Re: WHO Innovative Technologies

Dear Antonio,

The list is a relevant support to improve the development of projects and
policies, I appreciate receiving your kind email,

Best regards,
Rossana Rivas

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WHO Innovative Technologies

The World Health Organization is pleased to announce the posting of the list of selected innovative technologies that address global health concerns. Fifteen medical devices were selected in the framework of the call and can be found at the WHO web site. The selected innovative technologies were found to meet the selection criteria defined in the call by the team of external experts appointed by WHO.
More:
http://www.who.int/medical_devices/call/en/index.html


Antonio Hernandez

Senior Advisor

Health Services Physical Infrastructure & Technology

Pan American Health Organization – PAHO

World Health Organization – WHO

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Re: big picture, macro view, holistic policy

Dear INFRATECH colleagues,
I agree that a co-ordinated approach to the purchase and use of medical devices is required in which all stakeholders are involved. In the UK each hospital or cluster of hospitals would have a medical equipment management committee. HTM and HTA are of course important. Medical device regulations and policy (nationally and locally) are also important if the most “suitable” device for each situation is to be purchased. As Michael rightly said the local context is very important.
Warm greetings !
Len
Len Cornish
Biomedical Engineering Consultant
Global Healthcare Projects
58 Oakfield, Goldsworth Park,
Woking, Surrey, GU21 3QS, England.
Mobile: +44 (0)7855 459708
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CE/HTM Staff Job descriptions

Dear Malcolm and Calil,

Once upon a time… Yes, it is a story I am about to tell.

Some years ago, in an assignment in Sierra Leone, West Africa, we came out with the following as provisions for CE staff job descriptions and “executive-level” positions:

1. Job designations

Job designations were recommended with these main features:

i-                    The types of human resources (engineers, technicians, trades workers) are in conformity with ISCO-88 ( International Standard Classification of Occupations) designations and levels;

ii-                   New designations are provided for trades workers and technicians in the three fields of work (medical equipment, technical equipment, civil works);

iii-                 Designations are provided for technicians in the fields of technical equipment and civil works;

iv-                 All the engineers in the three fields of work shall be called “clinical engineers”;

v-                  Managerial positions (District Department Manager, Regional Department Manager, Director/Central Department Manager) and higher level officers (Senior Technologist, Chief Technologist, Chief Technology Manager) are proposed respectively at district, regional and central levels;

vi-                 Grades are provided for the managerial positions and higher level officers.

2. Schemes of Services (Job descriptions)

The existing Schemes of Service were reviewed and extended to provide a comprehensive Cadre for Clinical Engineering Staff in the MOHS. Each reviewed SoS is presented in the format of the former SoS i.e. with the following headings:

-          Post: the designation of the post

-           Salary Grade: attached to the post

-           Age: minimum age of entry or promotion to the post

-          Qualifications: by promotion from a lower grade or by direct entry

-           Duties: main duties, responsibilities and reporting

-          Prospects: for promotion to higher grades and posts.

3. Specific recommendations

The following specific recommendations were made:

i.                 The MOHS shall create a cadre for Clinical Engineering Staff

ii.                  This cadre should be taken into consideration in the MOHS Human Resources Policy and Plan

iii.                 Adoption of these reviewed job descriptions and Schemes of Service shall be formal.

NOTA: The definitions below were adopted for our work:

Clinical Engineering is defined as “the management, support, development and quality assurance of healthcare technology as part of safe, cost-effective and sustainable healthcare delivery”

- Task Group, Engineering Council, South Africa

A Clinical Engineer is a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.

- American College of Clinical Engineering (ACCE)

This proposal (details are provided in relevant documents) could well help to design an International CE/HTM Body of Job Descriptions by a Group of experts committed to Human Resource Development for CE/HTM.

Best wishes,

Andre.

Andre MBOULE
Engineer Manager, BEng., MBA, DMc
Institutional, Business, and Individual Development Specialist
Senior International Consultant
P.O Box 25096 Yaounde
CAMEROON

Mobile: +237-9982 8671
Mobile: +237-7509 2009

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Re: Dream List not a wishlist

Mladen, Andrei and other colleagues,

I fully concur with the usefulness of a common framework to help us
understand big-picture issues. I would like to share my own experience in
using common frameworks to bring out similarities as well as to contrast
dissimilarities between different systems.

For example: I developed a common framework in the WHO Document “Medical
Device Regulation: Global Overview and Guiding Principles”.
(www.who.int/medical_devices/publications/en/MD_Regulations.pdf). That
simple common framework (Table 1, page 10) is key to introducing the readers
to the essence of the five medical device regulatory systems (Australia,
Canada, EU, Japan and USA). It also fits all GHTF guidance documents into
the same common framework (Annex 2, page 40). That common framework brings
out similarities.

