Requesting Speakers from CDRH

The following explains the process for requesting speakers from the Center for Devices and Radiological Health (CDRH) to participate in meetings, conferences, and workshops which are being sponsored by outside organizations.

Where to Send Requests:

By Email: CDRHSpeakerLiaison@fda.hhs.gov

By Fax: 301-847-8142

Or Mail to:
FDA/CDRH/OCER
Attn: CDRH Speaker Liaison
10993 New Hampshire Ave, WO66 RM 4321
Silver Spring, MD 20993

Requests for speakers must be submitted at least 4 months in advance from the actual date of the event.

Note: If the event also includes invitations to staff from the Office of the Commissioner, other FDA Centers or the Office of Regulatory Affairs (ORA), the request should be addressed to:

FDA Office of External Relations/Office of the Commissioner
Attn: Kenneth Nolan
10903 New Hampshire, WO32 RM5314
Silver Spring, MD 20993
Email: Kenneth.Nolan@fda.hhs.gov
Fax: 301-595-7932

 

What to Include in Your Request to CDRH:

• Name, Date, and Location, of the Meeting
• Name of Organization(s) Sponsoring the Meeting
• Copy of the Invitation Letter
• Topic of Speaker’s Presentation and Desired Length of Presentation
• Targeted Audience and Expected Number of Attendees
• Organization Contact Information (Name, Phone/Fax Number, Email)
• Complete Program Agenda with all Invited Speaker(s) and Topic(s) (draft acceptable)
• Specify Media Coverage (i.e., general media and/or trade press)
• Other Information Pertinent to the Meeting

 

What Happens After Your Request Has Been Submitted?

The appropriate office(s) within CDRH will be contacted by the CDRH speaker liaison to determine the appropriate speaker. If additional details are needed, the speaker liaison will work with the requesting organization to collect the necessary information that is needed.

Some of the factors which may be used by Center management in considering requests are: timeliness of the topic, availability of staff, geographical location of meeting, targeted audience, expected number of attendees, and availability of funds to cover travel costs (if necessary).

Once a determination has been made, the speaker liaison will provide the official notification of CDRH participation to the requesting organization.
 

Article source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm304631.htm

Zithromax (azithromycin): FDA Statement on risk of cardiovascular death

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Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)

Este informe actualizado se hace en seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso de Revlimid (lenalidomida) y el posible aumento en el riesgo de nuevas neoplasias (en inglés) del 8/4/2011.

Anuncio de seguridad
Información adicional para pacientes
Información adicional para profesionales de la salud
Resumen de datos
 

Anuncio de seguridad

El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revlimid (lenalidomida). Las pruebas clínicas realizadas tras la aprobación de Revlimid mostraron que los pacientes que tomaron Revlimid y habían recibido un diagnóstico reciente, tuvieron un riesgo mayor de segundas neoplasias primarias en comparación con pacientes similares que tomaron un placebo. Específicamente, estas pruebas mostraron que hubo un riesgo adicional de tener leucemia mielógena aguda, síndromes mielodisplásicos y linfoma de Hodgkin.

 

Esta información de seguridad ha sido agregada a la sección de Advertencias y Precauciones en la etiqueta del medicamento Revlimid. La Guía del Medicamento para el paciente también ha sido actualizada para informar a los pacientes sobre este riesgo.

Los profesionales de la salud. deben tener en cuenta el beneficio potencial de Revlimid junto con el riesgo de segundas neoplasias primarias al momento de decidir usar este medicamento en el tratamiento, y observar a los pacientes con respecto a este riesgo.

Los pacientes deben consultar con su profesional de la salud si tienen preguntas o inquietudes sobre Revlimid.

En abril del 2011, la FDA anunció que se estaba realizando un estudio de seguridad para evaluar la posibilidad de un aumento en el riesgo de segundas neoplasias primarias con Revlimid. La FDA realizó una revisión completa de este asunto de seguridad (ver Resumen de datos abajo).

Información adicional para pacientes

• Debe saber que, en pruebas clínicas con pacientes que recibieron un diagnóstico reciente de mieloma múltiple, los que tomaron Revlimid tuvieron un riesgo mayor de nuevos cánceres, en particular, leucemia mielógena aguda, síndromes mielodisplásicos y linfoma de Hodgkin, en comparación con los pacientes que tomaron un placebo.
• Consulte con su profesional de la salud si tiene preguntas o inquietudes sobre Revlimid.
• Lea la Guía del Medicamento que acompaña su receta de Revlimid.
• Reporte cualquier efecto secundario con Revlimid al programa MedWatch de la FDA, usando la información en la sección “Contáctenos” en la parte inferior de la página.

Información adicional para profesionales de la salud

• Debe saber que, en pruebas clínicas con pacientes que recibieron un diagnóstico reciente de mieloma múltiple, los que tomaron Revlimid tuvieron un riesgo mayor de segundas neoplasias primarias, en particular, leucemia mielógena aguda, síndromes mielodisplásicos y linfoma de Hodgkin, en comparación con los pacientes que tomaron un placebo.
• Observe a los pacientes que toman Revlimid para detectar segundas neoplasias primarias.
• Tome en cuenta tanto el beneficio potencial de Revlimid y el riesgo de segundas neoplasias primarias al decidir un tratamiento con Revlimid.
• Aliente a los pacientes a leer la Guía del Medicamento cuando reciban su receta de Revlimid.
• Reporte cualquier efecto adverso con Revlimid al programa MedWatch de la FDA, usando la información en la sección “Contáctenos” en la parte inferior de la página.

