may be stretched beyond their limits. In order to manage the many ethical dilemmas inherent in this situation, physicians and hospital administrators will need specific guidelines,
Lo said (see Lo and White, page 192). His observations were echoed by several workshop participants, some of whom spoke from a personal perspective, as they themselves will be called to play certain roles in a pandemic. Among the challenges that pandemic influenza will present to clinicians, one of the likeliest and most daunting will be a grave shortage of mechanical ventilators. Such a shortage, Lo observed, will require physicians to choose which patients will receive the life-saving use of a ventilator and which will die without respiratory therapy. There will be no time to weigh alternatives in a pandemic, Lo argued, so it will be important to develop clear criteria ahead of time for when to triage patients, along with guidelines and procedures for addressing problems that will arise as the triage system is implemented, such as handling disagreements with family members and managing patients in respiratory failure who do not receive mechanical ventilation.

Lo urged pandemic planners to anticipate the ethical and legal dilemmas that doctors and other health-care providers will face in a “worst-case” ventilator shortage and to create, with input from the public and specialists in various disciplines, guidelines and procedures for dealing with shortages of ventilators another medical supplies. While suggesting that rules for triage should maximize the number of lives saved, Lo also pointed out that physicians must rely on limited evidence to predict a patient’s prognosis. Triage rules, he said, should be administered by an external authority, not the physicians dealing with the patients, and they should be implemented by physicians and other health-care workers in such a way that their fairness cannot be doubted. Fairness in allocating scare resources will be necessary to secure public trust in the process, Lo observed, but it will not be sufficient. Triage policies and priorities must also reflect popular will, he said. Moreover, the policies must be communicated clearly and in a way that people will understand. And they must be presented in a way that leads society to accept the idea that, during an infectious disease emergency, some patients will die who might otherwise have been saved under normal circumstances. Lo also stressed the importance of providing the public with ready access to the data, reasoning, and deliberative processes that support such triage guidelines. Unfortunately, Hearne observed, some states have not only failed to engage the public in pandemic planning, but they have actively excluded them from the process and have kept their plans secret, even from hospital workers and other health-care providers.

Civic Engagement
Since the nation’s experience with the aftermath of Hurricane Katrina, many Americans have come to be extremely cynical about government efforts meant to protect them from disaster, Hearne observed. As a result, she said, broad changes in public health law will be needed to prevent a potentially disastrous breakdown in public health authority during a pandemic.

Ethics in the Midst of Uncertainty
While recognizing the ideal of public participation in pandemic planning, workshop participants nonetheless agreed that public health professionals must expect most people to be entirely unprepared when the next pandemic strikes.

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The following excerpts dealing with ventilators are from the included paper:

INTENSIVE CARE UNIT TRIAGE DURING AN INFLUENZA
PANDEMIC: THE NEED FOR SPECIFIC CLINICAL GUIDELINES
Bernard Lo, M.D.
University of California, San Francisco
Douglas B. White, M.D.
University of California, San Francisco

During a severe influenza pandemic, a dire shortage of breathing machines— mechanical ventilators—is projected. According to one estimate, a pandemic will require 198 percent of the current supply of ventilators (Bartlett, 2006). If this happens, many people in respiratory failure who need mechanical ventilation in order to survive will not receive it. This grave shortage of ventilators will raise unprecedented allocation dilemmas that ought to be addressed before a pandemic strikes.

Ventilators should be considered a scarce resource to be allocated according to public health guidelines rather than by the decisions of individual physicians and patients.

Guidelines for allocating scarce medical resources during a pandemic will require several levels of specificity. At the broadest level, state public health laws express a general societal agreement that during a public health emergency the decisions of individual physicians and patients will be constrained by public health policies (Gostin, 2000). At the next level of specificity—the level of clinical care decisions—hospitals and physicians need criteria for triaging various patients who need mechanical ventilators when the demand greatly exceeds supply during a pandemic. To minimize overall loss of life during a pandemic, priority should be given to patients who require mechanical ventilation but who are highly likely to survive after only a few days on the ventilator. Finally, at the most specific level, frontline physicians need guidance in implementing these triage priorities in specific clinical cases.

