DRAFT National patient contact protocol for patients with Implanted Medical
Devices subject to Hazard Alerts
Version 0.6
i
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
ii
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
0.2
0.3
0.4
0.5
18 December 2013
20 December 2013
23 December 2013
28 January 2014
9 April 2014
0.6
5 May 2014
Dr Wellington
Comments N.Wilcox, T.Snioch
Revisions incorporated
Revisions incorporated
Revised following jurisdictional, Commission Executive and
private hospital sector feedback
Minor revisions
Distribution
Date Issued
Issued To
0.1 – 18 December 2013
0.3 – 23 December 2013
0.4 – 28 January 2014
0.5 – 10 April 2014
0.6 – 7 May 2014
0.6 – 9 May 2014
Project group
DRAFT submitted to Dept of Health
ACSQHC Inter-Jurisdictional Committee
Commission Executive review
Hospitals participating in the Proof of concept phase
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
iii
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 Australia1 and The Role of
the Therapeutic Goods Administration Regarding Medical Devices, Particularly Poly Implant
Prostheses (‘PIP’) Implants2, 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.
b.
c.
d.
a patient and consumer right;
a core responsibility of the health care system;
a normal part of an episode of care should the unexpected occur; and
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
1
The Senate. Community Affairs Reference Committee. The regulatory standards for the approval of medical
devices in Australia. November 2011.
2
The Senate. Community Affairs Reference Committee. The role of the Therapeutic Goods Administration
regarding medical devices, particularly Poly Implant Prostheses (PIP) Implants. May 2012.
1

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.
2
B.
Hazard Alerts
Therapeutic goods including Implantable Medical Devices may be recalled when, for reasons relating
to their quality3, 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:
a.
b.
c.
Class I Recalls occur when products are potentially life-threatening or could cause a
serious risk to health.
Class II Recalls occur when product defects could cause illness or mistreatment, but are
not Class I.
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:
a.
b.
c.
d.
Wholesale - includes wholesalers and state/territory purchasing authorities.
Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance
services, blood and tissue banks and laboratories as well as wholesale as appropriate.
Retail - includes retail pharmacists, medical, dental and other health care professionals as
well as wholesale and hospital as appropriate.
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 Coordinator, 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
3
That is, compliance with statutory or agreed standards.
3
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.
4
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.
5
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
Sponsor
N/A
Sponsor
N/A
May include recall letters, paid advertisements in the
daily print media and media releases as approved by
the TGA
5
Notification to the Federal Minister responsible for
Consumer Affairs
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
Healthcare Organisation
and relevant clinicians
K
PART 3 – RESPONSE
11
Implementing the Hazard Alert management
system
PART 4 – RECOVERY
12
Evaluating and reporting outcomes
Healthcare Organisation
and relevant clinicians
L
13
Supporting system level accountability
Healthcare Organisation
M
Sponsor
N/A
Australian Recall Coordinator
N/A
6
Progress of Recall and report
7
Follow-up action
6
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.
7
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:
a.
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;
b.
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;
c.
define and promulgate the role and responsibilities of the Hazard Alert Coordinator; and
d.
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.
The Hazard Alert Co-ordinator and their alternative should be senior medical, nursing or
allied health professionals.
Healthcare Organisations should notify State/Territory Recall Co-ordinators of the names
and contact details of the Hazard Alert Co-ordinator and their alternative.
3.
4.
H.
Establishing a Hazard Alert Committee
5.
Healthcare Organisations should establish a committee (‘Hazard Alert Committee’) to
advise the Hazard Alert Co-ordinator on the management of Hazard Alerts.
The Hazard Alert Committee should be chaired by a member of the Healthcare
Organisation’s senior management team.
6.
8
I.
Managing implanted device data
Collecting implanted device data
7.
8.
9.
10.
Healthcare Organisations, with the support of clinicians, should:
a.
develop and implement procedures to ensure the data described in Table 1 are
collected and accurately recorded in patient medical records for all episodes of
care in which a Implantable Medical Device is implanted in or explanted from an
patient;
b.
make all reasonable efforts to:
i.
record standardised data, as described in Table 1, in searchable
electronic systems (e.g. patient administration/ management system,
theatre management system or other searchable database); and
ii.
maintain the currency of those data over time;
c.
in accordance with their obligations under privacy law:
i.
inform patients, when the relevant data are collected, that they may
be stored, used or disclosed for the purpose of effecting patient
contact in the event of a Hazard Alert;
ii.
advise patients with Implanted Medical Devices that they should
always inform the Healthcare Organisation and Medicare Australia, in
writing and in a timely manner, of any changes to their permanent
contact details;
d.
include device-identifying data in patient-held discharge summaries and
discharge information sent to patients’ general practitioners and, if applicable,
other referring clinicians.
For additional patient contact options, Healthcare Organisations may also choose to
collect the email addresses and mobile telephone numbers, where available, of each
patient in whom an Implantable Medical Device has been implanted.
Healthcare Organisations should retain the data described in Table 1 in an accessible
format and location for all patients with Implanted Medical Devices for the minimum
statutory retention period following device explantation or patient death, but should
thereafter destroy or permanently de-identify data if no longer required for any purpose.
If data referred to in Table 1 are recorded in patients’ medical records and/or other
location(s) but are not stored in a searchable format, Healthcare Organisations may
establish a systematic process to retrieve those data and record them in a searchable
format.
9
Table 1: Data items to be held by Healthcare Organisations
Data item
Patient identifier information
Person Identifier (NHDD4). Identifiers for individual patients that will support patient
contact and Recall include:

