The U.S. Food and Drug Administration (“FDA”) recently celebrated the 20th anniversary of its MedWatch program, which gathers and shares important safety information about FDA-regulated products. FDA gathers some of this safety information through reports of adverse health effects related to drugs, medical devices, biologics, dietary supplements and human tissue/cellular products submitted by health care professionals (“HCPs”).
Like other health care entities, medical spas are not immune to adverse events. A January 2012 Boston Globe exposition on medical spas identified 930 reports to FDA of dermal filler injuries (such as facial palsy, infections and scarring) over a five-year period. Because of the involvement of HCPs, medical spas can be obligated, under threat of criminal and civil penalties, to report adverse health effects related to the medical products they use.
Mandatory Reporting
Medical Devices Reports (“MDRs”)
Under federal law, a user facility (e.g., hospitals, nursing homes, medical spas, etc.) is required to report to the device manufacturer and FDA whenever the facility has information that reasonably suggests a medical device has or may have caused or contributed to a patient’s death. If a facility has information that reasonably suggests a device has or may have caused or contributed to a patient’s serious injury, it must report this to the manufacturer, or if the manufacturer is not known, then to FDA. These reports must be filed, using FDA Form 3500, within 10 working days of becoming aware of the information.
If it meets the criteria above, user error in operating a medical device must also be reported to FDA, as FDA will use this information to determine whether or not relabeling or redesign of the device is necessary. A medical spa is not required to report a medical device malfunction but is encouraged to use the voluntary MedWatch program to inform FDA.
Medical spas must also submit a semiannual report to FDA on FDA Form 3419 if any individual adverse event report was submitted during the previous six-month reporting period. Semiannual reports are due by January 1 (for reports made July through December) and by July 1 (for reports made January through June) of each year.
Medical spas must also keep records of complaints from patients and MDR reports for a period of two years and provide FDA employees access, at all reasonable times, to all required records. These files must contain:
- Information in the possession of the medical spa related to the event, including all documentation of its reporting and decision-making process; and
- Copies of all completed MDR forms and other information submitted to FDA, distributors and manufacturers.
Medical spas are also required to develop, maintain and implement written procedures for identification, evaluation and timely submission of MDR reports and compliance with record-keeping requirements.
Failure to comply with these requirements may subject a medical spa to injunction proceedings, a criminal fine of $10,000 and imprisonment of three years and civil penalties not to exceed $15,000 per violation.
More information about FDA’s medical device reporting requirements for user facilities may be found at:
- FDA’s guidance document, “Medical Device Reporting for User Facilities“; and
- Center for Devices and Radiological Health (“CDRH”) reporting page.
HCT/P Establishments
Certain medical spas may be required to report adverse reactions related to the implantation, transplantation, infusion or transfer of human cells and tissue-based products (“HCT/Ps”). These medical spas have 15 days from the initial receipt of information to inform FDA of any serious adverse reactions involving a communicable disease that is:
- Fatal;
- Life-threatening;
- Results in permanent impairment of a body function or permanent damage to body structure; or
- Necessitates medical or surgical intervention, including hospitalization.
Depending on their administration, cellular and tissue-based therapies can also be considered new biologics or drugs and be subject to the adverse event reporting requirements applicable to manufacturers of those products. This may occur when the HCT/P product is more than minimally manipulated, intended for any non-homologous use, combined with certain other materials or has a systemic effect and is dependent upon the metabolic activity of living cells for its primary function, etc.
More information about reporting requirements for HCT/P user facilities can be found in FDA’s guidance document, “Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues and Cellular and Tissue-Based Products.”
Dietary Supplements
Manufacturers, packers and distributors of dietary supplements whose name appears on the label are required to report information about serious adverse effects to FDA. A retailer whose name appears on the label is likewise responsible for adverse event reporting, unless it has a written agreement with the manufacturer of the dietary supplement to submit the required reports.
Voluntary Reporting by HCPs
Unlike with medical devices, there is no federal requirement that medical spas report pharmaceutical-related adverse events to FDA. Similarly, when injury to a patient from other medical products does not meet the severity threshold (serious, life-threatening, etc.), no user report is required. In these situations, a medical spa may voluntarily submit a report using FDA MedWatch Form 3500.
Public Access to Information
Certain information in MedWatch is disclosed to the public. Before public disclosure, FDA deletes the names of any HCPs, except for those designated as contact persons. FDA will not disclose the identity of a medical spa that files a report, except in connection with enforcement actions and communications to the product manufacturer. MedWatch reports are also not admissible into evidence or otherwise available to be used in any civil action involving private parties, unless the facility, individual or physician who made the report knew that the information in the report was false.
State Reporting Requirements
Approximately 37 states have public or private patient safety programs that either mandate or encourage reporting of patient outcomes. Medical spas in these states may be required or encouraged to report adverse events to the relevant program. Most states that have mandatory reporting programs require health care providers to report serious events resulting in permanent disability or death and events likely to affect the broader patient population such as infections.
Practical Takeaways
User facilities, which can include medical spas, may have obligations to report adverse health effects related to the medical products they use. In order to identify and comply with its obligations, a medical spa should:
- Identify the drugs, medical devices, biologics, dietary supplements and human tissue/cellular products that it utilizes;
- Identify its roles in the distribution and application of those medical products, as well as the treatment of those roles by the FDA;
- Create the necessary internal processes and procedures to comply with state and FDA requirements relating to those products; and
- Designate a person to become familiar with state and FDA reporting mechanisms and take advantage of training materials published by the agencies.
If you have any questions about the reporting of adverse health effects related to medical products, please contact Mark Dahlby at 414-721-0902 or mdahlby@hallrender.com, Sara MacCarthy at 414-721-0478 or smaccarthy@hallrender.com or your regular Hall Render attorney.
