Letter to the Editor: Dermatologists Must Focus on Safety; Understand Device Clearances

As we enter the second half of 2019, we can say without hesitation that the aesthetic industry is booming. We are very fortunate that we have more and more patients entering the cosmetic arena. We are also fortunate that there are more and more providers of aesthetic services than ever before. This allows for greater access to care for our patients, but also raises concerns that we cannot gloss over without some form of discussion. As medical care providers, we need to focus on making sure that we are knowledgeable in the treatments that are being performed or delegated to staff, that we always put patient safety first in everything that we do.

While the concept of patient safety sometimes seems to be taken for granted, I cannot stress the importance of it enough. In our state, we have put this at the forefront of legislative initiatives, by passing under the auspices of The Tennessee Society of Laser Medicine & Surgery, our non-profit group that advocates for patient safety each and every day. The Tennessee Society of Laser Medicine & Surgery works with state legislators to make sure that all providers are taking the concept of patient safety seriously and has helped pass into law several initiatives, which are all designed with patient care and patient safety at the forefront. These initiatives are not meant to hurt or exclude one group from practicing aesthetic medicine, however we do make sure that the supervising physician in charge of the office is ultimately responsible for every treatment and every procedure that is being performed within that office, clinic, or spa. Our initiatives include a Truth in Advertising Law—that is, we want all medical spas in our state to be required to disclose who the Medical Director is along with their Board Specialty.

The Tennessee Society of Laser Medicine & Surgery has also instated a Spa Registry so we can keep track of who is operating a spa in our state and to make sure the Medical Director is in close proximity to that particular office. The purpose of these initiatives, and the enforcement of them, is to help assure to the best of our ability that the patients know what physician is overseeing the facility and their credentials. The patient needs to know that there is a medical doctor overseeing the spa and that this person has knowledge in the procedures performed. That being said, it is also the duty of the patient to ask the right questions and to determine the competence of all involved.

Patient and physician safety is of the utmost importance in every aspect of medicine and medical care. It is no different in an aesthetic practice because of what we are doing to improve the appearance of the skin. Treatment options have grown instrumentally since I entered this field more than 30 years ago. My main procedures back then were dermabrasion—full diamond fraises to remove the skin—and medium to deep chemical peels. These were procedures that were not easily delegated to my staff, so I did almost everything while my staff made sure that the areas being treated were cleansed properly and that our aftercare instructions were thoroughly reviewed with the patient. In today’s world, things are a little different. More and more of the non-invasive or minimally invasive procedures that we perform are being performed by ancillary staff. There is nothing wrong with this when those people are properly trained and follow appropriate protocols, however, it is equally important that they know what their limits are and have access to their supervisory physician at all times.

Microneedling has become one of the most popular procedures being performed at medical spas and at physician offices all over the country. With this increased popularity, it is important for the consumer to know that all microneedling pen devices—these very common and effective devices—are not the same. Several years ago many of these pen manufacturers received warning letters from the FDA that they were making claims about these devices without appropriate FDA clearance, forcing several of these companies to stop making inappropriate claims, which was a good thing for all of us. Some of the manufacturers, like Bellus Medical, decided to do the work required to achieve FDA clearance. Bellus’s SkinPen was the first FDA-cleared microneedling pen, and that, to me and many of my colleagues, is significant. It gives all of us the confidence that they, as a company, have done the work and gone through rigorous claims approvals and testing to prove to the FDA that their device works, but more importantly, is safe for our patients.

The SkinPen underwent more than 90 extensive and rigorous validation tests during the design and study phases. Among features of the FDA-approved device that prevent any potential cross-contamination are single-use needle cartridges, a sealed device body, and single-use device sheaths. The single-use lockout feature of the cartridge unit eliminates the possibility of double usage and cross-contamination. The proprietary biosheath acts as a barrier to prevent cross-contamination between procedures and ensures that the skin never actually touches the device and ensures that any fluids generated during the procedure do not pass from a contaminated glove to the SkinPen.

Moreover, it is a little peace of mind to know that if an action or lawsuit ever was filed against any of us, that from a device point of view, the SkinPen’s FDA clearance status shields physicians from liability as long as the device is being used correctly. Using a microneedling device without FDA class II clearance leaves one pretty indefensible in a court of law. SkinPen has received a CE mark for safety and efficacy in the European Union group of nations as well.

Can all of these enhancements assure patient safety 100 percent? Nothing can be 100 percent in our aesthetic world when it comes to patient safety. But with the attention to detail that Bellus Medical has employed, we can be assured that we have one of if not the safest, and most tested microneedling devices on the market. As physicians, we must ensure that we have proper protocols in place for the procedure to be done correctly and that we have appropriate post-care instructions for our patients. If we are going to use skincare products after using SkinPen, we also must make sure that these are well tested and appropriate skin care for the conditions that we are treating. Doing all of this is also crucial to assure patient safety each and every time the device is used.

We are very fortunate that we get to do what we do on a regular basis in our aesthetic practices and that we make people look and feel better each and every day. We can never take for granted what we do and it is crucial to remember that we must always put patient safety first. Know your limits, know your device limits, and know all that you can about the device that you are using.

—Michael H. Gold, MD
Nashville, TN