Medical Device Safety

1
Medical Device Safety
2
The importance of reporting adverse incidents

• What is an adverse incident?
• A device-related adverse incident is an event
  which can produce, or have the potential to
  produce, unwanted effects involving the safety of
  patients, users or other people. An adverse
  incident can arise from shortcomings in the
  device, its accessories, its operating
  instructions, user practice, servicing and
  maintenance and conditions of use. However, many
  adverse incidents are the result of user error.

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
3
If an incident occurs, what should I do?

• Check and take steps necessary for the well-being
  of the patient.
• Take device(s) involved out of action and label,
  together with other material evidence, e.g.
  packaging if available. If this is not possible
  the state of the device at the time of incident
  should be recorded.
• Record
• date and time of the incident
• device settings if relevant
• details of incident (how it happened and any
  outcomes for the person affected)
• details of device affected and any others (type,
  make, model and serial numbers)
• details of any error message or failures.
• Report incident to relevant manager and to the
  incident centre in your country.

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
4
An example of FDA Patient Safety News

• The Vapotherm 2000i Respiratory Gas
  Humidifier, which had previously been recalled
  because of potential bacterial contamination, has
  now been re-introduced to the market. The company
  has taken steps to correct the problem, but FDA
  is cautioning healthcare facilities to take
  certain precautions before using the
  re-introduced device.

Picture of a Vapotherm Humidifier, and a young
girl and an old man using the device.
http//www.fda.gov/cdrh/medicaldevicesafety/index.
html
5
An example of FDA Patient Safety News

• The Vapotherm device uses a nasal
  cannula(??) to deliver moisture and warm
  breathing gases to the patient. When the device
  was recalled, FDA noted that certain patients,
  including premature neonates(???) and the
  immuno-compromised, would be at particularly high
  risk for infection if they were exposed to
  breathing gases from a contaminated device.

http//www.fda.gov/cdrh/medicaldevicesafety/index.
html
6
An example of FDA Patient Safety News

• If using the re-introduced Vapotherm 2000i, here
  are the precautionary steps to take Be sure
  that the base unit has been disinfected by
  Vapotherm under the recalls corrective plan. Do
  not use the unit if this has not been done. Send
  it back to the company for disinfection(??).
  Discard all used Vapor Transfer Cartridges, all
  used disinfection kit components, and any
  disinfection kit that has been opened. If you
  have unopened Vapor Transfer Cartridges with
  product codes VT01-A and VT01-B, contact the
  distributor and exchange them for new ones with
  product codes VT01-AS and VT01-BS. Get the
  latest users manual from the company, and closely
  follow the revised instructions, particularly
  three important precautions- Each new Vapor
  Transfer Cartridge should be used only on a
  single patient and must be discarded after 30
  days of use.- Each disinfection kit is for a
  single use, and must be discarded after it is
  used.- Only sterile(????) water should be used
  in operating the device.

http//www.fda.gov/cdrh/medicaldevicesafety/index.
html
7
????

• ???????????? 300??????? http//tech.tom.com/2006-0
  8-24/04BI/82384574.html
• ????FDA?? ????????????? http//tech.tom.com/2006-1
  1-08/04BH/08325713.html
• FDA??DES???????????
• ?DES(drug-eluting stent)????????DES??????,????
  ??????,??????????(Food and Drug
  Administration,FDA)???????2006?12?7-8?????????????
  ???????DES??????????????????,?????????????DES?????
  ?BMS????????????????????????????????http//www.cch
  eart.com.cn/doctor/article/3846.html

8
Risk
Risk is a measure of the combination of
(1) the hazard (2) the likelihood of occurrence
of the adverse event (3) the severity or overall
impact. Risk assessment begins with risk analysis
to identify all possible hazards, followed by
risk evaluation to estimate the risk of each
hazard. In general, risk assessment is based on
experience, evidence, computation, or even
guesswork.
9
Risk Assessment

• In USA
• In EU
• The Global Harmonization Task Force (GHTF) is
  proposing a harmonized scheme for medical device
  classification

10
Global harmonization task force (GHTF)

• The Global Harmonization Task Force (GHTF)
  was founded in 1993 by the governments and
  industry representatives of Australia, Canada,
  Japan, the European Union, and the United States
  of America.
• The purpose of the GHTF is to encourage a
  convergence in standards and regulatory practices
  related to the safety, performance and quality of
  medical devices. The GHTF also promotes
  technological innovation and facilitates
  international trade. The primary means by which
  its goals are accomplished is via the publication
  and dissemination of harmonized guidance
  documents for basic regulatory practices.

