Guest guest Posted March 16, 2001 Report Share Posted March 16, 2001 Kendra, Thank you so very much for the info! It makes more sense to me now. I guess I'm a little nervous since the twins were casted today, I'm hoping that we are able to get a band that fits right. And thats what got me thinking about approval for casting. Thank you once again! I don't know how you do it, you have so much info to share! Niki > Niki: > Here is SOME info for you....(from the article mentioned in my previous post) > ........The device is assigned the generic name ``cranial orthosis,'' and > it is identified as a device intended for use on infants from 3 to 18 > months of age with moderate to severe nonsynostotic positional > plagiocephaly, including infants with plagiocephalic-, brachycephalic-, > and scaphocephalic-shaped heads. The device is intended for medical > purposes to apply pressure to prominent regions of an infant's cranium > in order to improve cranial symmetry and/or shape. > FDA identified the following risks to health associated with this > type of device: (1) Skin irritation, skin breakdown and subsequent > infection due to excessive pressure on the skin; (2) head and neck > trauma due to alteration of the functional center of mass of the head > and the additional weight of the device especially with an infant who > is still developing the ability to control his/her head and neck > movements; (3) impairment of brain growth and development from > mechanical restriction of cranial growth; (4) asphyxiation due to > mechanical failure, poor fit, and/or excessive weight that alters the > infant's ability to lift the head; (5) eye trauma due to mechanical > failure, poor construction and/or inappropriate fit; and (6) contact > dermatitis due to the materials used in the construction of the device. > FDA believes that the special controls described below address > these risks and provide reasonable assurance of the safety and > effectiveness of the device. Therefore, on May 29, 1998, FDA issued an > order to the petitioner classifying the cranial orthosis as described > previously into class II subject to the special controls described > below. Additionally, FDA is codifying the classification of this device > by adding new Sec. 882.5970. > In addition to the general controls of the act, the cranial > orthosis is subject to the following special controls in order to > provide reasonable assurance of the safety and effectiveness of the > device: (1) The sale, distribution, and use of this device are > restricted to prescription use in accordance with 21 CFR 801.109; (2) > the labeling of the device must include: (a) Contraindications for the > use of the device on infants with synostosis or with hydrocephalus; ( > warnings indicating the need to: (i) Evaluate head circumference > measurements and neurological status at intervals appropriate to the > infant's age and rate of head growth and to describe steps that should > be taken in order to reduce the potential for restriction of cranial > growth and possible impairment of brain growth and development and (ii) > evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and > to describe steps that should be taken if skin irritation or breakdown > occurs; © precautions indicating the need to: (i) Additionally treat > torticollis, if the positional plagiocephaly is associated with > torticollis; (ii) evaluate device fit and to describe the steps that > should be taken in order to reduce the potential for restriction of > cranial growth, the possible impairment of brain growth and development > and skin irritation and/or breakdown; and (iii) evaluate the structural > integrity of the device and to describe the steps that should be taken > to reduce the potential for the device to slip out of place and cause > asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., > skin irritation and breakdown that have occurred with the use of the > device; (e) clinician's instructions for casting the infant, for > fitting the device, and for care; and (f) parent's instructions for > care and use of the device; (3) the materials must be tested for > biocompatibility with testing appropriate for long term direct skin > contact. > > Kendra in Canada > For more plagio info, visit > www.plagiocephaly.org/support > . > . > . > ----- Original Message ----- > From: Kendra > Plagiocephaly@y... > Sent: Thursday, March 15, 2001 9:47 PM > Subject: Re: Just Wondering...... > > > Niki: > Here is some FDA info for you http://frwebgate.access.gpo.gov/cgi- bin/getdoc.cgi?dbname=1998_register & docid=fr30jy98-13 > also, check Cranial Tech's Information Center for more info. http://www.cranialtech.com/infocenter/infocent.htm > Kendra in Canada > For more plagio info, visit > www.plagiocephaly.org/support > . > . > . > ----- Original Message ----- > From: niki_jay175@y... > Plagiocephaly@y... > Sent: Thursday, March 15, 2001 8:44 PM > Subject: Just Wondering...... > > > I hope I don't cause any trouble here but I was curious about your > opinions here. Why is it so important if the band you are using is > FDA approved or not? I would think that since the band is made from > the head mold, shouldn't it really be the casting process that is > approved by the FDA? Is it even possible to have approval for > something like that? I'm sure I'm sounding like an idiot, but this > is something I was curious about, and I don't fully understand the > FDA's involvement. Any insights? > > Niki > Kaylie & Danny > Phila., PA > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 16, 2001 Report Share Posted March 16, 2001 Niki: Here is some FDA info for you http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1998_register & docid=fr30jy98-13 also, check Cranial Tech's Information Center for more info. http://www.cranialtech.com/infocenter/infocent.htm Kendra in CanadaFor more plagio info, visitwww.plagiocephaly.org/support... ----- Original Message ----- From: niki_jay175@... Plagiocephaly Sent: Thursday, March 15, 2001 8:44 PM Subject: Just Wondering...... I hope I don't cause any trouble here but I was curious about your opinions here. Why is it so important if the band you are using is FDA approved or not? I would think that since the band is made from the head mold, shouldn't it really be the casting process that is approved by the FDA? Is it even possible to have approval for something like that? I'm sure I'm sounding like an idiot, but this is something I was curious about, and I don't fully understand the FDA's involvement. Any insights?NikiKaylie & DannyPhila., PA Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 16, 2001 Report Share Posted March 16, 2001 Niki: Here is SOME info for you....