The Therapeutic Goods (Medical Devices) Act & Regulatory

Compliance for Assistive Care Equipment Manufacturers and

Suppliers.

Acknowledgements toLloyd 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…

ManufacturersA ManufacturerManufacturer 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 madeCustom 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 Principles1. the use of a medical device must not compromise

health and safety2. the design and construction of a medical device has to

conform with safety principles3. medical devices are to be suitable for the intended

purpose4. long term safety5. medical devices are not adversely affected by

transport or storage6. the benefits of medical devices are to outweigh any

side effects

Principles about Design and Construction

7. chemical, physical and biological properties8. infection and microbial contamination9. construction and environmental properties10. medical devices with a measuring function11. protection against radiation12. medical devices connected to or equipped with an

energy source13. information to be provided with medical devices14. clinical evidencehttp://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– 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 documentationThe 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• 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

• 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

• 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• 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.