FDA Issues Warnings About Research Participant Protections and Inadequate Sterilization of Medical Equipment to Mayo Clinic Care Network Hospital

Tuesday, April 19, 2016
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On April 12, 2016, the U.S. Food and Drug Administration (FDA) issued warnings that targeted the allegedly substandard protection of research participants at a hospital in the Mayo Clinic Care Network.  It also addressed shortcomings involving the sterilization of medical devices used to harvest fat during plastic surgery. Below are the enforcement actions taken by the FDA.

Hospital Allegedly Fell Short on Protecting Human Research Participants.

The FDA issued a warning letter to a Kentucky-based Pikeville Medical Center (PMC), one of about 30 U.S. hospitals that belong to the Mayo Clinic Care Network. The warning letter alleges numerous missteps at PMC’s institutional review board, a panel that oversees clinical research to protect patients. “We conclude that the IRB did not adhere to the applicable FDA regulations governing the protection of human subjects,” FDA officials wrote. To read the warning letter issued to PMC, click here.

PMC’s Violations According to the FDA.

One of the violations was a failure to review research frequently enough. According to the FDA’s warning letter, regulations require a review no less than once per year, but PMC took more than 18 months to review a pair of studies.

There was also an extensive lack of written procedures related to the board’s review obligations. According to the warning letter, PMC “failed to prepare, maintain and follow” written procedures for determining which studies should be reviewed more often than annually and be subjected to extra verification processes. The letter also said that PMC lacked procedures to ensure prompt reporting of suspended research and “serious or continuing” regulatory violations. The letter also complained about inadequate meeting minutes that didn’t properly document IRB votes, but it said that proposed remedial steps appear likely to prevent future lapses.

Enforcers Focus on Medical Devices Used to Harvest Fat During Plastic Surgery.

The FDA released a second letter on April 12, 2016, that went to Florida-based Miami Fat Supply Inc. (MFS), which manufactures tubes and canisters used to harvest, transfer and store fat during cosmetic surgeries. The procedures in question involve extraction of fat from an undesired place, such as the abdomen, and relocation of it to another area that a patient wants to augment.

The warning letter said that MFS has been allegedly selling its products without approval. “A review of our records reveals that your firm has not received pre-market clearance or approval to market these devices in the United States, which is a violation of the law,” the letter stated.
In addition, the FDA’s warning letter described eight categories of regulatory violations. Including one example, MFS allegedly failed to take appropriate action when it received complaints about products cracking and melting during sterilization.

MFS also failed to select suppliers based on their ability to satisfy regulatory requirements, neglected to create and implement suitable procedures for receiving and processing complaints and failed to do quality audits, the letter stated. Additionally, MFS failed to ensure that canisters could withstand repeated sterilization procedures, and it flouted a regulation that helps to ensure products meet their design specifications, according to the letter.

To read the FDA’s warning letter to MFS, click here.

To read one of my prior blogs on FDA regulations in 2016, click here.

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Overley, Jeff. “FDA warning wire: Hospital in Mayo Network Scolded.” Law360. (April 12, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: The U.S. Food and Drug Administration (FDA), human research participants, sterilization shortcomings, medical devices, fat transfer devices, Pikeville Medical Center (PMC), Mayo Clinic Care Network, regulatory violations, compliance, Miami Fat Supply Inc., (MFS), medical marketing, health care marketing, health care advertising, audit defense attorney, legal representation for a warning letter issued by the FDA, health care lawyer, health attorney, health law, The Health Law Firm

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