World Health Organization (WHO)
http//www.who.int/medical_devices/collaborations/
force/en/index.html
11
Global harmonization task force (GHTF)

• Most developing countries have inadequate
  national policies and regulations covering
  medical devices. WHO collaboration with the GHTF
  could facilitate access for developing countries
  (both those importing and those wishing to
  manufacture) to
• information on the major regulatory systems for
  medical devices
• device approvals and health technology assessment
  from highly regulated markets
• adoption of a single medical device nomenclature
  
• innovative technology advances
• networks for post-market surveillance and
  vigilance.

http//www.who.int/medical_devices/collaborations/
force/en/index.html
12
History of GHTF
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  ????????????????????,?????????????????????????????
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• ?????????????????????,?????????????????
  ????????1992????Nice??,????????????????????????199
  3?1?????????Global Harmonization Task Force,
  GHTF?????

http//medical.cms.itri.org.tw/links/index1.asp
13
Risk Management

• The goal is to maximize benefit and minimize
  risk.
• Manufacturers of medical devices also use
  the risk management approach.
• The International Organization for
  Standardization (ISO) has produced a document
  (ISO 149712000) providing manufacturers with a
  framework including risk analysis, risk
  evaluation and risk control for risk management
  in medical device design, development,
  manufacturing as well as for monitoring the
  safety and performance of the device after sale.

14
Risk-Analysis for Medical Devices According to
EN 1441
EN 1441 provides a tool to comply with the
risk-analysis requirements of the European
Medical Device Directive 93/42/EEC. However, EN
1441 does not cover all aspects of
risk-management.
CE-Marking A passport to the European Union
http//www.tuv.com/jp/en/medical_device_directive_
93_42_eec_.html
15

• The letters CE are an abbreviation of the
  French term conformité européenne. They
  indicate that the manufacturer complies with all
  applicable EEC legal requirements of the EU New
  Approach Directives. There are about 22
  Directives that are either already in use or
  under consideration which demand that the product
  be marked with the CE-Marking. More than one
  directive can apply to each product.

http//www.net-translators.com/safot/articles/medi
cal_translation_articles/language_requirements.asp
CE-Marking A passport to the European Union
16

• CE Marking on a product is a manufacturer's
  declaration that the product complies with the
  essential requirements of the relevant European
  health, safety and environmental protection
  legislations, in practice by many of the
  so-called Product Directives which contain the
  "essential requirements" and/or "performance
  levels" and "Harmonized Standards" to which the
  products must conform.

CE-Marking A passport to the European Union
http//www.net-translators.com/safot/articles/medi
cal_translation_articles/language_requirements.asp
17
Classification of a Medical Device

• The manufacturers have to classify their
  product according to these rules by taking the
  intended use of the product into consideration.
• Rules 1 to 4 are for non-invasive devices
  Rules 5 to 8 are for invasive devices Rules 9
  to 12 are additional rules for active devices
  Rules 13 to 18 are special rules

• With the above rules, the risk of the medical
  device for the patient or user can be identified
  and categorized and thereby the conformity
  assessment procedure is determined.

The higher the risk, the more stringent are the
requirements for the conformity assessment
procedure!
http//www.tuv.com/jp/en/medical_device_directive_
93_42_eec_.html
18
????

• Medical Devices - Application of Risk Management
  to Medical Devices - ISO 149712000, ISO,
  December 2000,
• Medical Devices - Application of Risk Management
  to Medical Devices, Rationale for Requirements -
  ISO 149712000/Amd 12003, ISO, 2003,
• Medical Electrical Equipment - Part 1-4 General
  Requirements For Safety - Collateral Standard
  Programmable Electrical Medical Systems - IEC
  60601-1-4, International Electrotechnical
  Commission, Geneva, Switzerland, April 7, 2000,
• Guidance For The Content Of Premarket Submissions
  For Software Contained In Medical Devices, Food
  and Drug Administration, May 11, 2005,
• General Principles Of Software Validation - Final
  Guidance For Industry And FDA Staff, Food and
  Drug Administration, January 11, 2002, or
• Guidance For Industry, FDA Reviewers And
  Compliance On Off-The-Shelf Software Use In
  Medical Devices, Food and Drug Administration,
  September 9, 1999.
• Medical Device Software - Software Life-Cycle
  Processes - IEC 62304

