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IMPLEMENTATION OF RISK MANAGEMENT
FOR MEDICAL DEVICES
ISO 14971 is a “Risk Management” standard. It covers
not only the risk determination activities but encompasses the whole application
of risk to overall activities. This includes all activities of the medical
device lifecycle:
- Design
- Manufacturing
- Installation
- And servicing
As part of the risk management process it is necessary that you have Risk
Analysis, Risk Evaluation, Risk Control and Monitoring. If your company is doing
only one or several of these but not ALL then you do not have an effective risk
management process implemented.
An error many manufacturers make is to failing to include all elements of the
risk management process. Many believe mistakenly that if they have a Risk
Assessment process that they are covered. Risk assessment is defined as the
processes of Risk analysis (Hazard identification, risk estimation) and risk
evaluation (Risk acceptability decisions). However, risk management also
includes risk control (option analysis, implementation, residual risk evaluation
and overall risk acceptance), AND post-production information (post production
experience, and review of risk management experience).
ACCEPTANCE OF ISO 14971 STANDARD
Recently the US FDA has recognized ISO 14971 as providing a basis for risk
assessment. Until now the standard was seen as an acceptable means of managing
risk.
Health Canada requires manufacturers to comply with ISO 13485 which indirectly
(only stated in footnote) that ISO 14971 is the standard of choice for dealing
with risk.
When all things are considered the choice of ISO 14971 as a basis for your risk
management standard should be very much considered. The rest of this article
assumes an approach based on this standard.
WHAT IS RISK MANAGEMENT?
Risk management covers many pieces of the risk puzzle, including:
Risk assessment
Risk estimation
Risk evaluation
Risk analysis
Risk control
Hazard identification
Hazard estimation
The 4 step process for ensuring safety and effectives which forms the basis for
this standard is: identify the hazard; estimate the risk; determine the
acceptability and mitigate the risk. The standard does handle more that just the
process though. For instance the guidance also includes information for
developing your Risk Management File and for dealing with post market
information.
ISO 14971’s risk management process takes us through the entire medical device
lifecycle from quality planning through to design transfer activities. This
progression demonstrates how the risk process “collects” information regarding
risk then “disseminates” this information back (to make the devices safer).
Collection Processes:
Quality Planning
Develop risk management plan
Identify hazards
Estimate risks
Validation (compile Risk Management File)
Dissemination Processes:
Design Input (catalog the risks desired to be reduced)
Design Output (reduce the risks)
Design Verification (overall risk evaluation)
MANAGEMENT RESPONSIBILITY
ISO 14971’s management responsibility directive states that management is
responsible for
developing an “Acceptability Policy” – taking into account international
standards and local (regional) regulations.
Management is also responsible for providing adequate resources.
Assigning trained personnel
And reviewing the results of risk management activities at defined intervals
through the process.
QUALIFICATION OF PERSONNEL
The manufacturer is responsible for ensuring that personnel with knowledge of
the risk management task have experience and knowledge of the medical device
including the application and use of that device.
RISK MANAGEMENT PLAN
The plan is a component of the risk management file and includes:
-The scope of the plan
-A verification plan
-Allocation of responsibilities
-Risk management review activities
-Risk acceptability criteria
A note on acceptability criteria: this is usually assisted by way of looking at
the company’s history with similar devices, looking at devices already on the
market (competitor’s devices), and/or looking at what the alternatives are
(other therapies).
RISK MANAGEMENT FILE
The ISO 14971 standard lists the records required for the management file and
include:
Risk Management Plan
Identification of hazards
Estimation of risks
Risk Evaluation (risk acceptability)
Measures for control
Evaluation of effectiveness
Risk Management Report (risk management results recorded)
Verification
THE RISK MANAGEMENT PROCESS
As stated earlier on the Risk Management Process consists of:
Risk Analysis
Risk Evaluation
Risk Control
And Post production Information
CONCLUSION
ISO 14971 provides an excellent framework of defining the different elements of
the Risk Management process of medical devices. When implemented properly the
standard will assist manufacturers in effectively reducing risk and will ensure
products are created safe and effective
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