Patient safety & Dentistry & Regulations · 2018-04-03 · Patient safety & Dentistry & Regulations ... WHO Multiprofessional Patient Safety Curriculum Guide For Health Professions

OSAP 2011 Symposium www.OSAP.org

Copyright N. Yamalik 1

Patient safety & Dentistry & Regulations

Professor Nermin YamalikDepartment of PeriodontologyFaculty of DentistryUniversity of HacettepeAnkara-Turkey

FDI Councillor

• Non-governmental organization• One of the oldest international health profession organisations(founded in 1900 – Paris) • Represent ~ 1 million dentists worldwide, ~ 135 Countries and >190 National Associations and Special Interest Groups• Governed by a Council elected Governed by a Council, elected by FDI General Assembly• Offices in Geneva• Official relations with the United Nations (UN) and the World Health Organization (WHO)• Member of the World Health Professions Alliance

www.fdiworldental.org



FDI & OSAP

Strong relationship / MoU – OSAP

FDI Education Comittee – Dr.Eve Cuny

WHO Multiprofessional Patient Safety CurriculumGuide For Health Professions – Dr.Enrique Acosta-Gio

FDI & OSAP partners – Patient safety

FDI & patient safetyPolicy statements

FDI POLICY STATEMENTThe basic responsibilities and rights of dentistsAdopted by the FDI General Assembly: 26th October 2007, Dubai, UAE

Commonly shared moral values and ethical responsibilities include the duty to:- recognise, promote and uphold fundamental human rights and the rights of their patients- represent, defend and advocate for both the oral health needs and best interests of patients and the public- provide safe, quality, competent and fair oral healthcare to every patient- improve the oral health and contribute to the general health and improve the oral health, and contribute to the general health and well-being of individual patients and the public at large-maintain the role, good reputation and dignity of the profession

As with their responsibilities, the interpretation of the professional rights of dentists may vary from country to country. However in all circumstances this must be:- in the best interests of individual patients and the public- in accordance with the professional and ethical codes, and the credibility, of the dental professionDentists must also recognise and comply with those situations where professional responsibilities should take precedence over their professional rights.



FDI POLICY STATEMENTThe basic rights and responsibilities of dental patientsAdopted by the FDI General Assembly: 26th October 2007, Dubai, UAE

Serving individual patients and the public is a primary focus of modern dentistry. Thus, recognizing fundamental human rights and patient rights - both individually and collectively - is one of the core values and commitments of the dental profession. Upholding these basic rights is a vital component to the provision of quality and ethical oral health care.

The many basic rights of dental patients include:

- to receive oral health care in a healthy and safe environment, and with compassion and respect for their rights and dignity- access to competent, high quality, fair and ethical oral health information and care- protection of their personal privacy- necessary concern for their needs, best interests, reasonable preferences, and complaints- encouragement to participate in decision-making processes affecting their oral health care

FDI POLICY STATEMENTAction Against Illegal Dental PracticeAdopted by the FDI General Assembly: 1 October 2002 – Vienna, Austria, Reconfirmed by the FDI Dental Practice Committee in September 2009 in Singapore

FDI POLICY STATEMENT

FDI POLICY STATEMENTBasic Dental TrainingReconfirmed by the FDI Dental Practice Committee in March 2007 in Ferney-Voltaire, France, Adopted by the FDI General Assembly: 18th September 2003, Sydney, Australia

FDI POLICY STATEMENTContinuing Dental EducationAd t d b th FDI G l A bl FDI POLICY STATEMENT

Supervision of Auxiliaries within the Dental TeamReconfirmed by the FDI Dental Practice Committee in March 2007 in Ferney- Voltaire, France , Adopted by the FDI General Assembly: November 2000 – Paris, France

Adopted by the FDI General Assembly: 12th September 2004 - New Delhi, India

FDI POLICY STATEMENTThe equivalency of dental diplomasAdopted by the FDI General Assembly: October 1995 – Hong Kong SAR China

FDI POLICY STATEMENTMercury Hygiene GuidanceOriginal version adopted by the General Assembly on October 1998, Barcelona, Spain, Revised version adopted by the General Assembly: 26th October 2007, Dubai,UAE

FDI POLICY STATEMENTPossible Local Adverse Effects of Amalgam Restorations

FDI POLICY STATEMENTAmalgam Waste ManagementAdopted by the FDI General Assembly: 24 September 2006 –Shenzhen, China, Reconfirmed by the FDI Science Committee in September 2009 in Singapore

Possible Local Adverse Effects of Amalgam RestorationsAdopted by the FDI General Assembly: 26th October 2007, Dubai, UAE

FDI POLICY STATEMENTBleaching Materials and Tooth WhitenersAdopted by the FDI General Assembly: 26 August 2005 Montréal, Canada

FDI POLICY STATEMENTAdverse Reactions to Resin-Based Direct Filling MaterialsAdopted by the FDI General Assembly: 24 September 2006 –Shenzhen, China, Reconfirmed by the FDI Science Committee in September 2009 in Singapore



