Dental Biomaterials: Reporting of Adverse Reactions
Information on reporting of adverse reactions (side-effects) observed with dental materials
This website is intended as a meeting place for those interested in the topic. Please inform me on new items that should be added, as well as corrections and comments. E-mail to Nils R. Gjerdet, University of Bergen, Norway.
Relevant paper: An overview of the current status of national reporting systems for adverse reactions to dental materials (van Noort-R, Gjerdet-NR, Schedle-A, Björkman-L, Berglund-A. J Dent, in press 2004). (Science Direct).
Reporting on adverse reactions to dental materials--intraoral observations at a clinical follow-up (Lygre-GB, Gjerdet-NR, Grønningsæter-AG, Björkman-L.Community Dent Oral Epidemiol. 2003;31:200-6) (PubMed abstract).
Tip:
FDA/CDRH: Manufacturer and User Facility Device Experience Database (MAUDE)
Reported adverse events involving medical devices (USA)
(Contains some reports involving dental materials. Try full-text term "dental")
Dental materials are widely used on a majority of
people in developed countries. Adverse reactions (side effects,
adverse events) do occur. The side effects range from objective
reactions based on observable phenomena, to more unspecific,
general reactions which may or may not be associated with dental
materials. Reactions are also seen in dental personnel handling
the materials. Such reactions may be troublesome for the
personnel and may indicate types of reactions in patients.
Participation by dental clinicians in spontaneous reporting
systems may reveal reactions that are not easily identified
during pre-clinical (pre-marketing) evaluation. Several reporting
systems of this kind are in action concerning drugs. With dental
materials the establishment of concordance between the material
and the reaction is complicated by the fact that each material
may contain several components, and the composition is sometimes
difficult to obtain. Such systems are still valuable tools in the
identification of adverse reactions associated with dental
materials.
Dental materials are classified as medical devices, according to
the European 93/42/EEC Medical Devices Directive. E.g. filling
materials are classified as Surgically Invasive Devices, class
IIa.
The Norwegian Dental Biomaterials Adverse
Reaction Unit was initiated by the Norwegian Board of Health in
1992 and began its activities in 1993. It is funded by the
Ministry of Health and Social Affairs. The activities are at
present organized in a academically and financially autonomous
unit (section) closely linked to the University of Bergen.
In addition to research activities, the main purposes are to:
(1) Implement a national adverse reaction registry based on
reports from health professionals.
(2) Offer clinical services to selected (referred) patients with
complaints and disorders associated with dental biomaterials.
(3) Supply information to health professionals and to the public
about issues concerning adverse reactions to dental biomaterials.
Following a commission by the Swedish Government,
and in accordance with the consequent parliamentary decision, The
Swedish National Board of Health and Welfare implemented a
national register on side-effects of dental materials in 1996.
The Board decided to make an external assignment and a formal
co-operative agreement was established between the Board of
Health and Welfare and the Faculty of Odontology, Umeå
University, for the creation of a national register of
side-effects relating to dental materials. The intention was to
elucidate the nature and the occurrence of side-effects that
could be connected with dental materials. Information arising out
of the work was to be distributed to the health and medical
services, including dental care services, and to other interested
parties.
In 2002 the specialized reporting procedure described above was replaced by
the more general procedures based on the EU-regulations. The reporting is made
mandatory in cases of (potentially) serious events. Reports are now handled
by the Swedish Medical Products Agency (
Läkemedelsverket).
The UK Adverse Reaction Reporting Project (ARRP) was set up in 1999 to develop the evidence base for adverse reactions to dental materials in the UK and was funded by the NHS National R&D Programme of Primary Dental Care It regularly sends out a reporting form, known as the green form to differentiate it from the yellow form used for the reporting of drug adverse reactions to all general dental practices in the UK. The design of the form was based on examples from the Adverse Reaction Units in Bergen (Norway) and Umeå (Sweden). The results of the survey are available on its website: http://arrp.group.shef.ac.uk.
Pictures and illustrations could
be located here as a source for general information and
discussion. It is important to protect patients' rights to
privacy. Thus, no identifying information should be presented.
(New picture(s) added March 05, 2000).
Nils R.