19
Quality and safety

• Medical devices and equipment need to be
  of adequate quality and safety to bring public
  health benefits without harming patients, health
  care workers or the community. Thus, regulations
  should mandate that all devices and equipment,
  whether imported or locally produced, meet
  international norms and standards (and WHO
  specification if relevant). In addition,
  countries should participate in global and local
  vigilance networks to ensure the effective
  management of adverse events.

http//www.who.int/medical_devices/safety/en/
20
Major phases in the life span of a medical device
http//www.tmia-med.org.tw/buffetnew/usa.htm
21
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http//www.tmia-med.org.tw/buffetnew/usa.htm
22
Conception and Development

• The scientific principles upon which a device is
  based are fundamental to its safety and
  performance.
• e.g. a cardiac pacemaker should deliver a minute
  electrical impulse of a certain size and shape
  that simulates the natural functioning of the
  heart. Significant deviation from this may
  compromise safety and performance.
• The more complex the device, the higher the risk
  of user error. Soundness of concept and adequacy
  of design, construction, and testing (including
  verification, validation and clinical trials)
  require the scrutiny of scientific experts to
  ensure that design parameters and performance
  characteristics do not impose unwarranted risks.

23
Manufacture

• Good, functional medical devices are
  produced when the manufacturing process is
  adequately managed. However, poor manufacturing
  management can produce inconsistency in the
  quality of products, such that non-conforming
  devices can filter through the production line to
  the market, even when the original prototype has
  been well-designed.
• This consideration has led to the
  development of good manufacturing practice (GMP)
  for drugs, biological products and medical
  devices. Now, GMP is more commonly referred to as
  quality systems in manufacturing.

24
Packaging and labelling

• Properly packaged medical devices pose little
  risk to individuals handling them, even if the
  medical device is biohazardous.
• Labelling is crucial in identifying
• the medical device and
• specifying instructions for its
• proper use.

25
Advertising

• Advertisement has the potential to create
  expectations and powerfully influence the belief
  in a medical devices capabilities. It is
  important, therefore, that medical device
  marketing and advertising are regulated to
  prevent misrepresentation of a medical device and
  its performance.

26

• Sale
• Use

27
Disposal

• Disposal of certain types of devices should
  follow specific and stringent safety rules.
• For example, devices that are contaminated
  after use (e.g. syringes) or devices that contain
  toxic chemicals, can present hazards to people or
  the environment and must be disposed of properly.

Bio medical waste incinerators are recommended
for elimination of hazardous bio medical wastes.
www.dhanaprakash.com/proinci.htm
The Disintegrator is a portable, easy-to-use
device that allows safe disposal of used insulin
syringes by disintegrating the needle.
www.idsa.org/idea/idea2004/b174.htm
28
Persons who directly manage the different phases
of medical devices
29
Ideal conditions for ensuring the safety and
performance of medical devices
the Manufacturer, Vendor, User, Public and
Government are the stakeholders. All five play
critical roles in ensuring the safety of medical
devices.
30
The Public
The role of each participant/stakeholder

• The public are the ultimate beneficiary
  of medical devices. They should be fully aware
  that all devices carry a certain risk and that
  they can help to promote safety and performance
  through self education and by putting customer
  pressure on manufacturers to comply with
  standards.

31
The Government
The role of each participant/stakeholder

• The government has the responsibility to
  oversee the efforts of manufacturers and vendors
  and ensure that medical devices sold or made
  available in the country are safe and effective.

Multiple images of FDA employees and areas of
regulation.
http//www.fda.gov/
32
FDA??????????????????????

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  ???
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  ????????,??510K(??????)???,???????
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  ????????????????????????(PMA),FDA???PMA??45???????
  ????,FDA????????????,??????GMP???

http//www.fdaus.net/FDA-CHINA-Status.doc
33
FDA??????

