Risk of Bacterial Meningitis and Death in Children with Cochlear Implants

[R2D2]

My 5 year old just got 7 vaccines in June. I'm not sure I could name every one without pulling out her yellow card listing them, and it would probably take me half an hour to find the card So I'm one of the most educated moms I know on the topic, and even I'm "unaware" Though I know she got "a" meningitis vaccination, there are two different ones out there and I don't honestly remember which one she got.

Same here - I wouldn't be able to tell anyone my daughter's vaccines one by one off the top of my head. I would have to pull out my daughter's blue book to see which vaccines she has had and which ones were repeated. I do know we are up to date on the schedule of vaccines for her age though because I got a certificate from the government saying that she "is up to date".

I think it's the same with adults as well. Most don't have any idea what they've been vaccinated for and whether they are up to date or not.

I don't think it's a good idea to conduct off the cuff surveys where people are expected to remember their status on the spot and then try and make out that the clinics have grossly failed in that regard. Is my GP responsible for the fact that I can't remember what vaccinations my daughter has had off the cuff?

Maybe the FDA should set up a database like we have in Australia where parents are told by mail when their childrens' vaccines are up to date. I don't know about the US but the meningitis and prevnar vaccines are part of the schedule for every child here so perhaps the same could be done there?

 

[jag]

I don't think it's a good idea to conduct off the cuff surveys where people are expected to remember their status on the spot and then try and make out that the clinics have grossly failed in that regard. Is my GP responsible for the fact that I can't remember what vaccinations my daughter has had off the cuff?

Maybe the FDA should set up a database like we have in Australia where parents are told by mail when their childrens' vaccines are up to date. I don't know about the US but the meningitis and prevnar vaccines are part of the schedule for every child here so perhaps the same could be done there?

Actually if you use the same primary care dr. most clinics do check the immunization record, at least around here. THey have always let me know which shots need to be given or if there's been one missed. I would have to check if my youngest has had the meningitus shot, I think she has. And if she has it's because they (gov?) have now added it to the list of shots for children.

I almost think she was offered it about 2 yrs ago and I was told it was highly recommended for her since she spends time in the dorms during the school year. I don't have to worry to much about her immunization record because the staff do keep it up to date. They always ask if she's recieved any vacinations since the last visit. She'll be getting the flu shot next week. Luck her. OUCH.

 

[SxyPorkie]

Kalista... every surgery of any kinds. has risks.... there are better technology to help them...

 

[jillio]

I didn't mean that sarcastically; I was just wondering out loud if what I was talking about was (or should be for the sake of safety) the domain of the people manufacturing these devices all the way to whomever is involved with the patient pre-implant. Surely, somewhere along the line somebody can make sure the vaccination has been given before allowing the implantation without running to the government to make sure this happens. Am I being too simplistic?

No, you are not being oversimplistic. It should be established protocol.

 

[jillio]

In some cases such as meninigitis where ossification of the ear bones can take place, which would make it difficult and sometimes impossible for the electrodes to be inserted, there are good reasons to have prompt CI surgery.

Also as LTHAdvocate mentions the window of speech development is in the first three years of life and this is a well established observation. After that it closes and those who are implanted in later years struggle much more, although of course there are always exceptions to the rule. I'm not sure how I feel about older children being implanted if they have never heard sound before or haven't developed spoken language already - I wonder if its just setting them up for more struggle especially if the goal is to develop spoken language. I think it's better for them to remain dedicated to ASL if they have already started that.

We've discussed this "window of opportunity before. While theer is indeed a developmental window in which the acquisition of language is optimal based on neurological and developmental timetables, that is the optimal point for acquisition. The actual window of opportunity extends well beyond that.

Likewise, I think we keep missing the point is that the intent of CI is to provide auditory perception, not language acquisition.

 

[jillio]

Same here - I wouldn't be able to tell anyone my daughter's vaccines one by one off the top of my head. I would have to pull out my daughter's blue book to see which vaccines she has had and which ones were repeated. I do know we are up to date on the schedule of vaccines for her age though because I got a certificate from the government saying that she "is up to date".

I think it's the same with adults as well. Most don't have any idea what they've been vaccinated for and whether they are up to date or not.

