Saudi FDAImplementation of incident reporting

Presented by / Muwayed Al-KhnainiSurveillance DepartmentMedical Devices Sector

15 November 2021

Post-Market Surveillance Activities

Reactive Activities(Vigilance)

Proactive Activities

• Reporting & Investigation (AE & incidents)

• Safety Alerts

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• Risk Analysis of MD• Post-Market Clinical Evaluation

Post-Market Surveillance Activities

Reactive Activities(Vigilance)

Proactive Activities

• Reporting & Investigation (AE & incidents)

• Field Safety Correction Action (FSCA)

3

• Risk Analysis of MD• Post-Market Clinical Evaluation

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Medical Device Definition

Instrument

Apparatus

Implant

Machine

Appliance

in vitro reagent or calibrator

Software

Material

Other similar or related

article

DiagnosisPreventionMonitoringTreatmentAlleviation

CompensationInvestigationreplacementmodification

or support of the anatomy or of a physiological process

Supporting or sustaining lifeControl of conception

Disinfection of medical devices

DiseaseorInjury

Intended to be use for one or more

Any

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Diversity of Medical Devices

>10,000 manufacturers> 1,500 capital equipment products> 3,000 surgical instruments> 500 implantable devices2,000,000 brands, models, and sizes> 22 000 generic devices groups

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DefinitionIncidentmeans any malfunction or deterioration in the characteristics or performance of adevice made available on the market, including use-error due to ergonomicfeatures, as well as any inadequacy in the information supplied by themanufacturer and any undesirable side-effect

Medical devices adverse eventmeans any incident that directly or indirectly led, might have led or might lead toany of the following:(a) the death of a patient, user or other person,(b) the temporary or permanent serious deterioration of a patient's, user's or

other person's state of health,(c) a serious public health threat

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MDS-G39Guidance on Requirements for Reporting and investigation

of Incidents and Adverse Events of Medical Devices

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https://www.sfda.gov.sa/sites/default/files/2020-09/MDS-G39e.pdf

Scope

• This guidance applies to medical devices Manufacturers, Authorized representatives, Importers,Distributors and healthcare providers.

• The reports included adverse events that lead to death or injuries to users or patients, or may lead topossible harm, and the medical device is directly or indirectly linked to it.

• This guidance applies to incidents and complaints related to the efficiency, quality of the medical devicewith no risk associated or potential harm

• This guidance applies to adverse events, incidents and complaints that occur in KSA.

General Requirements• Manufacturers, Authorized representatives, Importers, Distributors shall report to the SFDA any relevant

adverse events, incidents, complaints, of which it becomes aware, and provide SFDA with all documents andinformation related to the incident and the concerned medical devices.

• Type of required report include:• Adverse events that lead to death or injuries to users or patients, or may lead to possible harm, while

the medical device is directly or indirectly linked to this incident• Incidents and complaints related to the efficiency, quality of the medical device

• Authorized Representative and Importer and distributor shall have a tracking system to record the data andinformation of all imported and distributed medical devices within Saudi Arabia.

• Manufacturers, Authorized Representative, Importers, and Distributors shall assign and register contactperson with NCMDR

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MDS-G39Guidance on Requirements for Reporting and investigation

of Incidents and Adverse Events of Medical Devices

The period for reporting:Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon becoming awarethat adverse event, incident, a complaint has occurred, as follows:

• Not later than (2) working days from the date of awareness, if the adverse event, incident, and complaintrepresent a serious public health threat.

• Not later than (10) working days from the date of awareness if the adverse event, incident, complaint thatresults in an unanticipated death or unanticipated serious injury.

• Not later than (30) calendar days from the date of awareness for all adverse events, incidents, complaintswhich are not associated with high risks.

• If SFDA initiate a report of adverse event, incident, complaint, the response shall be received within (5)working days.

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MDS-G39Guidance on Requirements for Reporting and investigation

of Incidents and Adverse Events of Medical Devices

Required Documents:• Manufacturer , AR, and Importer, shall provide to SFDA the applicable investigation reports.

• SFDA will evaluate all submitted reports and information and may request additional informationor action if necessary.

• Investigation reports include:A. Initial ReportB. Follow-up ReportC. Final Report

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MDS-G39Guidance on Requirements for Reporting and investigation

of Incidents and Adverse Events of Medical Devices

Investigation completion:

The investigation must be completed and the final report shall be submitted as per following:

• Within 60 days from the date of awareness for all adverse events, incidents, complaints , in casethe device must be sent to manufacturer site.

• Within 30 days from the date of date of awareness for all adverse events, incidents, complaints,in case the device will not be sent to manufacturer site.

• Within 15 days for cases, that does not require testing or technical evaluation.

