Resources for medical device information Leave a comment

The Global Harmonization Task Force: www.ghtf.org
It provides general information and reports from the four study groups. It also offers an extensive list of web sites of countries around the world.

Australia: Therapeutic Goods Administration: www.health.gov.au/tga

Canada: Health Canada site: www.hc-sc.gc.ca
All medical devices guidance documents and medical device related information can be obtained from www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

European Union: http://europa.eu.int/comm/enterprise/medical_devices/index.htm
EU Member States with a different linguistic regime:
France: www.afssaps.sante.fr/
Germany: www.bfarm.de/de/index.php
Spain: www.msc.es/farmacia/home.htm

Japan: Ministry of Health, Labor and Welfare: www.mhlw.go.jp/english/index.html
For publications: www.mac.doc.gov/japan/source/menu/medpharm/medpub.html

United Kingdom: www.Medical-devices.gov.uk

United States of America: Food and Drug Administration: www.fda.gov/default.htm
Corresponding medical device-related information site: www.fda.gov/cdrh/index.html. (this site also offers “Device Advice” – www.fda.gov/cdrh/devadvice/ – a self-service site for medical device and radiation product information)
The FDA enforcement report site: www.fda.gov/opacom/Enforce.html also offers useful information for import control.

Some addresses to obtain Medical Device Incident Reporting Forms

International
Adverse event and Product Defect Reporting Systems
ECRI (formerly the Emergency Care Research Institute)
WHO Collaborating Centre
www.ecri.org
E-mail: accidents@ecri.org
Tel: +1 610 825 6000, ext 5223

United Kingdom
Adverse Incident Centre
Medicines & Healthcare Products Regulatory Agency
Hannibal House, Elephant & Castle
London SE1 6TQ
Tel hotline: +44 20 7972 8080
Fax: +44 20 7972 8109
E-mail: aic@mhra.gsi. gov.uk

Australia
Medical Device Problems and Adverse Events
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Tel: +61 (02) 6232 8713
Fax: +61 (02) 6232 8555
E-mail: iris@health.gov.au
www.health.gov.au/tga/docs/html/therprob.htm

Reuse, refurbished, home-use, donated, and maintenance of medical devices

Reuse of medical devices that are labelled single-use
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
August 14, 2000 www.fda.gov/cdrh/reuse/1168.html
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third Party and Hospital Reprocessors:
Food and Drug Administration (USA) www.fda.gov/cdrh/reuse/reuse-faq.html
Special Report: Reuse of Single-Use Medical Devices: Making Informed Decisions: ECRI(USA), info@ecri.org
Reuse of Single-Use Medical Devices in Canadian Acute-Care HealthCare Facilities: Canadian Healthcare Association, http://www.hc-sc.gc.ca/
Single-use Medical Devices: Implications and Consequences of Reuse: Medicines and Healthcare Products Regulatory Agency (UK) www.medical-devices.gov.uk/
Patients in Danger: The Reuse of Single-Use Medical Devices in Europe: European Confederation of Medical Devices Associations, Belgium: www.eucomed.be/
Reuse of Single Use Devices, 1999 Conference Proceedings and Tapes: Association for the Advancement of Medical Instrumentation (USA) www.aami.org/resources/reuse/index.html

Refurbished medical devices
US Department of Commerce: www.ita.doc.gov/td/mdequip/regulations.html#used International Association of Medical Equipment Remarketers and Servicers www.iamers.org/index.html

Home-use medical devices
Home-use Medical Devices: a need for consumer education; Leadership in Health Services, vol. 4, no. 1, Jan/Feb. 1995, Canadian Healthcare Association

Donated medical devices/equipment
Guidelines for Health Care Equipment Donation, World Health Organization, WHO/ARA/97.3
Guidelines for Medical Equipment Donation: American College of Clinical Engineering, 1995

Maintenance of medical devices/equipment
Chapter on Management of Medical Equipment, District Health Facilities: guidelines for operation and development, World Health Organization, Western Pacific Series No.22
El mantenimiento del material medico esencial: una prioridad insoslayable, Foro Mundial de la Salud, volumen 15, 1994

                                                                                                                                                                          From the World Health Organization