By admin | April 25, 2010
Dear: Andrei ISSAKOV
Thank you for your resource attached with your e-mail.
They are very important to my objective.Even I was in Ethiopian Scientific
Equipment Center I have never seen such document.It is great success to get from your side.
God Bless You
Mulugeta Mideksa,BME
Posted in Uncategorized | Also tagged training |
By admin | April 17, 2010
Andrei:
Fantastic plan. I look forward to participate in the promotion, the
distribution and access for such experience-rich material.
Yadin David
IFMBE/CED chairman
Posted in Uncategorized | Also tagged training |
By admin | April 17, 2010
Thank you, Yadin, for your generous words. I am now
finalizing the systematic archiving of all the documentation I’ve
accumulated during 25 years of my global work, both thematic and country
specific. When I’m done, it would be useful if this reference
database is accessible through several cross-referenced sites, i.e. IFMBE/CED,
IUPESM-HTTG, WHO, IFHE, etc., [...]
Posted in Uncategorized | Also tagged training |
By admin | April 17, 2010
I would like to recognize Andrei’s contributions to the on-going
efforts to develop and sustain HTM programs. This recent correspondence
illustrates how much Andrei experience and documents archiving can be
helpful in building future programs on the foundation of good work that was done
previously. We should improve the organization of and access to [...]
Posted in Uncategorized | Also tagged training |
By admin | April 14, 2010
Dear Mulugeta
Nice to hear from you.
In my opinion you have started to draft terms of reference for technical assistance by an HTM professional: this might be an efficient way to meet the objective of “creating a strong HTM unit in Ethiopia.”
Nevertheless you may find some useful information going to the [...]
Posted in Uncategorized | Also tagged training |
By admin | April 13, 2010
Hi all,
I am forwarding the request below to the INFRATECH group, to
introduce Mr. Mideksa, a new subscriber.
Please send any replies via INFRATECH, as others in the group may
find them of interest.
Thanks
Bill
Bill Gentles PhD., P.Eng., CCE,
INFRATECH Administrator,
From:
mulugeta mideksa
Sent: April 13, 2010 8:08 AM
To: Dr.Billgentles
[...]
Posted in Uncategorized | Also tagged training |
By admin | February 9, 2010
I have some curiosity about the differences between the way medical equipment maintenance is regulated/
controlled in the US and in Europe and would appreciate a brief “education”
on this topic from colleagues either in Europe or here in the US. I
understand that the ISO 9000 quality standards are widely recognized in Europe
[...]
Posted in Uncategorized | Also tagged Maintenance |
By admin | February 24, 2009
Hi Ledina,
Your question has two very different parts:
1. Safe devices.
2. In accordance with EU laws.
Others have addressed the laws and regulations.
The issue of patient safety has become much more prominent in recent
years. I refer you to “To Err Is Human: Building a Safer Health
System”, a book which reveals that as many as 98,000 [...]
By admin | February 24, 2009
Ledina and all,
I have been working over the past few months to develop equipment management standards for government hospitals in
Ethiopia. With the assistance of a team of key stakeholders we have recently finalized our first draft. We are now working to draft the implementation guidelines and hope to have that [...]
By admin | February 24, 2009
Dear Ledina,
Welcome to our list.
You got a really big and challenging task from your MoH.
I think you already got some links from Michael Cheng with regard to MD regulations in the EU – if you meant this with standards for MDs in hospitals.
However I would like to draw your attention [...]
By admin | February 23, 2009
Binseng:
I share your sentiments and struggled at first with that issue.
I would suggest if you can, take a look at the Veteran’s Administration
specifications for procurement of equipment. That document provides a fairly
comprehensive guide on the scope of supply which would affect the delivery of
patient care from the Clinical Engineers standpoint.
Hope [...]
By admin | February 23, 2009
Dear Ledina,
Medical Device Laws in EU Member States are derived from the three EU Commission Directives
Directive 90/385/EEC relating to active implantable medical devices (AIMD)
Directive 93/42/EEC concerning medical devices (MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)
In short, the laws require that all medical devices to bear a “CE mark” after satisfying conformity [...]
By admin | February 23, 2009
Hi Ledina,
Welcome to the list! I work at the United Kingdom Medical Research Council in The Gambia, West Africa, and we have just decided on our standards as we are setting up a quality system in our department.
There are two different types of standards we’ve selected; one for the electro-medical safety of MDs and one [...]
By admin | February 23, 2009
Dear All,
First of all I would like to tell you; I am happy to join this forum where there is so much knowledge and experience regarding the management of medical devices. I hope I will be able to share with you my experience and find answers to my questions.
My name is Ledina Picari. I am Biomedical Engineer at [...]
Dear Ronald,
Please let me know if the following discussion and specifications help you
A medical device with “acceptable quality” is not a subjective decision but
it must conform with international standards. For surgical instruments,
they must conform with product standards and quality management standards.
ISO TC170 is responsible for product standards for surgical instruments
(currently there are 6 standards):
<http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnu
mber=13745> [...]
