The Therapeutic Goods (Medical Devices) Act

1

• The Therapeutic Goods (Medical Devices) Act
  Regulatory Compliance for Assistive Care
  Equipment Manufacturers and Suppliers.
• Acknowledgements to
• Lloyd Walker (Tech4Life) and Greg Pearson (Hills
  Healthcare)

2

• Australian manufacturers and suppliers of
  assistive care equipment must comply with a
  number of Federal and State government regulatory
  compliance statutes. These statutes are aimed to
  ensure that the products supplied and issued to
  the individual user are designed and manufactured
  to prevent injury, failure or hindrance of their
  intended function to assist with recovery or to
  compensate from an injury, disability or
  degenerative physical condition.

3

• Manufacturers must be cognisant of these
  compliance matters when designing, manufacturing
  and supplying equipment.
• Over the past 10 years the industry has witnessed
  an increased emphasis from public healthcare
  procurement bodies (such as Health Corporate
  Network in WA) for compliance with a number of
  Federal and/or State regulatory statutes.

4
Therapeutic Goods Administration TGA

• In October 2004 the TGA regulated that assistive
  care products were to be included on the
  Australian Register of Therapeutic Goods (ARTG).
  The ARTG is a Federal government record of all
  medical devices supplied in Australia. The TGA
  carries out a range of assessment and monitoring
  activities to ensure medical devices are at an
  acceptable standard to prevent injury, further
  illness or death to the individual user.
• The TGA defines assistive care products as
  medical devices due to them alleviating or
  compensating for an injury or disability.

5
Australian Standards Quality Management Systems

• Most contracts offered by public health bodies
  now mandate manufacturer and supplier compliance
  with Quality Management System ISO 9001.
• Many suppliers have external certification to
  this Quality Management System Standard. This
  ensures internal processes and procedures are
  consistent to produce product in a uniform manner
  and operate the business at a professional level.

6
Product Standards Compliance.

• Reputable suppliers source, design or manufacture
  product to relevant Australian and International
  Standards.
• Where economically viable, certain products are
  also tested by an independent external testing
  facility. External testing is a significantly
  expensive and time consuming exercise, however is
  becoming mandatory in the public healthcare
  environment as it provides evidence of
  independence from the vendor.

7
The National Product Catalogue (NPC) and
eProcurement

• This is the most recent initiative introduced by
  governments at State and Federal levels. The NPC
  is a single data source for the Australian Public
  Health sector and its suppliers. The rationale is
  to support the industry's purchasing processes
  with an electronic "business to business"
  interface offering consistent information and
  purchasing processes to limit costs and improve
  time efficiency for both hospitals and suppliers.
  
• While this initiative may have a limited effect
  on the product procurement requirements for
  Occupational Therapists, it is aimed at providing
  an improved procurement process for hospital
  purchasing and supply departments.

8

• The increasing level of regulatory compliance for
  the assistive care equipment supply industry is
  conducive to supplying well made products and
  ensures that industry players operate as good
  corporate citizens. This is particularly relevant
  to the industry as it insulates the market that
  by nature, supplies equipment to people who may
  be more vulnerable due to illness, age or
  disability.

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What is a medical device

• any instrument, apparatus, appliance, material
  or other article (whether used alone or in
  combination, and including the software necessary
  for its proper application)
• intended by the person under whose name it is to
  be supplied, to be used for human beings for the
  purposes of one or more of the following
• - diagnosis, monitoring, treatment, alleviation
  of or compensation for an injury or handicap,
• and does not achieve its principal intended
  action in or on the human body by
  pharmacological, immunological or metabolic
  means..

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Classes of Medical Devices

• Class I - eg. Wheelchairs, pressure cushions
• Class IIa - eg. Single use catheters, hearing
  aids, MRIs
• Class IIb - eg. Orthopaedic implants, ventilators
  
• Class III - eg. Heart valves, breast implants
• AIMD - eg Heart pacemakers, implantable drug
  pumps.

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Class one devices

• Are not an item used to ameliorate or compensate
  for a disability that does not-
• contain a body supporting surface
• actively apply force to the body
• contain an energy source
• Everything else is in

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Manufacturers

• A Manufacturer is a person or organisation who is
  responsible for
• design,
• production,
• packaging and
• labelling
• OR,
• assembling,
• packaging,
• processing,
• full refurbishing and
• labelling of one or more ready made products
• AND/OR assigning to a ready made product an
  intended purpose
• A device may have only ONE manufacturer

13
Sponsors

• any person or organisation who imports a medical
  device and/or represents its manufacturer in
  Australia
• can be more than one sponsor in Australia
• is responsible for registering devices on ARTG