(from the article mentioned in my previous post) .........The device is assigned the generic name ``cranial orthosis,'' and it is identified as a device intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. FDA identified the following risks to health associated with this type of device: (1) Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin; (2) head and neck trauma due to alteration of the functional center of mass of the head and the additional weight of the device especially with an infant who is still developing the ability to control his/her head and neck movements; (3) impairment of brain growth and development from mechanical restriction of cranial growth; (4) asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant's ability to lift the head; (5) eye trauma due to mechanical failure, poor construction and/or inappropriate fit; and (6) contact dermatitis due to the materials used in the construction of the device. FDA believes that the special controls described below address these risks and provide reasonable assurance of the safety and effectiveness of the device. Therefore, on May 29, 1998, FDA issued an order to the petitioner classifying the cranial orthosis as described previously into class II subject to the special controls described below. Additionally, FDA is codifying the classification of this device by adding new Sec. 882.5970. In addition to the general controls of the act, the cranial orthosis is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness of the device: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109; (2) the labeling of the device must include: (a) Contraindications for the use of the device on infants with synostosis or with hydrocephalus; ( warnings indicating the need to: (i) Evaluate head circumference measurements and neurological status at intervals appropriate to the infant's age and rate of head growth and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development and (ii) evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and to describe steps that should be taken if skin irritation or breakdown occurs; © precautions indicating the need to: (i) Additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, the possible impairment of brain growth and development and skin irritation and/or breakdown; and (iii) evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of the device; (e) clinician's instructions for casting the infant, for fitting the device, and for care; and (f) parent's instructions for care and use of the device; (3) the materials must be tested for biocompatibility with testing appropriate for long term direct skin contact. Kendra in CanadaFor more plagio info, visitwww.plagiocephaly.org/support... ----- Original Message ----- From: Kendra Plagiocephaly Sent: Thursday, March 15, 2001 9:47 PM Subject: Re: Just Wondering...... Niki: Here is some FDA info for you http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1998_register & docid=fr30jy98-13 also, check Cranial Tech's Information Center for more info. http://www.cranialtech.com/infocenter/infocent.htm Kendra in CanadaFor more plagio info, visitwww.plagiocephaly.org/support... ----- Original Message ----- From: niki_jay175@... Plagiocephaly Sent: Thursday, March 15, 2001 8:44 PM Subject: Just Wondering...... I hope I don't cause any trouble here but I was curious about your opinions here. Why is it so important if the band you are using is FDA approved or not? I would think that since the band is made from the head mold, shouldn't it really be the casting process that is approved by the FDA? Is it even possible to have approval for something like that? I'm sure I'm sounding like an idiot, but this is something I was curious about, and I don't fully understand the FDA's involvement. Any insights?NikiKaylie & DannyPhila., PA Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 16, 2001 Report Share Posted March 16, 2001 Glad to help, Niki!! ) Kendra in CanadaFor more plagio info, visitwww.plagiocephaly.org/support... ----- Original Message ----- From: niki_jay175@... Plagiocephaly Sent: Thursday, March 15, 2001 9:07 PM Subject: Re: Just Wondering...... Kendra,Thank you so very much for the info! It makes more sense to me now. I guess I'm a little nervous since the twins were casted today, I'm hoping that we are able to get a band that fits right. And thats what got me thinking about approval for casting. Thank you once again! I don't know how you do it, you have so much info to share!Niki> Niki:> Here is SOME info for you....(from the article mentioned in my previous post)> ........The device is assigned the generic name ``cranial orthosis,'' and > it is identified as a device intended for use on infants from 3 to 18 > months of age with moderate to severe nonsynostotic positional > plagiocephaly, including infants with plagiocephalic-, brachycephalic-, > and scaphocephalic-shaped heads. The device is intended for medical > purposes to apply pressure to prominent regions of an infant's cranium > in order to improve cranial symmetry and/or shape.