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  ?(???????????),????????????2004?10?,??FDA?????????
  ?18??,????31???
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  ??,?????????????????????????????????
• ?FDA?????????????????,????????????

http//www.fdaus.net/FDA-CHINA-Status.doc
34
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  ?????????????????????
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  ???(??)(????),????????????????,????????????????
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  ??????????????,???10??????????????????????????????
  ????????,??????????????????

?????????????????????????????,????????????,
?????????????????????????? ? 2007-3-20
http//www.sunbl.cn/2007/3-19/14210420540.html
35
The Manufacturer
The role of each participant/stakeholder

• The manufacturer, as the creator of the
  device, must ensure that it is manufactured to
  meet or exceed the required standards of safety
  and performance.

36
CCC????????

• ?????China Compulsory Certification,???CCC
  ?CCC??????CCC,???????????????????????????(????
  ?????????????????5?)????
• CCC???????CCC????????,???
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• 4?CCCF   ??????
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  ??X???????????????????????????????????????????????
  ?????????

http//www.ccc51.com/1/a001/b001.htm
37
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  ?????????,?????????????????,????CE??,???FDA???????
  ???,??????????,??????????????????????

http//old.shouxi.net/hickey/200505/403_91252.aspx
38
??????
??
??
GS??????"Geprufte Sicherheit"(??????),??"Germany
Safety" (????)????GS??????????(SGS)???,????????EN?
??????DIN????????????,?????????????????
??
http//www.ccc51.com/1/a007.asp
http//www.ccc51.com/1/a008.asp
39
User Error and Human Factors Design

• The term user error is defined as an
  act that has a different result than that
  intended by the manufacturer or expected by the
  operator. User error may result from a mismatch
  between variables, for example the operator,
  device, task, or environment. By incorporating
  human factor engineering principles in design,
  and appropriate training for users, the risk of
  user errors can be minimized.

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????????????,???????????????
40
The C-Leg (computerized leg) from Otto Bock
Healthcare (Germany) is the worlds first
completely microprocessor-controlled dynamic
walking system with hydraulic swing and stance
phase control?
It can be adjusted to the individual persons
weight and gait
http//www.embedded-computing.com/departments/embe
dded_europe/2005/5/
41
Human Factors Design
http//www.atpm.com/7.05/datahand.shtml
Design Concepts, Inc. (DCI) partners with leaders
in the medical device industry to create
innovative products that change lives. DCI's
product development expertise includes
integrating the efforts of specialists in
Research, Industrial Design, Human Factors,
Mechanical Engineering, Electrical Engineering,
and Prototyping.
http//www.devicelink.com/consult/co/120/12011.htm
l
42
The Vendor
The role of each participant/stakeholder

• The vendor provides the interface between
  the product and the user. He/she should
• ensure that the products sold comply with
  regulatory requirements.
• provide after-sale service, take responsibility
  in supporting or training their customers.
• Participating in post-market surveillance??
  (receiving and reporting customer complaints/
  incidents) is critical for ensuring medical
  device safety and performance.

43
The role of each participant/stakeholder

• The user ?
• When using medical devices, users should
  always bear in mind that the safety and health of
  the patients are in their hands.

44
General Medical Device Safety

• USE LOOK AFTER ALL DEVICES PROPERLY -
  SOMEONE'S LIFE MAY DEPEND ON THEM!

http//www.qmc.nhs.uk/Divisions/Diagnostics/MESU/
45

• Up to 50 of equipment is not in use,
  either because of a lack of maintenance or spare
  parts, because it is too sophisticated, or simply
  because the health personnel do not know how to
  use it.

http//www.who.int/medical_devices/en/
46
General Medical Device Safety

• Inspect all Devices before use - ensure that
  there are no signs of damage
• Select the correct Device - ensure that it is
  appropriate to the patient's condition
• Are you comfortable with the Device? - ensure
  that you are competent have received training
  where necessary
• Ensure that the Device is working properly
• Ensure that the Device is set up safely
• Monitor the progress/function of the Device -
  also check the patient
• Know how to respond to reduce the risk to the
  patient in the event of a problem

http//www.qmc.nhs.uk/Divisions/Diagnostics/MESU/
47
General Medical Device Safety

• Also
• Get any damaged Device checked by MESU
• Store Devices safely
• Keep any battery operated Device charged up??
• Check that the Device is regularly maintained
• Check that any disposables?????? are appropriate
  safe to use

http//www.qmc.nhs.uk/Divisions/Diagnostics/MESU/
48
Using Medical Devices Safely

• Health and social care professionals use
  medical devices themselves and also provide
  devices which are then used by others, e.g. by a
  service user or carer. Health and social care
  professionals are personally accountable for
  their use of the device and therefore must ensure
  that they have appropriate training. They are
  also personally accountable for ensuring service
  users and carers have received appropriate
  training and know how to use the device that has
  been provided.

