[e-drug] Short term consultancy disposable injection equipment

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E-drug: Short term consultancy disposable injection equipment
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Subject: Terms of reference for a proposed guide to purchase disposable
injection equipment

Please find attached terms for reference for the production of a guide to
purchase disposable injection equipment.

We are looking for a consultant with experience in the area of (1) norms and
standards for medical devices and (2) national regulatory authorities who
would be interested in conducting this work under a WHO Agreement for The
Performance of Work (APW) contract.

Persons interested should contact the SIGN secretariat.

Best regards,
Yvan

Dr Yvan Hutin
Medical Officer
Safe Injection Global Network (SIGN)
Blood Safety and Clinical Technology (BCT)
World Health Organization
20, Avenue Appia, Rm. M 22
CH- 1211 Geneva 27
Switzerland

Tel: +41 (22) 791 34 31 (direct)
Fax: +41 (22) 791 48 36
E-mail: hutiny@who.int

www.injectionsafety.org
___________________________________________________________________________

Terms of Reference for a Proposed Guide to Purchase Disposable Injection
Equipment

BACKGROUND
* Quality and safety of injection equipment has been recently recognized as
an international public health issue.
* A number of stakeholders (e.g., UNICEF, governments) have to purchase
disposable injection equipment on the international market to supply public
health initiatives in countries that require assistance to strengthen their
National Regulatory Authority
* Stakeholders who wish to purchase disposable injection equipment may
make better informed purchased if guided to determine the level of quality
that a manufacturer is offering.

OBJECTIVE
* The objective of this project is to guide non-specialized stakeholders who
wish to purchase disposable injection equipment on the international market
so that they can determine the level of quality of the proposed good.

DELIVERABLE
* A 10 page / 1500 words long paper guide
* (If possible) An interactive version of the guide
The guide would include:
Background information
* About two page of background information summarizing key issues in
(1) international norms and standards,
(2) regulations for disposable
injection equipment,
(3) quality control procedures, and
(4) available sources of information on good quality product (e.g., WHO's
product information sheets for immunization injection equipment).

CHECKLIST
* About one page of checklist summarizing the elements for which
information is needed to make a decision, potentially including (List to be
determined):
Information regarding the manufacturer
* Available post market surveillance information regarding the
manufacturer on public databases
* Identification of a country of production
* Identification of a distributor
* Certification of compliance to national norms by a notified body
(e.g., FDA license)
* Exportation certificate delivered by the institution acting as
National Regulatory Authority (in some cases, this may be the Ministry of
Health)
* Certification of compliance to international norms of production
(ISO 9000 family) by a notified body
* Certification of compliance to international norms of product (e.g.,
ISO 7886-1) by a notified body
* CE Mark
Information regarding the country
* Regulation in place
* Zone of influence
Characteristics of each packaging unit of the product
* Mention of the manufacturer, with contact information
* Mention of the country of manufacture
* Condition of sterilization
* Distributor
* Instructions for use
* Manufacture date
* Expiry date
* Lot number
* Validation label (e.g., CE mark)
* Mention of "single use" ("Not for re-use" logo)
* About one page summarizing how to obtain the information on the checklist

DECISION TREE
* About three page documentation of the decision making process to use
the information obtained with the checklist to rank the quality of the
product into one of 5 categories (To be renamed):
1. Products from a manufacturer identified as dangerous or that cannot be
tracked
2. Indirect validation requiring further information
* Product not validated by a national body
* Product validated by a national body
3. Quality validated by authorized body
* About one page graphic illustration of the decision tree summarizing
how to use the information obtained with the checklist to rank the quality
of the product into one of four categories.
    Resources
* About one page summarizing resources available (e.g., WHO's product
information sheets for immunization injection equipment) References
* About one page of references

FEEDBACK QUESTIONNAIRE
* For users of the guide to evaluate the tool

WORK LOAD
* It is estimated that the work should take approximately one month of
work for an international expert. However, no mention of the time needed
would be in the contract and the contractor would only be accountable to a
delivered final product.

* New research should not be conducted as part of this work. The aim of the
document is to make better use of already existing information

TIMELINE
* M0: Signature of a contract
* M2: Draft one available, internal review at WHO and UNICEF
* M4: Draft two available, peer review
* M6: Final version available
    Contracting mechanism
* WHO's Agreement for the Performance of Work (APW)

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