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MDS-G39Guidance on Requirements for Reporting and investigation

of Incidents and Adverse Events of Medical Devices

Who Can

Report

Public

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Healthcare provider

Companies (Distributers/Importers Manufacturers Authorized Representative)

How to Report

19999

Email

NCMDR

How to Report

19999

Email

NCMDR

NCMDR.MD@SFDA.GOV.SA

AE.MD@SFDA.GOV.SA

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How to Report

19999

Email

NCMDR

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https://ncmdr.sfda.gov.sa

How to Report

19999

Email

NCMDR

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Report submit Review Assign Investigator

Enter information to

database

Contact Reporter / AR

Fulfill requirements

Need further action

Prepare final report close

Investigation Process

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If AE/incident occurred

Immediate Actions Plan• Protect patient and staff• Protect equipment / environment• Isolate equipment (including disposables)• Internal reporting (OVR,…)• Notify SFDA

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Preservation of Evidence

• Disposables - Save all!!

• Photographs – Take pictures

• Control Settings – Do not change

• Error codes in device memory!!! (event log) – Do not erase

• Isolating devices and Accessories

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Device Interfaces

Accidents Investigation Process

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• Device Factors• External Factors• Tampering and Sabotage• Support System Failures• User Factors

Causes of Device Incident/AE

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• Device Factors– Device failure– Design or labeling error – Manufacturing error– Packaging error – Software deficiency– Random component

failure

– Failure of an accessory– Device interactions– Improper maintenance,

testing, repair, or lack or failure of pre-use incoming inspection

– Improper modification

Causes of Device Incident/AE

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• External Factors– Power supply failure– Medical gas/vacuum systems– Electromagnetic EMI or Radio Frequency

Interference RFI– Environmental conditions

• Temperature, humidity, light

Causes of Device Incident/AE

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• Tampering and Sabotage (rare)– Family member– Patient– Healthcare workers (Doctor, Nurse, Aide)– Enemy– Hacking (Cybersecurity)

Causes of Device Incident/AE

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• Support System Failures– Poor device evaluation during trial process – Lack or failure of incoming and pre-use inspections – Using inappropriate devices– Improper storage– Failure to train and credential– Poor incident/recall reporting system– Lack of competent accident investigation – Failure to isolate incident devices– Error in hospital policy

Causes of Device Incident/AE

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• User Factors (user error, human error)

– Pre-use inspections– Labeling– Mis-assembly– Mis-connection– Improper connection– Incorrect clinical use– Incorrect control settings

– Incorrect programming

– Spills– Abuse– Inappropriate

reliance on automated features

– Failure to monitor– Maintenance or

incoming inspection

– 70% of device accidents

Causes of Device Incident/AE

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Outcomes of Investigationv Improved Design

v Improved Instruction/ Labelling /Training

v Device Recall/correction

v Advice to Users /Manufacturers , ..etc

v Suspension license (MDMA, AR,…)

v Safety Communication Noticev Competent Authority Notification

v Revised or new guidance

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Investigation Difficulties •Diversity of technologies -- Each technology requires a unique testing and

investigative • Communication • Numerous causes of injuries• Patient variability • Limited information available to/from manufacturer• Incident accessories, especially disposable devices, are discarded• Lose device data • Culture

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Examples on AE Investigation

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Covid-19 Collection and transport Kit

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Ø Serious injury to an infant.

Ø Investigation team carried out investigations that

included contacting user and checking OVR.

Ø Oropharyngeal / Nasopharyngeal

Ø IFU

Ø Safety communication

VentilatorØ Twins neonatal was connected on device and

died next day.Ø Investigation team carried out investigations that

included checking the device, checking event data stored in the machine's log.

Ø all tests were passed.Ø A description of the used configuration including

accessories has been analyzed.

Ø HME filters are directly connected to the Y-piece. In this position a filter is an additional dead space, expired gas is rebreathed by the patient.

Ø A warning statement is given in the Instructions for Use of the used HME filter not to use it together with active humidification due to the risk of insufficient ventilation.

Ø Training has been provided to the customer.

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Transport IncubatorØ A burn happened with transport incubator while

Transport patient from hospital to another hospital.

Ø The unit is 120V .

Ø No injury or death.

Ø One of the staff nurses changed the power cable from US to UK and plugged it into 220V socket.

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Patient MonitorØ Suddenly freeze and the image could turn

black and there is no more visual representation of the patient data on this monitor.

Ø Nevertheless, the Patient Monitoring system keeps on working and the audible alarms remain.

Ø Robustness issue with the filtering characteristics of an electrolytic capacitor on the invertor board

Ø SFDA have Request to Manufacturer to Submit a FSN and taking Corrective action.

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Ø Death report.

Ø The team analyzed the details of the event and the log on the day of the incident and conducted an investigation.

Ø The device works properly and the problem is caused by the user forgetting to reconnect the fresh air hose to the external fresh gas outlet after the previous case.

Ø Lack of sufficient fresh air reduces the concentration of oxygen in the inhalation, leading to insufficient ventilation for the patient.

Anesthesia machine

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NCMDR Statistics

Statistics

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2 7 87 114

20976

43682

686…

2008 2009 2016 2018 2019 2020 2021

# of reports

Thank You

Muwayed Al-KhnainiInvestigation Expert

AE.MD@sfda.gov.sa