Friday, February 29, 2008

Review of Ontario Health Plan for an Influenza Pandemic

I have reviewed other pandemic planning documents that deal with the shortage of ventilators before and today I will discuss one that has some particular importance for me. It is produced by the Ontario Ministry of Health and Long Term Care (MOHLTC), and is entitled “Ontario Health Plan for an Influenza Pandemic” (OHPIP). It is dated July 5, 2007 and is the fourth edition. This document is available at
Ontario has planned extensively and early for a possible flu pandemic. This is most likely because of its direct involvement in the SARS and the fear that it would become a pandemic.

This plan is important to me of course because I live in Ontario Canada. Previous OHPIPs issued by MOHLTC have been referenced by other planning organizations. Ontario has been early to recognize the need for a triage plan to deal with the expected crisis for health care in a pandemic, and particularly the shortage of ventilators and trained health care staff that will arise. As in other review posts I have done, I will concentrate mainly on the ventilator issue using excerpts with my attached comments.

The list of contributors to the document is very long and diverse including hospitals, community groups, and businesses as well as academia.

It first has a quote by John M. Barry:
“Every expert on influenza agrees that the ability of the influenza virus to reassort genes means that another pandemic not only can happen. It almost certainly will happen … influenza is among the most contagious of all diseases … the influenza virus can spread from person to person before any symptoms develop. If a new influenza virus does emerge, given modern travel patterns it will likely spread even more rapidly than it did in 1918.”

The document begins by discussing the need for pandemic planning and why there is a particular concern for an influenza pandemic now. It then discusses the role of the WHO and other governing and regulatory groups in pandemic planning. There is a discussion of the ethical framework required for the plan. It references “Stand on Guard for Thee”. Legislation that is required to implement the alteration of rights and government control required to implement the plan is also discussed. The planning goals are then explained. The plan uses the Meltzer model from the CDC, uses the FluAid 2.0 software, and assumes a pandemic of mild to moderate severity.

They do not mention central purchase of ventilators.
“The MOHLTC will provide centralized purchase and distribution of certain personal protective equipment, vaccines/antiviral drugs and other clinical supplies.”

Section 4 has a very good list of links to Ontario and world organizations and other information documents. I will post a copy of the links at the bottom of this post. There is also a very detailed section on credentialing including checklists. There are also general plans on how to increase the availability of staff levels. There is much more very good general planning information, but I will skip now to the portions relevant to ventilator shortages.

Here is a hospital capacity table.
This is also a “most likely “ scenario. I am not sure why there are no numbers for ventilators for weeks 9 and 10 in the scenario. Click on the image to see a clear copy.

Tables such as these are deceiving. At first glance it looks as if we will only have a real ventilator shortfall in weeks 4, 5 and 6, but this excludes the normal utilization of the ventilators in hospitals. They assume 1096 ventilators in Ontario. Now if we assume a normal inter-pandemic utilization rate of 80%, then we really only have 219 ventilators available from our existing pool.

The ventilator shortfall becomes this:

---------------Zero Extra Vents------------500 Extra Ventilators
Week 1 ------------58
Week 2 -----------368
Week 3 -----------683----------------------------183
Week 4 -----------972----------------------------472
Week 5 ----------1070---------------------------570
Week 6 ----------1035---------------------------535
Week 7 -----------777
Week 8 ----------469
Total ----------5374----------------------------1760

These are the numbers of ventilator triage decisions that will have to be made each week during this calculated scenario. Now remember, there is a very good chance that the real numbers could be much worse. If the number of supported ventilators could be doubled, then no ventilator triage decisions would have to be made. If the number of supported ventilators could be increased by 500 (50%), then the total number of ventilator triage decisions could be reduced from 5374 to 1760.

Here is a method they suggest to increase the ability to care for ventilated patients. In this example it doubles the capacity.