I don't think it's a good idea to conduct off the cuff surveys where people are expected to remember their status on the spot and then try and make out that the clinics have grossly failed in that regard. Is my GP responsible for the fact that I can't remember what vaccinations my daughter has had off the cuff?

Maybe the FDA should set up a database like we have in Australia where parents are told by mail when their childrens' vaccines are up to date. I don't know about the US but the meningitis and prevnar vaccines are part of the schedule for every child here so perhaps the same could be done there?

Here is the questions posed to the persons I spoke with.

Were you aware of the fact that CI implantation carries an increased risk of contracting bacterial meningitis.

Do you remember anyone in the medical profession ever saying anything about this to you?

Do you know if you have been vaccinated for bacterial meningitis prior to getting your implant?

The overwhelming answers were no, no, and no. This was not intended to be a research project, but simply questions asked of the CI implantees with whom I have daily contact to see if this unwareness that was spoken of was a generally occuring phenomenon. And their answers are consistent with the article posted earlier that unawareness of this possible complication and the need to take steps to prevent it is found in 50% of the population. No matter how you choose to look at it, people do not have the information they need. Why?

And, while memory may fail in the more generalized vaccines, such as DPT ,and rubella, if you have a child with CI, there is a spefic risk of bacterial memingitis. Therefore, if you were given inforamtion about a specific risk for your specific circumstances, would you not remember that? My brother contracted Hepatitis B in 1973. I had to be vacinnated because of the specif circumstances that created a specific risk. I remeber botht he cotor tellingme it was necessary, and the actual vaccincation process. And if I were asked by a physican today of I had received the Hep vaccine, I would say "yes".

 

[R2D2]

We've discussed this "window of opportunity before. While theer is indeed a developmental window in which the acquisition of language is optimal based on neurological and developmental timetables, that is the optimal point for acquisition. The actual window of opportunity extends well beyond that.

Likewise, I think we keep missing the point is that the intent of CI is to provide auditory perception, not language acquisition.

I wasn't talking about "language" as including sign language, which can be developed after the first three years. I was speaking specifically of spoken language and the perception of that language. There would be no real pressing reason to get a CI for a child unless there was a goal to develop and perceive spoken language whether in conjunction with sign or not. Right?

 

[jillio]

I wasn't talking about "language" as including sign language, which can be developed after the first three years. I was speaking specifically of spoken language and the perception of that language. There would be no real pressing reason to get a CI for a child unless there was a goal to develop and perceive spoken language whether in conjunction with sign or not. Right?

Spoken langauge fits into the optimal development period and window of opportunity. In fact, these theories are based on spoken langauge development, and have been applied recently to the acquisition of sign.

Correct. But the CI still affects only the auditory mechanisms. It is not a devise to develop speech skills. It does not directly affect the vocal mechanisms. The first goal, if realistic, is to provide sound perception. Anything else is a bonus.

 

[R2D2]

. No matter how you choose to look at it, people do not have the information they need. Why?

It seems to me that you are persisting with the angle that the clinics are not telling them they need to be vaccinated. You've drawn these conclusions from the study in the article and your poll with the students which showed that people are not aware of their vaccination status.

Sorry, I see problems here. There is no proof that the clinics did not actually provide the information because we are relying on memory here, which as we all know is not foolproof. Also, LTHAdvocate indicates that it is a standard practice for clinics to provide the information about the need for vaccination and that does not surprise me, since the legal implications of not doing that at all would be enormous.

Moreover, the news articles are not claiming that clinics are point blank failing to inform parents of the need to be vaccinated. It's more that parents need to be reminded and clinics need to follow up that it has been done. In other words, its not just enough to tell people of the risk of meningitis and that they need to get their shots.

 

[R2D2]

Correct. But the CI still affects only the auditory mechanisms. It is not a devise to develop speech skills. It does not directly affect the vocal mechanisms. The first goal, if realistic, is to provide sound perception. Anything else is a bonus.

Well, yes it is technically correct that a CI will not directly produce speech. But to produce speech you need to be able to hear and this is what the CI is designed to do so as to allow an easier path to speech acquisition.

When you look at the whole purpose and intent of the CI in children and all the broohaha with doing it early on, it's all about facilitating development of speech, which is very difficult to do unless you can hear to some degree.