Name (full name including middle names)

Medicare number (including individual reference number)

Healthcare Facility medical or unit record number

Patient date of birth and gender

Patient address at the date and time of implant, updated as relevant during
subsequent contacts with the health care facility

Where the patient is a child or an incompetent adult, the name and address of
the patient’s substitute decision-maker.
Device identifier information5

Device identifier (DI)

Production identifier (PI)
These elements respectively identify the device and provide production information such
as batch or serial number information that combine to form a Unique Device Identifier
(UDI):
UDI = DI + PI
Provider identifier

Clinician identifier
Date of admission for implantation, revision or explantation procedure
4
NHDD: National Health Data Dictionary, version 16 see http://www.aihw.gov.au/publicationdetail/?id=10737422826.
5
International Medical Device Regulators Forum (IMDRF), UDI Guidance: Unique Device Identification (UDI) of
Medical Devices, see: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance.pdf
10
Documenting and testing data retrieval processes
11.
Healthcare Organisations should:
a.
document a procedure for data retrieval that will enable timely and reliable
retrieval of patient-, device- and provider-identifying data for all Implanted
Medical Devices; and
b.
undertake a practical test, and periodically review the effectiveness, of the data
retrieval procedure.
Note: Notwithstanding clause 7.b7.b.i, arrangements to store, search and retrieve data
necessary to identify patients with specific Implanted Medical Devices will vary between
Healthcare Organisations and Facilities. For example, some Healthcare Organisations may
collect relevant data in searchable electronic patient records, while others may rely on
extracting inventory and/or procedure data from searchable electronic systems supported
by manual searches of patient records.
Procedures for generating patient contact lists will vary, therefore, between Healthcare
Organisations and Facilities, but should be documented in accordance with local
arrangements and tested periodically.
J.
Registering with Health Professional Online Services
12.
Healthcare Organisations should register with Medicare’s Health Professional Online
Services (‘HPOS’) to enable future access patient contact information held by Medicare6.
K.
Identifying Hazard Alerts
13.
The Hazard Alert Co-ordinator should regularly monitor the TGA website for new Hazard
Alerts.
Healthcare Organisations should establish a policy requiring staff and visiting medical
officers to inform the Hazard Alert Co-ordinator if they are notified of a relevant Hazard
Alert.
14.
6
More information about HPOS is provided in the Guide to implementing the National Patient Contact
Protocol.
11
PART 3 – RESPONSE
L.
Managing a Hazard Alert
Initiating the Healthcare Organisation’s response
15.
When a Hazard Alert is received, the Hazard Alert Co-ordinator should:
a.
immediately ensure all Implantable Medical Devices subject to the Hazard Alert
that remain in stock are quarantined;
b.
report the receipt of the Hazard Alert to the relevant Healthcare Organisation
or Facility quality, clinical governance and/or risk management committee(s);
and
c.
convene the Hazard Alert Committee;
d.
establish a log of key tasks; and
e.
assign responsibilities and preliminary timeframes for completion of all tasks.
Planning for patient contact
16.
The Hazard Alert Co-ordinator, in collaboration with relevant clinicians and with advice
from the Hazard Alert Committee, and taking into account the technical and clinical advice
available about the hazard, its urgency and management (including advice from the CMO
and/or the jurisdictional Recall Co-ordinator, if available), should:
a.
document a patient contact protocol that includes:
i.
the preferred mode(s) of patient contact (e.g. telephone, letter or a
combination of contact modalities) and the order in which they will
be effected;
ii.
who will contact patients;
iii.
the target timeframe for contacting patients;
iv.
key messages to be provided to patients, including:
A.
