Transcript Document

Legislation and regulation
Legislation
SFS 1982:763
Act on Health Care
SFS 1993:584
The Medical Product Act (harmonized with 93/42/EEG)
SFS 1996:786
Supervision of Health Care
SFS 1998:531
Act on professional activity on the field of health
care
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Legislation
LVFS 2997:1
Active Medical Devices Directive
LVFS 2009:18
Medical Devices Directive (LVFS 2003:11)
LVFS 2001:7
In Vitro Medical Devices Directive
LVFS 2001:8
The Manufacturers Obligation to report
Accidents and Near-accidents with medical
devices
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Legislation
SOSFS 2008:1
Use of Medical Devices
SOSFS 2005:12
Quality Systems in Health Care
SOSFS 2005:28
Reporting obligation under Lex Maria and
local procedures for adverse event reporting
AFS 2001:1
Systematic Work Environment Management
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SFS 1982:763
Act on Health Care
The patient shall, according to the Act on Health Care, be given
a good and safe care. Management of health care shall be
organised so that it provides high patient safety, good quality of
care and promote cost-effectiveness. There should be staff,
premises and equipment that is needed to give good care
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SFS 1993:584
The Medical Product Act
Requirements on medical devices
5 § A medical device shall be suitable for its use.
The product is suitable if it is in normal use, for the
purpose intended, will achieve the performances
intended by the manufacturer and meets the high
requirements on the protection of life, personal safety
and health of patients, users and others.
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SFS 1993:584
The Medical Product Act
A Medical Device, referred to in the Act, shall mean:
any instrument, apparatus, appliance, software,
material or other article,
whether used alone or in combination with any accessories,
including the software necessary for its proper application
intended by the manufacturer, to be used for medical
purposes on human beings.
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LVFS 2003:11
Medical Devices Directive
Includes:
• Essential requirements
• Reference to standards
• Classification
• Clinical trials
• CE-marking
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Responsibilities
SOSFS 2008:1
The application of the direction includes
1. Information systems connected to medical devices.
Information system – a system that collects, revises, stores
or distributes and presents information.
2. In-house produced medical products.
3. Handling of medical products, for example maintenance
and transporters.
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Responsibilities
SOSFS 2008:1
Care provider’s responsibility
4 § Care provider shall give directives and ensure that there are procedures in
the management system for
1. how each activity will be organized in order to allow for a safe use and
handling of medical devices, and
2. when a Director should be mandated to be responsible for the areas and
tasks set out in Chapter 3. 6-7 §§ and Chapter 4 5 – 6, §§.
5 § The health care provider may commission one Director to be responsible
for all or some of the fields and duties in an activity that some other Director
is responsible for. The duties of a care provider have assigned a Director
should be documented.
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Responsibilities
SOSFS 2008:1
Director's responsibilities
6 § The Director shall, after the signed commission, be responsible for:
1.
that only safe and medically appropriate medical devices and,
to these, connected information systems are used on patients;
2.
the medical devices and, to these, connected information
systems are controlled and properly installed before they are
used on patients;
3.
information from manufacturers and authorities on the medical
devices are made available for health workers and other
relevant personnel;
4.
procedures within the framework of the management system
are available for health workers and other interested personnel
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Responsibilities
SOSFS 2008:1
Health worker skills and responsibility
8 § The health workers who will use and manage medical devices and, to
these, connected information systems should have knowledge of
1. function of the products,
2. risks when using the products on patients;
3. handling of products, and
4. the measures to be taken to limit the extent of a treatment injury,
when an adverse event has occurred.
Health workers shall control medical devices before they are used on
patients. The control should be carried out in accordance with the instructions
given by the manufacturer, if available.
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Responsibilities
SOSFS 2008:1
5 Chapter. In-house produced medical devices
Requirements on in-house produced medical devices
1 § In-house produced medical devices should meet, where applicable, the
requirements for
1. CE marked medical devices Chapter Act (1993: 584) on medical
devices,
2. Medical Product Agency’s regulations (LVFS 2003: 11) on medical
devices,
3. Medical Product Agency’s regulations (LVFS 2001: 7) on medical
devices for in vitro diagnostic medical devices, and
4. Medical Product Agency’s regulations (LVFS 2001: 5) on the active
medical implants.
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Responsibilities
SOSFS 2008:1
5 Chapter. In-house produced medical devices
Requirements on in-house produced medical devices
2 § In-house produced medical devices shall
1. If possible have identification numbers,
2. do not have the CE mark,
3. have operating instructions on the Swedish language.
3 § A medical device used on a patient or handled differently than the
original manufacturer has intended is only considered to be a In-house
produced medical device if it satisfies the requirements in this chapter.
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Responsibilities
SOSFS 2008:1
Chapter 6. Adverse events and incidents with medical devices
3§ Notification will be made on malfunction and deterioration in the
properties or performance as well as at the inaccuracies and
deficiencies in the labeling or the user manual which might lead to
or have led to
1.
2.
a patient, a user's or any other person's death, or
a serious deterioration in a patient, a user's or any other
person's State of health
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Responsibilities
SOSFS 2008:1
Chapter 6. Adverse events and incidents with medical devices
• an investigation be initiated as soon as possible.
Event analysis/risk analysis!
(If the investigation shows that there are deficiencies in the quality
improvement measures are taken.)
• an assessment, whether it occurred must be notified in
accordance with paragraph 3 of the
• notification to the manufacturer and the medical products
agency
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Quality system
SOSFS 2005:12
”All work within the health care system must be included in a system
for planning, execution, follow up and development of quality”
- i.e. a system for quality control
All personnel must contribute to the systematic and continuous
quality development
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Quality system
cont.
The systematic quality assurance work must
1. aim to prevent nursing injuries;
2. start with the aim of the activities, identified and prioritised
on care and treatment processes,
3. be adapted to the orientation, size and scope of the activity,
4. assume measurable goals, documented and continuously
monitored, and
5. be well anchored among all employees in the organization.
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Quality system cont.
The quality system must include routines for
• co-operation
• methods for diagnostic and care
• competence
• maintenance and technology
• risk analysis and vigilance
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Systematic Work Environment Management
AFS 2001:1
Systematic work environment management shall be
included as a natural part of day-to-day activities. It shall
comprise all physical, psychological and social conditions
of importance for the work environment.
The employer shall regularly investigate working
conditions and assess the risks of any person being
affected by ill-health or accidents at work
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Systematic Work Environment Management
AFS 2001:1
The employer shall carry out, immediately or as soon as is
practically possible, the measures which are needed for the
prevention of ill-health and accidents at work.
The employer shall also take such other measures as are
needed in order to achieve a satisfactory working
environment.
Example: One must see that a right medical device is
chosen, for example from ergonomic or electrical safety
point of view
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