FDI POLICY STATEMENTInfection Control in Dental PracticeMerging of ‘Human Immunodeficiency Virus Infection and Other Blood Borne Infections (2000)’, ‘Infection Control in Dentistry’ (2007), and ‘Sterilization and Cross Infection Control in the Dental Practice’ (2005) Revised version adopted by the General Assembly: 4th September 2009, Singapore

FDI POLICY STATEMENTP t E P h l i f HBV HCV d HIVPost-Exposure Prophylaxis for HBV, HCV and HIVOriginal version adopted by the General Assembly: 26th August 2005, Montreal, Canada, Revised version adopted by the General Assembly: 4th September 2009, Singapore

FDI POLICY STATEMENTDental Unit Water Systems and Microbial ContaminationAdopted by the FDI General Assembly: 26 August 2005 Montréal, Canada

FDI POLICY STATEMENTQuality of Dental RestorationsReconfirmed by the FDI Science Committee in October 2007 in Dubai, UAE, Adopted by the FDI General Assembly: September 2001 – Kuala Lumpur,Malaysia

FDI POLICY STATEMENTQuality of Dental ImplantsOriginal version adopted by the General Assembly in September 2004, New Delhi, I di R i d i d t d b th

FDI POLICY STATEMENTLeading the World to Optimal Oral Health – The Role of the Dental TeamAdopted by the FDI General Assembly: 24 September 2006 – Shenzhen, China

FDI POLICY STATEMENTImproving Access to Oral CareOriginal version adopted by the General Assembly in October 1998, Barcelona,

India, Revised version adopted by the General Assembly: 26th September 2008,Stokholm, Sweden

FDI POLICY STATEMENTEndorsement of ISO StandardsOriginal version adopted by the General Assembly in September 2004, New Delhi, Revised version adopted by the General Assembly: 26th September 2008,Stokholm, Sweden

Spain, Revised version adopted by the General Assembly: 26 August 2005 Montréal,Canada, Reconfirmed by the FDI Dental Practice Committee in September 2009 in Singapore

FDI POLICY STATEMENTOral and Dental Care of People with DisabilitiesAdopted by the FDI General Assembly: 18th September 2003, Sydney, Australia

FDI POLICY STATEMENTCode of practice on tobacco control for oral health organisationsAdopted by the FDI General Assembly: 12th September 2004 – New Delhi, India, Reconfirmed by the FDI World Dental Development & Health Promotion Committee in September 2009 in Si

FDI POLICY STATEMENTInternational Principles of Ethics for the Dental ProfessionAdopted by the FDI General Assembly: September 1997 – Seoul, Korea

FDI POLICY STATEMENTEthical International Recruitment of Oral HealthProfessionalsAdopted by the FDI General Assembly: 24 September 2006 – Shenzhen, China

Singapore

FDI POLICY STATEMENTOral CancerOriginal version adopted by the General Assembly in October 1998, Barcelona,Spain, Revised version adopted by the General Assembly: 26th September 2008, Stokholm, Sweden

FDI POLICY STATEMENTThe Use of Academic, Professional and Honorary TitlesAdopted by the FDI General Assembly: 4th September 2009, Singapore

FDI POLICY STATEMENTGuidelines for Dentists against TortureAdopted by the FDI General Assembly: 26th October 2007, Dubai, UAE



ERO, ARO, NARO, APDF, LARO

PREAMBLE:Dentistry is a complex medical science with high

standards, which encompasses the prevention, diagnosis and rehabilitation treatment of whole Masticatory System, the hard and soft tissues of the mouth, the salivary glands, the nerves, the muscles and the jaws, recognising oral symptoms of the systemic diseases, including oral cancer, malformations and lesions of the teeth, mouth and jaws, as well as the replacement of missing teeth and the restoration of functional oral health.

Such treatment calls for medical knowledge, acquired with at least 5 years of University education, according to the European directives in force. This is an education level not reached by the other members of the dental team.

The dental team, led by the dentist, is essential in the prevention of oral diseases and in ensuring the

2. WORKING RELATIONSHIPWhen a dental treatment involves collaboration between a dentist and a dental laboratory technician and with the view to providing the best possible oral health care to the population, the dentist should work together with a duly qualified dental laboratory technician and make consistent efforts to develop and maintain the best possible working relationship.3. TASKSThe dentist shouldProvide top patient safety and quality assurance of oral health care. Comply with all legal responsibilities in the performance of all clinical procedures.Be solely responsible for both the diagnosis and the follow -up actions thereby ensuring the continuing care of the patient.Require the dental laboratory technician and the dental team to provide the highest quality of service,prevention of oral diseases and in ensuring the

best possible quality of oral health care. All members of the dental team shall have the education and training appropriated for their competencies and be legally allowed to participate in the delivery of oral health care always under the supervision and responsibility of a dentist. The Roles and responsibilities of all team members should be specified and defined by the regulatory official authorities and professional dental organisations. Professional dental qualifications should provide confirmation to dental authorities, to the public and to patients, of a dentist’s professional competence and entitlement to practise.

