Dr Phil Hammond, broadcaster and sessional GP in Bristol

ABPI Code of Practice: medical devices not included
 

I recently met an orthopaedic surgeon who had been on an all-expenses paid overseas jolly on the pretence of learning about a new hip procedure (or possibly a knee—he couldn’t quite remember). He had a lovely tan, as did his wife (or was she his secretary?) and his descriptions of the evening entertainment and freebies left me green. ‘Hang on,’ I said, ‘I thought all medical meetings now have to take place in a "£5-a-head” Travelodge in Barking with no partners, no alcohol, no freebies, and no fun.’ ‘Why would I go to that?’ ‘I dunno. But I think it’s part of the new ABPI Code.’ ‘The what?’

Now most doctors haven’t got much of a clue about the Association of the British Pharmaceutical Industry (ABPI) Code of Practice,1 and neither would I if I didn’t do so many after-dinner speeches for drug companies. But I was astonished to discover that the tough new Code doesn’t apply to medical devices, except when it can only be used with a specific medicine. So it seems that excessive hospitality is still alive and twitching in the world of stents, catheters, grafts, and joints. While GPs will soon be denied a pen, a post-it note, and a pork pie, surgeons of a certain disposition can still get a five-star pampering.

When I tried to get a logical explanation for this from Deep Larynx, my industry insider, she told me this was because medical devices are ‘not systemic’. This apparently means that they’re confined to a particular part of the body and don’t affect it as a whole. But everyone knows the knee bone is connected to the thigh bone, which is in turn connected by an intricate system of levers and pulleys to ossicles of the middle ear. So if you put in a dodgy knee joint, it affects your hearing. What could be more systemic than that?

Back on earth, we all know that any failed joint replacement is a painful disaster for a patient and that revision surgery can be tortuous and complex. You could argue that medical devices should be more tightly controlled than drugs, but for years we have allowed untrained surgeons to hammer unproven lumps of metal into old ladies’ thigh bones. When I first exposed this, research found that hip replacements done by trainees were 11 times more likely to fail than those done by consultants.2

As for the devices, there was no obligatory UK register to ensure that they were safe and effective and no compulsion for surgeons to use the tried and tested prostheses. NICE recommends the use of artificial hips that have been shown to last for 10 years or more,3 but many don’t and if you wanted to use a diamond-studded Lovejolly 300 because the manufacturers had wined and dined you in Tahiti, you could. I campaigned for a national joint registry, which now exists and is a huge step forward,4 but I don’t think it’s compulsory. This leaves the Medicines and Healthcare products Regulatory Agency to protect us from suspect devices, and it seems to have its hands full: the top story on its website on 1 February 2010 was an alert about a stair climber that can trap the attendant’s thumb.5

As for the ABPI, I visited its website to check the (lack of) guidance on medical devices. But if you type ‘Code of Practice’ into the search engine, it returns no hits at all. Not a sausage. I guess that’s what they mean by a voluntary code.

Dr Phil’s new book Sex, sleep, or scrabble? is out now.

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  1. Association of the British Pharmaceutical Industry. Code of practice for the pharmaceutical industry. London: ABPI, 2008.
  2. Marston R, Cobb G, Bentley G. Stanmore compared with Charnley total hip replacement. A prospective study of 413 arthroplasties. J Bone Joint Surg Br 1996; 78 (2): 178–184.
  3. National Institute for Clinical Excellence. Guidance on the selection of prostheses for primary total hip replacement. Technology Appraisal 2. London: NICE, 2000. Available at: www.nice.org.uk/guidance/TA2/Guidance/pdf/English
  4. National Joint Registry. www.njrcentre.org.uk
  5. Medicines and Healthcare products Regulatory Agency website. Medical device alert: C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) (MDA/2010/010). www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON070957?tabName=allTabs G