Resumen de datos

La FDA estudió las pruebas clínicas de Revlimid como terapia de mantenimiento en pacientes con mieloma múltiple recientemente diagnosticado y para el tratamiento de mieloma múltiple recurrente/ refractario, para evaluar el riesgo de segundas neoplasias primarias con Revlimid

Segundas neoplasias primarias en pacientes con mieloma múltiple de diagnóstico reciente

En tres pruebas al azar, prospectivas, los pacientes con un diagnóstico reciente de mieloma múltiple recibieron quimioterapia inicial o quimioterapia junto con trasplante de células madre sanguíneas, seguida por un tratamiento con Revlimid o un placebo. Este protocolo de tratamiento fue usado para estudiar el efecto de Revlimid como terapia de mantenimiento. En un análisis conjunto de las pruebas en curso que se están realizando, hasta el 28 de febrero del 2011 se detectaron 65 segundas neoplasias primarias en 824 pacientes recibiendo el tratamiento con Revlimid, en comparación con 19 segundas neoplasias primarias en 665 pacientes en el tratamiento que no incluyó mantenimiento con Revlimid (7,9% vs. 2,8%; p0,001). Esto muestra casi el triple de nuevas neoplasias en los grupos que recibieron Revlimid en comparación con los grupos que no recibieron Revlimid. Entre las segundas neoplasias primarias se detectaron leucemia mielógena (AML por sus siglas en inglés), síndromes mielodisplásicos (MDS por sus siglas en inglés) y cáncer de células B. En total, 30 (3,6%) cánceres hematológicos primarios segundos fueron reportados en el grupo tratado con Revlimid (22 MDS/AML, 5 linfomas de Hodgkin, 3 casos de leucemia linfoblástica aguda de células B) en comparación con 2 (0,3%) casos de AML en los grupos de estudio que no recibieron Revlimid. El lapso medio entre el inicio de Revlimid y el diagnóstico de una segunda neoplasia primaria fue dos años. En base a los datos disponibles, parece que no hay diferencia en la incidencia de cánceres de la piel que no son melanoma, o tumores sólidos entre los pacientes que recibieron Revlimid y los que no lo recibieron.

Segundas neoplasias primarias en pacientes con mieloma múltiple recurrente/refractario

Un análisis retrospectivo de varios estudios de segundas neoplasias primarias también fue realizado respecto a datos derivados de dos pruebas clínicas que sirvieron de sustento para la aprobación inicial de la FDA para mieloma múltiple recurrente. Fueron pruebas multicéntricas, de doble ciego, con un grupo de control con placebo, pruebas grupales en paralelo de terapia con Revlimid y más altas dosis de dexametasona, versus solo dexametasona, para tratar a pacientes con mieloma múltiple recurrente o refractario. Las tasas de incidencia de segundas neoplasias primarias durante la fase de tratamiento de estas pruebas fue 3,98 y 1,38 por cada 100 años-persona para pacientes en los grupos de Revlimid/dexametasona y placebo/dexametasona, respectivamente. La incidencia más alta de segundas neoplasias primarias en el grupo Revlimid/dexametasona se explicó por la mayor incidencia de cánceres de la piel que no eran melanoma con Revlimid (2,4 vs. 0,91 por 100 años-persona para los grupos de Revlimid/dexametasona y placebo/dexametasona, respectivamente). El tratamiento de los pacientes en el grupo Revlimid/dexametasona fue estudiado por más tiempo en comparación con el grupo placebo/dexametasona (467 años-persona vs. 218,7 años-persona, respectivamente). Cuando se prorratearon las diferencias en el tiempo de estudio observado, la tasa de incidencia de cánceres de la piel no invasivos que no eran melanoma, no era significativamente diferente entre los dos grupos (1,71 vs. 0,91 por 100 años-persona, respectivamente).

 

Contáctenos

 

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20857

Article source: http://www.fda.gov/Drugs/DrugSafety/ucm304391.htm

Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)

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FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

This update is in follow-up to the FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod) on 12/20/2011.

Safety Announcement
Data Summary

Safety Announcement

[05-14-2012] The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod).  The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.  FDA could not definitively conclude that Gilenya was related to any of the deaths (see Data Summary, below). However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients (See Data Summary).  

For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. See CONTRAINDICATION section of the drug label.

FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose.  FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya.  Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period.  Cardiovascular monitoring should continue until any symptoms resolve.

In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia.   Extended monitoring should include continuous ECG monitoring that continues overnight. See DOSAGE AND ADMINISTRATION section of the drug label. These higher risk patients include those:

• Who develop severe bradycardia after administration of the first dose of Gilenya
• With certain pre-existing conditions in whom bradycardia may be poorly tolerated
• Receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
• With QT interval prolongation (a type of heart rhythm abnormality) prior to starting Gilenya, or at any time during the cardiovascular monitoring period
• Receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes

Healthcare professionals are encouraged to review the updated drug label for Gilenya [ADD LINK] and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.

Patients should not stop taking Gilenya without talking to their healthcare professional. They should contact their healthcare professional and seek immediate care if they develop dizziness, tiredness, irregular heart beat, or palpitations–signs of a slowing heart rate. FDA continues to believe that the benefits of treatment with Gilenya outweigh its potential risks when it is used as described in the updated drug label.

FDA will update the public if any additional information on the cardiovascular risks of Gilenya becomes available.
 

Data Summary

In December 2011, FDA issued a Drug Safety Communication (DSC) concerning a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).  Based on the reported information, a cause of death could not be identified.  The patient also had extensive brainstem MS lesions; such lesions have been associated with sudden death.  The patient was also taking two blood pressure medications (metoprolol and amlodipine), which can also affect heart rate; whether they could have played a role in the patient’s death is unknown.  On the basis of the available data, a link between the first dose of Gilenya and the patient’s death could not be ruled out, however, there is not clear evidence that the drug played any role in the death.