On the other hand, I am using another common framework to contrast the
dissimilarities between drugs and medical devices, particularly the beyond
access “burdens” to the healthcare provider. I believe there are
significant differences. Let us first consider the safety aspect:

Figure: A common framework of life-span policy for drugs and
medical devices

The “access” regulatory burden (stage 1) is considerably more for drugs than
for devices because drug regulations are based on extensive review and
testing of all new drugs, while device regulations are based on risk
management approach.

The “beyond access” burdens (stages 2, 3), however, are significantly more
for devices for the following considerations

* The large variety of designs implies the need for technology
assessment and selection to ensure the proposed devices are appropriate
(e.g. compatible with the local human and environmental factors, qualified
operators, clean water, adequate electricity)

* Medical device is like a tool that requires not only knowledge but
also skills to operate. The operator interface stresses the importance of
proper education and training before using any medical devices. In addition,
implantation of active devices often requires effective coordination of a
team of specialists and supporting professionals

* The risk-based regulatory approach mandates post-market monitoring on
device performance as key in ensuring the continued safety and effectiveness
of devices in use.

* Durable medical devices are an asset that needs adequate recurrent
budgeting for proper management and maintenance in operation

* Safe and appropriate disposal. This applied to both disposable and
durable devices

Finally, I believe the “iceberg” burden, the donation of the durables and
the reuse of the disposables are good evidence of “beyond access” issues for
medical devices. HTM professionals has long been striving to gain
recognitions from healthcare decision makers and I believe the “beyond
access burdens” of medical devices should be a good “educational” topic to
promote the importance of HTM.

What do you think?

Michael Cheng

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Re: Dream List not a wishlist

Dear all,

The discussion about the importance of access to medical
technologies/services illustrates the necessary connections between Health
Technology Management (HTM) and Health Technology Assessment (HTA).

The bigger picture mentionned in the emails is the focus of HTA.

Reiner Banken

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Re: Intellectual Property/ patents vs access to medical devices

Dear Mladen,

Thank you very much for your answer. Perhaps should I have formulated my
question more precisely. I am sure you are aware of the “call for
innovative technologies that address global health concerns” from the
WHO. In these regards I was wondering what would happen in the following
scenario: let’s assume some company or team develops an appropriate
version of a pulse-oxymeter designed for the resource-constrained
markets. It is very likely that it will include some design solutions
that might have been patented by existing for-profit companies, active
worldwide but focused on developed markets (some companies use a “carpet
bombing” IP strategy where they patent everything on and around their
core technology). I am wondering if we will see similar developments as
with drugs. Perhaps will we just have to wait and see…

I hope this makes sense.

Tanks

Cordially

Klaus Schonenberger

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Body of Knowledge Survey for Clinical Engineering, Healthcare Technology Management and Clinical Systems Engineering

Dear Clinical Engineering Colleagues,

The American College of Clinical Engineering has just released its 2010 Body
of Knowledge Survey and we would like to invite you to participate.

The Body of Knowledge survey is critical in assisting the ACCE with defining
the scope of practice and knowledge base for Clinical Engineers, Healthcare
Technology Managers and Clinical Systems Engineers in their day-to-day work.

If you work in any of these areas we hope you will take ten minutes to
assist us in our efforts by completing the survey. If you know others who
work in these fields please pass this e-mail along to them.

The survey can be found at the following website:

http://www.surveymonkey.com/s/2010CEBOK

Thank you!

Frank Painter
For the ACCE Body of Knowledge Committee

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Re: Intellectual Property/ patents vs access to medical devices

Dear Klaus

I am not aware of patents being a barrier to access to medical devices,
but do know that the cost of patents (as well as the lack of accredited
testing bodies, limited access to funding and venture capital, etc.) is
a barrier for innovation in resource-poor countries (and even in some
moderately-resourced countries).

Kind regards

Mladen Poluta

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Engineering World Health is hiring

Hello all,

We are looking to hire a full-time employee based in Durham, NC to train
biomedical equipment technicians (BMET) in Rwanda and Cambodia. A complete
job description is attached. Please feel free to forward this to anyone who
may be interested in the position, and thank you for your consideration.

Justin

Justin Cooper, MSE
BMET Country Coordinator
Engineering World Health
The Prizery, Suite 330
302 East Pettigrew Street
Durham, NC 27701, USA
cell: 1.901.619.7765
justin.cooper_AT_ewh.org

EWH Dala Dala blog
Follow EWH on Facebook
rch&sid=2803047.2046209847..1>
and Twitter

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Re: Dream List not a wishlist

The idea of a broad and all-encompassing view of access is vital to
overcome all the barriers to accessing good (enough) healthcare.
The idea of good enough is also important as perfect is too far away and
in most cases always going to be far too expensive. This discussion
should also include transport, an often neglected part of health care.

