20 April 2019

Social Auditors and Medical Device IDs

'Assessing the Duty of Care for Social Auditors' by Tara Van Ho and Carolijn Terwindt in (2019) 27(2) European Review of Private Law 379–401 comments
This article analyses the appropriate duty of care under English tort law for social auditors towards third parties at risk of suffering damages from their negligence. After explaining the work of social auditors, the article considers whether the duty of care established for financial auditors is an appropriate one for social auditors. It concludes that a robust duty of care does exist for social auditors to guard against negligent audits that could harm workers at audited facilities. Due to differences between the financial and social audit, it further argues the duty of care for social auditors should be both broader than that required of the financial audit industry and non-delegable.

The TGA consultation on  Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia  comments 

Demand is growing for improved traceability of medical devices in the supply chain. There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential. The development and implementation of the Unique Device Identification System (the UDI System) is widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices. The International Medical Device Regulators Forum (IMDRF) - a group of the major medical device regulators from around the world, including Australia - is working to advance and strengthen international medical device regulatory frameworks, including those governing Unique Device Identification (UDI). IMDRF guidance documents (IMDRF UDI Guidance) provide a framework within which regulatory authorities and manufacturers can develop and implement their own UDI systems. The aim is to secure ‘a single, globally harmonized system for positive identification of medical devices’. Several international regulatory authorities have already implemented the UDI System, commenced work on implementation, or introduced enabling legislation. This includes authorities from the USA, Europe, Japan, Brazil and some members of the Asian Harmonization Working Party. 

This consultation 

We are exploring the feasibility of introducing the UDI System in Australia, including options for development of the UDI database (AusUDID). We propose to build on the work and experience of the IMDRF, the U.S. Food and Drug Administration (U.S. FDA), the European Union (EU) and other jurisdictions to inform the principles and design of a UDI System for Australia. The focus of this paper is to seek your feedback on:

• the proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia 

• whether the TGA or another body should be responsible for establishing and maintaining the Australian UDI database (AusUDID) 

• the potential scope of regulatory and legislative amendments required to establish the UDI System in Australia.

The introduction of any mechanism that allows unambiguous identification of medical devices in supply chains will impact many stakeholders significantly, especially if UDI is fully integrated into the Australian healthcare system. In recognition of this proposal’s complexity and broad impact, we plan to hold other consultations on further aspects of the UDI System’s introduction in Australia, including more detailed discussion on the regulatory requirements and seeking more targeted views on the impact of this change on specific groups of stakeholders. ...   

The UDI System 

The introduction of the UDI System is an important means of improving the identification and traceability of medical devices. UDI can provide significant support to other reforms designed to improve the effectiveness of pre-market assessments of medical devices and management of post-market safety-related activities. 

The UDI System consists of three interrelated parts: 

• the development and application of UDI globally harmonised standards 

• the requirement for manufacturers of medical devices to create and place a Unique Device Identifier on a device, its labelling and packaging 

• the requirement to enter specified information or certain data elements into a UDI database (UDID).

The Unique Device Identifier is a series of numeric or alphanumeric characters created by applying globally accepted device identification and coding standards. The Unique Device Identifier has two parts, the Device Identifier (UDI-DI) and Production Identifier (UDI-PI).   Any requirement to include a Unique Device Identifier will not override the Essential Principles requirements in the Medical Device Regulations relating to the safety and performance characteristics of medical devices; in particular, the requirement to provide patient information and instructions for use. A UDID contains essential information specific to the model of a medical device (UDI-DI and some key data elements) and allows access to this information. ... 

What are the benefits of implementing the UDI System? 

Identification of medical devices using the UDI System offers significant benefits throughout the supply chain, including:

• enhanced effectiveness of post-market safety-related activities, such as: faster and more accurate identification of problems; improved functionality in the reporting of incidents and adverse events; and more effective management of medical device recalls 

• a more robust pre-market assessment of medical devices due to the availability of better quality evidence-based data that is presented consistently and which includes post-market data and analysis 

• a reduction in medical and surgical procedural errors by allowing healthcare professionals and others to quickly trace a device and obtain vital information about its characteristics 

• enhanced analysis and research through the uniform documentation of devices in electronic health records, clinical information systems, registries and other data sources 

• a more robust and secure global distribution chain, which helps to tackle diversion and counterfeiting, and facilitates preparation for medical emergencies 

• better sharing of medical device information around the world.

For these reasons, we anticipate that the proposed establishment of the UDI System in Australia will benefit consumers, healthcare professionals, scientists, researchers, the medical device industry and regulators. 

International activities related to the UDI System 

The following provides an overview of international activities related to the UDI system. International Medical Device Regulators Forum (IMDRF) The IMDRF published UDI guidance: Unique Device Identification (UDI) of medical devices (UDI Application Guide) in December 2013. This document provided a high-level conceptual framework of the ‘basic core concepts’ of a UDI system. However, it has been recognised that further IMDRF guidance is required to better facilitate consistent implementation of UDI systems internationally. Accordingly, the IMDRF UDI Working Group—which is comprised of IMDRF members and representatives from relevant international industry bodies —was established in December 2017 to develop the UDI Application Guide. It is intended to be used as a supplement to the 2013 guidance and will provide the details and specifications necessary to ensure consistent development of UDI systems in different jurisdictions. A draft of the UDI Application Guide, together with other relevant information, was published in July 2018 for three months public consultation until 12 October 2018. .... 

Proposed implementation in Australia 

We propose that the UDI System in Australia be based on internationally harmonised principles as outlined in IMDRF UDI Guidance and informed by the work done by the EU, the U.S. FDA and other regulatory authorities. It is proposed that the Australian UDI System will apply to all devices placed on the market except custom-made devices and certain other medical devices. For example, in Australia some products are regulated as devices, while the same groups of products are not considered to be medical devices in some other jurisdictions. Also should UDI in Australia apply to Class I medical devices, particularly those other than Class I(m) (with measuring function) and/or Class I(s) (devices supplied sterile)? While it is highly desirable to align internationally, we seek stakeholders’ feedback on proposals for possible exemptions from UDI requirements. Sponsors will be responsible for ensuring their devices comply with the relevant requirements. Sponsors who import or supply medical devices in Australia will need to verify that, where applicable, device manufacturers have assigned a Unique Device Identifier to their devices and placed Unique Device Identifier carrier on the device, labelling and packaging as required. Sponsors must have an agreement with the manufacturer authorising the sponsor to include the key data elements and other relevant information in AusUDID. 

Proposed first actions 

It is proposed that the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 be amended to enable the establishment of the UDI System and include provisions to:

• allow the designation of Issuing Agencies (or Issuing Entities) and provide these with the power to issue Unique Device Identifiers Note: Further explanation on Issuing Agencies (or Issuing Entities) is provided on page 12. 

• prescribe requirements for the placing of Unique Device Identifiers on a device, its labelling and packaging 

• establish the AusUDID (potentially within the TGA infrastructure, see below) and link it to the Australian Register of Therapeutic Goods (ARTG). Consultation on the introduction of the UDI System will be a staged process.

The TGA will undertake further consultations on the proposal in order to clarify the design, scope, cost and information technology interface processes needed to implement the UDI System in Australia. The TGA is also aware that there are already views of different stakeholders that consider and discuss the need and feasibility of introducing UDI system in Australia.