14
Labelling

• Each Device must have the Manufacturers contact
  as well as a device identifier eg serial number
• That is
• if Australian manufacturer must have their
  address
• if imported must identify the sponsor name and
  address

15
Custom made devices

• prescription for an individual patient
• made of or includes non-standard components that
  are not listed on the ARTG (and potentially items
  that are on the ARTG)
• Custom made device manufacturer must
• have documented manufacturing process
• make sure and declare that, as far as possible,
  the device complies with the essential principles

16
Record keeping

• Maintain record of
• patient
• prescriber
• design characteristics prescription
• declaration of conformity

17
Essential Principles

• General Principles
• the use of a medical device must not compromise
  health and safety
• the design and construction of a medical device
  has to conform with safety principles
• medical devices are to be suitable for the
  intended purpose
• long term safety
• medical devices are not adversely affected by
  transport or storage
• the benefits of medical devices are to outweigh
  any side effects

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Principles about Design and Construction

• chemical, physical and biological properties
• infection and microbial contamination
• construction and environmental properties
• medical devices with a measuring function
• protection against radiation
• medical devices connected to or equipped with an
  energy source
• information to be provided with medical devices
• clinical evidence
• http//www.tga.gov.au/devices/epcheck.htm

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Documenting Modifications

• The technical documentation should include
• records of each design change
• the associated reasons
• any related verification and validation data
• evidence that the change achieved the desired
  effect
• evidence that the device continues to comply with
  the essential principles

20
Conformity Assessment

• Can you make it consistently?
• Quality Assurance is a key facet
• Can you track what went wrong and who else may be
  affected?

21
After market surveillance

• Aftermarket Surveillance- Manufacturers
• A proactive system that monitors product
• Ability to effect an adequate recall
• Potentially Risk Assessment
• Keeping TGA and Sponsors informed
• Subject to audit to verify compliance
  significant penalties
• Vigilance
• Reports from users, professionals manufacturers

22
Notification obligations on Sponsors/Manufacturers

• 48 hours after becoming aware of a serious threat
  to public health
• 10 days after becoming aware of the death, or
  serious deterioration in the state of health, of
  a patient, a user of the medical device or
  another person
• 30 days after becoming aware of an event, if a
  recurrence of the event might lead to the death,
  or a serious deterioration in the state of
  health, of a patient, a user of the medical
  device or another person.

23
Manufacturer supplied documentation

• The booklets provided with equipment now
  typically contain manufacturer provided
  information to a level that eliminates the
  necessity for the OT handouts typically given in
  the past other than for client specific
  information such as how long to use something for
  each day and when to report problems

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Topics covered in a Hills healthcare my mobility
wheelchair handbook

• INTRODUCTION
• PRODUCT SPECIFICATIONS
• INCLUDED EXTRAS
• OPTIONS
• ASSEMBLY INSTRUCTIONS
• FOLDING OPENING INSTRUCTONS
• TRANSPORTING OF WHEELCHAIR
• COMMON MISUSE OF WHEELCHAIRS
• USE OF YOUR MANUAL WHEELCHAIR
• DESCENDING ASCENDING GRADIENTS
• CROSSING KERBS OBSTACLES
• DESCENDING FROM KERBS OBSTACLES

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• BREAKDOWN OF MAIN WHEELCHAIR COMPONENTS
• FOOT RESTS
• ARM RESTS
• BRAKES
• LARGE WHEELS 24 INCH
• FORKS AND CASTORS
• CLEANING YOUR WHEELCHAIR
• UPHOLSTERY
• FRAME
• GENERAL SERVICING
• WARRANTY
• KCARE CONTACT DETAILS

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Shower commode swing tag

• INTRODUCTION
• INSTRUCTIONS FOR ASSEMBLY
• FUNCTION
• MAINTENANCE
• Care of frame
• Care of upholstered components
• Care of wheels (KA120S KA130S models only)
• Care of castors
• PATENTED CLIP IN SEAT TECHNOLOGY
• PRODUCT OPTIONS
• WARRANTY
• KCARE CONTACT DETAILS

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Maxi Tilt in space commode instruction booklet 10
pages

• KEY SPECIFICATIONS
• SAFETY PRECAUTIONS
• OPERATING INSTRUCTIONS
• MAINTENANCE INSTRUCTIONS
• CLEANING INSTRUCTIONS
• WARRANTY SERVICE AGREEMENT
• KCARE CONTACT DETAILS

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OT documentation

• The who, the why, the where, the when and the
  what.
• Must be able to track items for product recall.
  If the supplier can find you (or the hospital
  etc), you (or the hospital etc) must be able to
  find the client.
• Provide the manufacturers information to the
  client.