In order to support its programme goals and policies for children and women, UNICEF procures medical devices that meet specific programme requirements and can be supplied at competitive rates. The role of providing medical devices is essential and irreplaceable in the delivery of healthcare.
Over the years, UNICEF and other UN and bilateral aid agencies have provided support to governments and non-governmental organizations in the acquisition of medical devices. In addition, UNICEF Supply Division can provide technical support and expertise to health programmes on all aspects of procurement.
Medical devices and kits covers five products groups:
Each of these products groups is divided into several sub-groups that lead to individual items.
Important measures must be implemented to provide the foundation of a health programme aimed at improving the health of a community. They are related to:
These measures should interact and complement the curative care component of the health programme.
A health system can vary from one region to another. In order to address the population's needs properly, an assessment should be conducted and an evaluation made to clarify the quality level of the health system and local capacity.
As part of the development and implementation of health programmes, supply needs should be identified and planned to ensure the coverage of medical needs (drugs and medical devices) with adequate supplies.
The selection of medical devices depends on the targets and needs determined by type of medical activity and medical infrastructure to be covered in the health programme. These factors must be carefully considered, so that results will be accurate and therefore useful.
Protocols are the basis of any curative health programme and should be standardized in order to have an effective impact on the target diseases.
Therapeutic protocols should:
Therapeutic protocols should be adapted to the skills and knowledge of medical staff. They should cover prescription, curative and preventive measures, and cases that should be noted for referral to a higher level hospital. They should respect cultural traditions and the environment. Protocols should be reliable, facilitate observance and be adapted to the needs of patients.
The diagnosis is based on the clinical examination of the patient and laboratory investigation.
Training or re-training of medical staff should be carried out according to the programme objectives and be based on the technical level of staff. Guidelines and other documents are important tools for this task.
Coverage of a population can be improved by increasing public awareness, improving the quality of curative and preventive care, health education, and encouraging the exchange of information.
As part of programme management, the following components need to be evaluated and monitored:
The purchase of medical devices is critical as one of the ulterior stages could be the utilization in vivo of the purchased product. The purchased product must satisfy the requirement of security and functionality expected, to the benefit of the patients and users. This must be done through a combination of efficiency, quality and security, resulting in the highest quality at an affordable price with the lowest risk.
Medical devices are any instrument, apparatus, implement, machine, appliance, implant, in vitro regent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
(Definition from GHTF doc. SGI/N029R11 - date: February 25, 2002)
Government authorities of the country in which a product is manufactured or imported usually enforce regulations. However, many countries do not yet have regulations for medical devices, or these regulations are sparse or fragmentary. Although it is encouraging that some countries are in the process of establishing such regulations, a proliferation of different national regulations could hinder access to technology and should be avoided.
The Global Harmonization Task Force (www.ghtf.org) is a voluntary group of representatives from national medical devices regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of five founding members grouped into three geographic areas. The five founding members are the European Union, Japan, Australia, Canada and the United States of America. The three geographic areas are Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.
The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade. This is primarily accomplished through the publication and dissemination of harmonized guidance documents on basic regulatory practices.
The GHTF also serves as an information exchange forum through which countries developing medical device regulatory systems can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF founding members.
The means to ensure the safety and performance of the medical devices include standards and national regulations. In general, standards are voluntary while regulations are mandatory. However regulations can make certain standards mandatory. In addition, purchasers may also have their own specifications that a product must fulfil.
Product standards describe characteristics and performances of the product. Quality system standards provide the essential elements that a manufacturer should have in place to ensure that the quality of products manufactured is consistent.
Note: There are different types of standards (e.g.: private, public, organizational, regional, national and international standards). As health care products, medical devices normally follow international standards. The GHTF aims at harmonizing regulatory requirements and practices based upon essential principles and common criteria. At this time, conformity assessment requirements and other regulatory controls assigned to each class of devices by different regulatory authorities have yet to be harmonized and many vary.
Within UNICEF, Supply Division is responsible for identifying the most appropriate medical devices and ensuring that UNICEF offices and external customers can purchase quality medical devices at an affordable price.
In addition, UNICEF Supply Division provides technical support, which includes:
UNICEF aims to:
The essential medical devices offered in the UNICEF Supply Catalogue have been selected based on the criteria of quality, available quantity and timely delivery and are called 'standard items'. Most of these standard items are stocked in UNICEF's Copenhagen warehouse ready for set-packing and rapid delivery.
UNICEF pre-packed medical kits for emergency situations are stocked in UNICEF's warehouse in Copenhagen. UNICEF Supply Division can also provide customized set-packing of medical devices stocked in its warehouse.
UNICEF pre-packed kits and customized sets can be distributed directly to health care facilities. A pre-established schedule of regular shipments from Copenhagen can also be arranged.
Products that are not listed in the UNICEF Supply Catalogue are called 'non-standard items'. For all non-standard items, an agreement concerning availability must be reached with Supply Division. The decision to provide a non-standard product will be based on the relevance and importance of the medical device concerned and its availability from UNICEF's suppliers. This ensures that the medical device requested will be the most appropriate for the particular situation.
The quality of medical devices is a major concern for UNICEF Supply Division. As a result UNICEF follows strict procedures such as:
Technical, quality assurance and procurement processes have been established to ensure that both suppliers and the medical devices they offer are in accordance with UNICEF's expectations.
Technical and quality assurance processes for medical devices cover: