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Re: Laser therapy
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Re: Laser therapy - April 6, 2006 2:12:00 PM
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tucker
Posts: 182
Joined: May 24, 2003
From: Texas
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Drew,
I would be interested in any studies that support Anodyne...that are published in a peer-reviewed journal, not funded by the company, and do not have an author with a conflict of interest. I only know of two, Clifft's study and an article on balance published in the geriatric section's journal. Thanks in advance.
Darin
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Re: Laser therapy - April 6, 2006 4:48:00 PM
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PTupdate.com
Posts: 1478
Joined: October 8, 2001
From: Pittsburgh, PA USA
Status: offline
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Darin,
I believe the study done by Kochman et al in 2002 brought out some good points, including pain reduction and sensation of improved balance.
As far as material being in a peer reviewed journal, I am not sure that makes it gospel. One of the main things I do on my website is review current literature, and there is quite a bit published in peer reviewed journals, including our own Physical Therapy and JOSPT journals, that have some study flaws and issues.
Too many times people note a reference based on the abstract done by the authors, without delving into the meat of the material. How many studies that indicate Anodyne was not effective even performed a power analysis to determine if type II study errors were being made?
How do you know that certain PT's using this modality, along with a comprehensive program, are not having excellent outcomes? The nuances of one treatment style and one PT are hard to study by scientists.
I had an ortho surgeon indicate that while ACL reconstructions with interference screw usage show some loosening, he performed his own little technique with tying and looping the thread, thus ensuring the perfect tightness that all his grafts had when I saw them.
John Duffy, PT OCS
[URL=http://www.PTupdate.com]www.PTupdate.com[/URL]
_____________________________
John M. Duffy, PT
Board Certified Orthopaedic Clinical Specialist
www.PTupdate.com
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Re: Laser therapy - April 7, 2006 1:17:00 AM
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Andrew M. Ball PT PhD
Posts: 855
Joined: July 28, 2002
From: Charlotte, NC
Status: offline
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How many studies of good quality do you need? I agree that there are a lot of crappy ones out there, but evidence-based-practice doesn't mean witholding technique until there is a "perfect" study either. When I think about DPN, I think about the following studies, for all of their useful findings AND overgeneralized crap . . .
Treatment Options for PAIN
McLean M, et al. Static Magnetic Fields for the Treatment of Pain. Epilepsy & Behavior. 2, 2004. S74-S80. In a prospective study of 19 subjects, an 80% reduction in pain was achieved among 90% of patients with DPN using magnetic insoles between months 2 and 3 of intervention. The study went on to note that 30% of patients with non-diabetic neuropathy realized undefined pain relief between months 2 and 3 of intervention. Several issues must be considered. First, the use of placebos during only the first half of study makes results questionable, and second the authors used a 5 point pain scale (which may actually be the functional pain scale --- a more reliable and arguably more valid measure than the VAS, but this is not clear from the study text). Finally, it must be considered that there is considerable “anti-magnet” sentiment among both the public and mainstream healthcare professionals, and I’d need a study of much better construction (specifically appropriate use of placebo, and/or more than 19 subjects) before recommending magnetic insoles to patients with DPN.
Yuen KCJ, et al. Treatment of Chronic Painful Diabetic Neuropathy with Isosorbide Dinitrate Spray. Diabetes Care. 2002. 25(10); 1699-1703.
Speculating that impaired NO generation may play a role in DPN pain through deficits in local vasodilation, the authors tested the idea that ISDN spray (an NO donor with potent vasodilatation properties), would relieve some DPN symptoms. In a double-blind, randomized, placebo controlled, A-B crossover design study, 22 patients unresponsive to conventional therapies. Fifty percent of patients reported pain reduction with the ISDN, and 0% of patients reported pain reduction with the placebo spray. This is an interesting and intriguing study with respect to my patient, however, I am not in a position to order ISDN spray for my patients. Upon discharge from successful therapeutic intervention, however, I may be in a position to suggest for consideration, ISDN spray to the referring physician.
Somers DL, Somers MF. Treatment of Neuopathic Pain in a Patient with Diabetic Neuropathy Using Transcutaneous Electrical Nerve Stimulation Applied to the Skin of the Lumbar Region. Physical Therapy. (79)8. 1999. 767-775.