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
49
Using Medical Devices Safely

• ??????????????????????

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??????????????,???????,????????????,?????????????,
?????????????????????????????,?????????
??????,??????????????,????????????????????,???????
??????????????,??????????,????????,?????????
www.uhts.cn/jpg/huli05.jpg
http//www.allbring.com/Blogs/PrintArticleDetail.a
spx?BID7AID8
50
Using Medical Devices Safely

• ??????????????????????

??2 ICU??????,??????????????,?????????,????????
?????????,??????????????????,????24???????
,??????????,??????????????,?????????
???????????,?????????????,????????,?????,?????????
????????????????,??????????
http//past.people.com.cn/BIG5/tupian/75/20030526/
1000211.html
http//www.allbring.com/Blogs/PrintArticleDetail.a
spx?BID7AID8
51
ICUIntensive Care Unit?????
www.sesahs.nsw.gov.au
An Intensive Care Unit (ICU) or Critical Care
Unit (CCU) is a specialised facility in a
hospital that provides intensive care medicine.
http//www.aeromed.hu/krk/kep/aibo.jpg
www.georgetownbariatrics.com/images/ICUroomb.jpg
52
Using Medical Devices Safely

• ??????????????????????

??3  ???????????????,??????,???????????????
???????,??????????????????,???????,?????
http//past.people.com.cn/BIG5/tupian/75/20030526/
1000211.html
http//www.allbring.com/Blogs/PrintArticleDetail.a
spx?BID7AID8
53
Using Medical Devices Safely

• ??????????????????????

??4   ???????????????,???????????????
??????????????,???????35?,????????????????????????
35????,??????????????35?????,?????????
http//www.draeger.com/MT/internet/CN/cn/carearea/
emergencycare/monitoring/int_ec_sol_monitoring.jsp
?prversionyes
http//www.allbring.com/Blogs/PrintArticleDetail.a
spx?BID7AID8
54
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  ?????????????????????????????
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  ????????????,????,??????????????
• 2???????????????????????????????,??????????
  ??,???????????????????????(PM)???????
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  ???????,???????????????????????
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  ??????????????,??????????????
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  ??????,??????????,??????????????????????,????????,
  ??????,???????????????????????????

http//www.allbring.com/Blogs/PrintArticleDetail.a
spx?BID7AID8
55

• How to Use devices safely?
• ????

56
Using devices safely- BEFORE USE assessment
Use this checklist to ensure that you use medical
devices safely.

• What are the patients or clients clinical and
  social needs?
• Which of the medical devices available best meets
  those needs?
• Has a risk assessment been undertaken?
• Are the risks associated with this device
  acceptable and can they be minimised?
• If the device has been bought privately, is the
  patient or client aware of their personal
  responsibility?
• If the medical device is to be used by patients
  and/or carers, have the following been taken into
  account
• physical capabilities, e.g. manual dexterity
• sensory capabilities, e.g. vision, hearing
• ability to understand and remember
• previous experience with the medical device
• the patients or clients expectations
• the environment in which device will be used

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
57
Using devices safely- BEFORE USE knowledge of
device
Use this checklist to ensure that you use medical
devices safely.

• Is the way the device is to be used that intended
  by the manufacturer?
• What are the limitations and contra-indications(??
  ?) for use?
• Has the device been regularly maintained?
• When was the device last serviced and when is the
  next service due?
• Has the device been checked after servicing?
• Is the device within its expiry or use-by date?
• Are there any signs of wear, damage or faults?
• Where can a replacement device be obtained?

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
58
Using devices safely-Ask yourself
Use this checklist to ensure that you use medical
devices safely.

