Purpose

The purpose of this procedure is to outline the processes which should be undertaken in the case of a Patient Incident, Adverse Event, Safety Alert, Customer Information Bulletins or Product Recall occurring.

The procedure also identifies specific individuals empowered with responsibilities and accountability during such events, in order to ensure that all actions are undertaken correctly and that any regulatory reporting is submitted within the appropriate time frame identified by the applicable Regulatory Body.

Scope

This document covers:

• The reporting of Patient Incidents, Adverse Events, Safety Alerts, Customer Information Bulletins and Product Recalls
• Communication of such actions and reporting when required.
• The notification to Regulatory Affairs team and Regulatory Bodies
• The raising and distribution of any Advisory Notices/Safety Alerts/Customer Information Bulletins
• Approval and Implementation and reporting of Product Recall actions

Introduction

The procedure also meets the requirements of ISO 9001 and ISO 13485, in addition to providing the control mechanisms for the Post Market Surveillance.

Patient Incident and Adverse Event Reporting

Initial Notification:
Site may become aware of a Patient Incident via a number of different channels:

• Direct communication from a hospital/user
• Via a Product Specialist
• Notified by the manufacturer
• Notified via a Regulatory Body
• Via a media report

The details are recorded on the Product Complaint/Incident Reporting Form.

The RA/QA department assess the details of the Patient Incident as soon as the details are known and complete complaint form, Adverse Event Reporting Decision Tree. This form records the review of the details and whether the incident is required to be reported to a Regulatory Body (Adverse Incident). At this stage it is also determined during what time period the event must be reported, based on the criticality and risk to public health.

Where the RA/QA department deem the event not reportable, the rationale for such a decision must be clearly recorded on the form. This activity is undertaken in accordance with Post Market Activities guided by the regulatory agency.

The RA/QA Department will also raise a Corrective Action Report (CAR) to control all activities associated with the Patient Incident occurring.

Reporting to Regulatory Bodies:

Where the Patient Incident is deemed reportable (i.e. Adverse Event), the RA/QA department must enter all relevant details should be submitted to Regulatory bodies with proper acknowledgement.

Once the details have been drafted out on the report, the draft is sent to the RA/QA representative of the applicable Legal Manufacturer of the device involved in the adverse event. The Legal Manufacturer has the opportunity to review and amend any of the information in the report if required. The Legal Manufacturer will usually be required to enter information relating to the number of device manufactured and supplied to market and quantity of similar incidents for the product globally.

When the draft report has been agreed with the manufacturer, the RA/QA department submit the Initial report to the Regulatory Agency. In addition the manufacturer is also to be provided with a copy of the initial investigation report.

Formal Reporting of Communication /Requests from Regulatory Bodies:

If communication or a request for further information is received from a Regulatory Body, such communication must be forwarded immediately to the relevant Legal Manufacturer. All responses must be either originated by or vetted by the Legal Manufacturer prior to submitting to Regulatory Agency. All subsequent communication must also be processed in the same manner.

Samples for Evaluation:

Where applicable, if a sample of the product involved in the Adverse Event is available for evaluation, this is to be sent to the manufacturer by the RA/QA Department. Any samples being sent for evaluation must be processed to ensure that they have been adequately decontaminated and certified as such.

Safety Alerts

Safety Alerts may be instigated by the manufacturer or upon the recommendation or request of a Regulatory Body.
A Safety Alert issued by the manufacturer is where information is released to the public domain which will help the users of devices use them safely or more effectively.

Safety Alerts requested by Regulatory Bodies may be as a result of them receiving information in relation to an Adverse Incident, in which they feel a public announcement should be made by the manufacturer in order to mitigate a potential safety issue.

When issuing Safety Alerts to customers, an acknowledgement form is included with every alert, where the customer is requested to sign and return the form to acknowledge their receipt of the information. Records are maintained of all alerts distributed and all completed acknowledgement forms that are received back.

Customer Information Bulletins

A Customer Information Bulletin (CIB) is typically a document containing information similar to that within a Safety Alert, but of a lower significance in terms of the ability to negatively affect the user’s health, safety or well being.

The information contained in a CIB is typically related to a particular operating characteristic/labelling/operating instructions and is being communicated to the public in order to improve their understanding of the product in question.

Acknowledgement forms are not normally included with the release of CIBs.

Product Recall

Responsibilities

• Product Recall Coordinator
  Regulatory Affairs & QA Manager or RA/QA Coordinator in their absence
  In the absence of either position, the Managing Director will coordinate the recall. The applicable Regulatory Body will also appoint a nominated Recall Coordinator as a point of contact for the company.
• Product Recall Team
  Senior representatives from RA/QA, Logistics, Sales & Marketing, Customer Service and Senior Management as applicable.

The Product Recall Coordinator is responsible for inter-site liaison and ensuring that all details are communicated and appropriate approval for initiating a major product recall is obtained from the current Senior RA/QA Authority, in cases where the recall is being initiated by the company. This approval must always be obtained in writing.

The Product Recall Coordinator must also provide the Senior RA/QA Authority with the documented rationale for NOT conducting any Recall, Correction or Removal actions, in cases where this has been considered but decided against.

In cases where the product recall is initiated by a manufacturing site, formal notification of the reason, products affected and actions to be taken will be provided to the sponsor company by the appropriate manufacturer.

Types of Product Recall:

The main types of categories for product recall are:

Product Withdrawal
The product type or model is permanently withdrawn from supply for reasons of known or suspected unacceptable risk to the safety and well being of the public. This recall may be voluntary by the sponsor of the product or may be a result of a directive from a Regulatory Body.

Product Recall
A nominated amount of a product type or model is recalled from customers or from the manufacturer’s stock due to a known quantity having a defect which is known to pose or suspected of, posing an unacceptable risk to the safety and well being of the public. In this category the known quantity is typically quantified by serial number range, manufacturing lot number, manufacturing date or other means of identifying the affected products. In these cases only the affected products need to be recalled.
This recall may be voluntary by the sponsor of the product or may be a result of a directive from a Regulatory Body.

Recall for Product Correction
This category applies where it has been identified that a product currently being supplied to the public could have modifications to the device itself, or amendments made to any written information related to the device, such as operator’s manuals, instructions for use, product labelling and that such modifications may improve the safety and efficacy of the product.

Recalls for Product Correction are undertaken with close communication from the sponsor and the customer, in order to ensure that the minimum amount of customer disruption is incurred whilst the product are undergoing modification. With this in mind, Regulatory Bodies permit such product modifications to be undertaken progressively and at the customer’s or the sponsor’s premises, or at a location agreed by both parties. This recall may be voluntary by the sponsor or as a result of a directive from a Regulatory Body.

Communicating Product Recall Actions:

• Communicating to Regulatory Bodies

Each Regulatory Body has its own format for communicating with them with full details of the incident or product recall (i.e. Uniform Recall Procedure for Therapeutic Goods). This document stipulates the actions that are to be undertaken, the documentation that is to be raised and the time frames involved, in order for the company to meet its regulatory reporting requirements on product recall.

Some Regulatory Agencies have established contact list for device sponsors to reference when issuing safety alerts or product recall notifications. The list contains the names and e-mail addresses for key hospital / health authority personnel and sponsors must ensure that electronic copies of regulatory announcements are sent via e-mail to these individuals, in addition to any postal communication.

Quality Records

All documentation raised as a result of performing the processes related to Adverse Events and Product Recalls, are to be considered Quality Records and processed archived in accordance with quality procedure.