After receipt of this case, FDA re-evaluated clinical trial data related to the effects of Gilenya on heart rate and blood pressure, including data from trials that were ongoing at the time the drug was approved by FDA.  Analyses of changes in heart rate by 24 hour Holter monitoring confirmed that the heart rate-lowering effect of Gilenya is biphasic, with an initial decrease within 6 hours, and a second decrease, in part related to a circadian rhythm, around 12 to 20 hours post-dose. In order to allow an adequate response to possible severe symptomatic bradycardia in the 6- to 24-hour period after the first dose, FDA concluded that it would be prudent to extend the monitoring period beyond 6 hours in patients who experience a heart rate of less than 45 beats per minute in the first 6 hours, or in those who had their lowest heart rate at 6 hours post-dose, as further bradycardia is still possible after 6 hours.  In addition, in order to reduce the risks related to bradycardia or atrioventricular block, extended monitoring is now recommended in patients with certain pre-existing conditions, such as QT prolongation, and in patients receiving concurrent drugs that slow the heart rate or atrioventricular conduction.  

FDA also reviewed postmarket data reported for Gilenya, including other deaths from apparent cardiovascular origin or of unknown origin.  For each of these deaths, Gilenya’s contribution to the death was unclear.  The number of deaths of apparent cardiovascular origin or of unknown origin does not appear to be higher than in MS patients not treated with Gilenya.

In light of the findings of the clinical trial data and postmarketing data, including all reported deaths of cardiovascular or unknown origin, FDA has revised the Gilenya drug label with specific recommendations for monitoring patients and with new contraindications for use of Gilenya in certain patients.  

FDA will communicate any important new information about the cardiovascular safety of Gilenya when it becomes available.

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Article source: http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall

 

[Posted 05/14/2012]

AUDIENCE: Risk Manager, Consumer

ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/12/2012 - Press Release - Hospira, Inc.]

Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304044.htm

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

Date Issued: May 10, 2012

Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs).

Medical Specialty: Neurology, Interventional Radiology, Vascular Surgery.

Purpose: The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.

This communication is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.

Summary of Problem and Scope: MS is a progressive, immune-mediated disorder of the brain and spinal cord.  In this disorder, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms.

The underlying cause of MS is not known. Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord. This narrowing of neck and chest veins has been called CCSVI.

Studies exploring a link between MS and CCSVI are inconclusive. Some studies have suggested a link exists, while others have found no such connection.  At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS. In addition, the criteria used to diagnose CCSVI have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.

Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins. This procedure is sometimes called “liberation therapy” or the “liberation procedure”.

The FDA believes that using these medical devices in CCSVI treatment procedures poses a risk to patients because:

• There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.
• Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.
• The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.
• There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.
• It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.

The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.

Adverse Events: CCSVI procedures have been associated with serious, even fatal, complications.  The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment. Other serious complications of the CCSVI procedure reported primarily as individual incidents or case series in medical journals include: at least one death, stents migrating from their original location to another part of the body (including the heart), venous injury, blood clots forming in the jugular vein or in stents, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding. The frequency of these serious complications is not known.

Recommendations:

For People with Multiple Sclerosis:

• Be aware that there is lack of clear evidence of the existence of CCSVI. Furthermore, the link between CCSVI and MS and the safety and effectiveness of the CCSVI treatment procedure in MS patients has not been established.
• You should know that serious complications can occur as a result of CCSVI treatment procedures. Before you have any CCSVI procedure, discuss with your physician or other health care provider the signs and symptoms of such complications. If you have the procedure and you develop any of the signs or symptoms of a complication, contact your health care provider immediately.
• Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).
• If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.
• If you are considering participating in a clinical trial for CCSVI, learn as much as possible about the clinical trial and ask questions of the health care team conducting the trial. Read the informed consent document carefully, and ask for an explanation of anything you do not understand.  You can find additional information and recommended questions to ask your health care team on the Understanding Clinical Trials page of www.clinicaltrials.gov.
• If you undergo treatment for CCSVI and experience a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

For Physicians and Care Providers:

• Inform patients of the following concerns:
  • there is conflicting evidence about CCSVI as a clinical entity;
  • CCSVI’s relationship to MS is scientifically unproven; and
  • consensus on the diagnostic criteria of CCSVI has not been reached.
• You should be aware the FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and use of such devices in treating CCSVI are considered off-label at this time. While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject.
• Discuss the risks of CCSVI treatment with potential patients, including both the adverse events generally associated with catheter-guided endovascular intervention and those related specifically to use of balloon angioplasty devices or venous stenting for CCSVI.
• If your patient experiences a complication following CCSVI treatment, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

For Clinical Investigators and Institutional Review Boards (IRBs):

• The FDA has determined that investigations of medical devices for use in CCSVI treatment are significant risk studies.  Clinical studies of significant risk medical devices, such as in the case of balloon angioplasty devices and stents to treat CCSVI, require approval through an IRB and the FDA’s Investigational Device Exemption (IDE) program. The IDE regulations help ensure the rights, safety and welfare of patients are protected during these studies and that the risks are as low as possible and are balanced by any potential benefits.
• The FDA encourages clinical investigators to discuss trial design with the FDA in the early planning phase, through both the formal pre-IDE process and less formal meetings and conferences.
• If a patient in an IDE study experiences a complication related to the CCSVI treatment, sponsors and clinical investigators must comply with applicable adverse event recordkeeping and reporting requirements under the FDA’s IDE regulations.

FDA Activities:

The FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without an approved IDE. Because the FDA currently considers clinical studies evaluating CCSVI treatment with balloon angioplasty devices and/or stents to be significant risk, this study was in violation of the FDA’s regulations. The sponsor/investigator has reported the study has been voluntarily closed.

