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Page 1 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Who can support usIn proving healthcare at its best?
Harmonization for safety & effectivenessHeavily regulated industry: Medical
Copyright © Siemens AG 2008. All rights reserved.March 2008 - International Accreditation Forum, Bonn
Page 2 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Market development in healthcare
Market trends … Demands for …
More efficient and more effectivehealthcare services
Optimized workflow
Rural healthcare products
Supporting healthcare professionals in doing their workefficiently
Growing population
Aging population
Emerging rural healthcare
Cost pressure
Page 3 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
The vision of Siemens Healthcare
high quality and patient-centered carealong the healthcare continuumwith best processesand with proven outcomes.
We help our partners to provide …
Workflow-oriented IT
Prevention & early
detection In-vitroDiagnostics(IVD)
In-vivoDiagnostics(Imaging)
DiagnosisTherapy Care
Page 4 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
In-vivo diagnostics (major medical imaging systems)
X-Ray ComputedTomography
MagneticResonance
MolecularImaging Ultrasound
Healthcare ITIn-vitro diagnostics (major medical laboratory systems)
Immuno-diagnostics
Nucleid AcidTesting
Clinical Chemistry Hematology Urinalysis Lab
AutomationNear PatientTesting
First fully integrated diagnostics company
Page 5 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Contractual and liability claims
Siemens HealthcareMarket / regulatory complexity
Authorities
Customers
Patients
UsersSiemensHealthcare
Standards
ISO13485: 2003
ISO 14971:2000
IEC 60601-1-x
…
Regulatory Affairs
Europe MDD 93/42/EECIVD-Dir. 98/79/EEC
USA 21 CFR 82021 CFR 809
Canada CMDCAS
Japan PAL
China Order No. 276, …
World GHTF
…
Page 6 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical Devices General
Market access is a critical process for medical device manufacturers and for the patients, because it influences the time to market (clinical availability) as well as the commercial aspect (price).
The medical device is identified by the specific legal definition in the respective national legislation. As the definitions differ slightly the assessment (medical device or not?) must consider the differences (e.g. USA vs.EU).
The manufacturer defines the intended use of the medical device which is compared with the respective legal definition. The intended use typically covers:
Page 7 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical Devices Manufacturer
The manufacturer is the responsible legal entity placing the medical device on the market. This means that other companies can supply or produce components or complete systems, but are not manufacturers in the regulatory sense.
When multiple companies work jointly on a research project, the responsibilities must be clearly outlined. Either one single partner or a joint venture can assume the full responsibility for that device.
Aspects of product liability and intellectual property need also be considered.
Page 8 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical Devices Manufacturer
The manufacturer defines the intended use and the device with its accessories , interfaces etc. The risks are controlled through product risk management (acc. ISO 14971) and identify potential risks from the workflow, clinical application or third party products/markers.
When placing the devices on the market the manufacturer must ensure compliance with regulatory requirements (e.g. QMS, safety standards).
This traditional device oriented regulatory approach has some challenges when solutions (containing a combination of multiple devices) are developed. In this case the solution must “fit into the frame”. In general this means that the responsibilities for the manufacturer/s of system/solution must be clearly defined.
1. Define User group(Employees of AtlantiCare)
2. Updating Data in MA DB via web-interface
3. MA Card productionand distribution
ED Szenario/Kiosk
RFID Reader
MACard
Internet
SBS RFID Middleware
A) Read unique member ID
B) Request of PHR Data
C) Print PHR Data
MedicAlert DB
SBS RFID-Middleware
Web-Service
Printer
Web-Service
Page 9 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical DevicesClosing the Loop
PRE-MARKET POST-MARKET
PLACING ON THE MARKET
Page 10 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Conformity Assessment Procedure
Device Classification
Medical Device(intended use defined)
Affixing of CE Mark
Declaration of Conformity
Placing on the market
Product Type Listing
Establishment Registration
Essential Requirements
Intended Use of Medical Device
9999** Number assigned to NB
by EU Commission
Medical Devices Path to Market in the European Union
Page 11 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical Devices Path to Market in the United States
Product Classification(defined by FDA)
Medical Device(Intended use)
Product Type Listing
Market Access
Establishment Registration
Market clearance/approval by FDA*
•Premarket Notification [510(k)], or
• Exempt from 510(k), or
•Premarket Approval
Quality System Regulation
Page 12 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical DevicesSafety & Effectiveness
Once state of the art…
Page 13 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
State of the art technology develops continuously through systematic evaluation of post market data.
Page 14 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Medical DevicesPost Market Surveillance
To prevent adverse events (e.g. injury) it is necessary to have quick access to comprehensive and reliable post market information.
The international exchange of post-market information between authorities is increasing in the last years.
This “alert-network” is needed to protect the patients and users globally.
