DRAFT National Patient Contact Protocol for Patients with Implanted Medical Devices Subject

DRAFT National patient contact protocol for patients with Implanted Medical Devices subject to Hazard Alerts

Version 0.6

Contents

PART 1 – PRELIMINARY ISSUES 1

A. Introduction 1

B. Hazard Alerts 3

C. Scope of the Protocol 5

D. Stages of the Protocol 6

E. The role of State/Territory recall co-ordinators 7

PART 2 – PREPARATION 8

F. Adopting a Hazard Alert Management Policy 8

G. Appointing persons responsible 8

H. Establishing a Hazard Alert Committee 8

I. Managing implanted device data 9

Collecting implanted device data 9

Documenting and testing data retrieval processes 11

J. Registering with Health Professional Online Services 11

K. Identifying Hazard Alerts 11

PART 3 – RESPONSE 12

L. Managing a Hazard Alert 12

Initiating the Healthcare Organisation’s response 12

Planning for patient contact 12

Identifying affected patients 13

Contacting patients 14

Following up patients unable to be contacted 14

Responding to inquiries 15

Maintaining appropriate records 15

PART 4 – RECOVERY 16

M. Evaluating and reporting management and outcomes 16

N. Supporting system level accountability 17

DICTIONARY 18

DEVICE DATASET TO BE HELD AT HOSPITAL LEVEL - FORMAT 20

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COMMISSION SPONSOR

Professor Debora Picone AM

PROGRAM DIRECTOR

Mr Neville Board, Director, Information Strategy and Safety in eHealth

AUTHOR

Dr Heather Wellington, DLA Piper

Version control (Document Revision History)

Version / Date / Comment
0.1 / 18 December 2013 / Dr Wellington
0.2 / 20 December 2013 / Comments N.Wilcox, T.Snioch
0.3 / 23 December 2013 / Revisions incorporated
0.4 / 28 January 2014 / Revisions incorporated
0.5 / 9 April 2014 / Revised following jurisdictional, Commission Executive and private hospital sector feedback
0.6 / 5 May 2014 / Minor revisions

Distribution

Date Issued / Issued To
0.1 – 18 December 2013 / Project group
0.3 – 23 December 2013 / DRAFT submitted to Dept of Health
0.4 – 28 January 2014 / ACSQHC Inter-Jurisdictional Committee
0.5 – 10 April 2014 / Commission Executive review
0.6 – 7 May 2014 / Hospitals participating in the Proof of concept phase
0.6 – 9 May 2014 / Jurisdictional Recall Coordinators, ACSQHC Executive, Dept of Health

This is a managed document. For identification of amendments each page contains a version number and a page number. Changes will only be issued as complete replacements covered by a release notice. This document has not been released for use until authorised by the last signatory.

Authorised for release to the Department of Health:

…………………………………………………………………………………………. (___/___/___)

Professor Debora Picone, AM

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PART 1 – PRELIMINARY ISSUES

A.  Introduction

The Australian Government, through the Department of Health and in consultation with State and Territory health authorities and the private healthcare sector, has developed this national patient contact protocol (‘Protocol’) for application by Healthcare Organisations when implanted medical devices are subject to Hazard Alerts.

The Uniform Recall Procedure for Therapeutic Goods (‘URPTG’), which is the result of an agreement between the therapeutic goods industry and the Commonwealth and State/Territory health authorities, defines the actions to be taken by health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety or efficacy, are to be removed from supply or use, or subject to corrective action. The URPTG does not, however, specify how patients with Implanted Medical Devices should be contacted when those devices are subject to Hazard Alerts.

In its reports: The Regulatory Standards for Approval of Medical Devices in Australia[1] and The Role of the Therapeutic Goods Administration Regarding Medical Devices, Particularly Poly Implant Prostheses (‘PIP’) Implants[2], the Senate Community Affairs Reference Committee noted significant deficiencies in arrangements for contacting patients in these circumstances.

This Protocol defines the procedures that should be implemented by Healthcare Organisations when Implanted Medical Devices are subject to Hazard Alerts. It is based on the following principle:

Contacting individuals with Implanted Medical Devices that are subject to a Hazard Alert, and providing them with appropriate information and access to necessary services is:
a.  a patient and consumer right;
b.  a core responsibility of the health care system;
c.  a normal part of an episode of care should the unexpected occur; and
d.  a critical element of clinical communications.

The Protocol:

·  complements the URPTG;

·  will support Healthcare Organisations and clinicians to make reliable, sensitive and timely contact with patients with Implanted Medical Devices that are subject to Hazard Alerts;

·  has a consumer focus;

·  reflects opinions as to ‘best practice’ expressed by stakeholders who participated in a consultation process; and

·  supports good governance at an organisational and system level.