• Do I know how to set up and use this device?
• Have I read the user instructions, and are they
  attached to the device if this is possible ?
• Have I been trained in the use of the device?
• How was my competency?? in relation to this
  device assessed?
• Do I know how this device should perform and the
  monitoring that needs to be done to check its
  performance?
• Am I using the correct additional equipment, e.g.
  disposable infusion sets for an infusion pump?
• Do I know how to recognise whether the device has
  failed?
• Do I know what to do if the device fails?
• Do I know how and to whom to report a
  device-related adverse incident?
• Have I or others modified the device, if so, has
  liability been checked with the manufacturer ?

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
59
Using devices safely-during use
Use this checklist to ensure that you use medical
devices safely.

• Does checking the medical device indicate it is
  functioning correctly and to the manufacturers
  specifications?
• What action should be taken if the device is not
  functioning properly?
• Has this been documented?
• Is there up-to-date documentation to record
  regular checking of the device?
• What are the details (name and serial number) of
  the device being used?
• Is the equipment still appropriate in the light
  of changing needs of the patient or client, e.g.
  children can physically outgrow equipment?

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
60
Using devices safely-after use
Use this checklist to ensure that you use medical
devices safely.

• If used in the home, how will the medical device
  be returned to the owner, disposed of, or safely
  stored?
• What cleaning and/or decontamination is required?
• Does the medical device show any signs of wear,
  damage or faults that should be reported?
• Is any servicing, maintenance or repair required?
• Were there any problems in using this device
  which should be noted and could be rectified for
  the future? E.g. was any information missing from
  the patient/carer guidance which would have been
  useful?

http//www.dhsspsni.gov.uk/niaic_gp_devices_in_pra
ctice.pdf
61
????!!!Adverse event

• ?????????????????????????,??????????,??????
  ???
• 1 ?????????????????
• 2 ??????????????????
• 3 ?????? ?????????????,???????????????????????
  ???????????????

62
What should be reported?

• Typical problems includes in labelling,
  instructions or packing, defective components,
  performance failures, poor construction or
  design. Suggestions for rectifying the problem or
  improving product performance would be
  appreciated.

http//www.tga.gov.au/docs/html/forms/iris_udir.ht
m
63
What happened to your report

• The report will be investigated and
  discussed with the manufacturer/supplier. You may
  be contacted for further information. If
  appropriate both Agencies will assess the issue
  and it may also be reported to the orther Health
  Authorities. If action is considered necessary it
  may involve any of the following
• 1 Recall-removal of goods from sale or
  use, or their correction, for reasons relation to
  safety, efficiency or quality.
• 2 Safety Alert-urgent information to
  inform those responsible for the device, or
  affected by the problem.
• 3 reported in a TAG News Bulletin(a
  communication produced fy the TAG and distributed
  in Australia and New Zealand to convey
  information on medical devices) or other
  appropriate journal(s).

http//www.tga.gov.au/docs/html/forms/iris_udir.ht
m
64
Medical Device Incident Report
New Zealand and Australian
http//www.tga.gov.au/docs/html/forms/iris_udir.ht
m
65
http//www.tga.gov.au/docs/html/forms/iris_udir.ht
m
66
??????????Adverse Event Report

• ??????????,??????????,?????????????,????????
  ????????

www.lkkdesign.com/admin/upload/2006615164638.jpg
67
?????????? Adverse Event Report

• ???????????,????????,???????????????????????
  ,???????????????

???????????????
?????(?????)????,????????????????????
http//home.jsinfo.net/xinhua/web/subject2/2004/xi
nzang/zhibo_01.htm
??????,?????????,??????????
??????????
www.ha.org.hk/org/antitb/images/operation.gif
68
?????????? Adverse Event Report

• ?????????????????????????,?????????

???????????
http//www.biomaterial.net.cn/pictures/13.gif
??????????????
http//www.losn.com.cn/kxyfm/medcine/22.htm
69
??????????

• ?????????????????????????,?????????

http//www.zshospital.com/dept/xw.htm
???????????
http//www.biomaterial.net.cn/pictures/13.gif
http//www.losn.com.cn/kxyfm/medcine/22.htm
70
?????????? Adverse Event Report

• ????????????????????,???????????????????,?
  ?????????,????????????,??????????????,???????????

lifescan onetouch basic test strips
http//www.100md.com/html/DirDu/2006/10/30/26/23/5
4.htm
71
Lifescan OneTouch Ultra Meter

• The OneTouch Ultra Meter makes testing
  easy for anyone with diabetes. The OneTouch Ultra
  Meter gives you a test result in just 5 seconds,
  so there's no waiting. And it requires just a
  speck of blood. That can mean less pain, even
  when you test on your fingers. You can also test
  on your forearm, which is less painful than
  finger-testing.
• Fast, less painful testing.
• Results in just 5 seconds.
• Requires just a speck of blood.
• Lets you test on your forearm

http//minipharmacy.net/index.php?cPath23
http//www.bj-medicine.com/products/jnj-products/u
ltra.htm
72
???????????? ?????????????

