Product Management Guidelines

Appendix 14

Guidelines for Developing a Procedure for Medical Device

or Medicine Recall
Introduction

Each hospital or health service has a responsibility to carry out Therapeutic Goods Recall action i.e.
medical device or medicine recall when requested of it by the product supplier/sponsor. Timely and
effective response to a Therapeutic Goods Recall notice is necessary to ensure that any risk to
patients or staff through use of the faulty product or drug is minimised.

The therapeutic goods recall process should be carried out with knowledge of the Uniform Recall
Procedure for Therapeutic Goods (2001 edition) or URPTG. An electronic copy can be downloaded
from the Therapeutic Goods Administration website at http://www.tga.gov.au/docs/pdf/urptg.pdf or a
hardcopy purchased by using the order form found at http://www.tga.gov.au/docs/pdf/puborder.pdf

A summary of definitions and actions taken from the URPTG is provided at Appendix a.
Recall Process Steps
The basic steps that should be incorporated in developing a procedure for managing a Medical
Device Recall or Medicine recall at hospital level include:
Recognition of a Medical Device or Medicine Recall notice and the importance of taking
action
Delegation of recall responsibility
Maintenance of a recall log
Determination of product use
Identification of product issued or on-sold to another hospital
Identification of product provided to an outpatient
Understanding the urgency of action
Quarantining of affected stock
Replacement of product
Retention of recalled product
Collection of recalled product
Credit issue
Record keeping

1. Recognition of a Medical Device or Medicine Recall Notice and the Importance of

Taking Action
The URPTG specifies that a Medical Device or Medicine Recall notice shall be sent to the Chief
Executive Officer (CEO) of a hospital or health service and relevant department managers. The
envelope used to carry this information is labelled boldly across the top left corner in red print with the
type of recall. This is to make the envelope easily identifiable amongst the high volume of mail that
CEOs receive so that action can be taken swiftly to remove affected goods and minimise the risk and
uphold the duty of care to provide a safe environment for patients and staff.

It is important to understand where in your organisation Medical Device or Medicine Recall notices will
be sent, and have a process in place for identifying and moving the notice expediently though your
organisation to the designated staff member so that action can be taken.

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2. Delegation of Responsibility

The responsibility for taking recall action should be delegated to a specific person or persons within
the organisation, according to the type of recall. In this way, there can be an expectation that action
will be taken expediently and effectively, and that staff are aware of this delegation and the need to
respond when requested to effect recall action at a ward or department level.

e.g. Medical Consumables: Supply Manager, Clinical Products Advisor, Director of Nursing

Biomedical Equipment: Manager of Biomedical Engineering

Medicines: Pharmacy Manager/Director

3. Maintenance of a Recall Log.

It is recommended that a record be kept of all activities that are undertaken as part of the recall action.
This will assist in ensuring that an effective and consistent approach has been taken, and provides
proof that suitable action has been taken in response to the risk that has been posed by the recall.

Refer: Appendix b - Product Recall Action Sheet

4. Does Your Hospital Use This Product?

Information on the Medical Device or Medicine Recall notice should be sufficient for you to search
your local computer ordering system, dispensing system or card file to determine whether the product
has been purchased by the hospital.

Suppliers generally have sufficient user information to selectively send recall notices only to those
hospitals that have purchased affected product. It is important to bear this in mind when reviewing
Product Recall websites or bulletins. Additionally, when recall of a specific batch of product has
occurred, your hospital may not receive a Recall Notice if it has not purchased any of the affected
batch.

Determine how widely the product is used. Is this a stock line i.e. one that is held in the warehouse or
dispensary and issued to a wide range of customer departments (and potentially other hospitals) or is
it a product that has been purchased for one specific department or patient? The plan of action will
vary according to where and how much of the product has been issued.

If possible, identify the Purchase Orders that relate to the affected goods. The supplier may wish to
credit your hospital against those PO numbers. This will also assist in identifying the volume of goods
that potentially may be returned.

5. Have You Issued or On-Sold this Product to or Purchased this Product for Another
Hospital or Health Service?

Therapeutic Goods Recall notices include a statement to remind your organisation to consider any
stock which may have been issued to another hospital or on-sold. Does your hospital supply products
to other hospitals? If the answer is yes, you should also check if affected product has been issued to
your external customer(s) and include them in your effort to retrieve affected goods. A record should
be kept of these actions and the results.