Scaling Back Elective Services
Scaling back elective services and surgeries can free up hospital areas, such as surgical intensive care units, endoscopic units, step-down units and post anaesthetic care units [PACU], that are well equipped to provide critical care for influenza and non-influenza patients. How much critical care capacity can be increased will depend largely on the availability of ventilators, and personnel skilled in managing critically ill patients. Scaling back elective and non-urgent services can also provide additional personnel who may have skills transferable to critical care – particularly when a team care model is used (figure 17.2). In this model, health care providers who lack experience in a specific area can be supervised by those with the relevant experience. Instead of individual health care providers caring for one or two patients, a team that has a complete skill set and relevant experience collectively cares for a group of patients. For example, a team of 2 ICU nurses supervising 3 stepdown nurses working with a respiratory therapist and a physician could care for 8 to 10 patients instead of the usual complement of 4 ICU nurses caring for 5 ventilated patients (i.e., 1:1 or 1:2 ratio). The care team model has proven effective in past emergencies(5;6).

Here is the Protocol for prioritization of Patients

The final component of the triage protocol is the prioritization of patients for potential admission to the ICU and ventilation. For ease of use, the common blue-red-yellow-green colour scheme was used.

• Blue patients are those who fall in to the expectant category and should not receive critical care. Depending on their condition and medical issues the patient may either continue to have curative medical care on a ward or palliative care.

• Red patients are highest priority for ICU admission and a ventilator if required. The aim is to find the balance between those who are sick enough to require the resource and will do poorly if they don’t receive it, but are not so sick that they are unlikely to recover even if they do receive intensive care. Patients with a single organ failure, particularly those with respiratory failure due to influenza and who otherwise have a very low SOFA score are included in the red category -- if they have no exclusion criteria. The goal is to optimize the effectiveness of the triage protocol so that every patient who receives critical care will survive.

• Yellow patients are very sick and may or may not benefit from critical care. They should receive care if the resources are available but not at the expense of denying care to someone in the red category who is more likely to recover. At the re-assessment points, patients who are improving are given high priority (red) for continued care, while those who are not showing signs of improvement or worsening are prioritized as yellow.

• Green patients should be considered for transfer out of the ICU.

So what is my overall impression for the plan for my province?

I have worked in the Ontario health care system for about 20 years, and in my experience I have found that there is a strong commitment to caring for the patients we are entrusted to. This document addresses that commitment many times, even when it acknowledges that there are limits to what can be done. On first glance the plan looks very thorough, and is detailed in many areas. It does however have one glaring shortfall. It recognizes that there will be many possibly avoidable deaths because there will not actually be enough ventilators. It has plans to increase the physical space available, antiviral medications, legal issues, and even the staffing plans that could support more ventilators, but there is no plan to actually increase the stockpile of ventilators to a number that could have a significant impact.

The estimated number of ventilators seems low. It is stated as 1096 and is stated as the number of ventilator supported beds. The typical numbers used by US planning authorities is 105,000. The population of Ontario is about 12 million and the population of the US is about 300 million. This is a 25:1 ratio. (The US seems to have 4200 ventilators per 12 million population. This may include patients on chronic ventilators.) It seems that the issue of the number of ventilators available for use should be looked into more closely and this discrepancy accounted for.

The number of available anesthetic gas machines that could be used as ventilators should be accounted for as well. The plan does not go into how the number of available ventilators can be expanded or what the requirements for any acquired surge capacity ventilators should be.

I am sure that the MOHLTC does not want to make the types of planning errors in the face of an impending flu pandemic that the Canadian Red Cross made in the 1980’s in the face of the impending AIDS pandemic, where they could have done several things to save lives but they did not. The CBC archives has a retrospective on this at

If you are a pandemic planner, or you work for the MOHLTC, you may wish to listen to these clips, and while you listen, think of how you would respond to people who have lost loved ones in a pandemic due to a ventilator shortage, asking about whether you ever considered getting an additional supply of ventilators ahead of time.

