Study: Safety & Performance of Reactivated Thermage Thermacool Tips.

Before or after reading this post on a supposed study show that reactivated Thermage tips can be used for 50,000 pulses, read this post by Thermage: Thermage responds to study showing reactivated Thermage tips are safe.

 

Safety and performance of reactivated Thermage Thermacool tips.
Michael Stevens M.D., et all

Abstract

This study investigated the safety and performance of reactivated Thermage Thermacool tips. The Thermacool machine, made by Thermage Inc. in Hayward California, uses radio frequency (RF) energy to treat a variety of dermatological cosmetic conditions. The machine’s hand piece is coupled to a plastic tip which incorporates a microchip. This microchip contains data which limits the number of shots which the tip can be used for. By attaching an aftermarket replacement microchip (with the exact same data) to the plastic tip, the tip can be reused for many more shots. This study investigated in detail the safety and performance of such reactivated tips. The study found that the tips could be safely reactivated and used for more than 50,000 shots (more than 55 reactivations) with the same safety, performance and clinical results as obtained from a new tip.

Background and Objectives

The Thermacool machine, made by Thermage Inc. in Hayward California, uses radio frequency (RF) energy to treat a variety of dermatological cosmetic conditions. The machine consists of a main unit which incorporates a computer, power supply, and other components. The main unit is attached to a hand piece that has the components necessary to generate the RF energy and deliver cryogen coolant to a plastic tip. A plastic tip attaches to the hand piece and directs the RF energy and cryogen coolant to the patient’s skin. The plastic tip incorporates an EPROM microchip which contains data to tell the Thermacool machine as to how many shot the tip can be used for. Once the allowed number of shots has been used with the specified tip, the machine no longer allows the use of that particular plastic tip. The user of the device is then forced to throw away the used tip and purchase a new tip from Thermage at a very expensive price.

Read Thermage's reaction to this supposed study here: Thermage responds to physicians using reactivated tips.

Thermage claims that they have limited the use of the tips because of safety reasons. They claim that the tips are safe to be used only for the number of shots which they have been programmed for. However, Thermage currently produces identical tips which are programmed to be used for 150 shots, 200 shots, 300 shots, 450 shots, 600 shots, and 900 shots. Examination of the different plastic tips shows that they are all identical in their construction and quality. The only difference between them is the programming of the EPROM microchip to limit the number of shots used by each tip. This clearly shows that Thermage is aware that a tip which they have programmed for 150 shots can be safely used for as many as 900 shots, which is 6 times the number of 150 shots! This has lead many doctors who use the Thermacool machine to conclude that Thermage is limiting the number of shots on the tips for monetary gain and not for safety reasons.

Thermage has claimed that their Thermacool tips are made as a one-time use device for the following reasons: they claim that the membrane on the plastic tips deteriorates and is not safe for use after the allowed number of shots. Thermage also claims that the tips are limited to one-time use because of sterility reasons. All of these claims were fully investigated in this study and found to be incorrect.

Methods

20 new Thermacool plastic tips was taken apart and examined in detail. Tips of the size 1.0cm and 1.5cm were examined. Tips from all manufactured shot counts were examined. Components of the plastic tips were sent to experts in the fields of RF, computer circuitry, and various other manufacturing fields. All Thermacool plastic tips of the various shot counts (150 shots, 200 shots, 300 shots, 450 shots, 600 shots, 900 shots) were found to be identical in their composition, materials, and quality. The only difference between the tips was the programming of the EPROM microchip inside the tips.

Thermacool plastic tips were found to be a simple device made of ABS plastic. The plastic tip incorporated a standard thin film of a flexible electronic circuit (made of a thin flexible plastic), which incorporated small temperature sensors and an EPROM microchip. The EPROM microchip was programmed to the number of shots which the tips had been assigned and the size of the tip (1.0cm or 1.5cm tip).

The flexible circuit inside the plastic tip was positioned such that the center of the flexible circuit functioned as the “membrane” of the plastic tip. The “membrane” is the part of the tip which comes in contact with the skin during a treatment. This portion of the flexible circuit contained the temperature sensors to sense the skin’s temperature during the treatment. Analysis of the temperature sensors by experts in the field of electronic circuitry has confirmed that the temperature sensors are standard temperature sensors used in many electronics devices. These sensors have a very long life span of more than 10,000 hours of operation within their range of operating temperatures.

Each temperature sensor was found to have a contact lead at the other end of the flexible circuit such that when the flexible circuit was wrapped inside the plastic tip, the contact leads were positioned where the Thermacool hand piece touches the plastic tip’s connections. These leads then come in contact with the leads of the Thermacool hand piece to allow the machine to receive signals from the temperature sensors.

The EPROM microchip is also incorporated into the flexible circuit, covered within the body of the plastic tip. The EPROM microchip was found to be of a type which allows information to be written to it once only. This does not allow the reprogramming of the microchip once it has already been written to. The microchip communicates to the Thermacool’s main computer via two contact leads which are positioned at the same location as the contact leads of the temperature sensors. These leads then come in contact with the leads of the Thermacool hand piece to allow the machine to read the data from the microchip.

The fact that an EPROM microchip was used, which could only be written to once, it was not possible to reprogram the microchip inside the original tip in order to reactivate the plastic tips once they had been used. Therefore, new blank EPROM microchips were purchased from the same microchip manufacturer. The microchips were then programmed to the EXACT SAME data as a new tip from Thermage. A special flexible circuit was designed to allow the new microchip to be attached from the outside of the used Thermacool tips. Our designed flexible circuit contained 2 contact leads identical to the tip’s contact leads, which were attached to the plastic tip by the use of double tape. The 2 contact leads overlay the plastic tip’s original contact leads of the microchip, thus bypassing the original microchip inside the used tip and allowing the Thermacool machine to read the data from the newly programmed microchip. This simple design alleviated the need to make any alterations to the structural integrity of the plastic tips. No modifications or changes were made to the tips in any way.

The reactivation microchips were then attached to used tips and used on actual patients who consented to the study. Patients were randomly assigned to one of the two groups. One group treated with new tips, and the other group treated with reactivated used tips. Patients were blinded and did not know which group they were assigned to.

In total, 20 used Thermacool tips were used in the experiment, 10 of 1.0cm tips and 10 of 1.5cm tips. Each used Thermacool tip was reactivated by attaching to it a newly programmed microchip. Before each treatment, each tip’s membrane was also carefully cleaned and sterilized with alcohol pads to ensure sterility. The tips were then attached to the Thermacool hand piece and standard treatments were performed on the patients. Each reactivated tip was used on a single patient. Careful documentation was made as to whether patients reported any unusual side effects such as increased pain, erythema, burns, infections or other complaints. At the end of each patient’s treatment series, they were asked to fill out a questionnaire to report any side effects, infections, and if they noticed favorable clinical results from the treatment.

Once the number of shots were used on each tip after a single treatment, the tip was sent for testing and analysis. After each reactivation and use, the tip’s membrane was carefully examined. The membranes were visually examined for any cuts, breaks, tears or compromises in the integrity of the flexible circuit membrane. Small folds or wrinkles in the membrane were not a factor as these were present in many new tips from Thermage. The visual inspection was done by 3 different individuals at different times to ensure a non-biased examination of each tip.

After the visual examination of the membrane, each tip was tested for proper temperature sensing. Each used tip was subjected to various temperatures: 80 degrees Fahrenheit, 100 degrees, and 120 degrees. Individual temperature readings were obtained from all temperature sensors in the plastic tip and compared to readings from new Thermacool tips exposed to the same settings.

In the next stage of testing, the tips were tested for proper cryogen coolant delivery. The same coolant cryogen used by the Thermacool machine, Freon gas (R-134a, also called tetrafluoroethane), was used. At first, a visual inspection of the inner part of the plastic tip was done to make sure that no blockages have been formed on the plastic tip. A controlled cryogen coolant spray was applied to the area of the plastic tip which delivers the cryogen coolant to the tip’s membrane. The membrane’s temperature was then recorded and compared to the readings obtained from new Thermacool tips undergoing the same controlled cryogen coolant spray.

Lastly, a final visual inspection was performed on each tip to ensure that there were no other structural damaged or changes to the integrity of the plastic tip or contact leads which connect to the Thermacool hand piece.

Each used Thermacool tip was reactivated and used for a total of 50,000 shots, which translated to 50-100 reactivations/treatments based on the number of shots each tip was reactivated. 1.5cm tips were reactivated to 900 shots, whereas 1.0cm tips were reactivated to 450 shots.