> FDA identified the following risks to health associated with this > type of device: (1) Skin irritation, skin breakdown and subsequent > infection due to excessive pressure on the skin; (2) head and neck > trauma due to alteration of the functional center of mass of the head > and the additional weight of the device especially with an infant who > is still developing the ability to control his/her head and neck > movements; (3) impairment of brain growth and development from > mechanical restriction of cranial growth; (4) asphyxiation due to > mechanical failure, poor fit, and/or excessive weight that alters the > infant's ability to lift the head; (5) eye trauma due to mechanical > failure, poor construction and/or inappropriate fit; and (6) contact > dermatitis due to the materials used in the construction of the device.> FDA believes that the special controls described below address > these risks and provide reasonable assurance of the safety and > effectiveness of the device. Therefore, on May 29, 1998, FDA issued an > order to the petitioner classifying the cranial orthosis as described > previously into class II subject to the special controls described > below. Additionally, FDA is codifying the classification of this device > by adding new Sec. 882.5970.> In addition to the general controls of the act, the cranial > orthosis is subject to the following special controls in order to > provide reasonable assurance of the safety and effectiveness of the > device: (1) The sale, distribution, and use of this device are > restricted to prescription use in accordance with 21 CFR 801.109; (2) > the labeling of the device must include: (a) Contraindications for the > use of the device on infants with synostosis or with hydrocephalus; ( > warnings indicating the need to: (i) Evaluate head circumference > measurements and neurological status at intervals appropriate to the > infant's age and rate of head growth and to describe steps that should > be taken in order to reduce the potential for restriction of cranial > growth and possible impairment of brain growth and development and (ii) > evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and > to describe steps that should be taken if skin irritation or breakdown > occurs; © precautions indicating the need to: (i) Additionally treat > torticollis, if the positional plagiocephaly is associated with > torticollis; (ii) evaluate device fit and to describe the steps that > should be taken in order to reduce the potential for restriction of > cranial growth, the possible impairment of brain growth and development > and skin irritation and/or breakdown; and (iii) evaluate the structural > integrity of the device and to describe the steps that should be taken > to reduce the potential for the device to slip out of place and cause > asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., > skin irritation and breakdown that have occurred with the use of the > device; (e) clinician's instructions for casting the infant, for > fitting the device, and for care; and (f) parent's instructions for > care and use of the device; (3) the materials must be tested for > biocompatibility with testing appropriate for long term direct skin > contact.> > Kendra in Canada> For more plagio info, visit> www.plagiocephaly.org/support> .> .> .> ----- Original Message ----- > From: Kendra > Plagiocephaly@y... > Sent: Thursday, March 15, 2001 9:47 PM> Subject: Re: Just Wondering......> > > Niki:> Here is some FDA info for you http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1998_register & docid=fr30jy98-13> also, check Cranial Tech's Information Center for more info. http://www.cranialtech.com/infocenter/infocent.htm> Kendra in Canada> For more plagio info, visit> www.plagiocephaly.org/support> .> .> .> ----- Original Message ----- > From: niki_jay175@y... > Plagiocephaly@y... > Sent: Thursday, March 15, 2001 8:44 PM> Subject: Just Wondering......> > > I hope I don't cause any trouble here but I was curious about your > opinions here. Why is it so important if the band you are using is > FDA approved or not? I would think that since the band is made from > the head mold, shouldn't it really be the casting process that is > approved by the FDA? Is it even possible to have approval for > something like that? I'm sure I'm sounding like an idiot, but this > is something I was curious about, and I don't fully understand the > FDA's involvement. Any insights?> > Niki> Kaylie & Danny> Phila., PA> > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 16, 2001 Report Share Posted March 16, 2001 Niki, We went with the FDA approved band because we were told by one of our doctors that our insurance would be more likely to approve something that was FDA approved. I am not sure about other insurance companies. We are military and therefore have Tricare. Hope this helps a little. Johanna Tatijana's mom 06/26/99 banded 01/29/01 > > ----- Original Message ----- > > From: niki_jay175@y... > > Plagiocephaly@y... > > Sent: Thursday, March 15, 2001 8:44 PM > > Subject: Just Wondering...... > > > > > > I hope I don't cause any trouble here but I was curious about >your > > opinions here. Why is it so important if the band you are >using is > > FDA approved or not? I would think that since the band is made >from > > the head mold, shouldn't it really be the casting process that >is > > approved by the FDA? Is it even possible to have approval for > > something like that? I'm sure I'm sounding like an idiot, but >this > > is something I was curious about, and I don't fully understand >the > > FDA's involvement. Any insights? > > > > Niki > > Kaylie & Danny > > Phila., PA > > > > > > > > Quote Link to comment Share on other sites More sharing options...
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