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Legislation and regulation

Legislation and regulation. Legislation. Act on Health Care The Medical Product Act (harmonized with 93/42/EEG) Supervision of Health Care Act on professional activity on the field of health care. SFS 1982:763 SFS 1993:584 SFS 1996:786 SFS 1998:531. Legislation. LVFS 2997:1

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Legislation and regulation

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  1. Legislation and regulation

  2. Legislation • Act on Health Care • The Medical Product Act (harmonized with 93/42/EEG) • Supervision of Health Care • Act on professional activity on the field of health care • SFS 1982:763 • SFS 1993:584 • SFS 1996:786 • SFS 1998:531 2 Heikki Terio, 2011-11-18

  3. Legislation • LVFS 2997:1 • LVFS 2009:18 • LVFS 2001:7 • LVFS 2001:8 • Active Medical Devices Directive • Medical Devices Directive (LVFS 2003:11) • In Vitro Medical Devices Directive • The Manufacturers Obligation to report Accidents and Near-accidents with medical devices 3 Heikki Terio, 2011-11-18

  4. Legislation • SOSFS 2008:1 • SOSFS 2005:12 • SOSFS 2005:28 • AFS 2001:1 • Use of Medical Devices • Quality Systems in Health Care • Reporting obligation under Lex Maria and local procedures for adverse event reporting • Systematic Work Environment Management 4 Heikki Terio, 2011-11-18

  5. SFS 1982:763Act 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 5 Heikki Terio, 2011-11-18

  6. 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. 6 Heikki Terio, 2011-11-18

  7. 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. 7 Heikki Terio, 2011-11-18

  8. LVFS 2003:11 Medical Devices Directive • Includes: • Essential requirements • Reference to standards • Classification • Clinical trials • CE-marking 8 Heikki Terio, 2011-11-18

  9. Responsibilities SOSFS 2008:1 • The application of the direction includes • Information systems connected to medical devices. • 2. In-house produced medical products. • 3. Handling of medical products, for example maintenance and transporters. Information system – a system that collects, revises, stores or distributes and presents information. 9 Heikki Terio, 2011-11-18

  10. 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. 10 Heikki Terio, 2011-11-18

  11. Responsibilities SOSFS 2008:1 • Director's responsibilities • 6 § The Director shall, after the signed commission, be responsible for: • that only safe and medically appropriate medical devices and, to these, connected information systems are used on patients; • the medical devices and, to these, connected information systems are controlled and properly installed before they are used on patients; • information from manufacturers and authorities on the medical devices are made available for health workers and other relevant personnel; • procedures within the framework of the management system are available for health workers and other interested personnel 11 Heikki Terio, 2011-11-18

  12. 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. 12 Heikki Terio, 2011-11-18

  13. 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 ChapterAct (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. 13 Heikki Terio, 2011-11-18

  14. 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. 14 Heikki Terio, 2011-11-18

  15. Responsibilities SOSFS 2008:1 • 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 • 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 • Chapter 6. Adverse events and incidents with medical devices 15 Heikki Terio, 2011-11-18

  16. Responsibilities SOSFS 2008:1 • 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 • Chapter 6. Adverse events and incidents with medical devices 16 Heikki Terio, 2011-11-18

  17. 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 17 Heikki Terio, 2011-11-18

  18. Quality systemcont. • The systematic quality assurance work must • aim to prevent nursing injuries; • start with the aim of the activities, identified and prioritised on care and treatment processes, • be adapted to the orientation, size and scope of the activity, • assume measurable goals, documented and continuously monitored, and • be well anchored among all employees in the organization. 18 Heikki Terio, 2011-11-18

  19. 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 19 Heikki Terio, 2011-11-18

  20. 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 20 Heikki Terio, 2011-11-18

  21. 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 21 Heikki Terio, 2011-11-18

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