Carta Alir Mekanisme Penyampaian Aduan Peranti Perubatan

11 February
2016
Hirsham Junaidi

Medical device registration under
Section 5 ; Act 737

Establishment licensing under Section
15 ; Act 737

Post Market Surveillance & Vigilance
(administrative)* as of February 2016
1. To rapidly identify significant health hazards by
detecting, investigating unexpected incidents for
possible adverse incidents or complaints,
2. To monitor the clinical use of medical devices by
resolving and sharing with other users any useful,
preventive or corrective information resulting from an
adverse incident,
3. To provide the public information on marketed
medical device products.
Medical Device Industry Ecosystem in Malaysia
Materials: Rubber, Plastics, Steel, Electronics, etc.
Consumables
Technology
Products
Latex
Plastic
Surgical Instruments,
Implants & Clinical Devices
Metal
Glove, Contraceptives,
Catheters, woundcare,
Orthalmology, IVD, SUD
Machining
Healthcare
Equipment
Electronics
Pacemaker, Orthopedics,
Surgical instrument
Furniture
Radiation equipment,
Life Science Instrument,
Electrodes, Hospital beds
Companies
Supporting Infrastructure
Sterilization
Packaging
Certification
Biocompatibility
And Clinical Trial
UKM,
Info
Kinetics
Industry
Group
Education
Training
UM, USM, UKM,
UniMap, PSDC,
Medsociate,
Neville Clarke
Regulatory
Medical
Device
Act 2012
In this case: - fake thermometers have no
recognised brand name and can be
recognised by missing information on the
packaging.
These include:

No instructions for use leaflet

No lot or batch identification number is listed

No CE mark

No manufacturer or representative details

No four digit identification number to show that the device
has been through the appropriate safety assessment
(conformity assessment procedure by the CAB)
The MHRA launched its investigation after a pediatric
leukemia patient needed urgent care, despite a seemingly
normal temperature reading from what turned out to be a
fake thermometer

Post Market Activities are divided into 2*:
PROACTIVE – Post Market Surveillance
REACTIVE – Vigilance
* according to IMDRF :- previously known as the GHTF

Pro active data collection on quality, safety or
performance of the device(s) after they have
been placed in the market.