 

[jillio]

It seems to me that you are persisting with the angle that the clinics are not telling them they need to be vaccinated. You've drawn these conclusions from the study in the article and your poll with the students which showed that people are not aware of their vaccination status.

Sorry, I see problems here. There is no proof that the clinics did not actually provide the information because we are relying on memory here, which as we all know is not foolproof. Also, LTHAdvocate indicates that it is a standard practice for clinics to provide the information about the need for vaccination and that does not surprise me, since the legal implications of not doing that at all would be enormous.

Moreover, the news articles are not claiming that clinics are point blank failing to inform parents of the need to be vaccinated. It's more that parents need to be reminded and clinics need to follow up that it has been done. In other words, its not just enough to tell people of the risk of meningitis and that they need to get their shots.

Whose responsibility is it to inform the parents if it is not the physicans performing the surgery? LTHF Advocate said her clinic, not all clinics. Whose resposnibility is it to do the follow up. And, if the urgeon operates without first ascertaining that vaccine has been given, then who is responsible? Protocal begins and ends with the physician.

 

[LTHFAdvocate]

You don't engage in any longitudinal research regarding implanted indiviuals?

Of course we do, but we do it based on chart reviews. That doesn't require that we be in current contact with the patient.

Don't youthink soemthing as important as receiving the vaccine and being made aware of the risks is important enought to stress to the point that it will be remembered?

What makes you think that we have any control whatsoever about what our patients remember? I have come across families (through the appeals program, not at our clinic) where they can't even tell me what brand of implant their child has or when they had their last mapping, much less something that was told to them the week before surgery.

My point being.....why do so may people seem to be unaware of medical information that is crucial and important?

And I don't have the answer to that question, but I would ask you that when they aren't aware, what makes you conclude it's automatically the clinic's fault?

 

[shel90]

Of course we do, but we do it based on chart reviews. That doesn't require that we be in current contact with the patient.



What makes you think that we have any control whatsoever about what our patients remember? I have come across families (through the appeals program, not at our clinic) where they can't even tell me what brand of implant their child has or when they had their last mapping, much less something that was told to them the week before surgery.



And I don't have the answer to that question, but I would ask you that when they aren't aware, what makes you conclude it's automatically the clinic's fault?

I see the same with the families of our students. They dont know the brand names ...

 

[jillio]

Of course we do, but we do it based on chart reviews. That doesn't require that we be in current contact with the patient.

But, your research is based on chart reviews from your own clinic, or that of other medical professionals? Surely, that is updated information?

What makes you think that we have any control whatsoever about what our patients remember? I have come across families (through the appeals program, not at our clinic) where they can't even tell me what brand of implant their child has or when they had their last mapping, much less something that was told to them the week before surgery.

It would not matter what the patient or the family remembers, if it was standard protocol to have documentation of proof of the vaccine prior to ever wheeling that child into the operating room. And whowould be responsible for making certain that documentation was available? The physican directly, his auxillary staff indirectly. But as the auxillary staff function only as an agent of, and under the supervision of the physician, responsibility still falls squarely onthe shoulders of the person holding the knife.

And I don't have the answer to that question, but I would ask you that when they aren't aware, what makes you conclude it's automatically the clinic's fault?

Once again, who else provides the medical information to these patients? But I never said that all of the fault lies with the clinic. But the services would appear to be so fragmented that the left hand is oftern unaware of what the right hand is doing. The ball is getting dropped somewhere.

 

[LTHFAdvocate]

Whose responsibility is it to inform the parents if it is not the physicans performing the surgery? LTHF Advocate said her clinic, not all clinics. Whose resposnibility is it to do the follow up. And, if the urgeon operates without first ascertaining that vaccine has been given, then who is responsible? Protocal begins and ends with the physician.

Sorry Jillio, but I don't agree with you. Protocols change over time. There was a time (not really that long ago) where meningitis vaccinations didn't even exist, then there were but they weren't required, then there was one vaccine, now I think there are two. Protocols change over time, and individual physicians, as a whole, are reluctant to change their clinic protocols without recommendations from higher authorities, like the FDA, the AAO-HNS, or the manufacturers. What happens if it turns out 20 years from now that this new meningitis vaccination causes cancer or infertility? Then everyone would be screaming at the doctors for having a blanket requirements that everyone get these shots when the risk of meningitis was so low? Extreme example, I know, but you get my point.