The FDA will continue to monitor for adverse events related to medical devices commonly used in CCSVI treatment (e.g. angioplasty devices and stents) and take action when appropriate.

The FDA will continue to monitor this situation and keep the public informed as new information becomes available.

Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

Article source: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm

Pediatric X-ray Imaging

• Description
• Benefits/Risks
• FDA’s Role and Activities
  • FDA Initiatives in Radiation Protection of Pediatric Patients
  • Medical Community and Industry Activities
• Information for Patients and Parents
• Information for Health Care Providers
  • Principles of Radiation Protection
  • Resources for Radiation Protection of Pediatric Patients
  • Regulations and Guidelines Pertaining to Imaging Facilities and Personnel
• Information for Industry
• Reporting Problems to FDA

---

 

Computed tomography (CT), fluoroscopy, and radiography (conventional X-ray) all use ionizing radiation to generate images of the body. Ionizing radiation is a form of radiation that has enough energy to potentially cause damage to DNA and may elevate a person’s lifetime risk of developing cancer.

CT, radiography, and fluoroscopy all work on the same basic principle: an X-ray beam is passed through the body where a portion of the X-rays are either absorbed or scattered by the internal structures, and the remaining X-ray pattern is transmitted to a detector for recording or further processing by a computer. These exams differ in their purpose:

• Radiography – a single image is recorded for later evaluation.
• Fluoroscopy – a continuous X-ray image is displayed on a monitor, allowing for real-time monitoring of a procedure or passage of a contrast agent, or “dye” through the body. Fluoroscopy can result in relatively high radiation doses, especially for interventional procedures (such as placing catheters, or other devices inside the body) which require fluoroscopy be administered for a long period of time.
• CT – many X-ray images are recorded as the detector moves around the patient’s body. A computer reconstructs all the individual images into cross-sectional images or “slices” of internal organs and tissues. A CT exam involves a higher radiation dose than conventional radiography because the CT image is reconstructed from many individual X-ray projections.

 

Benefits/Risks

X-ray imaging exams are recognized as a valuable medical tool for a wide variety of examinations and procedures including:

• noninvasive and painless diagnosis of disease and monitoring of therapy;
• support of medical and surgical treatment planning; and
• interventional procedures such as placing catheters, stents, or other devices inside the body, or removing blood clots or other blockages.

The individual risk from a necessary imaging exam is generally quite small when compared to the benefit of helping with accurate diagnosis or intervention. Risks from X-ray imaging include risks from exposure to ionizing radiation and possible reactions to the intravenous contrast agent, or “dye” that is sometimes used to improve visualization.

Types of radiation risks include:

• tissue effects such as cataracts, skin reddening, and hair loss, which occur at relatively high levels of radiation exposure and are very rare in children; and
• a small increase in the possibility that a person exposed to X-rays will develop cancer later in life. Radiation-induced cancer risks depend on the radiation dose, the patient’s age at exposure, the sex of the patient (women are more radiosensitive than men), and the organ irradiated.

While the benefit of a clinically appropriate X-ray imaging exam generally far outweighs the risk, efforts should be made to minimize this risk by reducing unnecessary exposure to ionizing radiation. Ionizing radiation exposure to pediatric patients from medical imaging procedures is of particular concern because pediatric patients:

• are more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher);
• have a longer expected lifetime for any effects of radiation exposure to manifest as cancer; and
• use of equipment and exposure settings designed for adults may result in excessive radiation exposure if used on smaller patients.

The medical community has emphasized dose reduction in CT because of the relatively high doses of CT exams and their increased use, as reported in the National Council on Radiation Protection and Measurements (NCRP) Report No. 160 . However, the increased radiosensitivity of pediatric patients compared to adults makes it important to adjust equipment settings to optimize radiation exposure to pediatric patients for all types of X-ray imaging exams.

If there is a medical need for a particular imaging procedure and other exams using no or less radiation are unsuitable, then the benefits exceed the risks, and radiation risk considerations should not influence the physician’s decision to perform the study or the patient’s decision to have the procedure. However, “As Low as Reasonably Achievable” (ALARA) principles should always be followed when choosing equipment settings to minimize radiation exposure to the pediatric patient.

 

FDA’s radiological health program has a long history of protecting the public from harms of radiation through regulation, research and outreach. For example, the FDA issued a FDA Consumer Update article in 2008 on the extra care needed for radiological imaging for children. As a result of the increasing exposure of the U.S. population to ionizing radiation from medical imaging highlighted in the National Council on Radiation Protection and Measurements (NCRP) Report No. 160 , the FDA has bolstered its efforts in radiation protection in medical imaging, particularly for pediatric patients.

FDA’s goals are to:

• encourage manufacturers to address pediatric safety issues in improvements for X-ray imaging devices; and
• provide health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on pediatric patients.

As well as working with manufacturers and imaging experts to improve x-ray imaging devices, the agency is engaged in broad outreach efforts to incorporate radiation protection principles into facility quality assurance and personnel credentialing and training requirements.

The FDA seeks to lessen the burden necessary for medical professionals to safely use X-ray imaging devices on pediatric patients by:

• encouraging manufacturers (through publication of FDA guidance) to consider radiation safety of pediatric populations in the design of new X-ray imaging devices; and
• encouraging discussions among manufacturers and pediatric imaging experts on improvements to device design and instructions for use.

When final, the guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications” will apply only to new devices. However, the FDA encourages manufacturers to provide technical assistance to health care professionals on how to appropriately use currently marketed general use X-ray imaging devices on pediatric patients.

