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Re: Laser therapy
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Re: Laser therapy - April 14, 2006 3:15:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
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I'm not so sure their manufacturing problems have been addressed and corrected.
First of all, from what I saw there is a 501(K) premarket notfification database listing Anodyne Therapy Systems as an infrared lamp with a decision date of 3/31/1994.
On December 3, 2004 Anodyne Therapy Systems had a quality management system in place that met ISO 13485:2003 requirements.
On September 8, 2005 a full quality assurance was met on behalf of the British Standards Institute.
So.. if the FDA inspected their facility from June 28 - July 1, 2005, I would truly believe that there were quality issues that were NOT taken care of or addressed. In particular, I would tend to believe this based on the ISO certification. I have a familiarity with ISO certification and the processes involved. It's a ton of paperwork and a ton of follow-up when being ISO certified. If during the inspection process, the Anodyne folks couldn't produce within their huge spiral bound crap that gets generated quarterly anything to prove that 1) something was done and how it was done - then technically whatever was never actually done 2) if there were quality issues and nonconformities - that's what ISO is all about - those nonconformities are supposed to be reported with an action plan of how to address them, when to address them, and when to follow-up for another audit to see if the issue was rectified.
Now, when it comes to ISO, the individual company determines their quality standards - after the quality standards are defined, well, then the process of assessing quality follows the international process of meeeting the standards. If the company actually knew that there were quality issues, they obviously didn't follow ISO processes.
I don't know anything about the British Standards Institution, but if you have 2 quality processes within a company, that is strange to me... combined with what the FDA cited - sounds like there are some major problems within that company. Before you can even say what a product does, I would think that it would be highly important to produce a standardize product meeting strict quality standards. Without a clean manufacturing process, there is no guarantee that the product will even function as expected 100% of the time.
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Re: Laser therapy - April 14, 2006 9:40:00 PM
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goodlooks58
Posts: 425
Joined: October 21, 2002
From: CA
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I finally got my ML-830 laser for 30 day trial. Used it on 4 pts. today...a post-op RTC repair came with 30 degrees shoulder flexion, 8 minutes of laser...had 110 degrees of flexion. Another pt with DeQuervain's...functional thumb adduction-tip of the thumb to 2nd crease was at 4cms..improved to 1 cm after 4 mins of laser with significant pain reduction in 1st MCP region. I am just going by my pts' daily outcome. So far what I saw today was impressive. Will keep you guys posted on further daily outcomes.
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Re: Laser therapy - April 15, 2006 5:56:00 AM
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drbuddy
Posts: 429
Joined: July 30, 2005
From: Pennsylvania
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Hey, welcome to the wonderful world of low level laser therapy. I'm glad the ML-830 is working out for you. Let us know how it works for spinal conditions or larger joints like the hip. I seem to see the best results with more superficial tissues such as the ones you mentioned above.
I just love to look on patients' eyes when they perform a post test to find that pain is much less and function has greatly improved. I just know when I first use it and they cant feel anything that they think I am a nut.
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Re: Laser therapy - April 15, 2006 6:07:00 AM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
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I'm really confused... the ML-830 is only FDA approved for carpal tunnel syndrome. Legally, if the ML-830 is used for other conditions, what are the ramifications if 1) anyone was using it for other conditions and 2)serious side effects occurred during the use of the ML-830 for a condition different than carpal tunnel syndrome?
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Re: Laser therapy - April 15, 2006 12:36:00 PM
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goodlooks58
Posts: 425
Joined: October 21, 2002
From: CA
Status: offline
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SJ: Good question. I have copied your question to the president/ceo of ML-830 company. As soon as I get a "written" response I will post it.
Thanks.
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Re: Laser therapy - April 15, 2006 2:13:00 PM
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drbuddy
Posts: 429
Joined: July 30, 2005
From: Pennsylvania
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It is cleared by the FDA under another description too. I forget the specifics, but it describes it as a therapeutic device to aid in tissue healing, pain relief, etc.
I have spoken to someone at the FDA personally about some of these issues and one thing to note is that most of these laser companies 'piggy back' off of FDA clearances from earlier devices. If the technology is similar enough, a company is not required to conduct clinical trials and prove its saftey. So, when looking at clearances from the FDA, you will find almost exactly the same verbiage for each device.
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Re: Laser therapy - April 16, 2006 5:10:00 AM
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drbuddy
Posts: 429
Joined: July 30, 2005
From: Pennsylvania
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I found some information related to the current discussion on the FDA's website:
http://www.fda.gov/cdrh/consumer/laserfacts.html
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed.
Certain unapproved, nonsignificant risk Class III medical devices, including biostimulation lasers, may only be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device, or to investigators participating in a study under an Investigational Device Exemption (IDE) approved by the Center for Devices and Radiological Health (CDRH), as specified in the Code of Federal Regulations (CFR), 21 CFR 812. Even with IRB approval, a sponsor must comply with IDE requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices. The investigators would have similar responsibilities, also covered in 21 CFR 812.
Relating to the ML830 specifically:
http://www.fda.gov/cdrh/pdf/k010175.pdf (original clearance, for hand pain and CTS)
http://www.fda.gov/cdrh/pdf4/k041364.pdf
(updated clearance, for "elevating tissue temp, relief of minor muscle and joint pain, arthritis and muscle spasm, releiving stiffness, promoting relexation of muscle tissue, and to temporarily increase local blood circulation where applied")
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Re: Laser therapy - July 2, 2006 6:28:00 AM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
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The effect of 300mW, 830nm laser on chronic neck pain: A double-blind, randomized, placebo-controlled study.
Pain. 2006 Jun 23;
Authors: Chow RT, Heller GZ, Barnsley L
A randomized, double-blind, placebo-controlled study of low-level laser therapy (LLLT) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300mW, 830nm laser in the management of chronic neck pain. Subjects were randomized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck. The primary outcome measure was change in a 10cm Visual Analogue Scale (VAS) for pain. Secondary outcome measures included Short-Form 36 Quality-of-Life questionnaire (SF-36), Northwick Park Neck Pain Questionnaire (NPNQ), Neck Pain and Disability Scale (NPAD), the McGill Pain Questionnaire (MPQ) and Self-Assessed Improvement (SAI) in pain measured by VAS. Measurements were taken at baseline, at the end of 7 weeks' treatment and 12 weeks from baseline. The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group (difference 3.0, 95% CI 3.8-2.1). Significant improvements were seen in the active group compared to placebo for SF-36-Physical Score (SF36 PCS), NPNQ, NPAD, MPQVAS and SAI. The results of the SF-36 - Mental Score (SF36 MCS) and other MPQ component scores (afferent and sensory) did not differ significantly between the two groups. Low-level laser therapy (LLLT), at the parameters used in this study, was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months.
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Re: Laser therapy - July 2, 2006 6:20:00 PM
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SJBird55
Posts: 2438
Joined: May 10, 2004
From: Michigan
Status: offline
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What is the SEM for the VAS they used? And what is the MCID for the VAS they used? A 2.7 change for the better sounds good, but is it clinically relevant?
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