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The Therapeutic Goods (Medical Devices) Act & Regulatory Compliance for Assistive Care Equipment Manufacturers and Suppliers. Acknowledgements to Lloyd Walker (Tech 4 Life) 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 e. Procurement • 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 – – – 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 • • • 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 (KA 120 S & KA 130 S 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.