None of the plastic tips were found to have any defects to be removed from the experiment as all of the used tips passed all testing results after each and every reactivation and testing procedure.

After all 20 Thermacool tips were used for 50,000 shots EACH, the tips were taken apart and their components were closely examined. The flexible circuits which comprise the membrane of the tips were sent to experts in the fields of RF and electronics circuitry. The integrity of the flexible circuit membranes were examined in detail and compared to the original new tips. The ability of the membranes to uniformly deliver RF energy and cryogen coolant was examined by the experts. The integrity of the contact leads and temperature sensors within the flexible circuit were also examined in detail and compared to the original tips.

Results

In total, approximately 1200 treatments were performed using the reactivated used Thermacool tips. A total of 50,000 shots were used on each of the 20 used Thermacool tips. The study was conducted over a period of 12 months.

Clinical results and the occurrence of side effects were compared to those from patients undergoing treatments with new Thermacool tips. The study found no increase in the rate of side effects between the reactivated tips and new tips. In specific, there was no significant difference in patient reports of increased pain, erythema, burns, infections or other complaints.

These results confirm that used Thermacool tips can be safely reactivated and used on multiple patients without increasing chances of infections as claimed by Thermage. Simple cleaning of the tip’s membrane with alcohol is sufficient in the control of infections with reusing Thermacool tips.

Occurrences of Infections:

New Tips: 0% Used Tips: 0%

No significant difference (p<0.001)

Occurrences of Burns:

New Tips: 0.06% Used Tips: 0.04%

No significant difference (p<0.01)

Occurrences of Other Side Effects:

New Tips: 4.35% Used Tips: 4.5%

No significant difference (p<0.01)

Patients with Noticeable Clinical Results:

New Tips: 85% Used Tips: 87%

No significant difference (p<0.01)

The study did not find any significant deterioration or compromise in the integrity of the tip’s membranes after 50,000 shots. This is based on the visual inspection of the tip’s membranes after each treatment, and on the final analysis of experts at the end of the experiment once the tips had been taken apart. All 20 tips used in the experiment did not fail even once throughout the full length of the experiment for the duration of 50,000 shots used on each tip. (p<0.01)

Analysis of the temperature sensors showed that all reactivated used tips continued to perform within the accepted range of the temperature sensors for the duration of the experiment. There was no significant difference in the ability of the used tips to detect temperature changes as compared to new Thermacool tips. Temperature readings from used tips ranged from 98% to 101% of readings from new tips. This coincides with the experts’ analysis that the temperature sensors which are used in the Thermacool tips have a very long life span and will last far more than the 50,000 shots used on each Thermacool tip. This was seen in all various temperatures which were measured.

The study also found no significant difference in the ability of the used tips to deliver cryogen coolant as compared to a new tip. Temperature changes measured at the tip’s membranes were no different in the used tips after 50,000 shots as compared to a new Thermacool tip. Temperature readings from used tips ranged from 97% to 102% of readings from new tips. This shows that used Thermacool tips can effectively deliver cryogen coolant to the tip’s membrane after repeated prolonged use.

Conclusion

This study strongly confirms that Thermage Thermacool tips can be safely reactivated and reused for more than 50,000 shots. These findings apply to both the 1.0cm tips and 1.5cm Thermacool tips. The study found that there are no increased chances of infection or other side effects with reusing Thermacool tips, as long as simple measures are taken to clean the tips with alcohol and visually inspect the tip’s membrane.

The Thermacool tips can function safely for more than 50,000 shots and show the same clinical efficacy as a new tip. Used tips are just as effective as a new tip in delivering RF energy and cryogen coolant, proper and accurate sensing of skin temperature, and maintaining the integrity of the tip’s membrane. No deterioration of the tips’ membranes was found after 50,000 shots of use.

The findings in this study show that Thermage’s claims of decreased safety with reusing Thermacool tips are incorrect. It is clear that Thermage has limited the use of their Thermacool tips for monetary reasons only.

By attaching a newly programmed microchip to the used Thermacool tips, without any modifications or changes being made to the tip itself, doctors can safely and effectively reuse their Thermcool tips, thus lowering their overall treatment costs and expenses.