| Frequently
Asked Questions by Orthotists |
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What
types of cranial remolding orthoses are available from Orthomerica?
What
head shapes are most commonly treated with cranial remolding orthoses?
What
abnormal shapes and conditions are contraindicated for cranial remolding
orthoses?
What
is the difference between cranial remolding orthoses and other orthoses
such as cervical/spinal orthoses that I can order or fabricate in
my own facility?
What
type of regulatory controls are required to manufacture cranial
remolding orthoses [Class II devices]?
What
materials are used to fabricate a STARband?
What
materials are used to fabricate a STARlight?
What
materials are used to fabricate a Clarren Helmet?
Can
a practitioner request a design change?
What
transfer pattern options are available for the STARband?
What
is the turnaround time to fabricate any of the cranial remolding
orthoses?
How
do I order a cranial remolding orthosis from Orthomerica?
What
information will be included when you send me a custom STARband,
STARlight or Clarren cranial remolding orthosis?
What
type of clinical support does Orthomerica provide?
What
happens if a parent contacts Orthomerica directly about the care
their infant is receiving from an orthotist?
How
can I tell if it is time to end the cranial remolding orthosis treatment
program?
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What
types of cranial remolding orthoses are available from Orthomerica?
Cranial remolding orthoses are also referred to as bands, headbands
and/or helmets. Orthomerica has received FDA clearance to manufacture
three distinct styles of cranial remolding orthoses: |
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STARband—The
STARband is considered an active orthotic design and requires
consistent follow-up and ongoing adjustments to maximize outcomes.
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STARlight—Three
different designs made of clear plastic with strategically placed
padding including:
(1) Side-opening band
(2) Full cap
(3) Bi-valved
The STARlight designs are considered active systems and require
consistent follow-up and ongoing adjustments to maximize outcomes.
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Clarren—The
Clarren Helmet is considered a passive design, fits a bit looser
initially, and is held in place with a padded chinstrap. Consistent
follow-up and adjustments maximize outcomes. |
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What
head shapes are most commonly treated with cranial remolding orthoses?
Plagiocephaly, brachycephaly and scaphocephaly are the most common
head shapes. Evaluation of the specific head shape and treatment program
will determine which orthotic design will best meet the needs of the
infant. |
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What
abnormal shapes and conditions are contraindicated for cranial remolding
orthoses?
Craniosynostosis cannot be treated directly with a cranial remolding
orthosis. However, following corrective surgery to relieve the craniosynostosis,
a cranial remolding orthosis may be used once the affected suture(s)
has been removed. Uncontrolled hydrocephalus is also a contraindication
due to excessive volume changes. |
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What
is the difference between cranial remolding orthoses and other orthoses
such as cervical/spinal orthoses that I can order or fabricate in
my own facility?
Most O&P devices are categorized as Class I devices by the Food and
Drug Administration (FDA) and are exempt from many regulatory controls.
Class II and Class III devices are subject to significant regulatory
controls. Since 1998, cranial remolding orthoses have been classified
as Class II devices. Only companies that have submitted an application
(Form 510(k)) to the FDA and received written FDA clearance to manufacture
these devices may fabricate cranial remolding orthoses. |
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What
type of regulatory controls are required to manufacture cranial
remolding orthoses [Class II devices]?
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Strict
manufacturing documentation. |
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Physical
or electronic storage of molds. |
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Engineering,
risk analyses, verification and validation studies. |
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Extensive
labeling information. |
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High
level of technical skill development and training. |
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Recurring
audits by the FDA to demonstrate compliance. |
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Strict
CAPA (Corrective Action & Preventive Action) programs are mandatory. |
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Strict
Problem Reporting Systems are mandatory. |
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Must
be an FDA registered medical device manufacturer and be fully
compliant with its Quality System Regulation (QSR) and Current
Good Manufacturing Practices (CGMP). |
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What
materials are used to fabricate a STARband?
The
STARband is manufactured from a modified mold or unmodified
mold, cast, or scan provided by the orthotist. Modification
specifications are determined by the treating orthotist. Material
and design considerations include:
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3/8"
copolymer outer shell |
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1/2"
polyethylene foam liner |
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1
1/2" white Velcro® strap and chafe |
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Lateral
slot with polyethylene foam filler to maintain total contact
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Orthomerica
star on posterior side of orthosis |
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Optional
decorative patterns, caricatures, and solid colors |
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What
materials are used to fabricate a STARlight?
The STARlight designs are manufactured from a modified mold
or unmodified mold, cast, or scan provided by the orthotist.
Modification specifications are determined by the treating orthotist.
