BHF advice on pacemaker safety

[Helen_BHF]

Hi all,

Some of you may have seen the recent news about certain medical devices including pacemakers.

On Monday, an investigation was broadcast on BBC’s Panorama programme and found that some devices, including pacemakers, had not been adequately tested before they were used in patients. You can read more on this here: bhf.org.uk/what-we-do/news-...

If anyone was worried by this, I wanted to share some advice from the BHF on steps you can take:

It's important to stress that most pacemakers are very reliable and are checked regularly as part of routine healthcare. If you do have any concerns about your device, please do get in touch with the team that regularly check your pacemaker. You can also speak to your pacing clinic or GP who is familiar with the device you had implanted.

Any problems with your device can be reported on the yellow card website: yellowcard.mhra.gov.uk/

Our heart helpline team are available on 0300 330 3311 or [e-mail] if you have any questions.

Thanks everyone.

Have a lovely weekend.

[MichaelJH Heart Star]

I would like to add that I have come across people who have not had their pacemaker or similar device checked for an extended period. The checks also include the state of the battery. If your device has not been checked in over a year (please correct me if I am wrong) you should contact your GP.

[Midgeymoo17]

Personal (and very critical) opinion on the programme:

I think it is important to point out, as my dad did, there is not really a suitable way to test devices with out human implantation that is going to give the stringent assurances the programme was asking for. Firstly anything that is not a human is not going to accurately represent the stress and strains of a moving human. We move differently to animals. Our organs are shaped differently. Its not like testing a medicine where interactions are happening on a cellular level. There is not point designing a mouse shaped implant and testing tin a mouse- the structure for the human version would be so different that the results would be meaningless.

The system as it was is ridiculous- but there is a balance that the programme did not present. The programme presented the strict regulations of the US as the way to go. This has also had the affect of unnecessarily killing US patients. A well known example is a very safe drug that was developed in Germany for stomach ulcers. It was approved in Europe 10 years before the US due to lack of long term safety information. Result: America continued to perform major invasive Surgries and deaths from stomach ulcers were double (if not triple) the deaths in Europe. [Just food for thought about overregulation].

Another important point the programme failed to make is that the effectiveness of an implant is very dependent on the skill of the practitioner implanting. I previously worked on an outcomes audit as to why a certain implant was much more successful at one Uk hospital (where the protheses was developed) than in other centres performing the procedure. The main conclusion: Pre-mature failure was due to Insertion Method and lack of surgeon training. The angle of insertion was found to be substantially different in the other centres. Nothing wrong with prothesis/ implant. [Again food for thought].

What I think the programme did hi-light well (and were the key issues that need to be addressed) was:

1) that clinicians prescribing implants did not get to see what limited safety information was available about them. Reality is that while safety testing prior to approval will be limited by the constraints beyond anyones control, what little there is is being concealed by the manufactures and the approval bodies (can not remember the name). This means that clinicians are not able to adqueatly address the consent process.

2) The regulatory body appeared to have another agenda.

3)It also hi-light the craziness of companies having the ability to shop around for approval and

4)the fact we have no compulsory national register of implants and implantation failures. Which delays our ability to identify quickly and withdraw dangerous implants.

[MichaelJH Heart Star in reply to Midgeymoo17]

I will definitely have to watch this on catch-up. My work involves medical sensors in a different field and it suggests the regulation is nothing as tight as I thought.

[Midgeymoo17 in reply to MichaelJH]

Yeah the regulation was a joke- but as I said the same disadvantages apply to overregulation and it is equally important we do not go that way as this will severely resist the development of potentially life saving devices. The US really paid the price for being over regulated with that drug.

Personally I think there would be a happier medium if all devices were provisionally approved (with out any more evidence than now required) for a maximum number of years during which all inserted devices must be registered and failures reported. This would allow the benefits of quicker approval to stay- but also mandate quicker action in response to problems . It would also allow clinicians to clearly inform patients that full safety data about this device is yet to be collected at the consent point.

And think all safety testing should be available to clinicians prescribing the devices and approval bodies rather than concealed by manufactures.

{FYI: Although I support laxer regulation than in the USA, I am not a Tory!}

[not2worry]

One of the most important questions to ask your electrophysiologist is how many procedures does he do a year. What has been the success of his surgeries and what are the pros and cons of having a PM.

I don’t know why but many patients are intimidated about asking a doctor these simple questions. We’re more likely to ask these questions of our vet for our pets but not for ourselves.......then I conclude well who will be around to take care of my Trixie if not me.

Also it’s important to make sure the doctor you have the consult with performs the procedure.

Yours from Across the Pond