(See my earlier post ~ Trusting in the Pandemic Plans)

I will end with another quote from John Barry that was used in the document:

To have any chance in alleviating the devastation of the [1918 influenza] epidemic
required organization, coordination, implementation. It required leadership and it
required that institutions follow that leadership.

The Great Influenza, John M. Barry

Links from Chapter 4

General Information Resources for the Public

Ontario Ministry of Health and Long-Term Care Pandemic Planning information web site

Telehealth Ontario
A free, confidential telephone service you can call to get health advice or general health information from a Registered Nurse. 1-866-797-0000

Ontario Ministry of Health INFOline INFOline would direct callers to the appropriate information source for health information.
1-800-268-1154 (Toll-free in Ontario only)
in Toronto, call 416-314-5518, TTY 1-800-387-5559

Government of Canada Information on the Preparedness and Response to a Flu Pandemic One-stop access to information from Government of Canada departments and agencies on pandemic, avian and seasonal influenza.

Government of Canada pandemic influenza information hotline
For answers to specific questions or comments about avian, seasonal, or pandemic flu.

Public Safety Canada Web Site for Pandemic Preparedness
A compilation of pandemic preparedness plans from several organizations and levels of government (federal, provincial and municipal plans are linked from this site when available).

U.S. Government Avian and Pandemic Flu Information Managed by the U.S Department of Health and Human Services.

World Health Organization Web site for pandemic influenza Planning, technical and surveillance
information for pandemic influenza.

What you should know about a flu pandemic
A public information brochure by the Ontario Ministry of Health and Long Term Care, which is available in 24 languages.

An American Sign Language Video Visually presents the contents of the public information brochure.

Fact Sheets

Ten fact sheets including “What You Should Know About a Flu Pandemic,” are available in printable formats in 24 languages.

Centers for Disease Control and Prevention Information on Community disease control and prevention.

Canadian Pandemic Influenza Plan

World Health Organization

Health and Human Services, USA.
Pandemic Influenza Plan.

Resources for Health Care Providers
Ontario Ministry of Health and Long-Term Care Pandemic Influenza
Information for Health Care Professionals. Information includes provincial emergency status, the Ontario Health Plan for an Influenza Pandemic, fact sheets about treatment and patient care, and links to other health Web sites.

MOHLTC Healthcare Providers Hotline
For answers to health care providers’ questions. 1-866-212-2272

Ontario Ministry of Labour (Occupational Health and Safety)
Information on Occupational Heath and Safety regulations and protocols in Ontario.

Government of Canada Pandemic Influenza Information for Health Care Professionals
Provides information kits, technical information and Epidemiological Surveillance reports.

Public Safety Canada Website for Pandemic Preparedness
A compilation of pandemic preparedness plans from several organizations and levels of government (federal, provincial and municipal plans are linked from this site when available).

World Health Organization Website for Pandemic Influenza
Planning, technical and surveillance information for pandemic influenza.

Pandemic Information compiled by The Public Health Agency of Canada (PHAC).

The MOHLTC’s Emergency Management Unit Health Care Provider Hotline
Includes information for health care providers, employers and first responders.
Toll-free phone 1-866-212-2272; email

Important Health Notices (IHN)
Issued by the MOHLTC in response to abnormal events that require ministry direction. The information is intended primarily for use by health care workers and facilities/organizations providing health care, including pharmacies, hospitals, long-term care facilities, community-based health care service providers, and pre-hospital emergency services. IHNs are distributed by email, daily at midnight, and are posted to MOHLTC web site.

Fact Sheets for Health Care Professionals

Fact sheets for matters regarding protection, treatment, and patient care.

Centers for Disease Control
and Prevention Information on Community disease control and prevention.

Canadian Pandemic Influenza Plan

World Health Organization

Health and Human Services, USA.
Pandemic Influenza Plan

The Role of Health Leaders in Planning for an Influenza Pandemic
a Publication by the Canadian College of Health Service Executives

Context and Assumptions

Maintained by the Public Health Agencyof Canada (PHAC).
Includes archives and up-to-date information on influenza in Canada.

