Docstoc

Advisory Notice

Document Sample
Advisory Notice Powered By Docstoc
					Advisory Notice
Date: From: To: Re: 4 July 2008 Richard Lloyd, Quality Manager and Office Manager All Customers using the EPFX Electro Physiological Feedback Xrroid in the USA Advisory Notice

The EPFX Electro Physiological Feedback Xrroid (EPFX) is a registered Class II medical device with the United States Food and Drug Administration (FDA). This means that the device, from its documentation, to its manufacture, to its use, are regulated under the Code of Federal Regulations (CFR). There are two (2) purposes of this Advisory Notice: 1. To reinform the public of the Indications for Use of the EPFX 2. To inform the public and implement the revised Prescriptive Controls All of the actions in this Advisory Notice are effective immediately from today 4 July 2008. Each of these two (2) purposes will now be addressed: 1. Indications for Use

A biofeedback device is to be used for relaxation training and muscle reeducation. All of the claims and uses of the device must be for relaxation training and muscle reeducation. We have recently learned that individuals are marketing and/or using the EPFX Device for purposes outside of its indications for use. The EPFX was registered in 1989 and for almost two decades has had the following indications “for use for patients with stress.” The following is from the 1989 510(k) registration K892114 of the device : “The sole purpose of the EPFX system is to provide the patient with insight into the subtle changes in the temperature, skin resistance (sweat), and muscle voltage. No claims are made by the Eclosion Corporation for the ability of biofeedback to treat any medical condition. Even claims for stress reduction are not without critics or criticism. What we do claim is that the system measures subtle body electric and thermal changes in the patient and feeds them back to the patient via audio or video signals. These signals give the patient awareness of the electrical and thermal changes and thus allows them to better relax.” As per our e-mail conversation with Harold Pellerite, Assistant to the Director, Office of Compliance, on 29 July 2004, he states, “under freedom of speech anyone is free to state their praise for any product. And they are free to tell anyone. However, when such testimonials are used by firms or clinicians, they are considered to be labeling, since they are promoting the device, or making claims for the device.” Claims outside of the original EPFX indications for use, by a therapist are inappropriate and need to be responded to. Responses include direct Page 1 of 4

chastised communication, complete investigation of the details, warning letters, continued inappropriate action can result in official professional complaints submitted to all certification bodies, licensing boards and ultimately State authorities if necessary. 2. Prescriptive Controls Per Section 801.109(b)(1) of Title 21 of the Code of Federal Regulations, the device is restricted for sale in the United States on prescription by or on the order of a licensed healthcare practitioner. There is an updated label on the EPFX which reads as follows: “Caution: Federal law restricts this device to sale in the United States by or on the order of a licensed healthcare practitioner.” Here is a detailed explanation of what that means and how that pertains to you and your use of the device. The following Prescriptive Controls will be effective from 4 July 2008: a) Private users of the device, from this point forward, will have to have a prescription from a licensed healthcare professional to purchase a unit. The definition of private use is: i. At one’s own home ii. To use on themselves b) Current professional Biofeedback Technicians (who are currently using the device or who wish to purchase the device) will have to show proof of education, certification, and/or experience and can purchase the device on a character referral on an order from a licensed healthcare practitioner. Also, there should be no record of any official professional complaints involving the Biofeedback Technician. c) Future users of the device, that is future Biofeedback Technicians, will need to have a licensed healthcare professional provide the order for purchase and act as the sponsor for the therapist in sponsoring his/her education and use of the device. d) The prescription or order must have the following: i. The professional’s name and address. ii. The professional’s license number. iii. The issuing body of the license. iv. The date of expiry of the license. v. Prescriptions or orders for all device orders from the date of this letter must be sent to the Budapest Home Office via e-mail to prescription@eclosionepfx.com. Effective 4 July 2008, these prescriptive controls will be enforced for all sales. The Budapest Home Office will have to receive the prescription/order along with the Importation Agreement (IA) before a device can be shipped to the customer. We’d like to take this opportunity to further emphasize and strongly advocate that any patient who is not improving in their symptom profile or is manifesting other symptoms is referred to a licensed healthcare practitioner and/or their family doctor. All Biofeedback Technicians should have easily available the contact information of local emergency services.

Page 2 of 4

I would like to take a moment to explain the need for these prescriptive controls under regulation 21 CFR801.109. (This regulation can be found on www.fda.gov. On the main page on the bottom center column is the title “Reference Room” and under that is Code of Federal Regulations. Click on “Code of Federal Regulations” and search for the regulation under the number 801.109.) Section 801.109 deals with Prescription Devices states “…a device which, because of any potentiality for harmful effect….is not safe except under the supervision of a practitioner licensed by law to direct the use of such device….” The device was registered as a prescription device as this firm wanted the device to be used by professionals only. You might be asking that since the device is safe for use and registered as an insignificant risk device, why is the prescriptive control being implemented? The answer is that the EPFX has recently come under scrutiny by unprofessional press and people who fear drugless, alternative therapies. They have collectively and inappropriately categorized the EPFX with other devices that are illegal and potentially harmful. In order to be more strict with the use of our device and to remove it from such associations, we are voluntarily implementing the prescriptive controls to ensure that those who purchase and use the EPFX are doing so under consultation with a licensed healthcare practitioner. Such actions are warranted under the 21 CFR 820.100 section (a) which states: “Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for”….”(1) analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data [Manufacturer’s note: in this situation recent media publications] to identify existing and potential causes of nonconforming product, or other quality problems [Manufacturer’s note: in this situation the quality of our device is under concern due to the statements in the recent media].” In following with the regulations, our actions are part of the corrective and preventive action. Our actions are voluntary and part of our dedication to compliance to our FDA registration.

Summary: All of the above actions are guided under the 21 CFR 806 Reports of Corrections and Removals. This is an Advisory Notice which needs to go to all users of the device (private or public) in the USA. The Manufacturer will be contacting all users of the device and also ask that you can help by talking to your colleagues who also use the device to ensure that they have received this Advisory Notice. Perhaps their contact details have changed and therefore we kindly ask you to help us to implement this corrective action. The International Journal of the Medical Science of Homeopathy and other journals will be solicited to carry the report of the corrections for those that contact details have changed and have not informed us of the change. Furthermore, a listing of all users of the EPFX in the USA will be submitted to the FDA. The FDA have the right to contact you to verify that you have received this Advisory Notice.

Contact: For questions or clarification on this Advisory Notice, please feel free to contact any of the following Budapest Home Office Staff (in order of preference numbered below):

Page 3 of 4

1. Richard Lloyd, Office Manager and Quality Manager on richard@eclosionepfx.com or telephone +36-1-303-6043 ext. 340. 2. Edit Barota, CAPA (Corrective Action Preventive Action) Assistant on edit@eclosion-epfx.com or telephone +36-1-303-6043 ext. 330. 3. Sue Rado, Office Administrator on sue@eclosion-epfx.com or telephone +36-1303-6043 ext. 341. 4. If you cannot reach any of the above on the telephone, please try the Secretaries Erika Berta and Eva Barota on +36-1-303-6043 ext. 350 and ext. 351 and they will do the best they can to connect you to one of the above, or to get a message to one of the above who can then get back to you.

-- End of Advisory Notice --

Page 4 of 4


				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:185
posted:12/13/2008
language:English
pages:4