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| Material
and design considerations for the STARlight
side-opening include: |
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1/4"
clear plastic shell |
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Strategic
padding |
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1
1/2" white Velcro®strap and chafe |
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Lateral
slot |
Material and design considerations for the full STARlight
cap include: |
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1/4"
clear plastic shell |
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Strategic
padding |
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Full-form
design without any proximal or side openings |
Material and design considerations for the STARlight
bi-valve include: |
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1/4"
clear plastic anterior and posterior shells |
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Strategic
padding |
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Proximal
sliding mechanism |
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1"
white Velcro® strap and chafe |
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Full-form
design without any proximal or side openings |
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What
materials are used to fabricate a Clarren
Helmet?
The Clarren Helmet is manufactured from a modified mold or unmodified
mold, cast, or scan. Modification specifications are determined
by the treating orthotist. Material and design considerations
include:
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3/8"
polypropylene outer shell |
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1/8"
Aliplast foam liner |
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Ventilation
holes |
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Padded
chinstrap |
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Full-form
design without any proximal, side or ear openings |
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Can
a practitioner request a design change?
Orthomerica
is restricted to fabricating the design detailed in the 510(k) application,
as described above. Minor changes may be accommodated such as liner
options, pattern transfers, etc. as long as they do not raise safety
or effectiveness issues. Each design change or option requested must
be evaluated and carefully documented to ensure the integrity of the
basic design and compliance with FDA guidelines
are never compromised. |
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What
transfer pattern options
are available for the STARband?
Random pattern transfer designs
No transfer (plain) |
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What
is the turnaround time to fabricate any of the cranial remolding orthoses?
Turnaround time is 3-5 business days once Orthomerica receives the
completed paperwork and cast impression or scan. Remember, any style
of cranial orthosis must be fit within 10-14 days of casting or scanning.
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How
do I order a cranial remolding orthosis from Orthomerica?
First, Orthomerica recommends that practitioners attend one of our
cranial remolding orthosis seminars or have previous cranial remolding
experience or before ordering an orthosis for a patient. To order
a cranial remolding orthosis, send a completed Orthomerica Cranial
Remolding Orthosis Order Form indicating which style of orthosis
you desire, along with your modified/unmodified cast impression
or STARscan to the Custom Fabrication Department at Orthomerica.
You can contact the Custom Fabrication Department by Phone: 877.737.8444,
or Fax: 877.737.8445.
If
an unmodified cast or STARscan is sent, default modifications procedures
will be provided to obtain a symmetrical or nearly symmetrical shape,
depending upon the severity of the initial head deformation. If
you have specific modification criteria, please call Orthomerica's
Custom Fabrication Department to discuss prior to the fabrication
of your cranial remolding orthosis.
Your
modified cast impression should reveal your desired trimlines. These
trimlines will be followed within the guidelines of our FDA restrictions.
The integrity of the design must be maintained in conformance with
the functional performance identified in the documented 510(k) technical
package.
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What
information will be included when you send me a custom STARband,
STARlight or Clarren cranial remolding orthosis?
With
each order, Orthomerica will include labeling information, as
required by FDA regulations, and support materials, such as:
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Warnings
and contraindications |
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Order
form and patient information sheet |
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Casting
instructions |
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Tips
for trimlines |
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Directions
for fitting and improving the fit |
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Skin
check and troubleshooting information |
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Adjustment
information |
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Caregiver
instructions |
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What
type of clinical support does Orthomerica provide?
Orthomerica has three ABC certified orthotists on staff, as well as,
an experienced team of customer service representatives, and skilled
technicians that specialize in cranial remolding orthoses. This team
of Orthomerica professionals is available to assist you with any clinical
questions or concern you may have throughout the process of casting,
scanning, ordering, fitting, or adjusting the
orthosis for your patient's cranial remolding orthosis treatment program.
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What
happens if a parent contacts Orthomerica directly about the care their
infant is receiving from an orthotist?
Parents are directed back to their orthotist to address specific questions
about their infant's care. If the parent requests that one of the
clinical staff contact the orthotist, the parent must provide written
permission to allow the communication between Orthomerica and the
orthotist. In this matter, Orthomerica maintains strict compliance
with the Privacy Regulations delineated in HIPAA and
diligently protects all patients' Personal Health Information. |
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How
can I tell if it is time to end the cranial remolding orthosis treatment
program?
Generally, treatment is discontinued when any remaining asymmetry
is so mild that it would not require treatment with a cranial remolding
orthosis and the parents, physician, and orthotist are happy with
the infant's head shape. Measurements taken at the beginning and throughout
treatment will provide documentation for the changes that have occurred.
Parents should meet with the referring physician before treatment
is discontinued. |
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