The Meltzer Model.
Martin I. Meltzer M.I, Cox N.J, and Keiji Fukuda.
The Economic Impact of Pandemic Influenza in the United States: Priorities for Intervention. Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

FluAid 2.0 software
Developed by the U.S. Centers for Disease Control and Prevention

FluSurge program
Developed by the U.S Centers for Disease Control and Prevention

FluWorkLoss software
developed by the U.S. Centres for Disease Control
estimates the potential number of days lost from work due to an influenza pandemic.

The Role of Bioethics in an Influenza Pandemic.
Gibson J et al (2005). Ethics in a Pandemic Influenza Crisis. Framework for Decision Making. Joint Centre for Bioethics, University of Toronto. WHO Global Pandemic Alert Phases


The Ontario Health System ImprovementsAct (2007)

The Ontario Health Protection and Promotion Act (2006).

The Ontario Crown Employees Collective Bargaining Act (1993)
Provides information on the duties of “essential employees”

The Ontario Emergency Management Act

The Ontario Regulated Health Professions Act (RHPA).

The Ontario Occupational Health and Safety Act

The Ontario Workplace Safety and Insurance Act


Public Health Agency of Canada
FluWatch surveillance system provides a national picture of influenza activity.

The Canadian Network for Public Health Intelligence
Contains various internet-based applications and resources designed to provide a secure way for public health authorities to share information and manage resources in an outbreak situation.

Ontario Influenza Bulletin
Includes regularly updated information on influenza in Ontario

Infection Control

Preventing Respiratory Illnesses, Protecting Patients and Staff
Document created by the MOHLTC which includes the FRI Case Finding Protocol
(Note: these guidelines have been developed for non-outbreak conditions; however, because influenza is primarily droplet and contact spread, the principlesof infection control in the guidelines can be applied more broadly.

Infection Prevention
A reference booklet for health care workers produced by Engender Health.

College of Physicians and Surgeons of Ontario – Infection Control in the Physician’s Office.

Ontario Ministry of Labour (Occupational Health and Safety)
Information about occupational Heath and Safety regulations and protocols in Ontario as well as a reference about people’s rights as employees.

Infection Control Toolkit Strategies for Pandemics and Disasters.
Can be ordered through the Community and Hospital Infection Control Association (CHICA - Canada). Phone 204-897-5990 or 866-999-7111; email
Canadian Pandemic Influenza Plan Annex F

Infection Control and Occupational Health Guidelines during an Influenza Pandemic in Traditional and Non-Traditional Health Care Settings.

Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care.

Handwashing Techniques

Canada Communicable Disease Report Prevention and Control of Occupational Infections in Health Care.

Canadian Tuberculosis Standards 5th ed.
Produced by the Canadian Lung Association in 2000

Ontario Best Practice Manual
Contains information on proper cleaning, disinfection, and sterilization.

Infection Control Guidelines on Handwashing (Health Canada).

Engineering Controls. CSA Standard CAN/CZA-Z317.2-01
Special requirements for heating, ventilation, and air conditioning (HVAC) systems in health care acilities. Toronto: Canadian Standards Association, 2001.

Occupational Health and Safety

Ontario Ministry of Labour (Occupational Health and Safety)
Information about occupational Health and Safety regulations and protocols in Ontario as well as a reference about people’s rights as employees.

The Occupational Health and Safety Act
Regulation: Health Care and Residential Facilities

The Workplace Safety and Insurance Act

Ontario Safety Association for Community and Healthcare (OSACH)
Pandemic Planning Resources

For a complete listing of products and services available from all of Ontario's designated Safe Workplace Associations, see:

Canada’s National Centre for Occupational Health and Safety Pandemic Planning Portal

United States Department of Health and Human Services Health and Safety Information

Occupational Health and Safety Association (OSHA) Guidance on Preparing Workplaces for an Influenza Pandemic

Potential Training Resources for Volunteers
St. John Ambulance Brigade. Brigade Training System (1997).

