ISO 14971 Basics – Using a PHA for Risk Analysis
ISO 14971:2019 requires medical device manufacturers to perform a risk analysis. Here is how a Preliminary Hazard Analysis (PHA) can help.
Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5.
Risk analysis involves a systematic evaluation of all information available to identify hazards and to estimate the risk. As defined in the standard, there are two elements to the risk of harm associated with a medical device. These are the probability of harm (PoH) and the severity of that harm (S). Therefore, for each applicable hazard, all individual risks need to be identified and estimated in terms of the PoH and S.
The Risk Analysis Process
The risk analysis process involves the following 4 steps:
Intended use and reasonably foreseeable misuse: Risk analysis begins with a clear definition and scope of the intended use(s) of a medical device. In addition, we need to consider all reasonably foreseeable misuses in the context of the intended use. This exercise provides the context and a framework for conducting the risk analysis. Learn more about the intended use and reasonably foreseeable misuse in this video.
Characteristics related to safety: It is important to identify all characteristics of a device which may relate to safety. Depending on the type of a device, and its principle of operation, examples of such characteristics may include sterility, surface roughness, materials of construction, energy sources etc. This exercise allows the identification of all potential hazards associated with a medical device.
Hazards and hazardous situations: A systematic analysis of hazards and hazardous situations in the context of its intended use, reasonably foreseeable misuse, and characteristics related to safety, provides a clear and comprehensive understanding of different scenarios that may lead to a harm. A preliminary hazard analysis (PHA) is an effective method for this purpose.
Risk Estimation: As indicated above, this step involves estimating the PoH and S of each risk corresponding to the hazards and hazardous situations.
Understanding PHAs
A PHA is an inductive method of analysis to identify hazards, sequence of events, hazardous situations and harms. It is initiated in the early phase of the design and development process and continuously updated in subsequent phases as new information becomes available. A PHA for a similar device can be used as a starting point. The analysis involves the potential effects of materials of construction, components used, interfaces, operating principle (chemical, electrical, magnetic, mechanical etc.) and use environment.
In general, a PHA is a compilation of the relevant information in a tabular form. Here is an example of a single line item in a PHA table. A fully developed PHA may contain more than a hundred-line items depending on the complexity of the medical device.
It is important to develop a PHA in a cross-functional setting. Experts from Medical Safety, Engineering, Manufacturing, Quality, Regulatory and Supply Chain should be included. Other functional expertise may be required on an as-needed basis.
Check out the video below for further details and specific examples.
There is a lot going on in the medical industry right now. To stay current, subscribe to our YouTube Channel for our weekly updates. You can also sign up here for our exclusive, in-depth analysis of key topics in the medical industry. Contact Us if you have any questions or comments, or if you would like to learn more about any specific topics related to risk management.