The purpose of this case report was to describe the alteration of pain in a patient with severe, painful diabetic neuropathy following application of transcutaneous electrical nerve stimulation (TENS) to the low back. The patient was a 73-year-old woman with pain in the left lower extremity of the lateral aspect of the hip and entire leg below the knee. Pain prevented sound sleep. The intensity of the pain was measured with a visual analog scale. TENS was administered at 80Hz for 1 to 2 hours each da and during the entire night. On the first day of treatment TENS was administered for 20 minutes. This resulted in a 38% reduction in the intensity of pain. After 17 days, the patient reported no pain following 20 minutes of TENS and shat she could sleep through the night. While not a particularly high level of evidence, this case study was the justification behind using TENS on our patient when his plantar sensation began to return (a particularly painful 3-5 day period during the return-of-sensation process). Use of lumbar TENS did provide the patient some relief and a measurable improvement in the patient’s ability to ambulate 125 feet, versus 75 feet, before needing to stop secondary to foot pain.
Leonard DR, et al. Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects With Diabetic Peripheral Neuropathy: A double-blind, randomized, placebo controlled study with monochromatic near-infrared treatment. Diabetes Care. 21(7), 2004. In this sham-controlled, double-blind study of twenty-seven patients (9 of whom were insensitive to the 6.65 Semmes Weinstein monofilimant (SWM) and a modified Michigan Neuropathy Screening Instrument (MNSI), and 18 who were sensitive to the 6.65 SWM but insensitive to the 5.07 SWM) were studied. Each lower extremity was treated for 2 weeks with sham or active Anodyne Therapy System (ATS), and then both groups received active treatments for an additional 2 weeks. The group of 18 patients who could sense the 6.65 SWM but were insensitive to the 5.07 SWM at baseline obtained a significant (decrease from an average of 3.5 to 1.9 insensate points), decrease in the number of sites insensate after both 6 and 12 active treatments. Sham treatments did not improve the sensitivity to the SWM(4.0 insensate points), but subsequent active treatments did (3.7 insensate points). Pain reported on the VAS decreased progressively from 4.2 at entry to 3.2 after 6 treatments and 2.3 after 12 treatments. At entry, 90% of subjects reported substandial balance impairment; after treatment this decreased to 17%. Given the ease of administration of standardized balance tests such as either the BERG balance test or the Timed Up and Go, it is unclear as to why the authors used no more than a subjective question to monitor improvements in balance. Among the nine patients with greater sensor impairment measured by insensitivity to the 6.65 SWM at baseline, improvements in sensation, neuropathic symptoms, and pain reduction were not significant.
DeLellis SL, Carnegie DH, Burke TJ. Improved Sensitivity in Patients with Peripheral Neuropathy: Effects of Monochromatic Infrared Photo Energy. J Am Pod Med Assoc. 95(2), 2005.
In a retrospective analysis of 1047 patient files of patients with diabetic peripheral neuropathy using monochromatic infrared laser treatment, 66% of patients fully restored protective sensation and an additional 5% reported an improvement in protective sensation. Directly applicable, but a lower level of evidence than the double-blind, randomized, placebo controlled study conducted by Leonard DR, et al.
Pieper GM, et al. Short-term oral administration of L-arginine reverses defective endothelium-dependent relxation and cGMP generation in diabetes. Eur J Pharmacol. 1996. 19;317-320.
In this animal study, the authors examined whether acute dietary supplementation with L-arginine in vivo could reverse the defective endothelium-dependent relaxation in diabetic blood vessels assessed ex vivo. At 8 weeks of diabetes, streptozoticin-induced diabetic rates were given 1.25% L-arginine in drinking water 3 days prior to isolation of aortic rings for evaluation ex vivo. Plasma arginine concentration was reduced by diabetes but restored to normal in diabetic rats receiving dietary L-arginine. Although an animal study not directly applicable to human, much less the patient monitored in this case study, the data suggest that the substrate for nitric oxide synthesis by the endothelium is likely to be limited in diabetes but may be overcome by dietary supplementation with L-arginine.
Faldetta et al. L-arginine infusion decreases plasma total homocysteine concentrations through increased nitric oxide production and decreased oxidative status in Type II diabetic patients. Diabetoglogia. 2002. 45(8);1120-1127.
In a prospective double-blind cross-over randomized study of 20 normotensive, normolipidaemic, non-atherosclerotic Type 2 (NIDDM) diabetic patients and 15 healthy subjects, circulating concentrations of homocysteine, nitrate+nitrate and sulphydril groups were assessed at baseline and then 5’, 10’, 30’, and 60’ after the intravenous infusion of either L-arginine (the nitric oxide precursor) or placebo. At baseline, diabetic patients showed lower plasma sulphdryl group concentrations, nitrate+nitrate, and homocysteine concentrations than the control subjects. After L-arginine infusion, blood pressure levels and total homocysteine concentrations decreased, whereas nitric oxide and sulphydryl group concentrations increased in both the patients and control subjects. Acute L-arginine infusion in both Type 2 diabetic and healthy subjects appears to counteract oxidative stress and the availability of nitric oxide. Although the role of the DPT in suggesting dietary supplementation is currently up for debate and discussion, the use of L-arginine supplementation may provide our patient relief in isolation of any other intervention, and/or may enhance the effectiveness of therapy as combined with other interventions.
Treatment Options for BALANCE Improvement
Rao N, Aruin A. The Effect of Ankle-Foot Orthoses on Balance Impairment: Single-Case Study. JPO 1999. 22(1):15. In a single case study, the Computerized Dynamic Posturography test results of a subject with neuropathy due to long-standing diabetes is reported. Tests were conducted with and without solid-ankle AFO’s. With no orthoses, the patient had falls performing most of the tests. With bilateral solid-ankle AFO’s, the patient’s composite balance score increase four-fold.
Douris P. The effect of land and aquatic exercise on balance scores in older adults. Journal of Geriatric Physical Therapy. (26)1. 2003. 3-6. In an 11 subject 2 x 2 analysis of variance of balance impaired older adults (e.g. 70+ who were independent ambulators with or without an assistive device and independent in ADLs) comparing those treated 2x/wk for 6 weeks land-based versus those treated in an aquatic medium, the researchers found that regardless of exercise medium, significant improvements in balance (improved from 41-46 to 52-55 for aquatic-based patients, and 34-40 to 47-50 for land-based patients. Substantial limitations of the study noted by the authors included sample size, lack of random assignment. In addition, although all subjects crossed the 46/56 critical clinical threshold as defined by Shumway-Cook, the non-randomized nature of the study resulted in the balance abilities of the two groups being somewhat different. As such, and due to the fact that the subjects were not crossed over from one treatment medium to the other, caution must be taken in drawing any strong conclusions. It is possible that patients with higher initial BERG scores would have achieved even better results on land than they had in the pool, and that patients with lower BERG scores would have achieved even better results in the pool than on land. The study design disallows conclusion in that regard.
Simmons V, Hansen PD. Effectiveness of water exercises on postural mobility in the well elderly: an experimental study on balance enhancement. J Gerontol. 1996;51:M223-M227.
I’ve been unable to find a full-text of this article. I have, however, found several references to it in other high-quality articles suggesting that the study design had 4 groups and that improvements in forward reach were significant for both land and water exercise groups. This is in contrast to the abstract, which would seem to conclude that water exercises are more effective than land exercises in increasing forward reach (a single component of the BERG) in community dwelling elders. As such, I cannot yet make any conclusions that would augment or change my plan of care. More importantly, however, according to both references to the article and the article abstract, post-discharge compliance is much higher with 80% of subjects continuing to exercise several months after discharge. Compliance and post-discharge self-management are important issues to consider, and would appear to have no negative consequence.
Finally, I present the case study I completed:
Demograhics
Patient is a 60 y/o non-Hispanic white male living with his wife and father-in-law. He is a retired teacher with a college education referred to physical therapy by his neurologist.
Living Environment
Patient lives in a private one-story residence with stairs and a railing to enter. He has an elevated toilet and shower chair.
Mobility Assists
Patient’s durable medical equipment includes a Rollator Walker, a Motorized Scooter, and a Cane.
General Health Status
Patient rates general health status as poor. He is non-smoker and has not had alcohol in the past 15 years. He does not exercise beyond chores and ADL’s.
Family History
Patient has a family Hx of heart disease, HTN, stroke, emphysema and arthritis.
Medical/Surgical History
Includes osteoarthritis, hypertension, high blood sugar (but, patient is quick to point out, “not diabetes!”, hay fever, depression, and a head injury at 25 years of age. Within the past year, patient has experienced shortness of breath upon exertion, difficulty walking (coordination problems and frequent falls), joint pain and swelling of the feet, and night pain of the feet.
Current Conditions/Chief Complaint
Patient’s primary complaint is foot, leg and back pain associated with non-diabetic peripheral neuropathy. He reports difficulty walking and frequent falls/loss of balance. Pain is worsened by walking, and wearing socks/shoes. Problem began 7 years ago.
Patient Goals
1. Relieve Pain
2. Walk without Restriction
3. Travel
Functional Status
Patient reports difficulty with bed mobility, difficulty with transfers (bed chair, bed commode), difficulty with self-care (bathing, dressing), difficulty with Gait (on level and un-level surfaces, on ramps, on stairs), difficulty with home management (chores, shopping, driving), difficulty with community activity/travel.
CardioPulmonary System (Normal)
Heart Rate = 90bpm
Respiratory Rate = 15 rpm
Blood Pressure = 112/70
Integumentary System (Impaired)
Skin Integrity
Lack of sensation/pain lower legs and feet
Musculoskeletal System (Impaired)
Standing and Walking Impaired
Fwd flexed trunk leaning on rolling walker
Height = 5’ 10”
Weight = 325
Neuromuscular System (Impaired)
Balance Impaired
Gait and Locomotion Impaired
Transfers and Transitions Impaired
Educational Needs
Disease Process
Decreased free NO vasoconstriction DPN
Safety
Skin Inspection
Exercise Program
Typical Treatment Regimen for Patient:
Anodyne Monochromatic Cold Laser
• 8 bars of intensity
• T-pattern application
Lumbar TENS PRN (used twice during pain flare)
• 80 pps
Land-based stretches, therex and balance
• Gastroc and Soleus stretch
• Biodex Recumbent Bike
• Sit Stand transitions
• Timed up and go
• Gait training with cane for distance
Aquatic-based stretches, therex and balance
Ambulation
• Forward
• Backward
• side to side
Stretches
• Hamstring
• Calf
Balance
• Toe raise/Heel raise
• Single Leg Stance
• Tic-Toc
• Marching
OUTCOMES:
Patient treated over 24 visits improves:
Ambulatory Endurance
A typical improvement is the ability to walk 90% farther.
Balance
A typical decrease in fall frequency may be from 18/week to 0/week, a doubling of BERG balance score, and a 58% improvement in timed-up-and-go score.
Pain
A typical improvement may be from 8/10 intensity pain to 0/10 pain.
Sensory Integrity
Insensate area may improved from approximately 15 cm above the ankle to 0-3 cm above ankle.
Posture
Improved from 30 degrees trunk flexion to 20 degrees trunk flexion.
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 7, 2006 3:45:00 AM
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tucker
Posts: 182
Joined: May 24, 2003
From: Texas
Status: offline
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It appears that only the fourth and fifth study you listed is about Anodyne specifically, which we talked about already (co-author Burke having a financial conflict of interest). I am only looking for ONE supporting study by an independent group. I just don't know of one.
Junction, you brought up all of my concerns with the Kochman studies and you are correct...a peer review likely would have prevented the flaws.
Drew,
In your case report, what makes you think the Anodyne made a difference instead of positive effects of aquatic therapy, the education of proper skin inspection/care, and ther EX alone? Thanks.
Darin
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Re: Laser therapy - April 7, 2006 4:02:00 AM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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Drew... you had the patient practice sit to stand activities, practice the timed up and go, ambulate with a cane, ambulate in the aquatic environment, stretched the gastroc/soleus and perform balance activities in an aquatic environment.... the specific demands that you incorporated into the treatment would lead to adaptation and improvement, in athletic training it is the SAID principle - specific adaptation to imposed demands. You did that, and generally the body will respond and gains can be measured. And since the patient performed and practiced what you measured over 24 visits or probably 2 months, well, I'd expect that there should be changes. Without a control though, how much of a role did the Anodyne really have in the functional changes measured?
