During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these discrepancies are described in EN 14971: 2012 as “Content Deviations”. This newsletter deals with Content Deviations No. 6 - The First Risk Control Option and No 7 - Labelling Information Cannot Influence Residual Risk
Content Deviation #6 The First Risk Control Option: “Design and Construction”.
Clause 6.2 of the 14971 Standard list the first risk control option as: (a) Inherent safety by design However the Essential Requirement 2 of the MDD requires the manufacturer to “eliminate or reduce risks as far as possible (inherently safe design and construction)." The word construction can be interpreted in either of two ways: the materials of construction or the process of constructing the device e.g. assembly, welding etc.
Through the use of Content Deviation #6 the EU Commission is emphasising the need for inherently safe materials of construction and methods of construction for medical devices.
In order to address Content Deviation #6 manufacturers must consider whether or not safer materials and fabrication methods are available; if so it is clear from Content Deviation #3 Risk Reduction Economic Considerations that the safer materials and methods must be adopted regardless of the cost implications. The only justification for not doing so would be if it can be shown that to do so would not actually reduce the risk to the user or patient. For instance, any manufactures whose products still contain phthalates must consider if alternative phthalate-free materials are available which would make their product safer and if so initiate a programme to move to those materials.
Content Deviation #7 Labelling Information Cannot Influence Residual Risk
Content Deviation #7 states that no risk reduction shall be attributed to information provided to the user. This means that manufacturers are no longer able to improve the acceptability of a risk by adding information to the Instructions For Use (IFUs) and labelling. Such information must still be added, where appropriate but it cannot be used to reduce the risk scoring for the product.
In order to address Content Deviation #7 manufacturers will first need to revise their risk analysis documents such as FMEAs in order to remove and risk reduction associated information given to the user. Once this has been done the manufacturer will need to recalculate the risk scoring and review the acceptability of the revised risk. The manufacturer will then need to determine what new controls can be implemented in order to reduce the risks as far as possible and will need to assess whether or not the benefits of the device continue to outweigh the risks.
Addressing Content Deviation #7 may present considerable challenges for many device manufacturers as information given to the user was a common way of addressing use and misuse related risks. In the case of the most common form of misuse, reuse, this may prove especially difficult. Medical Device companies have long been looking for ways to make it impossible for users to re-use single use devices; Content Deviation #7 will force companies to again explore ways of doing so. Companies will be compelled to move to the State-of-the-Art on this and will not be able to use economic considerations to avoid doing so. For example companies will have to consider novel materials and/or designs to prevent the re-sterilization or cleaning of single use devices or incorporate hardware and/or software controls to detect and prevent different attempted reuse or other forms of misuse.
Final Newsletter in this Series:
Content Deviation #7 is the last of the Content Deviations between ISO 14971 and the MDD. In our next newsletter (the final one in this series), we will review that seven Content Deviations and their implementation as a whole.