Transcript TGA for Assistive Care Equipment Manufacturers and Suppliers

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)
• 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.
• 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.
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.
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.
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.
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.
• 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.
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..
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.
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…
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
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
Labelling
Each Device must have the Manufacturer’s
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
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
Record keeping
Maintain record of:
• patient
• prescriber
• design characteristics – prescription
• declaration of conformity
Essential Principles
General Principles
1. the use of a medical device must not compromise
health and safety
2. the design and construction of a medical device has to
conform with safety principles
3. medical devices are to be suitable for the intended
purpose
4. long term safety
5. medical devices are not adversely affected by
transport or storage
6. the benefits of medical devices are to outweigh any
side effects
Principles about Design and
Construction
7.
8.
9.
10.
11.
12.
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
13. information to be provided with medical devices
14. clinical evidence
http://www.tga.gov.au/devices/epcheck.htm
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
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?
After market surveillance
• Aftermarket Surveillance:- Manufacturers
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–
–
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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
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.
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
Topics covered in a Hills healthcare
my mobility wheelchair handbook
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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
K•CARE CONTACT DETAILS
Shower commode swing tag
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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
K•CARE CONTACT DETAILS
Maxi Tilt in space commode
instruction booklet 10 pages
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KEY SPECIFICATIONS
SAFETY PRECAUTIONS
OPERATING INSTRUCTIONS
MAINTENANCE INSTRUCTIONS
CLEANING INSTRUCTIONS
WARRANTY & SERVICE AGREEMENT
K•CARE CONTACT DETAILS
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.