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Re: Laser therapy - April 7, 2006 4:21:00 PM
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Andrew M. Ball PT PhD
Posts: 855
Joined: July 28, 2002
From: Charlotte, NC
Status: offline
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Without going into details, we started without anodyne 8 or so visits into the A-B study and observed an "uptick" in outcome measures as the anodyne was added. Furthermore, prior therapy from another therapist had "no effect." I had wanted to cut-off anodyne and collect data several months later and see what impact that would have A-B-A, but that was not possible with this patient.
In an ABA study, the conditions of the study create the pseudocontrol. It's hard to do a clean RCT under clinical conditions. Very rarely is any treatment technique provided in isolation. Initial studies are often conducted in the clinic, and "cleaned" in the ivory towered sterile and controled environment. We all have a role to play in the research process. For now, we have, in our clinic, a set of techniques that, used in combination, yield objectively meausred improvements in over 89% of patients with balance or sensation impairments related to DPN.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 8, 2006 9:22:00 AM
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Soleman
Posts: 58
Joined: March 12, 2000
From: USA
Status: offline
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"Like moist heat with Medicare patients...you don't get paid for it, but it is an integral part of the program and you just suck it up and do it."
Why do you write this off? Medicare doesn't pay for it, but that doesn't mean you have to write it off. Inform patients of the cost/benefits and let them decide if they want to pay for it or not. I have many patients who choose to pay for it. If it doesn't cost something, then its not worth anything.
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Re: Laser therapy - April 8, 2006 5:48:00 PM
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PTupdate.com
Posts: 1478
Joined: October 8, 2001
From: Pittsburgh, PA USA
Status: offline
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Soleman: It is my understanding that patients with Medicare cannot be billed for something that Medicare does not cover, yet was provided to the patient. SJ may have a better answer for that.
With regards to "If it doesn't cost something, then its not worth anything".....that's a kind of creepy philosophy.
John Duffy, PT OCS
[URL=http://www.PTupdate.com]www.PTupdate.com[/URL]
_____________________________
John M. Duffy, PT
Board Certified Orthopaedic Clinical Specialist
www.PTupdate.com
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Re: Laser therapy - April 8, 2006 6:14:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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With Medicare, hot packs are considered bundled... you can't unbundle hot packs and get paid for them AND you can't charge the patient for the hot pack.
If Medicare finds a particular service as not medically necessary, then I believe you first need to alert the patient, have the patient fill out an ABN (I think that's the one) and then the patient is supposedly held responsible. I also believe that when you bill out for a service that Medicare would not view as medically necessary that you also need to use some CCI edit or some modifier. It's late and I can't remember everything I've read, but that's what first comes to my head.
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Re: Laser therapy - April 11, 2006 4:38:00 PM
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goodlooks58
Posts: 425
Joined: October 21, 2002
From: CA
Status: offline
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Buddy and others: I talked to 2 PTs using a $4000 ML-830 Laser and they are getting significantly good results, however, the catch is that they have to sit and use it for 15 minutes not 23 minutes as advertised in the manufacturer's protocol. It is a great device for marketing purpose as laser is still well accepted amongst lay people. One PT is about to buy another unit and is training one of the staff PT aides to do the laser and then the PT will do his part of the treatment. Sounds like a good plan. Any comments?
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Re: Laser therapy - April 11, 2006 4:39:00 PM
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goodlooks58
Posts: 425
Joined: October 21, 2002
From: CA
Status: offline
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Soory a typo...2-3 minutes as adverised in the manufacturer's protocol and not 23 minutes.
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Re: Laser therapy - April 11, 2006 5:21:00 PM
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Andrew M. Ball PT PhD
Posts: 855
Joined: July 28, 2002
From: Charlotte, NC
Status: offline
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Be aware, by the way, with respect to Anodyne, that it is FDA approved as an infrared heater ONLY. All other applications (e.g. DPN, wounding healing) may be clinically appropriate, but are NOT as of yet FDA approved. The company that makes the Anodyne unit was just recently warned by the FDA for inappropriate marketing of the device.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 11, 2006 5:26:00 PM
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drbuddy
Posts: 429
Joined: July 30, 2005
From: Pennsylvania
Status: offline
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good,
I'm not suprised that they have to use it for that period of time. That is why I opted for the higher powered unit. Instead of the 15 minutes, you only need to use it about 30 seconds per point, with anywhere from 5-10 points per region. This isnt based on any company's protocols, but based on my own calculations of trying to get 5-10 joules to the target tissue.
