FAQs – Medical Devices Adverse Events & FSCA FAQs

An adverse event is a possible failure/s of a medical device including in vitro diagnostics (lVDs), or difficulties in the use of or an undesirable outcome associated with the use of a medical device including  lVDs; that can or does result in either death, serious injury or serious deterioration in the state of health of a patient, user, or other person – or – no death or serious injury/ serious deterioration in state of health of a patient, user or other person has occurred but the event is likely to lead to death or serious injury of a patient, user or other person if the event recurs.

Any adverse event that meets the three basic reporting criteria, even if it does not involve a patient or user, should be reported to the Regulatory Authority:

1. An adverse event has occurred
2. The medical device is associated with the adverse event.
3. The adverse event has led to the following outcomes:
   • death of a patient or user;
   • a serious injury; and
   • a near adverse event.

A near adverse event is an event that might have led to a death or serious injury. It may be that due to the timely intervention of a healthcare practitioner a death or serious injury did not occur.

For an event to be defined as a near-adverse event, it is sufficient that:

1. an event associated with the device happened.
2. if the event occurred again, it might lead to a public health threat, death or serious injury testing or examination of the device or the information supplied with the device, or scientific literature indicated some factor that could lead to a death or serious injury.

As a health care professional:

1. quarantine the identified medical device
2. Discuss the method of recovery, disposal or modification of the device
3. recommend patient follow-up with the supplier of the medical device (including IVD)
4. Report the adverse event to the manufacturer for further analysis.

As a patient or user:

1. stop using the device
2. quarantine the medical device
3. visit a healthcare facility to for assistance depending on the severity of the AE.
4. Contact SAHPRA to report the adverse event and be sure to include the following details:
   • Device name & model
   • Brand / manufacturer
   • Lot or batch number (usually on packaging)
   • Expiry date
   • Where and when it was purchased
   • Description of what went wrong
   • Any harm or consequence
   • Photos, if possible (packaging, device, results)

Keep the device and packaging if safe — it may help investigation

The Authorised Representative of the licensee and Holder of Certificate of Registration in respect of a medical device including IVDs must inform the Authority, in the manner and within the time frame determined by the Authority, of a suspected adverse event, reported to him or her, occurring as a result of the use of the medical device including IVDs, as outlined in the condition of sale of a medical device (including an IVD) in South Africa. The Authorised Representative of the licensee and Holder of Certificate of Registration is responsible for forwarding reports of all adverse events to the original manufacturer for assessment under the original manufacturers’ surveillance systems.

Kindly note:  Anyone can report an adverse event for a medical device including IVD.  Healthcare professionals and members of the public (users of the device) are encouraged to submit reports.

The period in which the Authorised Representative of the licensee and HCR must give information to the Regulatory Authority is:

1. if the information relates to an event or other occurrence that represents a serious threat to public health – 48 hours after the person becomes aware of the event or occurrence; and
2. if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person – 10 calendar days after the person becomes aware of the event or occurrence; and
3. If the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person – 30 days after the person becomes aware of the event or occurrence.

The Regulatory Authority should be contacted on the below contact details for medical device related adverse events or vigilance reporting as required by these guidelines:

Email: mdvigilance@sahpra.org.za

Tel: 012 501 0476

Physical address: Loftus Park
Building A
Kirkness Road, Arcadi
Pretoria

The Medical Device Adverse Event Reporting Form (GLF-MD-11A) should be submitted as per timelines and include one of the following report types with the following information:

1. Initial report: defined as the first information submitted by the licensee and HCR about a reportable event, but the information may be incomplete, and supplementary information will need to be submitted. This includes immediate notification.
2. Follow-up report: defined as a report that provides supplemental information about a reportable event that was not previously available).
3. Final report: defined as the last report that the licensee and HCR expect to submit about the reportable event. A final report may also be the first report or the follow-up report depending on the information available.

