A Common Sense Approach to implementing the Requirements of the Medical Devices Directive Andrew Bal

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A Common Sense Approach to implementing the
Requirements of the Medical Devices
DirectiveAndrew BallApril 15th 2005
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About the speaker

• Studying dental technology at Mathew Boulton
  technical college Birmingham, England from
  1977-82 qualified City Guilds.
• 1984 until 1990 in partnership running a full
  service dental laboratory.
• Jan 1991 to the present day managing director of
  PBC Dental Laboratory Ltd, full service lab
  producing mainly private sector prosthetics and
  crown/bridge.
• Training for the medical devices directive and
  audits October 94 to May 95 from DLA workshops.
• Joined the DLA Audit Committee to create DAMAS
  May 95. DAMAS is the DLA Dental Appliance
  Manufacturers Audit Scheme.
• Became the first DAMAS accredited laboratory in
  Jan 96.
• DLA Chairman June 2001 to Dec 2002.
• DAMAS Chairman Dec 2002 to the present day.

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Outline Presentation

• Outline of the presentation, a common sense
  approach to the implementation of the
  requirements of the Medical Devices Directive
  93/42 EEC.
• The Medical Devices Directive 93/42 EEC, for
  custom made devices as set out in (article 1.) is
  the law throughout the European Union you have
  no choice but to comply with its requirements.
  Rather than seeing this as an intrusion into your
  business, look at it as an opportunity.
• Prove that your business/laboratory is a quality
  business if you have to comply with the
  regulations why not wear the badge that says that
  you do. Based on sound ISO 9000 series
  principles, DAMAS is a business tool for the
  dental laboratory owner.
• Because DAMAS was written for and developed by
  dental laboratory owners, it is not overly
  complicated or bureaucratic in fact it will help
  you to run a more efficient and profitable
  laboratory.
• The system gains credibility from being third
  party audited (checked by someone else), its not
  just your word, you can prove that you comply
  with the Medical Devices Directive. This is not a
  paper chase, you have to have all of this
  documentation in place anyway, its the law, so
  why not take the professional approach and gain
  the most recognition for your efforts.

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The Medical Devices Directive 93/42 EEC, for
custom made devices as set out in (article 1.) is
the law throughout the European Union you have
no choice but to comply with its requirements.
Rather than seeing this as an intrusion into
your business, look at it as an opportunity.
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MDD

• The Medical Devices Directive 93/42 EEC for
  custom made devices as set out in (article 1.) is
  the law.
• You have no choice you must comply with the
  requirements of the directive.
• Rather than seeing this as an unnecessary
  intrusion into your business, look at it as an
  opportunity.
• As the previous speakers have pointed out, the
  Medical Devices Directive specifies that you must
  meet the essential requirements set out in Annex
  1 of the directive.
• Taking account of the intended purpose of the
  devices concerned.
• Annex 1 is in two parts, namely part 1 general
  requirements and part 11, requirements regarding
  design and construction.
• All of the general requirements in part 1 (1-6)
  apply. Essentially this is a catch-all
  requirement where the responsibility is on the
  manufacturer to ensure that the medical devices
  that he manufactures will not compromise the
  health and safety of the patients/ end users.

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MDD

• Medical devices must be fit for their intended
  purpose.
• Part 11. Makes requirements under specific
  headings such as 7 Chemical, physical and
  biological properties 8) Infection and microbial
  contamination 9 Construction and environmental
  properties 10 Devices with a measuring function
  11 Protection against radiation 12 Requirements
  for medical devices connected to or equipped with
  an energy source and 13 Information supplied by
  the manufacturer.
• If this was not complicated enough the labelling
  requirements specified in paragraph 13 of Annex 1
  of the MDD need to be addressed along with the
  conformity assessment procedures specified in
  Annex V111.
• The requirements of the directive place many
  responsibilities on the laboratory owner. If
  he/she is to make any practical use of these
  regulations so as they enhance and improve the
  business while at the same time demonstrating
  compliance with the Medical Devices Directive,
  then the best way forward is a quality management
  system. In the first instance it will allow you
  to comply with the regulations and in the second
  improve the day-to-day running of the laboratory.
• What we are looking for is a system that
  demonstrates your compliance with the Medical
  Devices Directive that allows you to run an
  efficient business, and improves patient
  protection. This leads me onto my second point in
  this presentation.

