Monitoring the use and outcomes of new devices and procedures: how does coding affect what Hospital Episode Statistics contribute? Lessons from 12 emerging procedures 2006-10.

BACKGROUND: New devices and procedures are often introduced into health services when the evidence base for their efficacy and safety is limited. The authors sought to assess the availability and accuracy of routinely collected Hospital Episodes Statistics (HES) data in the UK and their potential contribution to the monitoring of new procedures. METHODS: Four years of HES data (April 2006-March 2010) were analysed to identify episodes of hospital care involving a sample of 12 new interventional procedures. HES data were cross checked against other relevant sources including national or local registers and manufacturers' information. RESULTS: HES records were available for all 12 procedures during the entire study period. Comparative data sources were available from national (5), local (2) and manufacturer (2) registers. Factors found to affect comparisons were miscoding, alternative coding and inconsistent use of subsidiary codes. The analysis of provider coverage showed that HES is sensitive at detecting centres which carry out procedures, but specificity is poor in some cases. CONCLUSIONS: Routinely collected HES data have the potential to support quality improvements and evidence-based commissioning of devices and procedures in health services but achievement of this potential depends upon the accurate coding of procedures.

Automated non-invasive blood pressure devices: are they suitable for use?

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: A majority of models available on the European Union market were not validated by clinical trial to one of the recognized protocols.