factual advice about the nature and significance of the
hazard and its recommended management, consistent with
the advice provided to the Healthcare Organisation or
Facility by the Sponsor, the TGA, the Commonwealth CMO,
the relevant professional college(s), the State/Territory
CHO and/or the State/Territory Recall Co-ordinator;
B.
details of specific actions the patient is advised to take to
protect their health and wellbeing (for example, initiate an
immediate consultation with their general practitioner or
specialist);
C.
details of a contact telephone number for patient to make
inquiries; and
D.
a request for the patient or their family/carer to contact
the Healthcare Organisation or Facility within a specified
12
17.
timeframe to confirm they have received the advice about
the Hazard Alert;
b.
draft template patient contact letters, where required;
c.
prepare tools (e.g. standard forms) to record the outcome of each patient
contact;
d.
ensure adequate resources are available to provide appropriate clinical support
to patients including, where necessary:
i.
specialist consulting services;
ii.
theatre time and/or resources; and/or
iii.
a telephone inquiry line staffed by trained health care professionals;
and
e.
identify and train the staff who will be responsible for interacting with patients;
f.
consider whether inquiries from the public are likely and if so, implement
appropriate training and provide appropriate resources for Healthcare
Organisation and/or Facility personnel who may receive those inquiries.
Arrangements for clinical interventions are outside the scope of this protocol. In
collaboration with clinicians the Hazard Alert Co-ordinator should, however, commence
developing procedures addressing:
a.
any special elements of consent procedures needed to support the subsequent
clinical management of patients affected by the Hazard Alert;
b.
the need for comprehensive documentation in patient clinical records of:
i.
the clinical interventions undertaken in response to the Hazard Alert;
ii.
where explantation occurs, the observed state of the Implanted
Medical Device;
c.
any testing, photography or other procedures proposed to be conducted on
explanted devices; and
d.
the disposition of devices that are explanted as a result of a Hazard Alert, noting
that:
i.
the safety of individuals potentially exposed to explanted devices
must be a priority; and
ii.
legal ownership of explanted devices may vary depending on
contractual arrangements.
Identifying affected patients
18.
The Hazard Alert Co-ordinator should:
a.
in collaboration with relevant personnel (e.g. procurement, supply and clinical
personnel):
i.
determine how many of the Implantable Medical Devices that are
subject to the Hazard Alert have been purchased by the Healthcare
Organisation;
ii.
consider whether any of the Implantable Medical Devices that are
subject to the Hazard Alert have, or may have, been supplied by
visiting medical officers directly for patient use, and therefore will
not appear on usual hospital supply/inventory records;
13
iii.
b.
determine the number of patients in whom the Implantable Medical
Device that is subject to the Hazard Alert has been implanted; and
activate the documented procedure referred to in clause 11 to generate a
patient contact list.
Contacting patients
19.
20.
21.
22.
The Hazard Alert Co-ordinator should provide to the Healthcare Organisational staff
members and/or clinicians who have been allocated responsibility for effecting patient
contact:
a.
the patient contact list(s) generated in accordance with the documented
procedure referred to in clause 11;
b.
where contact will be made by telephone, written advice of the information to
be conveyed to patients;
c.
where contact will be made by letter, template patient contact letters;
d.
tools to record the outcomes of patient contact efforts; and
e.
the agreed method and timelines for reporting the results of patient contact
efforts to the State/Territory Recall Co-ordinator.
Written communications with patients should always be signed by a senior manager or
clinician, whose identity is clear.
Unless exceptional circumstances apply, all verbal communications with patients about