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Prove that your business/laboratory is a quality
business if you have to comply with the
regulations why not wear the badge that says that
you do. Based on sound ISO 9000 series
principles, DAMAS is a business tool for the
dental laboratory owner.
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Quality issues

• Prove that your laboratory is a quality business
  if you have to comply with the regulations why
  not wear the badge that says that you do. Based
  on sound ISO 9000 series principles, DAMAS is a
  business tool for dental laboratory owners.
• The Medical Devices Directive is a fact of life,
  and like it or not you will need to manage your
  compliance with the regulations, and the best way
  to do this is a quality management system.
• What is quality? This is a debate that we have
  had many times, what you consider to be a quality
  product may not be mine, beauty is in the eye of
  the beholder and is subjective at best. So my
  answer to the question what is quality? I shall
  reply with this statement
• Quality is the degree to which a set of inherent
  characteristics fulfils requirements.
• The dentist provides you with a prescription,
  impression and perhaps other items - these are
  your requirements.
• You manufacture a dental appliance to these
  requirements and check before despatch that the
  requirements have been met.

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Quality issues

• If the finished appliance fulfils the
  requirements you have manufactured a quality
  product.
• But how do you control the manufacturing process
  between each of the steps, from receiving the
  impression and prescription to delivering the
  finished appliance?
• You need a simple quality system that is suitable
  for use in the craft industry that is dental
  technology.
• What you do not need is an all singing and
  dancing quality system that meets the
  requirements of ISO 9001 2000 or ISO 134852003
  - unless of course your clients require you to
  have such systems.
• In the UK we decided to develop our own custom
  made quality system called DAMAS.
• What is a quality system?
• It is a set of procedures preferably documented
  that specifies how certain manufacturing
  processes are to be carried out so that the end
  result is predictable. The level of the detail in
  these procedures is up to the individual
  laboratory owner to decide, depending on the
  training and skills mix within the dental
  laboratory and the competencies of the staff
  carrying out the procedures.

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Because DAMAS was written for and developed by
dental laboratory owners, it is not overly
complicated or bureaucratic in fact it will help
you to run a more efficient and profitable
laboratory.
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DAMAS

• Because DAMAS was written by and developed for
  laboratory owners it is not over complicated or
  bureaucratic, in fact it will help you to run a
  more efficient and profitable laboratory.
• So, who is responsible for DAMAS?
• Between 1994-95 the Dental Laboratories
  Association Ltd in the UK put a team of
  Laboratory owners, ISO 9000 consultants and
  Quality system Auditors together to develop a
  system that would demonstrate compliance with the
  Medical Devices Directive. Basing the system on
  ISO 9000, as the most logical method of putting
  in to place a quality system, as we said at the
  time why try to reinvent the wheel?
• The DAMAS system is built upon ISO 9000
  foundations and is administered and laid out in
  much the same way.

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DAMAS

• Documented review of the prescribers
  requirements.
• 4.4 Patient contact materials.
• 4.5 Defined manufacturing process.
• 4.6 Training.
• 4.7 Maintenance and calibration of equipment.
• 4.8 Cleanliness and infection controls.
• 4.9 Documented review of the final product.
• 4.10 Defined handling and packaging.
• 4.11 Control of records.
• 4.12 Statement of compliance.
• 4.13 Labelling.
• 4.14 Complaints.
• 4.15 Internal audits and management review.
• So what did we leave out from ISO 9000?

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DAMAS

• Customer satisfaction, Analysis of data and
  Improvement. That was all that we omitted.
• To ensure that custom-made dental appliances
  satisfy the relevant essential requirements that
  apply to them, and to satisfy prescriber
  requirements, we must manufacture the appliances
  under controlled conditions. This is known as
  Defined Manufacturing process, and the quality
  system is the method of demonstrating that this
  is being done.
• Write down what you do in your lab and stick to
  it.
• Follow the materials manufacturers instructions
  for use and keep on file as evidence.
• Use the prescription ticket to give instructions
  (sufficient for a trained technician) and show
  evidence of correct completion by initials or
  similar, etc.
• Keep documented procedures simple. Its better to
  have a few rather than a very long one, e.g.
  separate procedures for Crown and Bridge,
  Prosthetics, Orthodontics, etc.
• This will all improve the efficiency of the
  laboratory by eliminating costly mistakes, and
  dramatically reducing the remake rates.
• My final point is to do with Audits.