Facilities should look for special pediatric use features when purchasing new X-ray imaging equipment, but should be aware that their current equipment, which may lack special pediatric features or instructions, may still be in use for many years. FDA is not suggesting that facilities immediately replace their older equipment. Instead, imaging team members (e.g., physician, radiologic technologist, and medical physicist), should work together to appropriately configure older equipment for use on pediatric patients. Organizations such as the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) provide free instructional materials on how to safely use X-ray imaging equipment on children. FDA has reviewed ARSPI’s instructional materials and believes they are appropriate. Hospital administrators should make radiation safety of pediatric patients a priority by actively encouraging their staff to make use of this information.

Examples of FDA medical radiation protection activities include:

• “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging,” released February 2010. The focus of the initiative is the high-dose modalities (CT, fluoroscopy, and nuclear medicine); however, conventional X-ray exams, while comparatively low dose, are of special concern for the pediatric population because they are performed much more frequently.
• Public meeting entitled “Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging” (March 30-31, 2010). Experts commented that many radiological devices are sold without the design features or labeling information necessary to allow the user to optimize benefit (clinically usable images) vs. risk (radiation exposure) for pediatric imaging. The recommendations received by FDA, which apply to all general-use X-ray imaging exams, included making available:
  • pediatric protocols and control settings;
  • targeted instructions and educational materials emphasizing pediatric dose reduction;
  • quality assurance tools for facilities emphasizing radiation dose management; and
  • dose information applicable to pediatric patients.
• Draft guidance for manufacturers entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications” (which, once final, will only apply to new X-ray imaging devices, including CT, fluoroscopy, and general and dental radiography). The purpose of the guidance is to encourage manufacturers to consider radiation safety of pediatric populations in the design of X-ray imaging devices. A public meeting entitled “Device Improvements for Pediatric X-ray Imaging” (July 16, 2012) will be held to solicit comment on the draft guidance and broader radiation safety issues for use of X-ray imaging devices on pediatric populations.
• Collaborations with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and industry (through the Medical Imaging and Technology Alliance (MITA)) to develop educational tools and training materials to reduce dose to pediatric patients. The Image Gently/FDA Digital Radiography Safety Checklist is now available. Ongoing collaborative efforts include a survey of technique factors for pediatric digital radiography and an FDA-funded project to develop training materials for radiation safety in pediatric fluoroscopy.

 

Medical Community and Industry Activities

Efforts to protect pediatric patients from unnecessary radiation exposure during X-ray imaging procedures are not new. Some activities include:

• The Society for Pediatric Radiology has addressed safety issues in pediatric imaging by holding ALARA conferences on: CT (2001), Computed Radiography and Digital Radiography (2004), Interventional and Fluoroscopic Imaging (2006), Building Bridges Between Radiology and Emergency Medicine (2008), and imaging for Oncology (2008).
• The Alliance for Radiation Safety in Pediatric Imaging (ARSPI) has held two vendor summits for CT (2008) and Digital Radiography (2010).
• ARSPI has launched the following radiation safety campaigns:
  • “Image Gently” for CT
  • “Step Lightly” for interventional radiology
  • “Pause and Pulse” for fluoroscopy
  • “Go with the Guidelines” for nuclear medicine
• ARSPI has partnered with the American Academy of Oral and Maxillofacial Radiology to address concerns specific to pediatric dental radiography .

Much of the focus of professional groups and industry has been on reducing radiation exposure in CT because of the relatively high doses involved; for example, ARSPI and MITA collaborated on developing online CT modules for radiologic technologists; however, other types of X-ray imaging are still of concern. To address this, the FDA, ARSPI, and MITA are collaborating on projects aimed at reducing radiation exposure to pediatric patients during digital radiography and fluoroscopy procedures. The resulting educational materials will be publicly available and add to the extensive information already available on the ARSPI website.

 

Information for Patients and Parents
 

The FDA recommends that medical imaging exams should be performed only after careful consideration of the patient’s health needs. They should be performed only when the child’s physician judges them to be necessary to answer a clinical question or to guide treatment of a disease. The clinical benefit of a medically appropriate X-ray imaging exam will outweigh the small radiation risk. However, efforts should be made to help minimize this risk.

The FDA recommends that parents:

• Keep track of their child’s medical-imaging histories as part of a discussion with the referring physician when a new exam is recommended (see the “My Child’s Imaging Record”   card, available from the Alliance for Radiation Safety in Pediatric Imaging).
• Ask the referring physician about the benefits and risks of imaging procedures, such as:
  • How will the exam improve my child’s health care?
  • Are there alternative exams that do not use ionizing radiation and are equally as useful?
• Ask the imaging facility:
  • What safeguards are in place to mitigate the risks to my child? For example, does the facility use reduced radiation techniques for children?
  • Are there any additional steps that may be necessary to perform the imaging study (e.g., administration of a contrast agent, sedation, or advanced preparation)?

FDA has reviewed the following additional resources for parents and patients and believes they are appropriate:

• FDA Consumer Update: Radiology and Children: Extra Care Required
• FDA Consumer Update and video: Reducing Radiation from Medical X-rays
• The Alliance for Radiation Safety in Pediatric Imaging: What Can I do as Parent?   and Frequently Asked Questions   pages
• The American College of Radiology (ACR) and Radiological Society of North America (RSNA) resource, RadiologyInfo: The Radiology Information Resource for Patients  
  • RadiologyInfo: Children’s procedures 
  • RadiologyInfo: Patient Safety
• The International Atomic Energy Agency (IAEA) Radiation Protection of Patients (RPOP): Patients and Public and Pregnancy and Children

 

Information for Health Care Providers

The individual risk from a necessary imaging exam is quite small when compared to the benefit of aiding accurate diagnosis or intervention. However, because of the increased risk of radiation exposure to younger patients, the FDA recommends that health care professionals and hospital administrators take special care in reducing radiation exposure to pediatric patients by following these steps:

• Discuss the rationale for the examination with the patient and/or parent to ensure a clear understanding of benefits and risks.
• Reduce the number of inappropriate referrals (i.e., justify X-ray imaging exams) by:

• determining if the examination is needed to answer a clinical question,
• considering alternate exams that use less or no radiation exposure, such as ultrasound or MRI, if appropriate, and
• checking  the patient’s medical imaging history to avoid duplicate exams.