So, you have to decide whether an extra $5-7,000 is worth saving 10 minutes per treatment. Plus, there is the depth factor. With 830 nm, it will only penetrate so far no matter how long the treatment.
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Re: Laser therapy - April 11, 2006 5:41:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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Goodlooks... a PT aide delivering treatment? Hmm... that is potentially a poor choice - the "skilled" aspect of the intervention is what? Best to look into state practice acts, never have a aide deliver any treatment to patients with Medicare... and then, if you choose NOT to have an aide deliver care to a patient with Medicare, then there is that logical issue of explaining differences in the quality of care provided... a questionable treatment combined with the inappropriate personnel - issues and more issues...
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Re: Laser therapy - April 12, 2006 1:35:00 PM
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drbuddy
Posts: 429
Joined: July 30, 2005
From: Pennsylvania
Status: offline
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I'm not so sure about that. I do not think that laser therapy would be a covered service under medicare. Also, like you said, it would depend on the state. In PA it says you can have unskilled aides provide services that do not require specialized training. I would argue that following a map of laser points on a picture and holding it at each point for a certain amount of time requires little to no "skill".
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Re: Laser therapy - April 12, 2006 1:50:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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Buddy... there is very, very clear language in Medicare regulations that aides are not to provide any treatments. If an aide provides any treatment to a patient with Medicare, technically, one cannot bill for that service because the service was not provided within the definition of the CPT codes of who is allowed to provide care.
LONG post... read carefully. I snagged this from [URL=http://www.ptmanager.com]www.ptmanager.com[/URL] today. Kind of interesting and gives pause to think...
Department of Health and Human Services
Public Health Service
Food and Drug Administration
555 Winderley PI., Ste. 200
Maitland, FL 32751
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-06-08
December 2, 2005
Craig H. Turtzo, President
Restorative Products, Inc.
13560 Wright Circle
Tampa, Florida 33626
Dear Mr. Turtzo:
During an inspection of your establishment located in Tampa, Florida on June 28 - July 1, 2005, an FDA Investigator determined that your establishment is a manufacturer and distributor of an infrared lamp device (Class 11). These products are devices, as defined by section
201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(h)]. The devices emit energy in the infrared spectrum to provide topical heating for the treatment of minor muscle and joint pain.
The investigator documented violations of the Act causing the devices to be adulterated within the meaning of sections 501(f)(1)(B) [21 USC 351(f)(1)(B)] and 501(h) [21 USC 351(h)] and misbranded within the meaning of section 502(o) [21 USC 352(o)] and 502(t)(2) [21 USC 352(t)(2)] of the Act.
Your device received clearance as an electric heating pad on March 30, 1994 (K931261). On October 19, 2001, FDA corrected this clearance and stated that the device "should have been classified as an infrared lamp rather than an electric heating pad." The clearance letter stated that you could "continue marketing your device as described in your Section 510(k) premarket notification." This 510(k) submission described the device as intended for relief of minor muscle and joint pain and improvement of superficial circulation.
Our inspection determined that your product labeling and internet website promote the Anodyne Therapy System for use in the treatment of wounds and ulcers, loss of protective sensation, gait and balance impairment, and other Diabetic Peripheral Neuropathy conditions, as well as conditions associated with Non-diabetic Neuropathies. Your company is also promoting the Anodyne Therapy System for the treatment of conditions including, but not limited to, soft tissue injuries, Carpal Tunnel Syndrome (CTS), and lymphedema. According to our records, however, you do not have marketing clearance from FDA to distribute into interstate commerce the Anodyne Therapy System for these uses.
The promotion of the Anodyne Therapy System for these uses indicates a major modification in the intended use of the device and requires a new premarket submission. 21 CFR 807.81(a)(3)(ii). Because you do not have marketing clearance from the FDA for these new intended uses, marketing the Anodyne Therapy System with these claims is a violation of the law. Your promotion and introduction into interstate commerce of this device for uncleared indications renders it adulterated under section 501(f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act.
For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).