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The system gains credibility from being third
party audited (checked by someone else), its not
just your word, you can prove that you comply
with the Medical Devices Directive. This is not a
paper chase, you have to have all of this
documentation in place anyway, its the law, so
why not take the professional approach and gain
the most recognition for your efforts.
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DAMAS

• The system gains its credibility from being third
  party audited (checked by someone else), its not
  just your word, you can prove you comply with the
  Medical Devices Directive. This is not a paper
  chase you have to have all this documentation
  anyway its the law, so why not take the
  professional approach and gain the most for your
  efforts.
• What is an audit?
• An audit is a check that what you say that you
  are doing is in fact what you are actually doing,
  are you following your procedures?
• This check should be conducted by a third
  party (not you). In the DAMAS system this
  check is by an independent auditing company,
  sub contracted by the Dental Laboratories
  Association Ltd to conduct DAMAS audits
  throughout the UK.
• This voluntary audit is conducted annually once a
  year to verify the laboratorys DAMAS status.

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DAMAS

• If the laboratory concerned is found to be
  working away from the documented system, this
  will be known as a non-conformity, there are
  three types of non-conformity -
• MINOR
• MAJOR
• SIGNIFICANT
• The laboratory must address any non-conformity
  before DAMAS status is confirmed, this is known
  as closing out non-conformities.
• Closing out is putting right the system also
  known as corrective action.
• Minor non-compliance, incoming inspection not
  completed or a box not signed something
  overlooked during a busy day in the lab.
• Major non-compliance, working away from a
  documented procedure such as not following the
  material manufacturers instructions for use,
  firing a new porcelain with the original furnace
  settings not updated.
• Significant non-compliance, no procedure in place
  at all, an omission in the documented system, for
  example, there were no training records available
  for any of the staff for the auditor to check.

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DAMAS

• For any of these non-conformities the laboratory
  concerned must put right and correct the
  faults/omissions before DAMAS status is given.
• This may seem to some as a burden, but look at it
  from this perspective.
• You have to have the documentation to comply with
  the MDD.
• You have to make the system work.
• You have to manage your business.
• DAMAS is a discipline, without it you can always
  find something more important to do in the lab,
  put things off, do it later, and of course it
  does not get done!
• With DAMAS, you dont put it off, the discipline
  it gives you makes you put things right as you go
  along.

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DAMAS

• In the United Kingdom the price for DAMAS
  accreditation is 428.00 pa
• Plus a registration fee of 25.00 pa
• This is approximately 30 cheaper than ISO 9000
  accreditation.
• There are over 100 labs in the UK DAMAS
  registered.
• There are now 7 labs in the USA DAMAS registered.
• There is interest being shown from many more
  countries.

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SUMMARY
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Summary

• Number 1. The Medical Devices Directive 93/42
  EEC, for custom made devices as set out in
  (article 1.) is the law you have no choice, you
  must comply. Rather than see this as an
  unnecessary intrusion into your business look at
  it as an opportunity.
• An opportunity to put in place a quality
  management system to demonstrate your compliance
  with the directive.
• An opportunity to put in place a management tool
  to improve your business.

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Summary

• Number 2. Prove that your laboratory is a quality
  business if you have to comply with the
  regulations why not wear the badge that says that
  you do. Based on sound ISO principles, DAMAS is a
  business tool for Dental Laboratory Owners.
• Prove that your laboratory is a quality
  laboratory by putting in place a documented
  system to give predictable results time after
  time.
• Prove that your laboratory is a quality business
  by becoming DAMAS accredited.
• Quality is the degree to which a set of inherent
  characteristics fulfils requirements.

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Summary

• Number 3. Because DAMAS was written by and
  developed for laboratory owners it is not
  over-complicated or bureaucratic, in fact it will
  help you to run a more efficient and profitable
  laboratory.
• Write down what you do in your laboratory and
  stick to it! Keep documented procedures simple
  Technicians will not follow over-complicated
  procedures.
• Reduce mistakes and cut remake rates.

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Summary

• Number 4. The system gains its credibility from
  being third party audited (checked by someone
  else), its not just your word, you can prove
  that you comply with the Medical Devices
  Directive. This is not a paper chase, you have
  all the documentation anyway, its the law, so
  why not take the professional approach and gain
  the most for your efforts.

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The Medical Devices Directive is the law you
must comply

• To demonstrate your compliance install a quality
  management system.
• Make that system work for you and take the credit
  for your actions.
• Follow the discipline of third party audits to
  make it work for you.
• SPEND AS MUCH TIME ON YOUR BUSINESS AS IN IT!

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THANK YOU FOR YOUR ATTENTION!