Whilst it must be for the national competent authority to decide upon the legal requirements and restrictions applicable, non-dental qualifications could be misleading both to patients and to the public by implying the attainment of a specialist or other higher diploma. A dentist and all the other members of the dental team should use only those qualifications or titles which are approved for recognition by the competent dental authority in that country (legislation in the establishment country, place of work, country where they practice).

Assume the legal responsibilities and claims in relation to the patient for both the clinical treatments and for the prostheses received and accepted from the dental laboratory technician and for all treatments delegated to other duly qualified members of the dental team. Provide to the dental technician, by means of the prescription, the written specification and the three-dimensional registers necessary to comply with the dentist’s instructions. Ensure that all members of the dental team at all times have the appropriate competence and training for the tasks that are delegated to them.Be responsible of Safety and Health of the dental team, including ergonomics and working environment.Monitor and supervise the performance of the dental team with the purpose of ensuring optimal quality of the oral health care delivered. Be responsible for the disinfection and sterilization control in the entire dental practice, as well as protection from radiation.Update his/her knowledge and training by attending continuing education courses, scientific and professional evolution, according to evidence based dentistry.Protect, as well as all the other members of dental team, all data in relation to the patient and his/her dental treatments, according to the Country’s legislation.

The dental laboratory technician should:Accept and follow the directions and specifications

provided by the dentist including protecting the data of the prosthetic treatments of the patient.

Guarantee the conformity with the prescription of the dentist of the working procedure and the utilised material.

Never be allowed to work in the mouth of the patient.

Th th b / f th d t l t h ld

CONCLUSIONSThe Dental Team shallPractice according to evidence based dentistry and to the principles of humanity.Safeguard the oral health of patients irrespective of their individual status.Prevent ethically and legally illegal dental practice.

The other member/s of the dental team should:Carry out only the delegated tasks, for which he/she is

duly and legally qualified or trained within the authorised practice of the country, but not tasks for which no such qualification or training have been completed.

Carry out these tasks solely under the supervision of the dentist who shall be present in the dental practice.

Refer back to the dentist any condition or task, which is outside the competence and training of the team member.

Accept and follow the directions and specifications provided by the dentist including the protection of all data of the patient.

Be trained on rules and code of behaviour towards the patients and the relationship inside the Team itself.

C. Auger (France) G. Cok (Slovenia)E. Cavallé (Italy) ChairmanM. Frank (Germany)B. Griffa (Italy) Board M.S. Hanson (Belgium) V.CE. Lai (Italy)H. Neuman (Israel)M. Otheo de Tejada (Spain)H. Schrangl (Austria)N. Sharkov (Bulgary)R. Wagner (Germany)

After approval, all member countries should communicate this statement to the public and to the government.



If the human mistake can’t be completely eliminated, weneed to create ideal working conditions and carry out actions that make it difficult for the single person to do mistakes.

(R 1992)(Reason 1992)

laws & regulations & patient safety

In general in most parts of the world there are no specific documents or direct laws or regulations about patient safety documents or direct laws or regulations about patient safety in dentistry.

BACKGROUND: Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. The aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. DESIGN AND METHODS: The frequency, type, impact, and causes of incidents found in the records of

Patient safety in Dutch primary care: a study protocol

primary care patients (objective one); an incident-reporting study in each of the participating practices, to determine the type, impact, and causes of incidents reported (objective two); to provide insight into patient safety management in primary care practices (objective three), + organizational and cultural items relating to patient safety. DISCUSSION: To estimate the frequency of incidents was difficult. Much depended on the accuracy of the patient records and the professionals' consensus about which types of adverse events have to be recognized as incidents.Harmsen M, Gaal S, von Dumen S, de Feiter E, Giesen F, et al. Implement Sci. 2010 Jun 28;5:50.



FDI Survey Patient safety & Risk Management ( March 2011 )FDI Survey - Patient safety & Risk Management ( March 2011 )

FDI Survey - Patient safety & Risk Management ( March 2011 )

AlbaniaAustraliaBelgium

BotswanaBurkina Faso

CanadaCroatia (2)

Czech RepublicCyprus

Kyrgiz RepublicMali

MauritusMyanmar

NetherlandNigeria

PortugalRomaniaCyprus

DenmarkFranceFiji (2)

GhanaGreece (2)

HaitiHong Kong

HungaryIrelandJapan

RomaniaSenegalSri LankaSweden

SwitzerlandThailandTurkey

UgandaU.S.A

Zimbabwe

As NDA, do you have any documents or activities regarding ;a) ‘Risk Management’ in dental practice?

5No knowledge

22

13

Yes

No

18



Infection control - best practice modules,/guidelines, hygieneprotocols (Ireland, Netherlands, Portugal, Canada, Belgium)

Radiation, waste management best practice models (Ireland)


From Positive Practice Environment Secretariat in Geneva(Uganda)

Sample document - operating manual of dental practice (CzechRepublic)

Instigating a national practice accreditation programme for safety and quality (Australia)

Only some information from health authorities (Denmark)

CDA published an Influenza A (H1N1) Pandemic Plan - 2012(Canada)

Health and safety management (Cyprus)

"Accidents of exposure to blood in dental office"; "Risk assessment; assistance for preparing the single document“(F )


(France)

Organizing lectures, conferences (Sri Lanka, Haiti)

Publication/booklet about risk management (Sweden),

"To Avoid Medical Disputes" issued by JDA (Japan)

Annual dental practice inspection (Thailand)

Under development - the clinical protocols (Kyrgiz Republic)

As NDA, do you have any documents or activities regarding ;b) ‘Patient Safety” in dental practice?