6. Have You Provided this Medical Device Or Medicine To An Outpatient?

Consideration should be given as to whether affected medical devices or medicines have been
provided to outpatients. If so, it may be necessary to make contact with them and arrange for return (if
practical) or disposal of the affected goods. A record should be kept of these actions and the results,
particularly where goods are to be disposed of.

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7. How Urgent is the Recall? How Should You Take Action?
The speed of action taken should be governed by the urgency of the recall (see Recall Classification
in Appendix 1). If the risk is life-threatening or likely to cause injury, action should be taken
immediately to recover product. This may include visiting wards/departments to search for and
retrieve affected stock.

In urgent situations, a company representatives may visit your hospital and collect any recalled stock
directly. It is important to ensure that this type of action is co-ordinated with the person designated to
manage recalls in your organisation so that appropriate records can be maintained.

If the recall is not deemed to be life-threatening, user departments can be contacted by internal mail or
Intranet to advise of the recall and of the need to check and return affected stock.

Refer: Appendix c - Urgent Memorandum Product Recall

8. Quarantining of Affected Stock.

Affected stock in the warehouse or dispensary should be quarantined and not issued, while stock in
user departments must be retrieved. This position should be maintained regardless of whether
replacement stock is available or not.

Where goods are being returned from multiple departments, a record should be kept of what is being
returned, from where, and the total volume of goods to be returned to the Supplier.

If possible, returned stock should be quarantined into a designated area of the hospital until the
supplier is able to arrange collection.

Refer: Appendix d - Returned Goods Register

9. Do You Need a Replacement Product?

It should be ascertained from the supplier if replacement stock can be provided immediately i.e.
another batch of the same product or a like product. If an alternative is not available from the existing
supplier, it may be necessary to source an alternative product from another supplier. Clinical/user
input may be required to determine a suitable alternative and the urgency of this action. In the case of
medicines, it may be necessary to consider an alternative drug, strength or form.

10. Should Staff be Permitted to Retain Recalled Product?

Performing a Therapeutic Device Recall in a hospital is a risk management exercise. The
supplier/sponsor and the Australian Recalls Co-ordinator have already determined that there is
sufficient risk to initiate the Recall process. User definition of whether the problem is of sufficient
magnitude to justify return is not an acceptable reason to fail to comply with the recall process.

11. When Will The Product Be Collected?

Once all affected stock has been retrieved, arrangements should be made with the supplier to have
the faulty product collected. It is important to keep a record of how much stock has been returned
(use Returned Goods form) along with the Purchase Order Numbers that stock may have been
delivered against.
Where there is a difference between the amount of goods ordered and the amount of goods returned
to the supplier, a reason should be identified as to where the stock has gone e.g. consumed,
discarded.

12. Will the Supplier Replace the Product or Issue a Credit to the Hospital?
Generally, there is a time lag between when product is withdrawn from the hospital and when the
supplier completes the reconciliation of the Recall action. As a rule, the Supplier will credit you with
the cost of the goods returned against the Purchase Orders that the goods were (potentially) received.
This will vary from case to case and from supplier to supplier.

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13. What Records Should be Kept?
A Medical Device or Medicine Recall file should be developed so that all records of all recall actions
can be retained in the one place, preferably in chronological order. This will provide evidence that
suitable action has been undertaken to address any risk posed by a Therapeutic Device Recall.
It is recommended that the file include all information relevant to each Recall activity.

