A recent article written by Dipl-Ing Oliver P Christ, CEO of Prosystems in Hamburg, for the 2012/2013 issue of the Fahrvereinigung Krankenhaustechnik (FKT – German Federation of Hospital Engineering)’s ‘Yearbook for Healthcare Engineering’, examines the impact for medical device manufacturers, and the hospitals that use medical devices, of the German version of the IEC 80001-1: 2010 standard, published in November 2012, as VDE 756 Part 1.
The article, which appears in the latest edition of the FKT’s ‘Jahrbuch Technik im Gesundheitswesen’, explains that the Standard was developed jointly by experts from IEC TC 62A (Electrical Equipment used in Medical Practice) and ISO TC 215 (‘Health Informatics’), working within a newly established Joint Working Group, JWG7. In Germany, the corresponding ‘mirror-group’ is UK 811.3 of the German Commission for Electrical, Electronic & Information Technologies of DIN and VDE (DKE), which has been chaired by Oliver Christ since 1999. Oliver Christ, who himself contributed to the writing of IEC 80001-1:2010, explains in the article that one of the anomalies with the ‘well-established’ Risk-Management Standard, ISO 14971:2007, is that it addresses risk management and conformity assessment for medical equipment only from the standpoint of the medical device manufacturer, and not from that of the Responsible Organisation (typically a hospital or private healthcare provider). The article explains that, generally (under ISO 14971: 2007), medical device manufacturers are only obliged to consider the safety of their own medical devices, and their intended use, meaning that, in most cases, they are likely to confine their risk assessments solely to scrutiny of the equipment’s user interface. Mr Christ says: “Given this limitation, how we can best address any risks deriving from the interaction between a number of medical (or indeed non-medical) devices used in combination, that results in additional functionalities not covered by the original ‘intended use’ of the individual items of equipment?” The article explains that, as far as the Medical Device Directive (s) in Europe, and the corresponding German law (Medizinproduktegestz, MPG, Section 10, Clauses 1 and 2) are concerned, the term, ‘Medical Systems’ is used to denote instances where a number of medical devices are used in combination. Clause 1 of section 10 of the MPG focuses specifically on where responsibility lies for the conformity assessment of medical devices used in conjunction with eachother, but gives three ‘options’:
• Option 1: Conformity assessment has been authorised by all the medical device manufacturers involved.
• Option 2: Additional Conformity Assessment is necessary for ‘extended functionalities’.
• Option 3: ‘Self-Conformity Assessment’ by the Responsible Organisation is permitted, under Section 12, Clause 1.
Mr Christ explains that Option 1 only ever occurs where a single medical device manufacturer puts together a complete ‘medical system’, and places it on the market within the EU under its own name. However, where ‘Treatment Units’ or ‘Systems’ are configured and combined under the auspices/authority of a Responsible Organisation using ‘medical devices and non-medical devices’ from several medical device manufacturers and/or IT providers, he argues that ‘gaps’ presumably then exist in terms of the fact that no one party or organisation feels legally responsible for risk/conformity assessment. Mr Christ says: “It is at this point where IEC 80001-1 comes especially into play. The new Standard is addressed predominantly at those Responsible Organisations operating IT networks that incorporate at least one ‘medical device’. IEC 80001-1 requires the Responsible Organisation in question to undertake a complete risk assessment, and implement the necessary risk controls.” For further information on the IEC 80001-1 Standard and its stipulations, email: oliver.christ@prosystem-ag.com