3No knowledge

23

14

3

Yes

No

No knowledge

17




Clinical Audit in Decontamination of Dental Instruments, Clinical Audit in Radiology (Ireland)

Infection control , hygiene protocols/guidelines/lectures(Netherlands, Myanmar, Greece, Fiji)

The clinical protocols is under the development (Kyrgiz Republic) +

F P iti P ti E i t S t i t i G (U d ) From Positive Practice Environment Secretariat in Geneva (Uganda) +

sample document - operating manual of dental practice (CzechRepublic) +

We have policy on Minimum Standards requirement of dental surgery and an nationally adopted infection control manual (Fiji)

Documents are in a draft form and we have policies in regard to safety and quality (Australia)


Regulations regarding official registration of qualifications of dentists; CED- Consultation on patient safety Council European Dentists: Manual of Dental Practice (Portugal)

Three documents produced by the Committee on Clinical and Scientific Affairs :Guidance Document Pertaining to Devices for Use in Dental Health Care; Guidance Document for Dentists Providing Human Allogeneic Transplants; Disclosure of Unanticipated g p ; pOutcomes: A Toolkit For Dentists. (Canada)

Health and safety management system (Cyprus) +

We have a publications about legislation and rules regarding patient safety in dental practice (France)

Booklet “To Ensure the Medical Safety in the Dental Clinics” (Japan)

Annual dental practice inspection (Thailand) +

Are there any national laws/regulations in your country regarding ; a) ‘Risk Management’ in dental practice ?

5No knowledge

16

19

Yes

No

24




Dental Council guidelines, legislation on Waste management,Health Safety and Welfare at work, National standards for the prevention and control of Healthcare Associated Infections, hand hygiene standards (Ireland)

infection prevention and others (Netherlands)p ( )

Only guidelines on Infection control from Ministry of Health(Uganda)

sample document - operating manual of dental practice(Czech Republic)

Dental law (Croatia)


National Dental Board requirements and a national quality and safety commission (Australia)

Laws regarding hazardous waste management, hazardous waste disposal and waste collection; Radiation use and protection; Regulations regarding Dental Office environment conditions (Portugal)( g )

In Canada the regulation of health care workers is a provincial jurisdiction. As a result Risk management in dental practice is regulated at that level and there are no national laws related to this issue (Canada)

standards of dental practice document (Albania)

We have new patient safety legislation in Sweden as from January 1st 2011 in which risk management is involved (Sweden).


The information of patients and the discussion about advantage and risks between practitioners and patients are legal obligations taken from the Public Health Code; Article L1111-1 and following articles (especially Article L1111-2 for the information on the risks). The risk management (of workers, not patients) is covered by the Labour Code which imposes the preparation of a Single Document in dental office All the risks must be listed in this Document in dental office. All the risks must be listed in this document and avoided (chemical, biological, radiological,electrical risks...); article L4121-1 and following articles(France)

Medical Service Law (Japan)

infection control (Belgium)

Issued by Dental Council of Thailand (Thailand)



Are there any national laws/regulations in your country regarding; b) ‘Patient Safety” in dental practice ?

4No knowledge

20

14

4

Yes

No

g18

Are there any national laws/regulations in your country regarding ; b) ‘Patient Safety” in dental practice ?

Dental Council guidelines, also as above (Ireland) +

infection prevention and others (Netherlands) +

Only guidelines on Infection control from Ministry of Health(Uganda) +

Dental law (Croatia) +

Infection Control Protocol (Fiji) +

Regulatory and non regulatory requirements both at a national and state level (Australia).

Regarding dental professionals qualifications registration and dental office environment (occupational, sanitary, hygiene and safety in general health, radiation management and protection,hazardous waste management)(Portugal)


Ministerial decrees (Greece)

But only as pertains to own and use intraoral x-ray machines(Botswana)

In Canada the regulation of medical devices is done at the national level. A list of Canadian Medical Device Regulations is

il bl t (C d )available at (Canada)

xray radiation control (Mauritus)

We have new patient safety legislation as from January 1st 2011(Sweden) +

Medical Service Law (Japan) +

infection control (Belgium) +




The code of ethics, which appears in the Public Health Code, imposes safe treatment. Article R4127-204: Dentists must not work in conditions that may jeopardize the quality of the treatment made as well as the patient's safety. Article R4127-269: The property of documents regarding all the personal information on patients. In any case, the quality of the treatments, their confidentiality, and the patient's safety must be guaranteed Article R4127 270: Dentist the patient s safety must be guaranteed . Article R4127-270: Dentist makes all the arrangements for the response to emergency situations, the quality, the safety and treatment continuity to beguaranteed on all the sites of exercise (France)

Issued by Dental Council of Thailand (Thailand) +

Health authoritiesSpecific bodiesBoardsMedical Chambers / National Dental AssociationsOthers..