The Protocol is accompanied by an implementation guide: Guide to implementing the National Patient Contact Protocol.

Important notice

This Protocol does not limit, affect or alter the obligations or duties in respect of Implantable Medical Devices imposed on any person by or under any contract, common law or legislation.

To the extent that this Protocol is or may be inconsistent with anything in the URPTG or the Australian Regulatory Guidelines for Medical Devices, the URPTG and those Regulatory Guidelines shall take precedence.

B.  Hazard Alerts

Therapeutic goods including Implantable Medical Devices may be recalled when, for reasons relating to their quality[3], safety or efficacy, they are to be removed from supply or use, or subject to corrective action. Recalls of therapeutic goods are governed by Section 23 of the Australian Regulatory Guidelines for Medical Devices and are implemented in accordance with the URTPG.

A Hazard Alert, which is a type of Recall subject to the URPTG, is the issuing of precautionary information about an implanted medical device.

Recalls (including Hazard Alerts) are defined according to the following European classification system:

1. Class I Recalls occur when products are potentially life-threatening or could cause a serious risk to health.
2. Class II Recalls occur when product defects could cause illness or mistreatment, but are not Class I.
3. Class III Recalls occur when product defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

The level to which a Recall (including a Hazard Alert) action is undertaken is based on the significance of the risk and the channels through which the goods have been distributed. The Recall levels are:

1. Wholesale - includes wholesalers and state/territory purchasing authorities.
2. Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue banks and laboratories as well as wholesale as appropriate.
3. Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale and hospital as appropriate.
4. Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate.

Device Sponsors are primarily responsible for implementing Recalls (including Hazard Alerts). Most Recalls are initiated by Sponsors in consultation with the Therapeutic Goods Administration (‘TGA’). Overall responsibility for coordinating Recalls lies with the Australian (Commonwealth) Recall Co-ordinator, who is an officer of the TGA. The agreement of the Australian Co-ordinator is required before Sponsors implement any recall strategies. Each State and Territory health authority also nominates an officer, and some also nominate a deputy, through whom information relating to Recalls is channelled and coordinated.

Once a Hazard Alert has been initiated, the TGA notifies a number of key stakeholders including State and Territory health authorities. The TGA has a standard operating procedure to alert the Chief Medical Officer (‘CMO’), State and Territory Chief Health Officers (‘CHOs’) and professional organisations (as appropriate) of certain Recall actions.

The URPTG requires Sponsors to notify defined individuals and organisations about Hazard Alerts in an agreed written format, but does not define a specific requirement for Sponsors, Healthcare Organisations or clinicians to ensure patients with Implanted Medical Devices are contacted regarding Hazard Alerts. Nor does it provide for verification of the success of efforts to contact patients. If the depth of a device Recall is to consumer level and consumers cannot be identified, Sponsors are required to insert advertisements in the daily print media of each State/Territory in which distribution has possibly taken place.

Following receipt of a Hazard Alert, public hospitals currently assume responsibility for contacting patients with the relevant Implanted Medical Devices, but some report that they have experienced considerable difficulty retrieving the necessary patient identification and contact information. Coordinating and accounting for patient contact has also been challenging in some circumstances. In the private sector practices vary. Some private Healthcare Organisations assume direct responsibility for identifying patients in whom devices subject to a Hazard Alert have been implanted, but many rely on the visiting medical officers who implanted the relevant devices in their private patients to identify and contact those patients. Across both the public and private sectors, governance arrangements and the effectiveness of patient contact efforts vary considerably.

This Protocol defines the procedures that should be implemented by Healthcare Organisations to ensure reliable, sensitive and timely patient contact and to establish appropriate organisational governance of Hazard Alerts.

C.  Scope of the Protocol

The Protocol defines ‘best practice’ arrangements for Healthcare Organisations to manage and govern Class I and Class II Hazard Alerts, including arrangements for:

·  collecting and storing information necessary for the future identification of patients who undergo implantation of medical devices;

·  retrieving information necessary to identify and contact patients with Implanted Medical Devices when a Hazard Alert is issued;

·  collaborating with clinicians to contact and advise patients with Implanted Medical Devices that are subject to Hazard Alerts;

·  evaluating the outcomes of patient identification and contact efforts; and

·  reporting to their State/Territory Recall Co-ordinator.