St. John Ambulance Brigade. Handbook on the Administration of Oxygen (1993)
ISBN 0-919434-77-0.

Yes, You Can Prevent Disease Transmission (1998).
The Canadian Red Cross Society

Immunizations / Vaccines

The Canadian Immunization Guide, 6th Edition
A comprehensive guide produced by Health Canada

Vaccine Storage and Handling Guidelines
A set of guidelines produced by Ontario Ministry of Health to ensure that vaccines are stored and transported at ideal temperature in the appropriate containers

California Department of Health Services Immunization Branch
Information on Comforting Restraining for Immunization

WHO Directions for the Vaccination ofChildren

Further Information on Safe Vaccine Administration, and Healthcare Worker Safety

Laboratory Services and Safety

The Laboratory Annex, Canadian Pandemic Influenza Plan
Contains additional information on avian influenza infection in

Transportation of Dangerous Goods Regulations
Detailed information on infectious substance (specimen) packaging and transport
World Organization for Animal Health (Office International des Epizooties)
All novel H5 and H7 influenza strains discovered in a laboratory should also be reported here because of possible “crossspecies” transmission and infection.

Public Health Agency of Canada Containment Levels
Updated information is available from the Office of Laboratory Security of the PHAC
(Phone) 613-957-1779, or (fax) 613-941-0596

Sunday, February 24, 2008

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.

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.

Saturday, February 16, 2008

Test of the Pandemic Ventilator with Manometer

It has been a while since I did much development work on the ventilator I am building. This is one of three pandemic ventilators currently being developed. A much more functional unit that requires some special order components (Vinnie) is also being built, and someone is building another unit with capabilities somewhere between my unit and Vinnie.

Now if you have seen my last demonstration, (link here) you will see I used another bellows unit as my test lung then. I had no idea of what weight to place on the bellows, so I guessed and put some wrenches on them. Since then I have acquired a proper test lung. It is a Puritan-Bennett 0612. I have also mounted the ventilator on an old chair stand to make it easier to work on and move around with the heavy weights.

Once we started using a real test lung, we found out that the wrench on the bellows lid would not do for weight. One pound per square inch is about 27 inches of water. The Ziplock bag I was using was about 100 square inches so it would need 100 pounds on the bellows. I don’t think the poor bag would stand that very long. I needed a replacement that was tough and readily available. I settled on a 2 liter peritoneal dialysis bag. I tested this by standing on it, so I knew it would withstand at least 200 pounds without bursting. I then tried a destructive test by jumping on it. It still did not burst. Case closed. The uninflated surface area of this bag is about 50 square inches. I put about 30 pounds of weight on the bellows .

The manometer is constructed almost exactly to the original plan. I decided to go with a small diameter tube to keep the total compliance of the system low. The internal diameter of this tubing is 0.17 inches (3/16 nominal), this is about 44mm, and adds about 3 c.c.s of compliance at 20 inches of pressure. This is a negligible amount for a 500cc tidal volume (0.6%). This size of tubing (3/16ths) is about as small as you can go with water. If you go with a smaller tubing diameter you can end up with sections of air between water sections that are difficult to purge. This small diameter will not let me use my floating magnet trick for a sensor. I added food grade coloring to make it easier to see the level.

You can see it runs fairly well. As near as I can calculate, it is running a tidal volume of about 500 cc. I checked this by inflating the test lung to this size and placing it in water and comparing it to the pre inflated displacement. The rate is about 18 breaths per minute. This works out to a minute volume of about 9 liters. Not bad. I think I am getting close to a truly useful device for use in a pandemic.