U.K.

The NCAS is a division of the National Patient Safety Agency (NPSA),established to ensure that patients have better protection and doctors and dentists have better support. The service aims to help NHS Trusts and Primary Care Organisations (PCOs) to clarify concerns about the performance of doctors and dentists, offering advice and support for local case management and carrying out performance assessments where necessary.

Working Protocol between the British Dental Association andthe National Clinical Assessment Service

Patient safety is central to the work of the BDA and the NCAS, and both organisations are committed to ensuring the best possible experience of dentistry for patients by seeking to cultivate the highest possible standards of dental performance. The following are the key areas of communication and collaboration:i. Sharing of data and planned research workii. Training and educationiii. Public announcementsiv. Policy development



U.K.

The national specifications for cleanliness in the NHS: Guidance on setting and measuring performance outcomes in primary care medicaland dental premisesThe cleanliness of health care premises and equipment has been firmly fixed on the NHS agenda as a key issue since 2000. Over these years, much has been issued in the way of advice and

2 (1) The registered person must, so far as reasonably practicable, ensure that —(a) service users; (b) persons employed for the purpose of the carrying on of the regulated activity; and (c) others who may be at risk of exposure to a health care associated infection arising from the carrying on of the regulated activity, are protected against identifiable risks of acquiring such an infection by the means specified in paragraph (2). (2) The means referred to in paragraph (1) are —(a) the effective operation of systems designed to assess the risk of and to prevent, detect and control the

Regulation of regulated activities

guidance but this has, in the main, been aimed at the acute sector. The registration requirements of The Health and Social Care Act 2008, which will apply to primary dental care providers (from 2011) and primary medical care providers (from 2012), state: Criterion 2 of the Code of Practice levies on providers a specific duty to: Provide and maintain a clean and appropriate environment in managed premises that facilitates the prevention and control of infections (Health and Social Care Act 2008 Code of Practice criterion 2)

p ,spread of a health care associated infection; (b) where applicable, the provision of appropriate treatment for those who are affected by a health care associated infection; and (c) the maintenance of appropriate standards of cleanliness and hygiene in relation to —(i) premises occupied for the purpose of the carrying on of the regulated activity, (ii) equipment and reusable medical devices used for the purpose of carrying on the regulated activity, and (iii) materials to be used in the treatment of service users where such materials are at risk of being contaminated with a health care associated infection. (Health and Social Care Act 2008)

Socialstyrelsen SWEDEN – the new Swedish Patient safetylegislation ( as from January 1st 2011)

Concerning the work on Patient Safety in Sweden. Swedish Dental Association (SDA) is continuously participating in reference groups for a national patient safety congress for all health professionals (taking place in September 2011) and for a patients’ handbook on patient safety (initiated by the Swedish government). SDA also watching over developments concerning the new Swedish patient safety

SWEDENReporting malpractice or dissatisfaction in Health Care or Social Services : You are entitled to express your views and lodge a complaint if you are dissatisfied with the treatment you have received or with the work of the social services. Where the complaint should be made depends on what the complaint concerns. What do you want to do?Submit a complaint about poor treatmentReport deficiencies in organisation andco ce g e e S ed s pa e sa e y

legislation (as from January 1st 2011). SDA especially interested in the reporting of malpractice and dissatisfaction in dental care – and the consequences for the individual dentist - which is reorganized as a result of the new legislation. You can read more at the website of the National Board of Health and Welfare www. Socialstyrelsen.se/reportingmalpractice. SDA has a document on risk management in dentistry with useful advice to our members, but unfortunately we only have a Swedish version.

p goperationsReport errorsRequest financial compensation formalpracticeAppeal a decision taken by themunicipality on the work of social servicesSubmit a complaint on the execution of thework by the social servicesReport serious deficinecies in the socialservices or that no one listensSubmit complaints on public careReport incorrect or unfair treatment by an authority

Australia

4 June 2009 – Australian Dental Association Media Release

ADA fears for patient safety if dental therapists treat adults.

The Australian Dental Association Inc. (ADA) fears that the South Australian Government’s plan to allow dental therapists to treat ad lts against e pert ad ice poses a risk to patient to treat adults, against expert advice, poses a risk to patient safety and to their long term dental health.The ADA insists that removing the limitation that these practitioners only treat children from current Regulations dramatically alters the scope of practice for dental therapistsby allowing them to perform treatment that is beyond their expertise and so poses a danger to the public. Dental therapists are just not trained or qualified for these duties and should not perform them.



Nothing much specific for dentistry...

SPAIN

The Law of cohesion and quality of the health system (Law 16/2003)

SPAIN

Spain operates as a federal state in terms of health policy (each of the regions has its own regulations, although they are all very similar).

