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HTA and medical devices

HTA and medical devices. Adriana Velazquez B. Essential Health Technologies, WHO. Technology is a double edge sword. Technology can represent: Benefits for patients Greater productivity Increased accesibility More risks Higher costs Additional work in training and maintenance

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HTA and medical devices

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  1. HTA and medical devices Adriana Velazquez B. Essential Health Technologies, WHO.

  2. Technology is a double edge sword... Technology can represent: • Benefits for patients • Greater productivity • Increased accesibility • More risks • Higher costs • Additional work in training and maintenance • Iddle resources

  3. Health technology refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives. http://www.who.int/topics/technology_medical/en/

  4. Definition of medical devices • From the GHTF: • Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: • a) intended by the manufacturer to be used in diagnosis, prevention, monitoring, treatment or alleviation of disease,.. • b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means.

  5. Challenges in medical devices • Drugs take all importance in health products. • Drugs have regulatory issues • Drugs are specified in clinical protocols • International Pharmacopea is developed • International Classification is accepted • Pharmacovigilance has been encouraged in countries • Generic drugs and drug policies are being applied • Eventhough medical devices are also health technologies, Medical devices are still not in the MoH agenda!

  6. Medical unit or service ICU, OR, GP office, etc Management Drugs and medical disposables Skilled personnel Medical equipment Facilities Maintenance CPG Other medical units Information systems

  7. Mexican Situation in Medical Equipment • Hospitals want to get top of the line technology, not always the appropiate one. • There is not an equitable distribution of the technological resources according to the needs. • Unfortunately, the technolgy available not always responds to the real needs of the population it serves.

  8. FOTO:Global Marine Drilling, en St. Johns, Acquisition 20% Consumables Instalation Salaries Energy Maintenance Spare parts Operation 80% FOTO: GLOBAL MARINE DRILLING ET JOHNS, IDEA ORIGINAL: YADIN DAVID Total cost of ownership Environmental impact

  9. Mexico, through CENETEC, proposed a resolution on Health Technologies to the Executive Board of the World Health Organization. • The resolution was accepted by the member states in May 2007.: WHA60.29

  10. WHA60.29 Resolution • Mandates to member states: • 1.2 to formulate as appropriate, national strategies and plans for the establishment of systems for the assessment, planning, procurement and management of health technologies, in particular medical devices, incollaboration with personnel involved in Health technology Assessment and biomedical engineering. • 1.4 to establish where necessary, regional and national institutions of health technology, and collaborate and build partnership with health care providers, industry, patients associations and professional, scientific and technical organizations.

  11. Resolution WHA60.29 • Requests the director General (WHO): • 2.1 To work with interested Member States and Collaborating Centers on the development … of guidelines and tools, including norms, standards and glossary of definitions… • 2.2. to provide… mechanisms to assess national needs for health technologies… to assure availability and use. • … • 2.6 to establish a web based health technologies database to serve as a clearinghouse which will provide guidance on appropiate medical devices according to levels of care… • 2.7 … identify health technologies,in particular medical devices that facilitates access to quality services in primary health care… • …

  12. Way forward • Priority medical devices project in development at WHO to provide a report in 2009. • Funding from Gates foundation and Lux development to WHO to develop or update tools and guidelines, for maintenance, procurement, donations, policies. Etc. which will include working with pilot countries. • WHO is updating the webpage to further include a clearing house on medical devices. www.who.int/eht.html

  13. Medical devices in M o H • Important to have HTA to define priorities, needs, an implications • Economic • Clinical • Organizational • Ethical of the use of medical devices • Important to have clinical engineering to better procure, maintain, plan medical equipment in the country according to the epidemiological needs and to the available infrastructure. • Important to have a regulatory agency to supervise the entrance of the medical device to the countries health System, and minimize the risk.

  14. Thank you • velazquezberumena@who.int

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