• Purchase equipment that is designed for use with pediatric patients, if possible, and request information from the manufacturer on how to properly configure the equipment for small patients.
• Use the pediatric protocols or technique charts included with the equipment. If pediatric protocols or technique charts are not available for the currently marketed X-ray imaging device, ask the manufacturer or a pediatric imaging expert for assistance on how to appropriately use the device on small patients.
• For existing equipment that may not have specific features or instructions for pediatric use, consult the general recommendations made by the Alliance for Radiation Safety in Pediatric Imaging . By consulting these recommendations, this existing equipment may be configured appropriately for use on children.
• As part of a quality assurance program emphasizing radiation management, monitor doses to patients and check the facility doses against diagnostic reference levels , where available.

 

Principles of Radiation Protection

The FDA recommends that imaging professionals follow two principles of radiation protection of patients developed by the International Commission on Radiological Protection (Publication 103, The 2007 Recommendations of the International Commission on Radiological Protection; Publication 105, Radiological Protection in Medicine ):

1. Justification: The imaging procedure should be judged to do more good than harm to the individual patient. Therefore, all examinations using ionizing radiation should be performed only when necessary to answer a medical question, treat a disease, or guide a procedure. The clinical indication and patient medical history should be carefully considered before referring a patient for any X-ray examination.
2. Optimization: X-ray examinations should use techniques that are adjusted to administer the lowest radiation dose that yields an image quality adequate for diagnosis or intervention (i.e., radiation doses should be “As Low as Reasonably Achievable” (ALARA)). The equipment used should be designed for pediatric use; the technique factors used should be chosen based on the clinical indication, patient size, and anatomical area scanned; and the equipment should be properly maintained and tested.

Communication between the referring physician and imaging team can help ensure that the pediatric patient receives an appropriate exam at an optimal radiation dose. Optimization of pediatric imaging exams should be carried out by a knowledgeable imaging team (e.g. imaging physician, technologist, and medical physicist). Note that there may be a range of optimized exposure settings for use on pediatric patients, depending on the capabilities of the imaging equipment and the image quality requirements of the physician. Radiation exposure may be optimized properly for the same exam and patient size at two facilities (or on two different models of imaging equipment) even though the radiation exposures are not identical.

The FDA’s Center for Devices and Radiological Health defines the ages of the pediatric population as birth through 21 years. However, for purposes of obtaining a clinically acceptable image at an optimized radiation exposure, patient size, not age, is the controlling factor. This is because images are created by X-rays that pass through the body. These X-rays are absorbed as they pass through the body; larger patients absorb more X-rays than smaller patients, and therefore, generally require a higher radiation dose to generate images of the same quality.

It is important to note that there is considerable overlap between the sizes of larger pediatric and smaller adult patients. It is the patient’s size, not the patient’s age, that determines the dose needed for an optimal image for a particular indication. For example, based on a National Health Statistics report, a very small U.S. adult female is similar in size to an average 12-year-old child (male or female of similar size). If the same X-ray imaging exam is performed on adult and pediatric patients of the same size, the imaging parameters should be similar for both patients.

The risks of ionizing radiation-induced cancers depend on the amount of radiation received, the organ irradiated, and the age and gender of the patient. While the cancer risk per unit dose of ionizing radiation is higher for younger patients, the overall cancer risk is low for medical imaging exposures no matter what the age of the patient. If the X-ray procedure is medically necessary then the medical benefit will always exceed the cancer risk. Therefore, numerical cancer risk estimates should not be factored into the decision of whether or not a particular exam should be performed for a particular patient. The decision of whether an X-ray imaging exam is justified needs to be made by the child’s physician based on the medical needs of that particular child and the information the exam could provide. If there is a medical need for a particular X-ray procedure and other exams using no ionizing radiation (e.g., ultrasound and MRI) or less radiation are unsuitable, radiation risk considerations should not influence the physician’s decision to perform the study or the patient’s decision to have the procedure. However, ALARA principles should always be followed when choosing equipment settings.

 

Resources for Radiation Protection of Pediatric Patients

FDA has reviewed the following resources for referring physicians with a focus on justifying radiation exposure and believes they are appropriate:

• American Academy of Pediatrics: Radiation Risk to Children from Computed Tomography   and What Pediatricians Should Know about Medical Radiation Safety  
• The Alliance for Radiation Safety in Pediatric Imaging has published information directed at referring physicians .
• The International Atomic Energy Agency has published information for Referring Medical Practitioners .
• American College of Radiology (ACR): Appropriateness Criteria® Guidelines  
• The American College of Cardiology: Appropriate Use Criteria

FDA has reviewed the following resources for the imaging team (e.g., imaging physican, radiologic technologist, and medical physicist) with a focus on optimizing radiation exposure for pediatric patients and believes they are appropriate:

• The joint FDA and Conference of Radiation Control Program Directors (CRCPD) Nationwide Evaluation of X-ray Trends (NEXT) program surveys radiation exposures for common procedures; these data have been used to develop diagnostic reference levels, which can be used by a facility to benchmark radiation doses for its imaging procedures in comparison to other facilities. Surveys of pediatric procedures were conducted in 1998 (pediatric chest) and 2005 (CT; data currently being analyzed).
• The ACR has launched a pilot program, Quality Improvement Registry for CT Scans in Children to track CT radiation dose indices to pediatric patients.
• The National Cancer Institute: Radiation Risks and Pediatric Computed Tomography (CT): A Guide for Health Care Providers
• The Alliance for Radiation Safety in Pediatric Imaging   has material available to professionals regarding X-ray imaging Tests and Procedures and information directed at technologists, radiologists, medical physicists, and referring physicians.
   
