Sims Andrew J, Menes Julian A, Bousfield Derek R, Reay Christopher A, Murray Alan
Regional Medical Physics Department, Freeman Hospital, Newcastle Upon Tyne, UK.
Blood Press Monit. 2005 Oct;10(5):275-81. doi: 10.1097/01.mbp.0000173487.82766.be.
Measurement of blood pressure by a trained observer using a mercury sphygmomanometer is accepted as the gold standard, but there has been an increase in the use of automated devices employing the oscillometric technique. Not all such devices have been clinically validated, and some do not carry an appropriate CE mark. This survey aimed to assess the state of the European Union market for automated non-invasive blood pressure devices in terms of information provided by companies relating to compliance, validation and intended use.
A total of 116 companies were identified as being potentially active (i.e. manufacturer, supplier, agent or distributor). Of these, 110 that could be contacted were asked to provide details of their company and their non-invasive blood pressure products via a questionnaire.
Eighty-six companies were found to be actively involved in the supply of 158 different models of automated non-invasive blood pressure device. These included 54 devices for use on the arm and 62 for use on the wrist (total 116 in our main categories), and 42 others (ambulatory monitors, patient monitors, defibrillators or finger devices). We received responses for 61% (71/116) of the main category arm and wrist devices and 80% (57/71) of these provided claims for CE marking. Of the CE marked devices for which we received a response, 41% (12/29) of arm devices and 39% (11/28) of wrist devices claimed some form of clinical validation, or evidence was found subsequent to the survey. Of these claims, 65% (15/23) related to an earlier, or similar, product and 48% (11/23) were based on published studies. Inconsistencies were found between claims for diagnostic suitability and claims for clinical validation.
A majority of models available on the European Union market were not validated by clinical trial to one of the recognized protocols.
由经过培训的观察者使用汞柱式血压计测量血压被公认为是金标准，但采用示波技术的自动化设备的使用有所增加。并非所有此类设备都经过临床验证，有些也没有适当的CE标志。本次调查旨在根据公司提供的有关合规性、验证和预期用途的信息，评估欧盟自动无创血压设备市场的状况。
总共确定了116家可能活跃的公司（即制造商、供应商、代理商或经销商）。其中，110家可以联系的公司被要求通过问卷调查提供其公司及其无创血压产品的详细信息。
发现有86家公司积极参与供应158种不同型号的自动无创血压设备。其中包括54种用于手臂的设备和62种用于手腕的设备（我们主要类别中共有116种），以及42种其他设备（动态监测仪、病人监护仪、除颤器或手指设备）。我们收到了主要类别中手臂和手腕设备61%（71/116）的回复，其中80%（57/71）声称具有CE标志。在我们收到回复的带有CE标志的设备中，41%（12/29）的手臂设备和39%（11/28）的手腕设备声称进行了某种形式的临床验证，或者在调查后发现了相关证据。在这些声明中，65%（15/23）与早期或类似产品有关，48%（11/23）基于已发表的研究。在诊断适用性声明和临床验证声明之间发现了不一致之处。
欧盟市场上的大多数型号未按照公认的方案之一通过临床试验进行验证。
