New Mexico Attorney General Hector Balderas recently jumped on the anti-regenerative medicine bandwagon when he announced a criminal investigation into an Albuquerque clinic where several patients were infected with HIV after undergoing what is known as the ‘vampire facial’. Balderas is well within his legal authority to launch such an investigation. He also has the right to take a political position on the matter.
Balderas is not alone in his opposition to stem cell injections and PRP treatments. His voice is just one among many politicians and healthcare experts who want to see regenerative medicine so restricted that clinics cannot operate without spending tens of millions of dollars on FDA approval.
In fairness, the regenerative medicine industry is partly responsible for bringing this trouble on themselves. The industry has allowed unscrupulous doctors and clinics to operate in ways that exceed current FDA limits. Rather than putting pressure on these doctors and clinics in an attempt to get them to stop, the industry has turned a blind eye.
Things can be turned around at the grassroots level if regenerative medicine providers are willing to make some changes. Below are five suggestions for doing so. Implementing these five things can guarantee that clinics maintain safety and compliance.
1. Stick with Current Regulations
FDA regulations allow doctors and clinics to utilize minimally manipulated autologous material for medical procedures without further approval. If they would just stick to those rules, a lot of the problems we have seen over the last few years would go away on their own.
If a doctor or clinic wants to go above and beyond the minimally manipulated mandate, then the proper approval procedures must be followed. Moving ahead without approval only compromises patient safety and draws greater FDA scrutiny.
2. Implement Proper Sterilization Procedures
The Albuquerque case was a direct result of improper sterilization procedures. This sort of thing should never happen in a regenerative medicine clinic. Apex Biologix, a Utah company that provides clinics with equipment and supplies, says that the same sterilization practices a primary care physician uses are applicable in a stem cell clinic. Those procedures should be followed to the letter, every time.
3. Control Who Administers Procedures
Next, PRP and stem cell clinics should be particular about who actually administers the procedures in question. Only licensed doctors and nurses should be given the green light. Why? Because every procedure includes at least a blood draw and an injection. In most states, you cannot legally draw blood unless you are a licensed doctor, nurse, or phlebotomist.
4. Insist on Proper Training
In addition to controlling who administers regenerative medicine procedures, clinics should insist that those professionals be properly trained. There are right and wrong ways to administer PRP and stem cell therapies. Doing it right means being trained first.
5. Employ a Medical Director
Finally, clinics can go a long way toward maintaining both safety and compliance by hiring a medical director to oversee all aspects of a clinic’s operation. A medical director acts as a third party of sorts, separate from clinicians and support staff. It is his or her job to make sure that everyone else does what they do safely and in compliance with the law.
It is unfortunate that cases like the one in Albuquerque continue to occur. The regenerative medicine industry can bring them to an end by insisting that doctors and clinics do things the right way. If everybody stuck with current regulations and implemented the same practices found in nearly every other area of medicine, all would be well.