• Size-Specific Dose Estimates (SSDE) in Pediatric and Adult Body CT Examinations (American Association of Physicists in Medicine (AAPM) report 204, 2011).
• The International Atomic Energy Agency (IAEA) Radiation Protection of Patients has published FAQs specific to minimizing exposure in Children   and free, downloadable Paediatric Radiology training material for specific types of exams.
• The International Commission on Radiological Protection (ICRP) has published a draft report on: Radiological protection in paediatric diagnostic and interventional radiology .
• ICRP Publication 113 Education and Training in Radiological Protection for Diagnostic and Interventional Procedures (2009) contains an “Outline of Specific Educational Objectives for Paediatric Radiology” (Annex B).

 

Mammography Quality Standards Act (MQSA), FDA regulates personnel qualifications, quality control and quality assurance programs, and accreditation and certification of mammography facilities. FDA also has regulations covering the safety and effectiveness and radiation control of all x-ray imaging devices (see the section “Information for Industry: X-ray Imaging Device Manufacturers and Assemblers”). Individual states and other federal agencies regulate the use of the x-ray imaging devices discussed on this webpage (CT, fluoroscopy, general and dental radiography) through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation.

In accordance with the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, suppliers that furnish the technical component of advanced diagnostic imaging procedures on or after January 1, 2012 (such as those facilities that perform CT, MRI, or nuclear medicine) and that seek Medicare reimbursement for those procedures must be accredited by one of three accreditation organizations (the American College of Radiology , the Intersocietal Accreditation Commission , or The Joint Commission ) recognized by the Centers for Medicare Medicaid Services (CMS). CMS has posted further information on Advanced Diagnostic Imaging Accreditation. This requirement does not apply to hospitals, which are subject to separate Medicare Conditions of Participation at 42 CFR 482.26 and 42 CFR 482.53, governing the provision of radiologic and nuclear medicine services, respectively. Information regarding CMS interpretive guidelines for these hospital regulations can be found in the State Operations Manual Appendix A- Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals. A full list of CMS Internet-Only Manuals is also available.

Individual states have regulations and guidelines applying to imaging facilities and personnel. The Conference of Radiation Control Program Directors (CRCPD) publishes Suggested State Regulations for the Control of Radiation , which may be voluntarily adopted by states. A number of states are updating their regulations and guidelines to improve radiation safety.

FDA is working with the Environmental Protection Agency and the federal Interagency Steering Committee on Radiation Standards (ISCORS) to develop and publicize Federal Radiation Protection Guidance for Diagnostic and Interventional X-ray Procedures (FGR-14) on medical use of radiation in Federal facilities. While this comprehensive set of voluntary guidelines for pediatric and adult imaging was written for federal facilities, most of the recommendations are applicable to all X-ray imaging facilities and professionals. This draft document will be released soon.

 

Electronic Product Radiation Control (EPRC) and medical device provisions of the Federal Food, Drug, and Cosmetic Act.

Draft guidance for manufacturers on “Pediatric Information for X-ray Imaging Premarket Notifications” (covering CT, fluoroscopy, and general and dental radiography) has been published, with the goal of encouraging manufacturers to consider radiation safety of pediatric populations in the design of X-ray imaging devices. When finalized, this guidance will only apply to new devices. However, many currently marketed X-ray imaging devices have general indications for use that cover a broad range of clinical applications and populations; therefore, FDA encourages manufacturers to provide technical assistance to health care professionals on how to appropriately and safely use these older devices on pediatric patients.

FDA has also issued a guidance on “Premarket Assessment of Pediatric Medical Devices”, which applies to all medical devices.

For more information on bringing an X-ray imaging system to market and for post-market requirements see:

• Getting a Radiation Emitting Product to Market
• Device Advice: Comprehensive Regulatory Assistance
• Postmarket Requirements (Devices)

For more information specific to your type of X-ray imaging device, see FDA’s Medical Imaging webpage.

 

MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Medical device manufacturers, distributors, importers and device user facilities (which include many health care facilities) must comply with FDA’s Medical Device Reporting (MDR) Regulations at 21 CFR Part 803.

Health care personnel employed by facilities that are subject to FDA’s device user facility reporting requirements should follow the reporting procedures established by their facilities.

 

Article source: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm

May 10th, 2012. Comment now »

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks. These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions. At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer. As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of these medical imaging exams while minimizing the risks.

In 2010, FDA’s Center for Devices and Radiological Health (CDRH) launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging and held a public meeting on Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging (March 30-31, 2010). These efforts were in response to increasing exposure to ionizing radiation from medical imaging highlighted in the National Council on Radiation Protection and Measurements Report No. 160 and safety concerns highlighted in FDA’s Safety Investigation of CT Brain Perfusion Scans.