Page 15 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
USA(QSR)
Canada
PRC
...
South America
Australia
Japan
EU
1348513485
ISO 13485:2003One common standard
Page 16 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
USA(QSR)
Canada
PRC
...
South America
Australia
Japan
EU
1348513485
JGMP Report
Certification
Certification & inspection
ISO 13485:2003One common standard & multiple audits
FDA Inspections
CMDCS Certification
EC certificate
Registration & inspectoins
Page 17 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
ConcordOCS
Hoffmann Estates(Chicago)
MIAX Piscataway
A
KnoxvilleMI
Oxford MR Erlangen/Forchheim
AX, SP, CT, MR, AHS, CO, RV, SW, CS
Madrid SP
SingaporeA
Shanghai CT, AX, CO
Malvern HS
Mountain ViewUS
Suzhou A
Shenzhen MR
Goa CO
Kemnath CO
Rudolstadt RV
Kyongju-siUS
Indonesia A
WuxiRV
BangaloreHS, IKM
Divisions/HeadquartersManufacturing sites
~49,000 employees worldwide (after closing of Dade Behring acquisition)
Dublin DX
FlandersDX
IssaquahUS
Siemens HealthcareGlobal presence & multiple organizations
LlanberisDX
SudburyDX
Heidelberg OCS
SeoulUS
Cary CS
ElkhartDX
Walpole DX
Marburg DX
New Jersey DX
Wales DX
DeerfieldDX
TarrytownDX
Los AngelesDX
Page 18 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Integration versus Cummulation
Integrate4Efficiency Management SystemsAudit Requirements
Quality ManagementISO 13485:2003ISO 9001:2000EC CertificateCanada, Japan, Taiwan, etc
Environmental Management ISO 14001
Financial ControlsSOA
Information TechnologyISO 27001
Process ImprovementCCMi
…
Page 19 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Added Value
Audits
Inspections
Assessments
Certificates
1.
4.3.
2.Market Access Outsourcing
Tenders Compliance
Accepted controlsCustomer Requirements
Regulatory Requirement Indicator for Quality
Enable the manufacturer to control the operations for placing safe and effective medical devices on the market and ensure a high customer satisfaction
Page 20 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Harmonization for safety & effectivenessConclusions
Complexity in a highly regulated environment
Support integration and reduce complexity
Standardization in auditing must provide tangible benefits
1.
2.
3.
Transparency is needed for market control and trust building4.
Page 21 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Thank you!
Dr. Gerd [email protected]
Carlos [email protected]
Siemens AGHealtcare SectorHenkestr. 127D - 91052 Erlangen
Siemens HealthcareAnswers for life
March 2008
International Accreditation Forum, Bonn
Page 22 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
Biography
Carlos Arglebe is the head of the Quality Management System and Processes Unit at Siemens Healthcare, based in Erlangen (Germany).
His responsibilities include the global development of process- and quality management. Amongst others, his focus is set on Product RiskManagement, the Corporate Quality & Regulatory Competency- and Compliance Audits Program.
He has a degree in law, an MBA in Health Care Management and large experience in Quality Management Systems.
Since 2007 he represents the medical device industry of the European Union as member of the Global Harmonization Task Force (StudyGroup 3 - Quality Systems).
Page 23 March, 2008Copyright © Siemens AG 2008. All rights reserved.
Siemens Healthcare, Quality Management
SynopsisHarmonization for safety & effectiveness
The industry sector of medical devices is heavily regulated on a global
scale. There are multiple regulatory models which have distinct
requirements but a common objective: ensure safety and effectiveness.
The ISO 13485:2003 quality management standard is well accepted
and broadly implemented, providing a common basis for global
operations. The standard is process oriented, supporting the fact that
product quality is determined by a company’s processes. Quality
Management Systems have therefore become a key requirement for
market access. Although a common standard exists, the number of
audits and inspections increased in the last years due to country
specific requirements and the lack of mutual recognition of existing
certificates. This is in many cases the cause for redundancies which
impact the operations of the manufacturer. Minimizing auditing efforts
without imparing the effectiveness of Quality Management Systems
must be a common objective.
Covering multiple applicable standards and regulations into one audit is
a valid solution and an efficient approach. This reduces redundancies
and the burden set on the manufacturer (time & effort).
In this context the calculation of audit man-days needs to be further
developed, so that such a combined audit does not cummulate, but
integrate the applicable requirements. There is no direct correlation of
man-days and the number of employees. Instead it is the process
complexity, the amount of automation and the level of risk which are of
relevance. Additionally the knowledge gained by the certification body
throughout the years allows a more focussed and in deapth auditing
compared to an initial audit by a third party.
To improveme competiveness and the reliability of certifications, more
transparency about the certification bodies with a warning system
similar to medical device manufacturers is a new approach which
should be evaluated.