For details to be included in an adverse event report, refer to the Guideline SAHPGL-MD-03 for completing an adverse event report form for licensed holders.

The intention of the Field Safety Corrective Action (FSCA) FAQ, is to provide interim guidance to ensure accurate and timely reporting in accordance with regulatory requirements

An action taken by a manufacturer to reduce the risk of death or serious deterioration in the state of health associated with the use of a medical- device. Such actions should be notified via a Field Safety Notice (FSN).

A communication sent out by a manufacturer or its authorized representative to the device users in relation to a field safety corrective.

An FSCA may be prompted by information about the occurrence of one or more adverse events and/or incidents of already distributed medical devices including IVDs that poses an unacceptable increase in risk when the device is used.

An FSCA initial report should include the at least the following information:

1. name of the manufacturer, product name, product code and lot number of the affected medical device or IVD:
   • if the FSCA relates to certain lots only, an explanation as to why the other lots/batches are not affected should be included;
   • list of all countries affected;
   • background information and reason(s) for issuing the Background information should include:
     • a description of the medical device or IVD deficiency, fault or malfunction;
     • clarification of the potential hazard associated with continued use of the device
     • the associated risk for the patient, user or any other person; and
     • any possible risk(s) to the patients associated with previous use of the device;
     • relevant elements of the risk analysis;

1. description and justification of the corrective and/or preventive action;
2. advice on the actions to be taken by the distributor and the user, which may include, but not limited to:
3. • identifying and quarantining the medical device and IVD;
   • method of recovery, disposal or modification of the device and IVD;
   • recommended patient follow up; and
   • a request to forward the attached FSN to anyone who should be aware of

1. by sending an email or registered mail;
2. by sending a fax;
3. by visiting the affected users;
4. by contacting the affected users telephonically; and
5. by any other appropriate method.

A follow-up report should be submitted by the manufacturer or distributor or holder of certificate of registration or an authorised representative to SAHPRA within 30 days from the initial notification of the FSCA.

The report should include:

1. 1. an update on the progress of reconciliation of the FSCA and estimated timelines for completion; and
   2. proof of FSN receipt by the users, where practical and/or necessary

After completion of the FSCA follow-up report, the manufacturer or distributor or holder of certificate of registration or an authorised representative should submit a final report to SAHPRA, if the affected product was marketed in South Africa.

The final report should include information on the effectiveness of the action per country involved (e.g. percentage of medical device or IVD to which FSCA was applied). The final report should describe the following:

1. outcome of the reconciliation of the FSCA; and
2. root cause of the problem, if known, and CAPA/ proposed action (e.g. redesign, update in the field, improved instructions for use) to reduce the likelihood of

Furthermore, the FSCA should stipulate the following:

1. return of affected stock to the manufacturer;
2. an update of the instructions for use IFU; and
3. modification/update of existing medical

The records of completed actions should be fully reconciled against distribution records, to allow easy monitoring of FSCA progress.

The FSN report should:

1. display a clear title such as “Urgent Field Safety Notice” on the notice itself and “Urgent Field Safety Notice _Company name and its license number” in the subject line (only email submissions are accepted);
2. clearly indicate the intended recipient of the notice;
3. include a concise description of the product, including product code and lot number;
4. include a factual statement explaining the reasons for issuing FSCA, including a description of the hazards and/or risks associated with the specific failure of the device;
5. where appropriate, include the likelihood of occurrence, considering the intended users;
6. describe the recommended action(s) to be taken by the recipient of the FSN, including any action(s) recommended for previous users or people who have been diagnosed through the use of the product;
7. where appropriate, include timelines by which the action(s) should be taken by the manufacturer or holder of certificate of registration or an authorised representative and user(s); and
8. give the designated contact point from whom the recipient of the FSN may obtain further information.

A recall is the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety, or efficacy.

Send an email to mdvigilance@sahpra.org.za, or call 012 501 0476.

Send an email to recalls@sahpra.org.za, or call 012 501 0476.