Recalcitrant C. difficile infections are a large concern in healthcare. When faced with the failure of conventional treatments many physicians are turning to fecal microbiota transplantation.
The procedure, while not a new concept, has just recently come to the fore as a promising treatment. Researchers at the Massachusetts Institute of Technology have even opened a stool bank specifically to create a source of safe, reliable donor samples. The procedure is being performed in a number of settings, including ambulatory surgery centers. Zoe Wendolowski, RN, administrator, and Kerre Nichols, RN, nurse manager, describe the process of bringing FMT to Salem (Ore.) Endoscopy Center.
The first FMT was performed at Salem Endoscopy Center in 2013. A physician performing cases at the center and caring for a patient with a refractory C. difficile infection initially broached the idea. The procedure, though seemingly simple, required a great deal of preparation on the ASC's part. "There was a lot of coordination involved, much more than we even initially thought," says Ms. Wendolowski.
Patient and donor selection were the first considerations. Candidates for the procedure are patients suffering from a C. difficile infection that failed to respond to multiple first line treatments. Donors undergo a thorough social history and a number of laboratory tests before making the donation. Payers often do not reimburse for these lab tests, which can cost from $300 to $600. "Most people are willing to shoulder those costs," says Ms. Wendolowski.
The endoscopy center did not require much additional equipment to prepare for the procedure. The center was well-equipped with scopes; it just need to acquire special tubing to attach to the scopes. The largest issue to contend with is the fact that a patient with an infection is entering the center. ASCs are known for low infection rates and striving to maintain that minimal level is paramount to patient safety and quality of care. At Salem Endoscopy Center, FMT patients are scheduled on days with an open procedure room. Afterwards, the room and equipment undergoes an intense cleaning process to ensure C. difficile does not spread.
As with any new procedure, ASC staff must undergo training to prepare. "From an OR perspective, fecal transplants go completely against all infection control training," says Ms. Wendolowski. "It has been quite a learning process." One Salem Endoscopy Center RN with GI clinic experience coordinated the program and took the lead in training the center's nurses and technicians.
In the midst of Salem Endoscopy Center's program launch, the FDA determined it would require an Investigational New Drug Application for each FMT performed. "It ground our program to a halt," says Ms. Wendolowski. "The physicians decided to work through the IND process, but while we were wading through that the FDA reversed its decision."
Since 2013, the center has performed a few FMTs. Some payers have begun to reimburse for the procedure, while in other cases patients must pay the costs out of pocket. "For the most part, patients are willing to take on this cost," says Ms. Nichols. "The difference in their lives is huge." Thus far, Salem Endoscopy Center has had a high success rate amongst its FMT patients.
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The procedure, while not a new concept, has just recently come to the fore as a promising treatment. Researchers at the Massachusetts Institute of Technology have even opened a stool bank specifically to create a source of safe, reliable donor samples. The procedure is being performed in a number of settings, including ambulatory surgery centers. Zoe Wendolowski, RN, administrator, and Kerre Nichols, RN, nurse manager, describe the process of bringing FMT to Salem (Ore.) Endoscopy Center.
The first FMT was performed at Salem Endoscopy Center in 2013. A physician performing cases at the center and caring for a patient with a refractory C. difficile infection initially broached the idea. The procedure, though seemingly simple, required a great deal of preparation on the ASC's part. "There was a lot of coordination involved, much more than we even initially thought," says Ms. Wendolowski.
Patient and donor selection were the first considerations. Candidates for the procedure are patients suffering from a C. difficile infection that failed to respond to multiple first line treatments. Donors undergo a thorough social history and a number of laboratory tests before making the donation. Payers often do not reimburse for these lab tests, which can cost from $300 to $600. "Most people are willing to shoulder those costs," says Ms. Wendolowski.
The endoscopy center did not require much additional equipment to prepare for the procedure. The center was well-equipped with scopes; it just need to acquire special tubing to attach to the scopes. The largest issue to contend with is the fact that a patient with an infection is entering the center. ASCs are known for low infection rates and striving to maintain that minimal level is paramount to patient safety and quality of care. At Salem Endoscopy Center, FMT patients are scheduled on days with an open procedure room. Afterwards, the room and equipment undergoes an intense cleaning process to ensure C. difficile does not spread.
As with any new procedure, ASC staff must undergo training to prepare. "From an OR perspective, fecal transplants go completely against all infection control training," says Ms. Wendolowski. "It has been quite a learning process." One Salem Endoscopy Center RN with GI clinic experience coordinated the program and took the lead in training the center's nurses and technicians.
In the midst of Salem Endoscopy Center's program launch, the FDA determined it would require an Investigational New Drug Application for each FMT performed. "It ground our program to a halt," says Ms. Wendolowski. "The physicians decided to work through the IND process, but while we were wading through that the FDA reversed its decision."
Since 2013, the center has performed a few FMTs. Some payers have begun to reimburse for the procedure, while in other cases patients must pay the costs out of pocket. "For the most part, patients are willing to take on this cost," says Ms. Nichols. "The difference in their lives is huge." Thus far, Salem Endoscopy Center has had a high success rate amongst its FMT patients.
More Articles on Gastroenterology:
Horizon BlueCross BlueShield of New Jersey Launches Program to Improve Colonoscopy
Advocacy in the Gastroenterology Field: Q&A With AGA President Dr. Anil Rustgi
The Most Exciting Advances in the GI Field: 9 Gastroenterologists Weigh In