General law nationwide on patient safety is a part of the "Law of cohesion and quality of the health system (Law 16/2003) although is cohesion and quality of the health system (Law 16/2003), although is very brief. In the Community of Madrid, there is an order opening the Centre of Health Risks (Decree 134/2004) and a Risk Functional Units in each hospital (Order 1087/2006). Such legislation exists in each region. The patient safety system is very active in Spain today.

About patient safety in dentistry, there is nothing specific. The observatory that are about to be launched (the Spanish Observatory for Dental Patient Safety) will be the first, and its scope will be all over Spain.

Turkey

6 Nisan 2011 ÇARŞAMBA Resmî Gazete Sayı : 27897

YÖNETMELİKSağlık Bakanlığından:

HASTA VE ÇALIŞAN GÜVENLİĞİNİN SAĞLANMASINA DAİR YÖNETMELİKBİRİNCİ BÖLÜM

Amaç, Kapsam, Dayanak ve Tanımlar

6 April 2011 Regulation number: 27897Ministry of Health

Establishment of Safety of Patients and Health Personnel

Goal, content, reason and descriptions



European Union

The Council of European Dentists (CED) is the representative organisation for the dental profession in the EU, representing over 320,000 practising dentists through 33 national dental associations. Established in 1961 to advise the European Commission on matters relating to the dental profession, the CED promotes high standards of oral healthcare and effective patient-safety centredprofessional practice across Europe.

Directives are regulations for action adopted by an institution, legitimized by law, rules of professional conduct or statutes, that are binding within the jurisdiction of that institution and whose non-observance may entail defined sanctions

25.07.1978. Council Dirrective 78/686/EEC - concerning the mutual recognition of diplomas, certificates and other evidence of the formal qualifications of practitioners of dentistry. 25.07.1978. Council Directive

78/687/EEC - concerning the coordination activities of dental practitioners.25.07.1978 Council Decision

78/688/EEC - setting up an Advisory C itt th T i i f D t l

Directives regulating dentistry

There are no directregulations regardingPatient safety within theEU;

However CED has ethicalcodes and directives whichindirectly address safety of Committee on the Training of Dental

Practitioners.25.07.1978 Council Decision

78/689/EEC - setting up a Committee of Senior Officials on Public Health07.09.2005 Directive 2005/36/EC -

mutual recognition of professional qualifications comprehensively regulatesmobility within the EU by setting minimum training requirements for health professionals, including dentists.

indirectly address safety of dental patients

(e.g. Cross-border health caredirective, directive on medical devices, directivesregulating dental educationand recognition of professional qualifications, electronic commerce etc..)

Seven sectoral directives for ,“sensitive“ professions: dentists, doctors, nurses, midwives, pharmacists, veterinarians and architects

This directive states that in cases of cross-border healthcare safety and quality standards enforced in the country of treatment apply. The Directive includes provisions on structures and procedures for

Principle of free movementof people and services withminimal obstacles/barriersFacilitation of services must be in context of respect for public health and safety and consumer protection

pinforming cross-border patients about these standards (transparency) as well as provisions for cooperation between member states aimed at increasing quality and safety.

The CED believes that professional and ethical standards can best bedeveloped at national or regional level.



CED & Standards at the EU Level

No European standards for service provision of dental care is available.

There are national/regional standards – they reflectnational/regional organization of healthcare systems, local needs and capacities;

there is a general agreement on common values for healthcare g g(universality, access to good quality care, equity and solidarity), but the organization and reinforcement is up to Member States .

quality of provision of dental care to a large extent depends on appropriate education/training of dentists in line with Directive 2005/36/EC.

- personal responsibility of dentists in delivery of care, guaranteed by respecting ethical codes at local/national/EU level (CED Code of Ethics) i supported.

CED POSITION PAPERSEducation and Professional QualificationsCED Resolution on the profile of the dentist of the future November 2007 CED Resolution on the Bologna Process and dental training November 2005Joint statement of the sectoral professions March 2005DLC position paper on draft Directive June 2002Joint statement of the sectoral professions June 2002Infection controlCED Code on Infection Control May 2009Tooth-whitening productsCED Resolution on tooth-whitening products May 2007AmalgamCED Resolution on Amalgam November 2009CED Resolution on amalgam May 2007 C i i lt ti EU h lth t tCommission consultation on an EU health strategyCED position paper - responses to Commission discussion document February 2007Commission consultation on health servicesCED position paper - responses to Commission consultation January 2007CED position paper - executive summary January 2007 Medical DevicesCED position paper regarding the review of the Medical Devices Directives May 2006DLC contribution to public consultation on amendments to the Medical Devices Directive June 2005 Services DirectiveJoint statement of European health professional organisations March 2005 DLC position paper October 2004

INFECTION CONTROL CODE (CED Resolution on decontamination, cleaning disinfection,sterilization, waste management and a wide range of hygienic procedures)ANNEX - // RECOMMENDATIONSThis annex lists CED-agreed voluntary recommendations for the basic procedures necessary to maintain a safe environment for both dental staff and patients.Recommendation 1: Choice of equipmentRecommendation 2: Choice of flooring and bench materialsRecommendation 3: Patients’ medical recordsRecommendation 4: ImmunizationRecommendation 5: Hand-washing and disinfectionRecommendation 6: GlovesRecommendation 7: Masks and goggles/dental clothingRecommendation 8: Surface protection and coveringRecommendation 9: Labeled single-use itemsR d ti 10 Di i f ti t i l

