October 4, 2012 Docket No. FDA-2012-N-0378
Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III preamendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, we oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.”[i] FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective”[ii] therefore, the devices have no public health benefits, and that also rules out the use of a PDP.
We strongly oppose the petitions by BioElectronics Corporation; Diapulse Corporation of America; and MEDicept, Incorporated requesting that the FDA change the classification of SWDs to Class II devices. SWDs pose significant health risks to patients, but provide no measureable benefits. We would like to examine the “new information relevant to the classification of the device”2 that the companies are supposed to provide, but it is not available. The companies state the information is restricted and “not for public view.”[iii] However, the missing information directly affects public health and it should be made available.
FDA’s Physical Medicine Device Classification Panel identified four health risks from SWD devices: cellular or tissue injury, pacemaker interference, tissue necrosis and burns, and electrical shock. Adverse events reported to the Manufacturer and User Facility Device Experience (MAUDE) confirms the Panel’s concerns. MAUDE reports regarding SWDs include blisters, third degree burns, shock sensations, and interference with a pacemaker.[iv]
FDA notes that SWDs are associated with burns and “research has demonstrated that such devices [non- thermal SWDs] do have a thermal effect and a direct correlation between pulse rate and thermal sensation exists.”2 Studies have shown that SWDs can “cause heating of implanted wire leads,”2 which can cause thermal injuries to patients even when the implanted device is not turned on or has been removed from the patient’s body but the metal leads are left in-place.
FDA is also aware of radiation hazards caused by SWDs, not only to patients but to the operator of the SWD because “the majority of SWD units in clinical use do not have shielded leads to transmit the high frequency generated to the applicator.”2 FDA is rightly concerned about the health of SWD operators, especially if they treat several patients a day.
Another concern cited by FDA, is that abnormal cell growth caused by non-thermal SWDs has been reported in in vitro studies in human and rat cell lines. FDA notes that, “The effects of cellular changes by the electromagnetic field of the SWD devices require further clinical study to show that the magnetic fields do not produce harmful effects on the cells.”2
SWDs are used to treat joint pain and muscle strain, and are used for postoperative pain relief in superficial soft tissue. Alternative treatments to SWD devices are available. These include everything from opioid and anti-inflammatory medications to therapeutic ultrasound, interferential therapy, and transcutaneous electrical nerve stimulators (TENS).
The FDA notes that submitting a PMA application would cost manufacturers of a SWD device an estimated $2.6 million, but the only alternative that would save companies money would be to down classify the device to Class II. However, “FDA has determined that it has insufficient information to implement adequate general and specials controls”2 for SWD devices to be cleared by the 510(k) process. In these difficult economic times, we do not wish to add unnecessary burdens to device manufacturers. But if SWD devices are not safe and effective, then hospitals, patients, the government and insurance companies will be paying for an ineffective product. Even more important, the FDA’s main mission is to protect the public health, and that is not possible if the FDA continues to allow potentially dangerous devices of questionable effectiveness on the market.
SWDs should be Class III devices because they have serious adverse health consequences (third degree burns and shocking of patients with pacemakers or implanted defibrillators) and unproven effectiveness. SWD for all other uses should require a PMA, which requires valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device.
For the above reasons, we strongly support FDA’s proposed rule to classify the SWD for all other uses as a Class III device, which will require a PMA; we do not support a PDP for this device. We agree with FDA that a PMA for these devices “should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device.”2
[i] Food and Drug Administration (2012). Medical Devices – PMA Applications Methods (Web site). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm048168.htm