Hazard Alerts should be by senior healthcare professionals with specific knowledge of
both the implant that is subject to the Hazard Alert and the hazard that has been
identified.
The person(s) responsible for effecting patient contact should, in accordance with the
parameters defined in clause 15.d15.d:
a.
make patient contact as expeditiously as possible;
b.
maintain accurate records in the agreed format of the outcomes of both
successful and unsuccessful patient contact efforts; and
c.
submit those records to the Hazard Alert Co-ordinator in a timely manner.
Following up patients unable to be contacted
23.
24.
25.
Where the agreed patient contact procedures are followed but the Hazard Alert Coordinator is unable to reliably verify that an affected patient has been contacted, the
Hazard Alert Co-ordinator should:
a.
if the urgency of the situation permits, make further patient contact efforts;
b.
if the patient cannot be contacted, utilise HPOS to identity the patient’s current
contact details as recorded in the Medicare customer database.
Following receipt from Medicare Australia of the patient’s current contact details as
recorded in the Medicare customer database, the Hazard Alert Co-ordinator should repeat
the step defined in clause 22 above.
Healthcare Organisations or Facilities should add an alert to the medical record of each
patient with an Implanted Medical Device that has been subject to a Hazard Alert if the
patient has not been contacted, to ensure that if the patient contacts the Healthcare
Organisation or Facility in the future the relevant information will be provided to them.
14
Responding to inquiries
26.
Subject to privacy and confidentiality obligations:
a.
the Healthcare Organisation should:
i.
provide accurate and timely responses to members of the public
and/or patients who initiate inquiries about the Hazard Alert;
ii.
consider establishing a ‘fast track’ process to provide specific device
information in writing to patients who have received an implant of a
similar type but are unsure whether their particular device is subject
to a Hazard Alert, which:
A.
minimises time delays and inconvenience for patients;
B.
is appropriately recorded; and
C.
does not incur any cost for patients.
iii.
maintain accurate records of all relevant inquiries and responses;
b.
the Hazard Alert Co-ordinator should respond to all relevant inquiries by the
State/Territory Recall Co-ordinator, the TGA/Australian Recall Coordinator
and/or the CHO about the progress and/or effectiveness of the Hazard Alert
management process.
Maintaining appropriate records
27.
The Hazard Alert Co-ordinator should ensure accurate records of the processes and
outcomes of the Hazard Alert management process are maintained, including
a.
the number of affected patients;
b.
records of all committee meetings and correspondence (email and other) about
the Hazard Alert and its management;
c.
a log of all telephone calls relating to the Hazard Alert and its management,
including a summary of issues discussed;
d.
date(s) letters are sent and/or telephone calls are made to patients;
e.
date(s) patient contact is confirmed;
f.
date(s) patients are reviewed by a clinician (if applicable);
g.
date(s) of receipt of returned written communications to patients;
h.
date of accessing the HPOS system to ascertain further contact details from the
Medicare customer service database;
i.
identified adverse events associated with the Hazard Alert and/or the device
that is the subject of the Hazard Alert;
j.
a log of complaints and other consumer feedback about the process; and
k.
outcomes of patient contact efforts.
15
PART 4 – RECOVERY
M.
Evaluating and reporting management and outcomes
28.
When implementation of the Hazard Alert management plan is completed, the Hazard
Alert Co-ordinator should:
a.
collate data and other information relevant to the organisation’s performance
in managing the Hazard Alert;
b.
lead a local review of the timeliness, efficiency and effectiveness of
management of the Hazard Alert incorporating:
i.
engagement of relevant local personnel including the organisational