CED RESOLUTIONS

Recommendation 10: Disinfection materialsRecommendation 11: Instrument decontamination and sterilizationRecommendation 12: Sterilization monitoring and indicatorsRecommendation 13: Handpiece sterilizationRecommendation 14: Sterilization of burrs and endodontic instrumentationRecommendation 15: Decontamination of equipmentRecommendation 16: Decontamination of impression materialsRecommendation 17: Decontamination/sterilization of orthodontic appliancesRecommendation 18: Handling of blood spillsRecommendation 19: Aerosol splatters and air qualityRecommendation 20: Waste disposal managementRecommendation 21: Amalgam and toxic materials disposal managementRecommendation 22: Biopsy tissues, teeth and small tissues managementRecommendation 23: Inoculation injuries protocolAdopted unanimously at the CED General Meeting in Brussels on 20 November 2009



NOVEMBER 2010 - CED RESOLUTION

DENTAL AMALGAM//HEALTH CONSIDERATIONS

EU Scientific Committee on “Safety of amalgam and alternative dental restorative materials”.

“dental health can be adequately ensured by both types of material. All the materials are considered safe to use and they are all

i t d ith l t f l l

MAY 2008 - CED RESOLUTION - PATIENT SAFETYINTRODUCTION The dental profession is committed to providing safe dental care, which is necessary for ensuring good general health, and aims to minimise risks and establish an open culture of patient safety, in which practitioners can learn from their own and others’ experiences. A number of international studies in recent times have concluded that action is needed to reduce the number of adverse events that occur in the health sector. Various international bodies, such as the World Health Organization (WHO), the O i ti f E i C ti d associated with very low rates of local

adverse effects with no evidence of systemic disease.”

ENVIRONMENTAL CONSIDERATIONS -

CED emphasises that the dental professional has an obligation to work within the legal framework governing mercury containing products. The CED calls on Member States to ensure the fullimplementation and enforcement of EU waste laws, and fully supports examination into whether this is happening.

Organisation for Economic Cooperation and Development (OECD) and the Council of Europe, have sought to identify patient safety risks and develop recommendations to help prevent adverse events. The European Commission has stressed the importance of patient safety as a political issue at EU level and is preparing proposals on patient safety in 2008. These proposals should build on the international work already done and should primarily seek to recommend action for Member States to implement in their health systems. It has to be remembered here that in accordance with the EC Treaty it is Member States which are primarily responsible for the organisation of healthcare services.

PATIENT SAFETY IN THE DENTAL HEALTHCARE SETTING It is essential that action to improve patient safety at national, European and international level take into account the various healthcare settings in which patients are treated, since the types of patient safety risk and most appropriate ways of minimising them may vary according to healthcare setting. Most dental care in Europe is provided in liberal practice, in small structures, and in an

i t h th d ti t ll

Reduction of adverse events and improvement of patient safety is most effectively achieved through prevention, and preventive action to reduce adverse events is in turn a facet of high quality healthcare. Quality cannot be promoted through force or sanctions from outside. It must be ensured that new measures ostensibly to improve patient safety, which can often add to the bureaucratic burden in the dental practice, do not hinder dentists from spending sufficient time with each patient, as this is an important parameter of high quality. The dental profession in every Member State has self-

l t f ti i ti hi h lit d

MAY 2008 -CED RESOLUTION - PATIENT SAFETY

environment where the dentist generally has complete individual responsibility for the whole procedure of care of the patient. The risk of adverse events is present throughout that whole procedure, relating, for example, to diagnosis, faulty equipment, general safety of the practice, poor communication with the patient or other health professionals, inadequate infection control or waste management. It is important to remember that in the field of medical care "zero risk" does not and cannot exist.

regulatory functions in promoting high quality, and works, when necessary, with its respective governments in a co-regulatory context to achieve the same objective. The dental profession seeks to promote quality in many ways, including providing for continuing professional development to keep skills up to date; establishing local study groups for dentists and dental practices to learn from each others’ experiences; developing systems for reporting adverse events or near misses; and ensuring compliance with infection control and waste management laws. Much of this is implemented already in Member States, although action to improve patient safety is an ongoing preoccupation.

Quality & Standards in dental education

European Quality Assurance European Quality Assurance Register for Higher Register for Higher EEducationducation

European Association of Institutions in Higher Education Institutions in Higher Education

European Students’ Union

European University Association

European Association for Quality Assurance in Higher Education



Core Competences respecting different educational methods and approaches. (Global Congress in Dental Education, 2002)

Profile of an international dentist (ADEE/DentEvolvesDresden 2003) Third TNP “Dented III” (2004-2007)

From specific competences to broad learning outcomes in dentistry

) ( )

Profile and Competences for the new European dentist (ADEE Cardiff, 2004)

Profile and Competences document (PCD) (Plasschaert et al., 2004): seven domains, major competences and supporting competences.