The Protocol notes the role of State/Territory Recall Co-ordinators in supporting the management of Hazard Alerts and assumes that State/Territory Recall Coordinators and/or CHOs may provide Healthcare Organisations in their jurisdictions with nationally consistent information about the appropriate timelines for patient contact, together with template information that they can provide to patients. The Protocol does not, however, address the processes for producing such information or communicating it to Healthcare Organisations. The Protocol also does not address:

·  responsibility for provision of and/or payment for health care required by patients with Implanted Medical Devices that are subject to Hazard Alerts; or

·  ownership and/or disposition of Implanted Medical Devices following their Explantation.

D.  Stages of the Protocol

The Protocol complements the URPTG. The URPTG is divided into seven stages and the Protocol is divided into four parts – preliminary issues, preparation, response and recovery (Figure 1).

Figure 1: Stages of URTPG and Patient Contact Protocol

URTPG recall stage / Protocol part / stage / Procedure / Responsibility / Protocol section
1 / Notification to the Coordinator Crisis Management / Sponsor / N/A
2 / Information required to assess Recall / Sponsor / N/A
3 / Assessment of Recall / Sponsor and Australian Recall Co-ordinator / N/A
4 / Recall
May include recall letters, paid advertisements in the daily print media and media releases as approved by the TGA / Sponsor / N/A
5 / Notification to the Federal Minister responsible for Consumer Affairs / Sponsor / N/A
PART 1 - PRELIMINARY ISSUES
1 / Introduction / N/A / A
2 / Hazard Alerts / N/A / B
3 / Scope of the Protocol / N/A / C
4 / Stages of the Protocol / N/A / D
5 / The role of State/Territory Recall Co-ordinators / State/Territory health authorities / E
PART 2 – PREPARATION
6 / Adopting a Hazard Alert management policy / Healthcare Organisation / F
7 / Appointing persons responsible / Healthcare Organisation / G
8 / Establishing a Hazard Alert Committee / Healthcare Organisation / H
9 / Managing implanted device data / Healthcare Organisation / I
10 / Identifying Hazard Alerts / Healthcare Organisation, clinicians and others / J
PART 3 – RESPONSE
11 / Implementing the Hazard Alert management system / Healthcare Organisation and relevant clinicians / K
PART 4 – RECOVERY
12 / Evaluating and reporting outcomes / Healthcare Organisation and relevant clinicians / L
13 / Supporting system level accountability / Healthcare Organisation / M
6 / Progress of Recall and report / Sponsor / N/A
7 / Follow-up action / Australian Recall Co-ordinator / N/A

E.  The role of State/Territory recall co-ordinators

Subject to local arrangements, State/Territory Co-ordinators may assume a co-ordinating and/or governance role in relation to Hazard Alerts, which may include:

·  maintaining an up-to-date contact list of Hazard Alert Co-ordinators in their jurisdictions;

·  when a Hazard Alert is issued:

o  contacting Hazard Alert Co-ordinators in their jurisdictions to determine the number of patients potentially affected by the Hazard Alert;

o  supporting Hazard Alert Co-ordinators to access up-to-date information from the TGA, the Supplier, the CMO, the CHO and other relevant sources;

o  ensuring Hazard Alert Co-ordinators have access to agreed national advice on:

§  the information that should be provided to patients with implanted devices that are subject to the Hazard Alert;

§  the time frames within which patients should be contacted;

o  monitoring the effectiveness of management of the Hazard Alert;

o  creating a central point in the jurisdiction for communication about management of the Hazard Alert;

o  reporting outcomes of management of the Hazard Alert locally and nationally in accordance with agreed protocols; and

·  supporting Healthcare Organisations to take a continuous quality improvement approach to the management of Hazard Alerts.

PART 2 – PREPARATION

F.  Adopting a Hazard Alert Management Policy

1.  Healthcare Organisations should issue a policy (‘Hazard Alert Management Policy’) confirming their intent to adopt this Protocol and their approach to its implementation.

G.  Appointing persons responsible

2.  Healthcare Organisations should:

1. nominate a position or individual to assume responsibility for coordinating the management of Hazard Alerts (the Hazard Alert Co-ordinator) in each Healthcare Facility, and ensure they have appropriate delegated authority to undertake the responsibilities detailed in this Protocol;
2. nominate an alternative position or individual to assume responsibility for coordinating the management of Hazard Alerts in the event the Hazard Alert Co-ordinator is unavailable;
3. define and promulgate the role and responsibilities of the Hazard Alert Co-ordinator; and
4. nominate the position or individual who is responsible for generating patient contact lists in the event of a Hazard Alert, and a second position or individual to assume delegated responsibility for list generation in the event that the responsible person is unavailable.

3.  The Hazard Alert Co-ordinator and their alternative should be senior medical, nursing or allied health professionals.