Update: Safety Guidance for Microneedling and Other Injectable Procedures

Safety Guidance for Microneedling and Other Injectable Procedures

After the New Mexico Department of Health (NMDOH) recently urged customers of an Albuquerque medispa who had received “any type of injection-related service” to get tested for HIV and other blood-borne infections due to unsafe practices, aesthetic medical professionals are looking for guidance on how to protect their patients and their practices.

Though the article linked above that reported the health agency’s recommendation cited a popular treatment often involving microneedling, the NMDOH did not specify any particular treatment that caused an issue but stated that practices were identified that “could potentially spread blood-borne infections such as HIV, hepatitis B, and hepatitis C.”

While this report is concerning, it should be noted that microneedling is ­a safe procedure when practitioners follow proper procedures and use validated, FDA-cleared microneedling devices. As the maker of the only FDA-cleared microneedling device, SkinPen®, Bellus Medical would like to offer safety recommendations backed by good clinical practices and our FDA-reviewed protocols.1 Here’s what physician-directed aesthetic medical providers need to know:

  • Follow proper medical protocols. These include washing hands, wearing gloves, and putting disposables in the proper receptacles.
  • Check your microneedling device for features that prevent cross-contamination. These include single-use needle cartridges, a sealed device body, and single-use device sheaths.
  • Find out if your device is clinically tested for safety. If it’s not, your patients might be at risk.
  • Look for regulatory validation of the device. For instance, FDA clearance, a valid CE mark, and/or ISO certification.
  • Use only FDA-cleared devices to guard against lawsuits. “In many medical device liability cases, a doctor is shielded from liability when properly using a cleared and compliant device, since the FDA review and clearance would ensure all likely hazards are controlled,” said Marc C. Sanchez, an FDA attorney who worked on B­ellus Medical’s microneedling De Novo submission. “That defense is totally washed away when using an unapproved medical device.”

If you have any further questions, please contact the Bellus Medical Information team at medinfo@bellusmedical.com.

1See intended use, important safety information, and clinical trial details (data on file) at bellusmedical.com.
2018-09-15T20:11:13+00:00