Quality System Regulation
The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations observed include, but are not limited to, the following:
1. Your firm failed to establish and maintain procedures for implementing corrective and preventive action. In particular, you do not have a procedure to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3). Your firm has received
29 reports of burns (thermals) from users of the Anodyne Therapy System from August 2004 to April 2005 and failed to adequately investigate all of the reports and to take effective preventive action (FDA 483, Item #1).
2. Your firm failed to analyze processes, quality records, service records, and other sources of quality data to identify existing and potential causes of non-conforming product, or other quality problems as required by 21 CFR 820.100(a)(1). In particular, your firm failed to analyze in-process rejects and to analyze burn report trends. Your firm only analyzes complaints when the actual device is returned to your facility (FDA 483, Item #10).
3. Your firm's corrective and preventive action (CAPA) procedure does not include a requirement that each CAPA be verified or validated to ensure that such action is effective and does not adversely affect the finished device (FDA 483, Item #9). 21 CFR 820.100(a)(4).
4. Where the results of a process cannot be fully verified by subsequent inspection and test, the process must be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820.75(a). Your firm failed to document the validation study of (1) the new Pick & Place and Wave Soldering Equipment which are used to produce printed circuit boards for the Anodyne Therapy device, and (2) to complete adequate validation of the new Inserter device used to produce Array boards as follows:
a) Lacks documentation of installation and operation qualification of equipment,
b) Fails to establish a high degree of assurance that the device meets specifications and can be manufactured consistently in that only 4 Array boards were included in Performance Qualification; and
c) Failed to document settings used for the Performance Qualification (FDA 483, Item #2). 21 CFR 820.75(b)(2).
5. Your firm failed to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). Your firm failed to obtain adequate information during the investigation of 7 reports related to patients receiving burns as a result of using the Anodyne Therapy device. During investigation of six reports, your firm failed to determine if the user who sustained the injury received medical treatment, the severity of the burns received, and whether the patient was diabetic. This is a repeat of an observation made during the previous inspection dated July 8, 2003. During the investigation of Complaint #1457 dated 10/29/2004, your firm documented that arrays were repaired, but not what was needed to repair the arrays. During investigation of Complaints #1814 and #1952 dated 1/27/2005, your firm documented that defect(s) were found but there is no documentation of the exact nature of the defect(s) (FDA 483, Item #6).
6. Your firm failed to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a). In particular, your firm did not establish and maintain procedures for calibrating temperature and speed controls on wave soldering equipment and an oven. (FDA 483, Item #7).
7. Your firm failed to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c).
Your firm's soldering work instructions require that sensitive components and circuit boards, when not being worked on, must be enclosed in shielding bags or boxes. The investigator observed a minimum of 10 antistatic bags containing sensitive components and p.c. boards in open bags in the storage area (FDA 483, Item #8).
8. Your firm failed to maintain complete design history records
(DHRs) as required by 21 CFR 820.184(d). Your DHR fails to include complete acceptance records that demonstrate the device is manufactured in accordance with the device master record (DMR). Your firm fails to document the visual inspection by magnification of p.c.
boards after wave soldering (FDA 483, Item #3).
9. A design history file (DHF) must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j). Your firm's DHF fails to demonstrate that the design was developed following the approved design plan and the design control requirements, e.g., (a) your firm lacks documentation of design verification, design review, design validation, risk analysis, approval by a designated official, and the effective date of a design change made to wiring of arrays for the Anodyne Therapy device which was first released on 5/26/2005 (FDA 483, Item #4).
10. Your firm failed to designate a responsible individual(s) to review for adequacy and approve prior to issuance all documents established to meet the QSR requirements. The approval, including the date and signature of the individual(s) approving the document, shall be documented as required by 21 CFR 820.40(a) . Approval of your firm's procedure for testing the temperature of arrays did not have a signature and an effective date (FDA 483, Item #11).