If we wanted to change these parameters we could:
  • widen the bellows settings to increase the tidal volume or
  • narrow the bellows settings to decrease the tidal volume
  • increase the weight on the bellows to reduce the inspiration time or
  • decrease the weight on the bellows to increase the inspiration time
  • increase the cycle time of the PLC to increase the expiration time or
  • reduce the cycle time of the PLC to reduce the expiration time

Things I learned:
  • The peritoneal dialysis bag will work OK. I am a lot less worried about reliability with this bag.
  • The bellows should be built more sturdy.
  • The manometer principle is valid for peak inspiratory pressure.
  • I will have to think about the best way to handle the manometer level sensing. In order to sense the level accurately, I will need sensors for fluid in tubing or use conductive sensors.
  • I will have to improve the sensing position adjusters. i may use mechanical switches instead of magnetic switches.
  • I may try adding the maximum weight on the bellows for a safe maximum pressure and adjust the inspiration time with a manually operated valve that lets me control the flow rate out of the bellows.
  • I need better regulation of the input air pressure.
  • Once I get all the bugs worked out I will rebuild it to a more useful form factor.
  • I will have to do a calibration of the system using other pressure sensing equipment, then I can mark the levels on the manometer.

Friday, February 15, 2008

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 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.

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

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.

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:,com_docman/task,cat_view/gid,17/Itemid,26/lang,English

Sunday, February 10, 2008

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:

Available from The National Academies Press at

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


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.


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

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?

Wednesday, February 6, 2008

A Personal Account of Home Made Ventilator Saving a Life

My post from last week about homemade ventilators used during the polio epidemics in the 1940s and early 1950s (Everything Old is New Again) generated some response. I received a personal account of a ventilator being quickly made for a child during a polio outbreak in Marquette Michigan. This is an account I got from Joan and Don Miller in Marquette, who generously let me reprint it here.


These are some recollections of mine regarding the iron lung that I saved from my grandfather Max Reynolds belongings. It appears that the story I remember takes place in the late 1930's here in Marquette during the polio epidemic. I will start out with a bit of background on the gentleman and then relate the story of this device.

Grandfather Max came to Marquette as a civil engineer with an explosives company. He married into the Peter White family, one of the founding fathers of Marquette. As time went along Grandfather got very involved with what then was St. Lukes Hospital- now Marquette General Hospital, The Michigan Crippled Children's Clinic, and Bay Cliffs Health Camp. He also pursued two of his most cherished hobbies- boating and photography. The boating interest lead to the building of the Lake Superior Yacht Yard along with it the shop where many things were created and built.

Maxwell K. Reynolds became a director and chairman of the board at the hospital, then a small nonprofit hospital. So he was very interested in the day to day operations of the hospital. When the polio sickness arrived, he got started creating and building the Iron Lungs. I'm not really sure where he picked up the ideas, but he was a very inventive and creative person. So he guided his staff in making a number of these devices. Some of the lungs he made were built out of old oil drums, boxes, or about anything else he could find.

One day the hospital called with an urgent request for a lung. Apparently, they had a patient that required help quickly, and could he help. Max said he would provide a device. He went quickly to the old railway station and found an old refrigerator box- made of plywood in those days. He got that to the Shop and the crew started putting together the unit I still have. A door was made on one side, secured with window sash locks. The neck hole was secured with a rubber knelling pad with hole to fit the youngsters neck. Next, a source of vacuum, so grandmas vacuum cleaner was connected to the box. The air was let into the box with a simple plug valve that would be operated by an attendant to control the child's breathing. Later they tried a phonograph as an actuator, but that required some extra time to perfect. So the story goes, from the first call to the time the unit was delivered was 4 hours!

I guess there are not too many people around now that can assist with this accounting. This is as I recall, and I must add that grand pa Max died when I was about 8 years old. He had many talents and tried to get me started on some of them. I only wish that we had a bit more time, since he was quite a guy!

Recalled by Peter W. Frazier, grandson to Maxwell K. Reynolds, Marquette, Michigan

There is a similar account in the Marquette Monthly of Sep 2006, Back Then.

Link here:
The Wooden Lung, Fighting polio with boxes and vacuum cleaners. by Becky Kratz