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Appendix a
Therapeutic Device Recall Background Information
Hospitals and Health Services should carry out the process and actions of a Medical Device or
Medicine Recall in knowledge of the Uniform Recall Procedure for Therapeutic Goods (URPTG).
This process has been developed as the result of an agreement between the therapeutic goods
industry and the Commonwealth and State/Territory health authorities.
Its purpose is to define the action to be taken by sponsors (suppliers) and health authorities when
therapeutic goods are subject to a recall or other corrective action. The following information has
been summarised from the URPTG.
Definitions
Recall: an action taken to resolve a problem with a therapeutic good for which there are established
deficiencies in quality, efficacy or safety where quality refers to compliance with statutory or agreed
standards.
There are 2 types of Recall Action:
1. Recall: the permanent removal of a therapeutic good from supply or use for reasons relating to
deficiencies in the quality, safety or efficacy of the goods; and
2. Recall For Product Correction: The repair, modification, adjustment or relabelling of therapeutic
goods for reasons relating to deficiencies in the quality, safety or efficacy of the goods.
In addition to this and relating only to implantable medical devices:
Hazard Alert: The issuing of precautionary information about an implanted device where it has been
proven that there is no stock to be recalled and all affected devices are already implanted.
Sponsor: the person, business or company that has primary responsibility for the supply, including
for clinical investigational use, of the product in Australia. The sponsor may also be the manufacturer
of the goods.
Non Recall Action:
Safety Alert, Product Notification and Withdrawal are associated actions that are not recall actions and
therefore not subject to the Recall Procedure.

Safety Alert: advice regarding a specific situation with respect to a therapeutic good which, whilst
performing to meet all specifications and therapeutic indications, might present an unreasonable risk
of substantial harm if certain specified precautions in regard to its use are not observed.

Safety Alerts are issued to provide information on the safe use of goods as distinct from recall action
which addresses product deficiencies.

Product Notification: the issue of precautionary information about a therapeutic good, in a situation
that is unlikely to involve significant adverse health consequences.

Withdrawal: the sponsors removal from supply or use of a therapeutic good for reasons not related
to their quality, safety or efficacy

Sponsor: the person, business or company that has the primary responsibility for the supply of the
product in Australia. The sponsor may also be the manufacturer.

Therapeutic Goods: goods that are likely to be taken for:

therapeutic use; or
use as an ingredient or component in the manufacture of therapeutic gods
use as a container or part of a container for the above.

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Therapeutic Use: use in or in connection with

Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or
animals; or
Influencing, inhibiting or modifying a physiological process in persons or animals; or
Testing the susceptibility of persons or animals to a disease or ailment; or
Influencing, controlling or preventing conception in persons; or
Testing for pregnancy in persons; or
The replacement or modification of parts of the anatomy in persons or animals.

Recall Situations
The Therapeutic Goods Act 1989 contains recall provisions in four situations:
1. Where therapeutic goods have been cancelled from the Australian Register of Therapeutic
Goods (ARTG).
2. Where therapeutic goods have been unlawfully supplied in Australia and not entered in the
ARTG.
3. Where a batch of therapeutic goods fails to meet an applicable standard.
4. Where therapeutic goods have been or could be, subject to actual or potential tempering.

Tampering with Therapeutic Goods

Any threat of criminal tampering with a companys products should be considered to be genuine and
therefore serious and should be immediately reported to the Australian Recall Co-ordinator who will
convene a Crisis Reference Group (CRG) which will co-ordinate the activities required to resolve the
crisis. The CRG consists of:

the Australian Recall Co-ordinator

the State or Territory Health Department Recall Co-ordinator
State Police officers nominated for this purpose by the Police Ministerial Council
senior personnel of the company concerned.

Source of Recalls
A recall may be initiated as a result of:

reports to sponsors or recall co-ordinators from manufacturers, wholesalers, hospital user

departments, clinicians, Supply or Pharmacy departments
analysis and testing of samples of therapeutic goods by sponsors or testing laboratories
advice received from:
o Australian Drug Evaluation Committee
o Adverse Drug Reaction Advisory Committee
o Therapeutic Device Evaluation Committee
o Medicines Evaluation Committee
o Complementary Medicines Evaluation Committee
Additional information is required to allow assessment of validity of reports, determine the potential
danger to consumers, and the action appropriate to the situation. Serious problems that may lead to a
recall should be reported directly to the TGA for investigation.

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Problem Reporting Forms

The following forms can be used to report problems to the Therapeutic Goods Administration:
Medicine Problem Report
Medical Device Incident Report
Human Blood & Tissues Report Form.
These forms are available from the TGA website or by contacting the TGA Secretariat & Recalls
Section on (02) 6232 8637.