Ventilator Shortages During a Pandemic
Suppose for the sake of a dramatic example that an ICU in the midst of a pandemic has only one available bed and ventilator. In the emergency department are several patients in respiratory failure, all of whom will die without mechanical ventilation. It is not feasible, given staff shortages, to keep these patients alive by manually squeezing a bag to drive air into the lungs. One patient is a 30-year-old whose only medical problem is respiratory failure, presumably from influenza. Another patient has not only respiratory failure from influenza but also hypotension and renal failure. The presence of these additional problems means that the second patient has a worse prognosis than the first (Graf and Janssens, 2005). Additionally, there are two other patients in the emergency department with respiratory failure who also will die without mechanical ventilation. One is a 22-year-old with an acute asthma attack who has no clinical evidence of influenza. Another is a 58-year-old who requires emergency coronary bypass surgery for continued myocardial ischemia despite optimal medical management.

These latter two patients are expected to survive if they receive just a few days of mechanical ventilation. Thus the shortage of ventilators will affect not only patients with influenza but also those who have respiratory failure from other causes.

Ethical Guidelines for Triage of Mechanical Ventilators During a Pandemic
A scarcity of ventilators during a pandemic will require an allocation policy based on different ethical guidelines than those governing usual clinical care. The term triage is commonly applied to the process of sorting, classifying, and assigning priority to patients when available medical resources are not sufficient to provide care to all who need it

The first ethical guideline for ventilator use during a pandemic is that increasing the number of lives saved may take priority over patient autonomy. Public health officials, working in concert with clinical experts and public representatives, should set guidelines for prioritizing patients who need mechanical ventilation.
Individual physicians and patients must then make decisions that are consistent with these guidelines.

The second guideline is that patients with a high likelihood of surviving after a few days of mechanical ventilation should receive the highest priority. Characterizing this group will be difficult, however, because data are incomplete and uncertain.

The third guideline is that during a public health emergency fairness and perceptions of fairness are crucial.

The fourth guideline is that transparency is essential during a public health emergency. The public needs to know how ventilators will be allocated in order to trust that the allocation is fair. Triage priorities and policies should be explicit. The public should have ready access to the triage guidelines, the data and the reasoning underlying them, and the process by which they were derived.

Applying Triage Principles to Specific Cases
Even if there is wide agreement on the triage principle of minimizing loss of life during a pandemic, hospitals and health-care workers will still face many difficult decisions when making triage decisions in specific cases. Before a pandemic occurs, it will be important to identify these dilemmas, analyze them, and reach some agreement on how to resolve them.

During Triage, Should Patients Already on Ventilators Be Reassessed?
We have framed the problem of allocating ventilators as “the last bed in the ICU.” In reality, the situation is more complex because patients already in the ICU on ventilators may have a worse prognosis than new patients with respiratory failure. Suppose, for example, that one of the ICU patients is a 38-year-old man with influenza who has developed multi-organ failure and whose condition has worsened during five days of intensive care. His prognosis now is worse than that of a new patient who presents with respiratory failure as her only medical problem, with no other organ failure. Or suppose that there is also a 68-year-old patient with chronic emphysema and respiratory failure who is gradually improving but who is likely to require several weeks of ventilator support as his lungs slowly improve. Keeping such current ICU patients on ventilators leaves fewer ventilators available to other patients in respiratory failure, who will die without them and who are likely to survive after receiving ventilation for only a few days. Therefore, allowing patients already in the ICU to remain on ventilators without regard to new patients with respiratory failure is likely to decrease the total number of lives saved. On the other hand, removing patients from ventilators who are not improving after several days would violate the usual ethical guideline that a physician should act in the best interests of patients and be faithful to them.

What Other Considerations Should Be Taken into Account During Triage?
We have identified a high likelihood of survival and a short-term need for mechanical ventilation as two criteria for giving high priority to patients with respiratory failure during a pandemic. If there is still a shortage of ventilators after these criteria have been applied, a number of other criteria might be considered. Such criteria might include the likely duration of life and the likely quality of life in a patient after treatment or the existence of personal behaviors that may have led to the respiratory failure, such as smoking or non-adherence with asthma medications. Judgments about quality of life and personal behaviors are more subjective that a strict medical prognosis and inevitably involve value judgments over which reasonable people may disagree. Because incorporating these considerations into triage decisions would heighten concerns about unfairness, they are best avoided during a public health emergency.

How Will Disagreements by Family Members Be Managed?
Civilians have no experience with triage, unlike military personnel who are familiar with the approach. Faced with the death of a relative which might be averted with mechanical ventilation, families might strongly object to foregoing the use of the ventilator. In light of this, several issues likely to face frontline physicians should be addressed before a pandemic strikes. Would it be feasible, for example, to create timely appeals mechanisms for decisions regarding ventilator use? During public health emergencies, governments have the police powers to enforce public health measures; will there be police in hospitals to enforce triage decisions about ventilators? And how can the risk of violence be minimized?