Profile and Competences for the graduating European dentist - update 2009 (Cowpe et al., 2010):

‘Requirement’ – is a binding or mandatory policy and, in this document, it is also a ‘best practise’.

‘Recommendation’ (Guideline) – in EU terminology is not binding, or mandatory, and in this document would constitute suggestions for improving practice.

1.Quality management can only be implemented when the explicit goals and objectives of all of the functions of a dental school are clearly defined.

2. Every dental school (and hospital) should pursue explicit quality management, improvement and enhancement.

3. Quality is the responsibility of everybody.

Requirements for dental education

8. Student feedback, obtained through appropriate evaluation mechanisms

9. Feedback from recent graduates, patients and support staff

10. Any quality improvement method employed should ensure that outcomes from the feedback and review mechanisms are communicated to teachers, students, graduate and postgraduate trainers.

11 All of those involved in and associated everybody. 4. Appropriate Quality systems should

be an integral part of all of the activities at a dental school (and hospital

5. Schools should have critical self-evaluation systems

6. Assessment of quality should be systematic, periodic and cyclical

7. Continual quality management processes and their outcomes should always be documented properly.

11. All of those involved in, and associated with, learning and teaching should receive a regular formal appraisal

12. There should be a properly documented period of ‘educationally related’ training for all new (and returning) teaching staff with clear guidelines

13. The management and committee structure within the Dental School, Hospital and the providers of other ‘clinical support’ training facilities should include systems for quality assurance and improvement at every level.



Laws & RegulationsGuides/manuals are available to assist dental professionalsGuides/manuals are available to assist dental professionals

Centers for Disease Control and Prevention -guidelines,recommendationshttp://www.cdc.gov/

DENTAL OSHA MANUALSBloodborne Pathogen Standard [1910.1030]Recordkeeping Requirements [1910.1904] Chemical Hazard Communication Standard [1910.1200] Infection Control in dentistryCDC's Sterilization proceduresTuberculosis (Epidemiology & ExposureControl)Latex AllergyExposure to Berryllium in Dental LaboratoriesExposure to Nitrous Oxide

safety recommendations for medical facilities - the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

There are currently no specific standards for dentistry. However, exposure to numerous biological, chemical, environmental, physical, and psychological workplace hazards that may apply to dentistry are addressed in specific standards for the general industry. (OSHA)

Exposure to Ionizing Radiation [29 CFR 1910.1096] Means of Egress [29 CFR 1910.36] Emergency Action Plan [1910.38] Ergonomics Control in Dental IndustryWalking-Working Surfaces [1910 Subpart D] Electricity Safety Standard [1910 Subpart S]Fire Safety Standard [1910 Subpart L]Comprehensive OSHA ComplianceChecklistTraining Outline to assist you in your trainingplan

ea ca e O ga a o s (JC O) or those related to workplace safety such as Occupational Safety & Health Administration (OSHA).

Ethical dentistry

FDI POLICY STATEMENT

International Principles of Ethics for the Dental Profession

Adopted by the FDI General Assembly: September 1997 – Seoul, Korea

CED CODE OF ETHICSAgainst a background of cross-border mobility of patients and health professionals in the EU and the EEA, the CED drew up a Code of Ethics in 1965, which served as a framework of reference for all dentists in their cross-border practice.

The Code was most recently updated in 2007. The principles it contains reflect the standard of professional conduct and ethics which underpin high quality dental care and services throughout Europe.These are general principles that underpin the codes in the individual Member States.

The national codes reflect the different cultures, traditions and needs of the public and patients in the various countries of the EU. Dentists working in another country should familiarise themselves with the national codes of that country, and respect them

CED CODE OF ETHICS



MAY 2008 - CED RESOLUTION - PATIENT SAFETY

Reduction of adverse events and improvement of patient safety is most effectively achieved through prevention, and preventive action to reduce adverse events is in turn a facet of high quality healthcare.

Quality cannot be promoted through force or sanctions from outside.

It must be ensured that new measures ostensibly to improve patient safety, which can often add to the bureaucratic burden in the dental practice, do not hi d d ti t f di ffi i t ti ith h ti t thi i hinder dentists from spending sufficient time with each patient, as this is an important parameter of high quality. The dental profession in every Member State has self-regulatory functions in promoting high quality, and works, when necessary, with its respective governments in a co-regulatory context to achieve the same objective. The dental profession seeks to promote quality in many ways, including providing for continuing professional development to keep skills up to date; establishing local study groups for dentists and dental practices to learn from each others’ experiences; developing systems for reporting adverse events or near misses; and ensuring compliance with infection control and waste management laws. Much of this is implemented already in Member States, although action to improve patient safety is an ongoing preoccupation.

Legislations & Laws – Dentistry & Risk Management –PatientSafety - ‘immature’

(Especially in the developing world)

I cannot say whether things will get better if we change; what I can say is they must change if they are to get better.

Georg Christoph Lichtenberg



Thank you..

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