Classification of Recalls
Recalls classification is determined from a consideration of the potential of deficient goods to cause
harm or injury to the user. Recalls are deemed to be Urgent or Routine: Where the hazard is
significant, the recall is classified as urgent; otherwise it is classified as routine.
Class I: when products are potentially life-threatening or could cause a serious risk to health
Class II: when product defects could cause illness or mistreatment but are not Class I
Class III: when product defects may not pose a significant hazard to health but withdrawal may be
initiated for other reasons.
Where a recall is safety-related the sponsor must, under the Trade Practices Act 1974, notify the
Commonwealth Minister responsible for Consumer Affairs within 2 days of taking recall action or be
subject to significant financial penalty.
The Minister can impose a mandatory recall if the sponsor fails to take satisfactory action to remove
the hazard created by the goods.
Levels of Recall
Four levels of recall exist. In determining the level, the principal factors to be considered are the
significance of the hazard, the channels by which the goods have been distributed, and the level to
which distribution has taken place.

Wholesale Level
Includes
State purchasing authorities

Hospital Level
Includes:
Nursing homes, hostels and other institutions
Clinical investigators and the institution in which investigations are being performed
Hospital pharmacists, hospital blood banks, pathology laboratories, operating facilities,
fractionators, human tissue banks and personnel in other departments; and
Wholesale level
Retail Level
Includes:
Retail pharmacists
Medical, dental and other health care practitioners
Other retail outlets e.g. supermarkets and health food stores; and
Wholesale and hospital levels.

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Consumer Level
Includes:
Patients and other consumers; and
Wholesale, hospital and retail levels.

Recall Notices
The URPTG sets out the style of letter, envelope and advertising that must be adopted by the sponsor
for any recall or remedial action.
Recall letters should include a factual statement of the reasons for the recall together with specific
details that will allow the product to be easily identified. The Australian Recall Co-ordinator must
approve the text of the recall letter before it is sent out. The letter, which may be sent by mail, fax or
email (and then posted if sent by fax or email) should be despatched within 48 hours of the Co-
ordinators agreement.
The envelope must be distinctive to ensure that it is easily recognised among the large volume of mail
usually received by hospitals or professional people.
Recall Letters and envelopes must be addressed, according to the type of product.

1. Medicine Recalls
Address to Chief Pharmacist
Clinical Investigational Medicine:
Address to Clinical Investigator and Chief Pharmacist in the institutions in which the clinical
investigations have been performed.
Radiopharmaceuticals
A copy of the letter should be sent to the head of each relevant department of nuclear medicine and
pharmacy (e.g. Director of Nuclear Medicine)

2. Medical Device Recalls:

Address to the Chief Executive Officer and marked to the attention of the head of the appropriate
department
Clinical Investigational Device:
Address to Clinical Investigator and if appropriate Chief Biomedical Engineer and/or Director of
Nursing.

3. Human blood or tissue:

Address to Senior Scientist and/or Pathologist
And if appropriate, the Recipients Surgeon

Responsibility of Sponsors (i.e. Suppliers)

Sponsors must maintain records and establish procedures that will assist in facilitating recall
should such action become necessary, and take the prime responsibility for implementing a recall
where it is necessary.
Sponsors must maintain records for the products manufactured by them such that complete and
up to date histories of all batches of products from the starting materials or components to the
finished products are progressively recorded. This includes utilisation and disposal of all starting
materials or components and bulk products.
For products having an expiry period, complete records of manufacture should be retained for at
least one year after the expiry date of the batch; or the complete records pertaining to the batch
should be retained for at least 6 years after the date of its manufacture (other legislature may
impose much greater retention periods.

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Sponsors should maintain records of problem reports received about each product. These reports
should be evaluated by competent personnel and appropriate action taken.

Pre-Recall
Where evaluation of a problem report indicates that a recall may be necessary, the report must be
conveyed immediately to the Australian Recall Co-ordinator.

Recall
The sponsor has prime responsibility for implementing a recall and for ensuring compliance with the
recall procedure. Where significant hazard to consumers exists, company personnel may be used to
immediately disseminate information on the recall. This includes telephone advice to quarantine stock
pending recall. Company representatives may be utilised to recover stock that is subject to recall.
Where goods have been distributed outside the hospital level eg supermarkets, health food stores, the
sponsor must insert appropriate notices in the daily print media of each state and territory where the
distribution may have occurred until complete and accurate distribution lists are available.