Through this initiative, the FDA strives to promote patient safety through two principles of radiation protection developed by the International Commission on Radiological Protection :

• Justification: The imaging procedure should be judged to do more good than harm to the individual patient. Therefore, all examinations using ionizing radiation should be performed only when necessary to answer a medical question, help treat a disease, or guide a procedure. The clinical indication and patient medical history should be carefully considered before referring a patient for any imaging examination.
• Dose Optimization: Medical imaging examinations should use techniques that are adjusted to administer the lowest radiation dose that yields an image quality adequate for diagnosis or intervention (i.e., radiation doses should be “As Low as Reasonably Achievable”). The technique factors used should be chosen based on the clinical indication, patient size, and anatomical area scanned, and the equipment should be properly maintained and tested.

FDA is pursuing efforts using its regulatory authority as it applies to imaging equipment and manufacturers. Equally important gains will be made through key partnerships with professional organizations, industry and other governmental agencies to incorporate radiation protection principles into facility quality assurance and personnel credentialing and training requirements.

Many efforts have been undertaken by a large number of groups to help ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose. FDA hopes to provide a comprehensive approach for this effort with collaborative activities in the following areas:

• Facility guidelines and personnel qualifications
• Education and communication
• Appropriate use
• Equipment safety features
• Tracking radiation safety metrics
• Research and development

Each of these areas requires coordinated efforts by regulatory, professional and industry partners to achieve common goals as described below.

Facility guidelines and personnel qualifications: For facilities participating in the Medicare program, the Centers for Medicare Medicaid Services (CMS) has established minimum standards for hospital radiologic services, and accreditation requirements for freestanding advanced diagnostic imaging facilities. States and/or accreditation organizations may have additional requirements that go beyond the CMS requirements. In complying with these requirements, facilities can ensure adoption of policies and procedures that govern safe administration of radiation for imaging purposes. Facility accreditation can also have a direct impact on how equipment operators establish and maintain qualifications necessary to understand equipment functionality and operate equipment safely.

Education and communication: Qualified medical professionals should have ready access to up-to-date radiation safety training material, in particular for the equipment models in use at the facility. In addition, patients should have access to information that permits discussion with their medical professional on why they need a particular exam, what are the risks, and whether an alternative exam is possible. Medical professionals should be prepared to address possible patient concerns.

Appropriate use: Providers should receive training on the principle of justification and the availability of medical specialty guidelines to help assess the need for a particular exam and promote ordering of only those exams that are appropriate for the patient’s condition. In addition, automated decision support systems should be considered for implementation if data from test programs, such as the ongoing CMS Medicare Imaging Demonstration, support their use. Electronic health records should include complete information on the patient’s imaging history to aid the physician in choosing an appropriate exam.

Equipment safety features: Once an appropriate exam is ordered, the imaging equipment used should be capable of providing information and tools to operators that promote optimized delivery of radiation. Equipment features should address capture of patient information and dose, transmission of that information to data systems, controlling user access to equipment settings and features, and alerting the operator when patient safety is at risk.

Tracking radiation safety metrics: Development of information systems and analysis tools to track radiation safety metrics will play an important role in promoting radiation protection and patient safety. Collection of equipment parameters and dose for imaging exams in dose registries can be used to benchmark imaging practice through establishing diagnostic reference levels, thus improving the practice of radiology through quality assurance. A long-term goal is automated real-time updating of dose registries to facilitate comparison of exam parameters and dose indices with established reference levels, enabling immediate notification and mitigation of patient safety hazards. Tracking adverse events can establish trends and allow prospective correction of possible radiation safety problems related to equipment or operator training. Automated tracking of radiation safety metrics (e.g., through participation in a dose registry) will help fulfill quality assurance and quality improvement requirements for facility accreditation and personnel continuing education, while ensuring that operators use equipment optimally to promote patient safety.

Research and development: Continued research in medical imaging, with a focus on radiation safety and dose optimization, is crucial for all of the above areas. Scientific research facilitates better evaluation of the risks and benefits of imaging exams, and forms the foundation for the development of national and international standards for dose and image quality assessment for medical imaging devices.
 

Article source: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm

Public Workshop – Device Improvements for Pediatric X

The Food and Drug Administration (FDA) is announcing a public Workshop on “Device Improvements for Pediatric X-ray Imaging.” The main purpose of the workshop is to discuss the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.” This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. The guidance document was released in draft form for public comment on May 10, 2012. A Notice was published in the Federal Register on this same date for an open comment period for the guidance document that runs through September 6, 2012. In addition to soliciting public feedback on the draft guidance, the FDA has organized this meeting to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.

• Date, Time and Location
• Federal Register Notice [Not Yet Available]
• Background
• Agenda
• Transcripts
• Public Comment
• Registration
• Contact Us

FDA Campus Information

This meeting will also be webcast. Persons interested in viewing the webcast must register online by July 9, 2012. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after July 12, 2012. If you have never attended a Connect Pro event before, test your connection. Also available is a quick overview of the Connect Pro program. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

Federal Register Notice

The Food and Drug Administration is announcing a public meeting to discuss the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.”

• Federal Register Notice [Not Yet Available]

Press Release: FDA proposal aims to help reduce unnecessary radiation exposure for pediatric patients

Draft Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications

• Notification of Availability of draft guidance [Not Yet Available]

Pediatric X-ray Imaging Webpage: Provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and health care providers to help reduce exposure to unnecessary radiation, and information for manufacturers of x-ray imaging devices.

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Agenda

Transcripts

As soon as a transcript is available, it will be accessible at: http://www.regulations.gov.

Public Comment

Regardless of attendance at the public meeting, any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. It is only necessary to send one set of comments. Comments are to be identified with the docket number FDA-2012-N-0385. Received comments may be seen in the Division of Dockets Management between 9am and 4pm, Monday through Friday. To ensure consideration, all comments must be received by September 6, 2012.

cynthia.garris@fda.hhs.gov.

Article source: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm301989.htm

May 9th, 2012. Comment now »