Gjerdet - University of Bergen, Norway
Arne
Hensten-Pettersen - Scandinavian Institute of
Dental Materials (NIOM), Norway
Anders Berglund
- University of Umeå Sweden
Lars Björkman -
Norwegian Adverse Reaction Unit, Norway
Richard van Noort
- University of Sheffield, UK
Paul V. Hatton -
University of Sheffield, UK
Andreas Schedle
- University of Vienna, Austria
The
Norwegian Adverse Reaction Unit (NARU) - Dental biomaterials
(Bergen - Norway)
National Survey of Adverse Reactions to Dental Materials - ARRP) (With on-line reporting form) (UK)
Coding of materials as used by the Norwegian Unit - Based on CEN CR12401:1996E (Nils R. Gjerdet): PDF
Disease classification: ICD-10 system (WHO): http://www.who.int/whosis/icd10/. Drug classification: ATC-system (European Pharmaceutical Marketing Research Association): http://www.ephmra.org/GLOBAL MEDICAL DEVICE NOMENCLATURE (GMDN):
Two papers on GMDN by Jacob Nordan (NKKN), Richard Moore (EUCOMED) and Masaaki Naito
(JFMDA) members of GMDN Project Council -
Document 1 and Document 2.
(documents downloaded from NKKN
and BSI.
See also The Global Harmonization Task Force (GHTF)
Epidemiology of Medical Devices "(from Supercourse" Univ. of Bergen mirror site)
DESIGNING A MEDICAL DEVICE SURVEILLANCE NETWORK: Report to Congress, September 1999. Prepared by Susan Gardner Ph.D., Marilyn Flack M.A. (from: www.fda.gov/cdrh/postsurv/medsun.pdf). An appendix: "Final report of a study to evaluate the feasibility and effectiveness of a sentinel reporting system for adverse event reporting of medical device use in user facilities" (from: .../medsunappendixa.pdf : PDF - downloaded 99-10-30)
THE USE OF DENTAL FILLING MATERIALS IN NORWAY. (English summary). Norwegian Board of Health, August 1999 (IK-2675). Full report (IK-2652. In Norwegian - 2MB) (from: http://www.helsetilsynet.no/trykksak.htm : PDF - downloaded 99-10-10)
Everything You Wanted to Know about Medical Device Surveillance and Medical Errors But Had No Clue What Questions to Ask. by Larry Kessler, Sc. D., Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health DCRI 13 April 2000 (PDF - downloaded 00-04-22 from CDRH)
Review paper concerning drugs, but with relevant discussions with respect to our field: Goldman SA & al: The Clinical Impact of Adverse Event Reporting (Medscape published, see abstract)
Presentation given at the Nordic Medical Devices Workshop, May 2000 (Nils R. Gjerdet. PDF)
Gjerdet NR, Askevold E: National Reporting of Adverse Reactions to Dental Materials. The Norwegian Registry. (Poster - PDF) presented at the 76th General Session & Exhibition of the IADR, Nice - France, June 24-27 1998
Lygre G, Gjerdet NR, Björkman L: Objective Intraoral Findings from Adverse Reaction Reports. (Poster - PDF) presented at the 79th General Session & Exhibition of the IADR, Cheba - Japan, June 27-30, 2001
Gjerdet NR, Björkman L: A Specialised National Reporting System of Adverse Reactions to Dental Materials (Poster - PDF) presented at the British, Continental European, Irish and Scandinavian Division of the IADR; Cardiff, September 26-28, 2002
The European Commission: Medical devices - Directives, Notified Bodies etc.
ISO International standards: http://www.iso.ch/cate/cat.html
FDA - U.S.
Food and Drug Administration (USA)
MedWatch
- The FDA Medical Products Reporting Program (it is now
possible to report via the Internet)
Center
for Devices and Radiological Health (CDRH): Information
on Releasable 510(k)s - Premarketing notification
(PMN, 510(k)) of medical and dental devices and materials
(searchable database)
FDA/CDRH: Manufacturer and User Facility Device Experience Database (MAUDE)
Reported adverse events involving medical devices (USA)
CDRH
Product coding and classification: Center for Devices
and Radiological Health (CDRH) uses this coding
Post Approval Studies (new April 2007>
Bundesinstitut
für Arzneimittel und Medizinprodukte - BfArM
(Germany)
(Contains a reporting form - See under section
"Medizinprodukte")
DIMDI - Deutsches Institut für Medizinische Dokumentation und Information (Germany - English version)
MHRA - Medicines and Healthcare products Regulatory Agency (UK)
TGA - Therapeutic Goods Administration (Australia)
MEDSAFE - New Zealand Medicines and Medical Devices Safety Authority" (New Zealand)
ECRI An independent nonprofit health services research agency (USA) (about nomenclature)
NKKN - Norwegian Nomenclature (Norway)
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Updated April 8, 2007 by Nils R. Gjerdet