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Refers to incident that can occur with the device
(including IVDs), when they do not perform as
intended (and can cause injury or death).
How the establishment coordinated the action
and provision of information between their
counterparts and the authority.
How they evaluate incident to prevent
reoccurrence,
How they determine the effectiveness of all the
CAPA
*MDA may requires access to the manufacturer‘s technical file
•Provide requirements for POST MARKET.
•Requirements are to be imposed to the
establishment.
•Consist of 6 sections which specify provision on
 37. Distribution records
 38. Post-market surveillance and vigilance
 39. Complaint handling
 40. Mandatory problem reporting
 41. Field corrective action
 42. Recall
Manufacturer:
 To ensure that medical devices manufactured to meet or
exceed the required standards of safety and
performance
 To participate in post market surveillance (receiving and
reporting customer complaints/incidents)
Importer/Distributor/AR:
 To ensure that medical devices enter the market or sold
comply with regulatory requirements
 To avoid making misleading or fraudulent claims or
issuing false compliance certificates
 To participate in post market surveillance (receiving and
reporting customer complaints/incidents)
 To
ensure that medical devices sold or made available in
the country are safe and effective by establishing and
implementing policies and regulations to control medical
devices
 To oversee the efforts of manufacturers and
importer/distributors in ensuring the safety and
performance of medical devices.
 MDA gives license to the establishment, and register the
CABs and all medical device including the IVDs .
 To employ the medical device only for the intended
indications.
 To ensure the proper use of medical device by being a
competent user (having appropriate qualification,
training and experience).
 To share experience gained with medical devices with
others (user, distributor and manufacturer) by reporting
any incidents to a coordinating centre from which
warnings can be issued.
 To ensure proper maintenance of medical devices
during active use and safe disposal of obsolete medical
devices.
v
1.Do I know how to handle the medical device in my unit?
2.What preparation have I been given in how to use a particular medical
device, example infusion pump ; was the preparation formalized and
recorded? Or did I just pick it up as I went along?
3.How was my competency to use this equipment safely assessed?
4.Am I familiar with the IFU and any warning labels?
5. When was this equipment last service?
6. Do my junior staff know how to use this?
7. What is the correct cleaning procedure/decontamination for this device?
And what is my responsibilities?
8. Who is responsible for risk management in my organization?
9. Do I know how to report adverse incident?
10. Do I have any access to any country medical device authority to read
and to get information about this device hazard and safety notices?
11.Who is the person responsible (company/establishment) for this
medical device?
MDA Device
Registry
User
requirements
Disposal
Procurement
Technical
personnel
competency
Maintenance
Technical
personnel
competency
Testing &
Commissioning
Usage
Hosp.
Devices
register
Field Safety
Corrective
Actions
Incident
reporting
Training
Competency
Healthcare
provider
Healthcare
professional
User
complaint
Raw materials
Sub-contractors
Manufacturer
Via AR/Dist/Imp
copy
Patients
Medical Devices
Incident
Conformity
Assessment
Body
Incident description
Device Quality
•What happened to the device
•What happened to the patient
•How the patient was treated after the
incident occurred?
•Specification
•Durability
•Manufacturing records
Technical Information
Cause Analysis
•How the device was used
•Maintenance records
•Experience of the users
•Opinion of the users
•Device Analysis Results
•Simulations Experiments
•Occurrence of similar incident
•Establishment conclusion on the analysis
Patient Information
•Background (A/S/L/W)
•Complications
•Medications/Treatment
•Clinical examination value
•Condition
•Patient outcome
Safety Measures
•Taken measures & Future plans
•Recall ?
•Repair?
•Written in the IFU
•FCA
•Device modification
•Improvement on Training program
1.
2.
3.
Quality defects, problem with durability, strength;
Sophisticated/complexity of devices;
Lack of information by the establishment;
7.
Inexperienced users
Poor maintenance
Insufficient environmental management
Inappropriate use (off label, contraindications)
8.
Patient condition (complication/allergy)
4.
5.
6.
*multifactorials
Device/
establishment
Usage

Attending all Medical Device complaints
◦ Establish, implement documented procedure for
complaint handling;
◦ Review all complaints concerning defective and
counterfeit by describe the action and report to
the MDA;
◦ Record and investigate complaints (identify
reason for the complaint);
◦ Maintain records of the complaint, investigation
and any subsequent actions taken;
◦ Follow up action.

Field corrective action (FCA)
◦ Establish documented procedures for handling of FCA;
◦ Define responsibilities for planning, conducting and
reporting of corrective actions in the procedure;
◦ Establish recall or withdrawal procedure;
◦ Inform MDA prior to execution of FCA;
◦ Inform all customers;
◦ Inform overseas counterparts if the medical devices are
exported;
◦ Request that the recalled medical devices be removed
immediately from usable stock;
◦ Maintain records of all action taken.(including approval by
the manufacturer)
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―field corrective action (FCA)‖ is an action taken by a manufacturer to reduce
a risk of death or serious deterioration in the state of health associated with
the use of a medical device, which may include—
(i) return of a medical device to the manufacturer or its representative;
(ii) medical device modification, which may include—
- retrofit in accordance with the manufacturer's modification or design
change;
- permanent or temporary changes to the labelling or instructions for use;
- software upgrades including those carried out by remote access;
- modification to the clinical management of patients to address a risk of
serious injury; or
- death related specifically to the characteristics of the device.
(iii) medical device exchange;
(iv) medical device destruction;
(v) medical advice given by manufacturer regarding the use of the device.
Note: In assessing the need of the FCA the establishment is advised to use
the methodology described in the ISO 14971:2007 Medical devices –
Application of risk management to medical devices;