Medical Device Reporting (MDR)
The above stated inspection also revealed that these devices are misbranded under section 502(t)(2) of the Act (21 U.S.C. 352(t)(2)), in that your firm failed to furnish material or information as required under section 519 of the Act and regulations implementing that section at Title 21 Code of Federal Regulations (21 CFR), Part
803 - Medical Device Reporting (MDR). More specifically your firm failed to report within 30 days, whenever you receive or otherwise become aware of information from any source that reasonably suggests that a device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Your firm received 29 reports of burns to users of the Anodyne Therapy device from August
2003 to April 2005. At a minimum your firm failed to submit nine (9) of the reports referencing burns to users to FDA as serious injuries, e.g., Complaints #144 dated 1/2/2004, #858 dated 8/19/2004, #1014 dated 9/13/2004, #1452 dated 1/14/2005, #1457 dated 10/29/2004 concerning two patients, #1625 dated 1/14/2005, #1883 dated 3/8/2005, and #2175 4/26/2005 (FDA 483, Item #5).
Establishment Registration and Device Listing
We have reviewed your firm's Establishment Registration and Device Listing records. Although you have an active Establishment Registration under Registration Number 1055581, you previously had a duplicate Establishment Registration under Registration Number 30044562499. When this duplicate Establishment Registration was purged from our database, the associated Device Listing for an Infrared Lamp (21 CFR 890.5500) was also purged. Please submit a new FDA Form 2892, Device Listing, to include an Infrared Lamp among your Device Listings.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no applications for premarket approval to which QS regulation deficiencies are reasonably related will be approved until the violations have been corrected.
Also, no requests for Certificates for Products for Export will be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure the similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Sincerely,
/S/
Emma Singleton
Director, Florida District
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Re: Laser therapy - April 12, 2006 2:03:00 PM
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Lehmkuhler
Posts: 69
Joined: December 14, 2005
Status: offline
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For chiropractors, medicare doesn't pay any modalities (yet), just cSMT. Modalities are completely uncovered by Medicare, and billed directly to the patient. From what I understand, Medicare's rules as to who performs the therapy would not apply since it is completely uncovered. State laws obviously will still determine whether or not the DC must perform the service, but not Medicare.
In the demonstration project currently underway, the DC must perform modalities. Some DC's are hoping that the demonstration does not succeed. This would mean Medicare oversight for all modalities and it would become something that must be done by the DC instead of being delegated appropriately (when possible) to staff.
At least that's my understanding at this point.
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Re: Laser therapy - April 12, 2006 3:45:00 PM
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Andrew M. Ball PT PhD
Posts: 855
Joined: July 28, 2002
From: Charlotte, NC
Status: offline
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Earlier today I communicated my concerns regarding the FDA letter to the president of the company that makes Anodyne.
They have filed a 510(K) with the FDA for an additional marketing clearance for Anodyne for the treatment of peripheral neuropathy. In their submission, they reported to the FDA that this application in supported by published clinical references derived from more than 6,000 patients who received treatment for peripheral neuropathy.
Furthermore, Medicare is currently conducting a national coverage analysis of "infrared therapy devices". The public comment period closed with more than 1,000 comments from healthcare professionals and patients regarding this technology. If any of you would like to gain access this public information please go to
https://www.cms.hhs.gov/mcd/viewpubliccomments.asp?id=&cov_id=&state_id=&list_type=&goto=viewpubliccomment&nca_id=176#0126200602262006.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 12, 2006 5:05:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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According to that warning I posted, the issue appears larger than just a "marketing" issue... conformity issues, calibration issues, quality issues, burns and not investigating complaints indicate more than just some marketing clearance issue.
In the automotive world, conformity is a big deal. Any company that makes parts for the automotive world have to definitely meet quality standards and criteria and there are multiple "sampling" of products to ensure that the product is within the defined quality standards. If a product is sent to an automotive company and if there is a particular amount of non-conforming product parts... all I know is it costs a lot of money and there are consequences for the manufacturing company.
I'm reading that warning from the view that there are manufacturing/quality issues that should also be resolved. In my interpretation, the issues outlined are not specific to marketing alone requiring published clinical references.
Uh, Drew... that link is just opinions... how does that assist with addressing the other issues?
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Re: Laser therapy - April 14, 2006 2:17:00 PM
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Andrew M. Ball PT PhD
Posts: 855
Joined: July 28, 2002
From: Charlotte, NC
Status: offline
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It doesn't address the other conformity and calibration issues. I am told that the manufacturing problems have been addressed and corrected, but I don't have any more specifics than that. I am anxious to hear what the FDA's response to the new 510k will be, as it will have to take into account ALL issues, including manufacturing quality.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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