Post Recall
The sponsor must submit reports to the Australian Recall Co-ordinator at two and six weeks after the
implementation of the recall. As well as background information to the recall, these reports should
include:
confirmation where possible from hospitals that the recall letter was received
the result of the recall - quantity of stock returned, corrected, outstanding
the method of destruction or disposal of recalled goods
These reports establish the effectiveness of the recall. If satisfactory reports are not received, further
recall action may be considered necessary.
Resources:
1. The website for the Therapeutic Goods Administration (TGA) in Canberra www.health.gov.au/tga
lists all the medical-related recalls. A copy of Uniform Recall Procedure for Therapeutic
Goods (URPTG) can be downloaded from this site. Alternatively, a copy can be purchased by
emailing TGA-information-officer@health.gov.au
2. The website www.recalls.gov.au is co ordinated by the Consumer Affairs Division of the Treasury.
It brings together all types of recalls including medical-related, food, consumer, agricultural and
veterinary chemicals and motor vehicles.

Responsibility for Recall Action

The following authorities have overall policy responsibility for monitoring the conduct and outcomes of
recalls in Australia:

Type of Recall Responsible Authority

Medical-related Therapeutic Goods Administration (TGA)
Food Australia New Zealand Food Authority (ANZFA)
Consumer Products Consumer Affairs Division of the Treasury
Agricultural & The National Registration Authority for Agricultural & Veterinary
Veterinary Chemicals Chemicals (NRA)
Motor Vehicle Australian Transport Safety Bureau (ATSB)

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Appendix b
<Insert HOSPITAL LOGO>

<Insert HOSPITAL/HEALTH SERVICE NAME>

Product/Medicine Recall Action Sheet

<with examples>

Date of Recall
Product
Supplier/Manufacturer
Problem
Batch/Lot Numbers
Contact Person
Phone No

DATE ACTION
<date> Recall notice received. <initialled>
<date> Warehouse stock quarantined <initialled>
<date> Spoke with supplier, no alternative available. Must source new product.
<initialled>
<date> Recall notice sent to wards/departments. <initialled>
<date> Alternative product identified <product details> Goods ordered, due <date>.
Warehouse advised. <initialled>
<date> New product arrived and being issued. Discussed with major users. Alternative
product functioning well. <initialled>
<date> All faulty stock consolidated and returned to supplier. <initialled>
<date> Credit notice received and sent to Finance for action. No further recall action
required. <sign-off>

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Appendix c

<Insert HOSPITAL LOGO>

<Insert HOSPITAL/HEALTH SERVICE NAME>

URGENT MEMORANDUM

TO: : <Ward/Department>
FROM: : <Designated Recall Co ordinator>
DATE: :
SUBJECT : Product Recall

<Product X from Supplier Y>

Stock/Non Stock Number: <your code for this product>
Unit of Issue/Supply: <each, box>

We have been advised by <Supplier> that <Product/Medicine> has been recalled because of
problems with <fault>. This recall involves <specify batch number(s) or all batches>.
According to our records, your department may be holding stock of this product. Would you please
check your stores/drug storage areas, complete the details at the bottom of the form and return it with
any affected product to <designated officer or quarantine area> by <date>.
Because of the risk to patient safety, affected products should not be retained but must be returned to
the Supply Department/Pharmacy Department.
As an interim measure, we have obtained alternative stock of that product from <supplier> and will
substitute this under the usual stock code.
Thank you for your assistance. If you have any queries, please contact <name> on <phone
number> or <email address>.

<designated officer>
<title><department>

Device/Medicine Recall: [Insert Product Name] from [Insert supplier Name]

Ward/Department Cost Centre

Contact Person: Phone No:

Yes, we are returning the following affected stock

Quantity:______________<unit of supply i.e. each, boxes>

No, we are not holding any stock that is subject to the recall.

Thank you for taking the time to respond to this request.

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Appendix d:
<Insert HOSPITAL LOGO>
<Insert HOSPITAL/HEALTH SERVICE NAME>

Medical Device/Medicine Recall

Returned Goods Register
[Insert Product Name] from [Inset Supplier Name]

Date Ward/Department Site Cost Centre Quantity Reminder

Code Returned Sent

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