Getting a patient to an appropriately (good enough) equipped facility
with enough time to spare to allow the correct intervention will save
life or improve the outcome. The key questions that need answering
are (and always have been) What is good enough, what is time is quick
enough, what is the right intervention – and of course how to supply the
above.

Each discipline has it’s contribution to make. Mine is patient transport
and logistics. Work we have done with Maternal Mortality reduction shows
clear benefits to motorised transport for mothers with problems. 20- 30
Km is a killer if you need medical care within 2hrs. Yes, there needs to
be a facility, yes there needs to be staff, yes – they need equipment
and training.

Let’s continue to seek solutions to the full length of the problem from
beginning to end, and I suggest the beginning is education.

Pete Sonderskov
The Ranger Production Company
(www.eranger.com)

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Intellectual Property/ patents vs access to medical devices

Dear All,

I have a question for which I would love to have the opinion of this
community: in how far are patents representing a barrier to access to
medical devices in resource-poor countries? When I was in charge of IP,
in my former life as an exec in a medical devices company, we strictly
never filed any IP in those countries, but this might be due to the
specific technology we were selling (rehabilitation products).
The situation for medical devices is certainly different from drugs
where you have generics and compulsory licensing (see TRIPS agreement)
however, I wonder if this question has surfaced in any way in your
experience.

Cordial greetings to all

Klaus

/Dr. Klaus Schönenberger, PhD/

/The Essential Medical Devices Foundation/

+41 21 534 33 64

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Re: Dream List not a wishlist

Mladen,

I couldn’t agree more with what you are saying. The idea of a broad and all-encompassing view of access, and within a common framework, was exactly the one behind my brief comment. And you very well, as always, elaborated on this bringing in a bigger picture. Access to (benefits of) medical devices, and health technology as a whole to this matter, is indispensable element in achieving effective coverage with health interventions, and I’ve been actively promoting these ideas when my team at WHO was responsible in early 2000s for the WHO work on developing the concepts of effective coverage and designing tools and indicators for its measurement. And when we talk about health technology in this context, it is natural to view it in its broad internationally accepted definition encompassing not only devices and drugs, but also procedures, and organizational and supportive systems, e.g. virtually everything that constitute health systems and make them work for better health.

Best regards.

Andrei Issakov

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Re: Dream List not a wishlist

Dear Michael and Andrei

No one is suggesting that Access to medical devices is all that
matters, but it is a crucial step in achieving the benefits of medical
devices via healthcare interventions, and constitutes one element (the
other two being utilisation and effectiveness) of Effective Coverage,
defined as ˜the ratio of actual health gain from healthcare
interventions to maximum potential health gain achievable from the same
interventions” (WHO).

Access is understood as meeting the requirements of the 4A’s:
availability, accessibility, affordability and acceptability. These
certainly apply to medical devices in their own right and the 3 elements
of Effective Coverage combined, I would suggest, cover the issues that
you are alluding to. My own view therefore is that Access for medical
devices should not be seen or defined differently from that for drugs or
other health technologies, since there is much to be gained from a
common framework.

I would further submit that barriers to true benefits from
drugs/medicines ALSO lie beyond access, and they too have issues around
˜management capacities and recurrent budgets” that need to be
addressed (case in point: the possible cuts in PEPFAR and Global Fund
support for ARVs and the effects this could have in resource-poor
environments).

All that I was suggesting is that we need to leverage and tap into
significant initiatives related to health- and healthcare technologies
as a whole, in order to advance our own cause. That said, I accept that
many Infratechers (myself included) depend for their livelihood on the
fact that medical devices are different from drugs ; )

A luta continua !

Best regards

Mladen Poluta

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Re: Dream List not a wishlist

Dear All,

Fully agree with Michael. Perhaps we should look at access differently and
define it differently in the case of medical devices. We should look at it
not as just a physical access to a piece of hardware, but as access to
medical device benefits. With this view of access, we will embrace all
components on which getting these benefits depend. And these are not only
pure HTM issues, but also, for example, the capacity of users to use and
apply devices properly, or match of available devices with the community
health care needs and prevailing clinical practice.

This is very much like preaching for improving access to health facilities.
Physical proximity and easy access to a dilapidated health centre building
with no basic equipment, no essential drugs and completely demotivated
health worker means very little, if anything, to a patient seeking care. We
need to talk about access to services, and moreover good quality services.

With best regards.

Andrei Issakov

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