• 2004???2005?3???,LifeScan?????????40??????????????
  ???????????,LifeScan?????????????,????????????????
  ???LifeScan???????????????????,???????????????????
  ????????????
• ???,?????????????2001??2003?????????????????2001??
  2005????????15????
• ??,??????,?????????,??????????????
• 2005?6?1?,????LIFESCAN??????????,????LifeScan????
  ??(??????????)???????????????,?????????????
• ???????,?????????????,????????????????????????????
  ????????????/?(mmol/L),???/??(mg/dL)??????????????
  ?????????????????????????????/?(mmol/L)?
• ????,??????????????????,?????????????,????????????
  ?????????????????????,?????????????18??

http//finance.news.tom.com/1001/1006/200561-24210
1.html
73
?????????? Adverse Event Report
cardiograph

• ???????????????,??????????

http//www.discoveriesinmedicine.com/images/mdis_0
000_0002_0_img0069.jpg
http//www.used-medical-monitors.com/t_hp_Pagewrit
er_XLi_ekg_ecg_heart_monitors.asp
74
???????????
Infusion pump

• ????????,?????????(?????????),????????????

http//www.rhone.ch/lambda/syringe_pump.jpg
http//www.extramed.ru/foto_b/0436.jpg
http//csio.gov.in/wpe8.jpg
http//www.kurzweilai.net/sponsor/images/ut_minime
d.jpg
75
???????????

• ???????????????,??????????
• ???????????(????)?????????????
• ??????????????,?????????????,????????,????????????
  ????????

76
???????????

• ?????????????????????????????????????,??????User
  Error
• ?????????????????
• The term user error is defined as an act
  that has a different result that that intended by
  the manufacturer or expected by the operator.
  User error may result from a mismatch between
  variables, for example the operator, device, task
  or envioronment.

????????????????????????????????????,???????????
????????????,???????????????
77
??????????

• ?????????????
• ?????????????
• ?????????????,???????????????????,?????????????
• ????????????????,??????????????
• ??????????,??????????????????????

78
??????

• ??????????????????????????????,??????????,?
  ????????????????????,???????????????

http//www.ocome.com.cn/UploadFiles/index27.jpg
79
Questions and Discussion

• Abbreviation
• The function of GHTF?
• How to ensure medical device safety ?

80
????????(Total Product Life Cycle, TPLC)
????

• ??????????????????????????????,????(Safety
  ) ?????(Performance)??????????????????????????????
  ?????????????????????(Total Product Life Cycle,
  TPLC)????????????,????????????????????PLC?????????
  ????????????????????,?????????????????????????????
  ??????????????????,??,????????????????????????????
  ?????????????????????????????????,??????????????,?
  ????????,?????????????????????????????????????,???
  ?????

http//www.tmia-med.org.tw/buffetnew/usa.htm
81
????????(Total Product Life Cycle, TPLC)
????

• ???????TPLC????????????????????,??????
  ??(Conception and Design)???(Prototype)
  ??????(Packaging and Labeling)??????(Preclinical
  test)?????(clinical test)???(manufacture)???(Adver
  tising)??????(Sale and Use)?????(Disposable)??????
  ??????????????????????????????(post-marketing
  assessment and surveillance)??????????????????????
  ?????????????????????,????????????????????????????
  ,?????????????,???????????????????????????,???????
  ?????????????

http//www.tmia-med.org.tw/buffetnew/usa.htm
82
????????(Total Product Life Cycle, TPLC)
????

• ????,????????(1)
  ?????????,???????,???????????(2)
  ????????????????????(3) ???????????(4)
  ?????????????????????????(1) ?????????????(2)
  ???????????????????,????????????????,?????????????
  ?????????????????????,??????????????????????

http//www.tmia-med.org.tw/buffetnew/usa.htm