Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Things that make you go hmmmmm.
- Samantha M Bardell (16 May 2003)
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Dangerous devices
- Phillip J. Colquitt (17 May 2003)
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Samantha M Bardell, Compliance Manager for medical device manufacturer Diomed Ltd, Bldg 2000, Beach Drive, Cambridge Research Park, Cambridge, CB5 9TE
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Seven years ago, as the person responsible for investigating reported incidents of product failure for a UK manufacturer of infusion pumps, I reviewed the downloaded event history of somewhere in the region of 200 products. A number of factors became evident:- 1. What was reported by the doctor, nurse or practitioner in their written statement of events did not always tie up with the recorded event history. Very few users appreciate that the machine can record any event (changing settings, opening doors, removing IV lines, etc.) regardless of whether it is switched on, connected to the mains or apparently as 'dead as a dodo'. 2. There were frequent incidents of the wrong amount (volume or flow rate) being set by the user. In most incidents the prescribed rate was recorded in the patient’s notes, not the actual rate selected. 3. In some instances, despite product specific training, users exhibited bad practice (removing the IV from the pump without closing the clamp first). I was so concerned by the increasing evidence showing lack of training, lack of assessment for competence following training and general bad practice that I contacted, on behalf of the company, the Medical Devices Agency to express our concern. The response I received was that (1) it was not the problem of the MDA and they had no obligation to forward our comments to the appropriate party and (2) that the most appropriate party to contact was the Secretary of State for Health. Following a number of calls to try and identify a contact to discuss the matter prior to a formal letter from the company I was thwarted at every turn. Eventually I just gave up trying. I have heard many excuses for these kind of problems, both back then and now; high staff turnover, insufficient resources for staff training, too wide a variety of equipment in the same area for the same job, etc. If a hospital was run as a business, with an integral quality system, there would be documented procedures for operating the machines in the wards where the machines are, documented training records including assessment of competence and management responsibility for making resources available. I no longer work for that manufacturer, but my concerns about the state of practice within the NHS remain. Competing interests: None declared |
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Phillip J. Colquitt, RN Independent comment
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It is dangerous to have a less than useful device in a clinical setting. Unnecessary work and staff inefficiency result from a given device’s inadequate ‘alarm’ sounds. Will the experts and others referred to in White’s article[1], please respond by saying that the sounds made by the IMED electronic intravenous infusion devices[EIIDs] are not dangerously inadequate. To my awareness, there is no published and/or binding standard, which can be applied to the directional properties of ‘alarm’ sounds made by EIIDs. By that I mean… “Can you tell where the beep is coming from?” Or is it merely a case of.....”You can hear it, but have no idea where the sound is coming from.” So, in evaluating the usefulness of EIIDs, with particular reference to directional properties of ‘alarm’ sounds, I have only my own experiences(RN), and statements from other clinicians, and patients, to guide me. In a previous related rapid response[2], I expressed my ‘dissatisfaction’ with the IMED brand EIIDs, which seem to dominate the hospital market. [1] White C. UK agency unveils plans to cut infusion device errors. BMJ 2003;326:1053 (17 May). [2] Colquitt PJ. No plan is cheapest. bmj.com/cgi/eletters/326/7387/460#30073, 28 Feb 2003. Competing interests: None declared |
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