risk and quality assurance managers and participating clinicians;
ii.
review of data and other information relevant to the organisation’s
performance in managing the Hazard Alert; and
iii.
identification of potential improvements;
c.
lead implementation of improvements identified in step b above;
d.
prepare a final report including:
i.
a reconciliation of the patient contact list with the patients
contacted;
ii.
an assessment of the effectiveness of management of the Hazard
Alert; and
iii.
specific recommendations for improvement;
e.
submit the final report, as appropriate, to:
i.
relevant clinicians;
ii.
the Healthcare Organisation or Facility quality manager and/or risk
manager;
iii.
relevant Healthcare Organisation and/or Facility quality, clinical
governance and/or risk management committees; and
f.
subject to relevant Healthcare Organisational protocols and privacy and
confidentiality obligations, submit the final report, as appropriate, to State and
Territory Recall Co-ordinators.
16
N.
Supporting system level accountability
29.
Subject to relevant healthcare organisational protocols and privacy and confidentiality
obligations, the Hazard Alert Co-ordinator should respond in a timely manner to requests
for information about the effectiveness of implementation of this Protocol from:
a.
the State/Territory Recall Co-ordinator;
b.
the CHO;
c.
the Sponsor;
d.
the TGA and/or
e.
any other relevant authority.
END OF PROTOCOL
17
DICTIONARY
Active Implantable Medical Device means an active medical device, other than an Implantable
Medical Device, that is intended by the manufacturer:
(a)
(b)
either:
(i)
to be, by surgical or medical intervention, introduced wholly, or partially, into
the body of a human being; or
(ii)
to be, by medical intervention, introduced into a natural orifice in the body of a
human being; and
to remain in place after the procedure.
Active Medical Device means
Hazard Alert means the issuing of precautionary information about an implanted device.
Hazard Alert Co-ordinator means the person appointed from time to time to assume the
responsibilities of coordinating the management of Hazard Alerts in a Healthcare Organisation or
Facility.
Healthcare Facility means any facility in which an implantable device is implanted in a human being.
It includes hospitals, day procedure centres and professional consulting suites.
Healthcare Organisation means any organisation that operates one or more facilities in which
implantable devices are implanted in human beings.
Explantation means the removal of an Implanted Medical Device from a patient’s body.
Implantable Medical Device means a medical device (other than an Active Implantable Medical
Device) that is intended by the manufacturer:
a.
b.
c.
to be, by surgical intervention, wholly introduced into the body of a human being, and to
remain in place after the procedure; or
to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a
human being, and to remain in place after the procedure; or
to be, by surgical intervention, partially introduced in to the body of a human being, and
to remain in place for at least 30 days after the procedure.
Implanted Medical Device means an Implantable Medical Device or an Active Implantable Medical
Device that has been implanted in a patient.
Recall means the permanent removal of therapeutic goods from supply or use for reasons relating to
deficiencies in the quality, safety or efficacy of the goods. It includes:
a.
b.
requests to pharmacists, hospitals, pathology laboratories, fractionators, operating and
research facilities, biomedical engineers or others to check and return goods found to be
defective; and
removal from supply or use of goods with inherent design or manufacturing defects.
18
Sponsor means the person, business or company that has the primary responsibility for the supply,
including for clinical investigational use, of the product in Australia. The Sponsor may also be the
manufacturer of goods.
State/Territory Recall Co-ordinator means the person(s) appointed from time to time by each State
and Territory to coordinate recalls of therapeutic goods in their jurisdictions.
19
DEVICE DATASET TO BE HELD AT HOSPITAL LEVEL - FORMAT
[Pending]
20