Mandatory reporting:
Establishment and any
designated person
should report any
incident that is related
to a failure of the
device; deterioration
in its effectiveness;
any inadequacy in its
labeling, which has
resulted in an adverse
incident
What event to report?
(i) Malfunction or deterioration
(ii) Inadequate design or manufacture
(iii) Inaccuracy in labeling
(iv) Significant public health concern
(v) Other information from testing or literature
(vi) A change in trend
When to report?
(i) Incident must have occurred
(ii) Medical device was associated with the incident
(iii) The event led to the death or serious injury of a
patient user or other person, or might lead to
death or serious injury if the event re-occurs
What information to be reported?
(i) Event information: facility details, patient details,
event type & description, resolution
(ii) Device information: manufacturer, generic
device group, disposition, results of analysis,
corrective action
(iii) Others: comments, details of CAB, sample of
failed device
Recall: Establishment
may recall any defective
device at any time and
provide the information
about the device;
establishment;
reason(s) for the recall;
and evaluation of the
risk – this is for
voluntary recall

What is a recall?
"Recall“ means any action taken by the establishment
responsible to recall or correct the device, or to notify its
owners and users of its defectiveness or potential
defectiveness after becoming aware that the device;
i) is or may be hazardous to health;
ii) fails or may fail to conform with any claims made by
the Vendor relating to the effectiveness, benefits,
performance characteristics or safety of the device;
iii) does not comply with the regulations.
Requirements for written recall procedure
(i) Details out steps to be taken,
(ii) Identifies all personnel involved and their functions &
responsibilities
(iii) Sets out channels and means of communications
(iv) Specifies level of priority and assigns time frame for
completion of the recall
Recall strategy
Should address the following elements;
(i) Depth of the recall
(ii) Recall communications
(iii) Effectiveness checks
(iv) Stock control
BRIEF BASIC–FLOW
Flowchart : MDA expectations
establishment
complaint
Complaint handling procedures (39)
investigate
Distribution records (37)
1. Inside/outside Malaysia ?
2. Device available in Malaysian market?
3. Any incident recorded fulfilled the
criteria as in (40) ? :
Decide: Based on criteria
Mandatory Problem
Reporting (40)
Comm.withMDA
Decide: Based on Risk Management
approach & technical investigation result
FSN/FCA/Recall
communicate
MDA
Users
Overall, this is how the MDA expect the establishment monitor
the safety and performance of a medical device – all vigilance
report is recorded and evaluated (38)
a. Failure of device and deterioration in
its effectiveness, inadequacy of
labelling/IFU
b. Has led to death or serious
deterioration of health of a patient,
user or others? Or could do so if it
reoccur?
c. Serious threat to public health?
FCA may include (41):
- Return of device to the establishment,
- Modification of the device,
- Exchange of the device,
- Destruction of the device,
- Specific advice on the use of the
device,
- It may involve recall as part of the
action needed (42).
Incident Reporting Timeline
By the establishment to MDA
Establishment
becomes aware of an adverse incident
Initial Report to be submitted:
Immediately but no
later than 48 hours
for events that
represents a serious
threat to public health
Immediately but no
later than10 days for
events that has led to
death or a serious
deterioration in health
of a person
Immediately but no later
than 30 days for
events where
recurrence of events
might lead to the death
or a serious
deterioration in
health of a person
Submit Final Report within agreed timeframe *complexity/device dependant
- meliputi salah satu atau gabungan perkara – perkara
berikut:
 kejadian yang telah mengakibatkan kematian pesakit;
 kejadian yang telah mengakibatkan kemerosotan
serius tahap kesihatan pesakit, pengguna dan orang
lain;
 kejadian yang memiliki ancaman serius pada
kesihatan awam;
 kegagalan peranti perubatan itu berfungsi, atau
kemerosotan dalam keberkesanannya, atau apa-apa
kekurangan dalam pelabelan atau petunjuk
penggunaannya
 Aduan ‗brand preference‘ atau jenama
pilihan yang lebih digemari pengguna.
 Isu aesthetic (rupabentuk) pembungkusan
peranti perubatan.
 Aduan tentang peranti perubatan tidak
memenuhi spesifikasi ditetapkan seperti di
dalam perjanjian awal di antara pembeli
dengan pembekal
 Isu penghantaran peranti perubatan melebihi/kurang
daripada kuantiti yang tercatat di dalam perjanjian.
Hal ini termasuklah isu ketidakcukupan bekalan
aksesori.
 Aduan melibatkan isu waranti ke atas peranti
perubatan yang telah dipersetujui di antara dua pihak
yang berurusan.
1.
2.
3.
4.
5.
6.
7.
Identify clearly the genuine complaint that can be
forwarded to the establishment.
Identify your supplier and their contact details, and
PIC.
Complaint formally to the *establishment, CC to the
Authority.
Describe in details about the complaint, incident and
about the device.
Give full co-operation to the establishment and the
MDA during investigation.
There is a need to create one structured and
organized acceptance test system for medical device,
Always monitor the storage condition and always able
to adhere to the manufacturer‘s recommendations.
Deficiency of a device found by the user prior to its use :
Examples:
 The packaging of a sterile single use device is labelled
with the caution 'do not use if the packaging is opened or
damaged'. Prior to use, obvious damage to the packaging
was observed, and the device was not used.


