Minimally Invasive Cancellous Bone Extraction

Ranfac Marrow Cellution™ Percutaneous Autograft Collection produces autologous cancellous graft material with osteoconductive, osteoinductive and osteogenic properties using a minimally invasive cancellous bone extraction technique. It may be combined with allogeneic, autologous or synthetic bone chips hydrated with Marrow Cellution™ aspirate (www.ranfac.com/mcaspirate).

To use, insert 8-gauge Trephine Needle with Sharp Stylet until anchored in the cortex and remove Sharp Stylet. Next, advance cannula into bone marrow space with a gentle clockwise—counterclockwise motion, causing cancellous bone to enter the cannula. Then, insert sounding rod to measure length of bone inside cannula. Remove sounding rod and advance further if more volume is desired. Once adequate length is determined, insert extraction tool through the handle, pressing firmly with your palm to trap the trephi`ne specimen with the extraction tool.

There are several more steps in the extraction process, and it is important to fully understand them all before using the Marrow Cellution™ tool. To help clinicians, Ranfac created an easy to follow video that clearly demonstrates all the steps in the process. To learn more about how to complete this technique, please enjoy the video from Ranfac, a single source manufacturer of medical devices.

 

 

Ranfac’s Internal Auditing System Guarantees the Quality of Homegrown Products 

Ranfac’s Internal Auditing System Guarantees the Quality of Homegrown Products 

For modern organizations, process owners face the responsibility of ensuring the quality and compliance of both their own tasks, as well as the tasks of their team. As organizations break down past barriers and innovate new procedures to avoid internal problems, there will always be the human element. In order to make sure small internal issues don’t balloon and fall on the customer, team-based organizations must search out effective, cordial ways to reduce process variation and human error. Ranfac’s processes for Measurement, Analysis, and Improvement, keep this goal in mind.

A Reflection on Recent FDA Guidance - When Does A Physician Become A Manufacturer? 

A Reflection on Recent FDA Guidance - When Does A Physician Become A Manufacturer? 

The FDA recently published guidelines on cell and tissue-based products, establishing clear boundaries around what it deems to be a safety risk and stating they intend to enforce these guidelines. The FDA maintains that a doctor cannot manufacture a device or drug, prescribe it to a patient, and ignore all laws governing the medical device and pharmaceutical industry simply because they’re an MD. The FDA asserts that rules that govern device and drug manufacturing apply to all companies and individuals, including clinicians. Let’s take a closer look at the recently published FDA guidelines.