Physicians cannot assume a lifetime of responsibility for a patient. They are responsible for the services they provide and ongoing care as long as the patient remains part of that practice. If the device is raising the risk of meningitis, then it is the device manufacturers' responsibility to notify patients of the changing nationwide recommendations. They have the money, and they have more up to date contact information for the patients. That is how patients implanted 10 years ago when meningitis vaccinations either didn't exist or weren't done should be contacted about getting their shot records examined and updated.

 

[LTHFAdvocate]

It would not matter what the patient or the family remembers, if it was standard protocol to have documentation of proof of the vaccine prior to ever wheeling that child into the operating room. And whowould be responsible for making certain that documentation was available? The physican directly, his auxillary staff indirectly. But as the auxillary staff function only as an agent of, and under the supervision of the physician, responsibility still falls squarely onthe shoulders of the person holding the knife.

Be careful with your quotes, Jillio, I didn't say that but you have it attributed to me

 

[jillio]

Be careful with your quotes, Jillio, I didn't say that but you have it attributed to me

Are you talking about the quote that was cited in your above resposne? No those are not your words, they are mine. They were not attributed to you at all.

 

[LTHFAdvocate]

Yet they show up in the grey box marked "Originally Posted by LTHFAdvocate"

Are you talking about the quote that was cited in your above resposne? No those are not your words, they are mine. They were not attributed to you at all.

 

[R2D2]

Whose responsibility is it to inform the parents if it is not the physicans performing the surgery? LTHF Advocate said her clinic, not all clinics. Whose resposnibility is it to do the follow up. And, if the urgeon operates without first ascertaining that vaccine has been given, then who is responsible? Protocal begins and ends with the physician.

I didn't say that the surgeon wasn't responsible for improving their systems. It's clear that parental forgetfulness must be taken as a given, even when information is provided and there is a need for the clinics to improve their systems to take account of this. It's quite normal in the medical world and elsewhere for systems to continuously undergo improvement after information is provided via the feedback loop.

 

[jillio]

Sorry Jillio, but I don't agree with you. Protocols change over time. There was a time (not really that long ago) where meningitis vaccinations didn't even exist, then there were but they weren't required, then there was one vaccine, now I think there are two. Protocols change over time, and individual physicians, as a whole, are reluctant to change their clinic protocols without recommendations from higher authorities, like the FDA, the AAO-HNS, or the manufacturers. What happens if it turns out 20 years from now that this new meningitis vaccination causes cancer or infertility? Then everyone would be screaming at the doctors for having a blanket requirements that everyone get these shots when the risk of meningitis was so low? Extreme example, I know, but you get my point.

Physicians cannot assume a lifetime of responsibility for a patient. They are responsible for the services they provide and ongoing care as long as the patient remains part of that practice. If the device is raising the risk of meningitis, then it is the device manufacturers' responsibility to notify patients of the changing nationwide recommendations. They have the money, and they have more up to date contact information for the patients. That is how patients implanted 10 years ago when meningitis vaccinations either didn't exist or weren't done should be contacted about getting their shot records examined and updated.

Yes, protocols do change over time, and when it is discovered that there is a procedure that caqn reduce the risk, then it becomes standard protocol. So why is it not protocol to simply chaeck a patient's medical record to see if there is documentation of the completed vaccine. Physicans check for medication allergies and complicating health issues prior to surgery. Why not the vaccine? It isn't that difficult, and it requires minimal effort. The medical record is available. All that has to be done is to look in the chart for documentation. No documentation, no surgery until documentatio0n is there. Can't get much simpler than that.

And, no physicians, unless practicing in the field of family medicine, generally are not responsible for the life time of any given patient. However, a surgeon is responsible for that patient pre-surgically, during surgery, and post-surgically. Pre-surgical responsibility would imply that the surgeon determine whether the vaccine had been completed prior to putting the patient under the knife. If a dentist fails to insure that an orthopedic implant patient has been premedicated with antibiotics prior to dental procedures, and that patient contracts bacterial endocarditis as a result, the dentist is held responsible, because it is his area of expertise to insure that the patient is not put under undue risk. Likewise,the implant surgeon who fails to insure that a patient has been vaccinated, and that patient later contracts bacterial memingitis as a result, the surgeon is resposnible under the same premise of expertise.