Intravenous administration set tip protector has fallen off
the set during distribution resulting in a non-sterile fluid
pathway. The intravenous administration set was not used.
A vaginal speculum has multiple fractures. Upon activating
the handle, the device fell apart. The device was not used.
Service life or shelf-life of the medical device
exceeded:
EXAMPLE:
 Loss of sensing after a pacemaker has reached
end of life. Elective replacement indicator has
shown up in due time according to device
specification. Surgical explantation of pacemaker
required.
 Insufficient contact of the defibrillator pads to
the patient was observed. The patient could not
be defibrillated due to insufficient contact to the
chest. The shelf life of the pads was labelled but
exceeded.

Protection against a fault functioned correctly
Examples:

 An infusion pump stops, due to a malfunction, but
gives an appropriate alarm (e.g. in compliance with
relevant standards) and there was no injury to the
patient.
 Microprocessor-controlled radiant warmers
malfunction and provide an audible appropriate alarm.
(e.g., in compliance with relevant standards) and there
was no deterioration in state of health of the patient.
Expected and foreseeable side effects
Examples:

 A patient who is known to suffer from claustrophobia
experiences severe anxiety in the confined space of a MRI
machine which subsequently led to the patient being
injured. Potential for claustrophobia is known and
documented in the device product information.
 A patient receives a second-degree burn during the use in
an emergency of an external defibrillator. Risk assessment
documents that such a burn has been accepted in view of
potential patient benefit and is warned in the instructions
for use. The frequency of burns is occurring within range
specified in the device master record.


Abnormal use needs not be reported by the
manufacturer to the Authority. Abnormal use
should be handled by the healthcare facility
and appropriate regulatory authorities under
specific appropriate schemes not covered by
this document.
If manufacturers become aware of instances
of abnormal use, they may bring this to the
attention of other appropriate organizations
and healthcare facility personnel.
Bil
Recorded
(Jan – Dis 2014)
Recorded
(Jan – Nov2015)
Various written M.D Complaints
545
535
*Safety & Performance related
471
180
472
259
2.
FCA
291
412
3.
Recall
33
63
4.
Advertisement Complaints
28
15
5.
Advertisement Enquiries
4
-
6.
*On-line Incident Reporting
various cases/various medical
devices
408
414
7.
‗Counterfeit‘*
2
1
1311
1429
1.
Issues
Solved with response from
establishments
Total PMSV issues recorded :
Notes:
1.Includes incomplete and non safety & performance related ‗ On line Reporting‘
2. Counterfeit – due to parallel importation and Non-authorized dealers bring in the devices into the market. NOT REAL
counterfeit issue