Design Theory of Closed System Drug Transfer Devices

Recent surveys have shown that traditional vial-to-syringe technique is one of the riskiest modes of occupational exposure to hazardous drugs. Vial over-pressurization can lead to spraying and leakage. These sprays and spills are frequently unnoticed, which may result in exposure of contaminated finished products to staff and patients in healthcare centers.

Closed System Drug Transfer Devices are special protective devices, designed to reduce the risk of occupational exposure. They provide a safer system for administrators to reconstitute and transfer hazardous drugs from manufacturers drug container to the patient specific equipment while operating patients. These have closed cabinets which prevent spills, leakages during the preparation, administration and disposal of these drugs.

Various types of drug transfer devices have already entered into the market and have made success in delivering effective results. They include a complete line of closed, vial and bag access products for safe preparation, transfer and administration of hazardous substances. They also assure protection through the entire spectrum of hazardous drug delivery.

Genie, designed by ICU Medical System is a closed, needle-free, vial-access device that automatically equalizes vial pressure. When the desired amount of drug is taken out from vial, the genie balloon automatically inflate to equalize the pressure thereby reducing aerosols, vapors and leaks caused by pressurization of vials. Similar systems having dual-venting feature to enhance the equalization of vial pressure and automatically self-seals when disconnected, have been already designed.

There are various guidelines on the effective way of usage of these devices, which must be followed by nurses and practioners in healthcare centers. These devices should always be used with in a ventilated cabinet while following appropriate personal protective equipment and work practices. Staff members should be properly instructed and observed regularly while using these devices. In addition, system failure reports should be immediately reported by all users including pharmacy and nursing, to the manufacturer.

Presently, use of Closed System Drug Transfer Devices has been the strategy employed by healthcare centers, to minimize the risk of exposure to hazardous drugs. However, the consistent and proper usage of these systems is paramount in ensuring containment.

For more information on Hazardous Drugs and the benefits of Exposure to Hazardous drugs please visit the mentioned website.

Regenerative Medicine - Treatment With Induced Pluripotent Stem Cells

New developments in the use of induced pluripotent stem cells (iPS cells) are appearing every month in the literature. The initial hurdle is to be able to reprogram adult human cells without using agents that might cause cancer. The first reprogramming method used a viral delivery system to introduce the reprogramming genes into cells. But a virus can insert into the cell's genome, possibly causing severe unanticipated outcomes such as cancer.

Also, refinement of the reprogramming factors is necessary. The initial group was composed of Oct-4, c-Myc, Sox2, and Klf4 genes. c-Myc has potent oncogenic properties - expression of c-Myc can cause a cell to become cancerous. c-Myc was discovered in the late 1970s - expression of c-Myc has a profound role in the development of breast cancer and has a central role in most types of human malignancies.

In order for these cells to be used safely in humans, reprogramming alternatives to c-Myc needed to be identified. An optimal scenario would be to identify alternatives to using any gene for reprogramming. Inserting new genes into a cell could result in mutations, disruption of other normal genetic processes, and additional negative effects. Such deleterious outcomes would increase in number and severity as cells and tissues introduced into a patient continue to divide and replicate.

The field is moving forward quickly. Many research teams have been successfully investigating the use of small molecules as reprogramming factors. Small molecules include very short nucleotide segments (nucleotides comprise the basis of the genetic code), peptides (amino acid sequences), and short-chain sugars. Recently a team led by Dr. Hongyan Zhou at the Scripps Research Institute in La Jolla, CA, generated induced pluripotent stem cells using direct delivery of a set of reprogramming small molecules. This groundbreaking work provides a new method of creating safer cells for potential uses in treatment and transplantation.

Initial work is being done to use iPS cells for the treatment of many serious and life-threatening diseases. Important preliminary work has been done with amyotrophic lateral sclerosis (ALS), Parkinson's disease, sickle cell anemia, thalassemia, muscular dystrophy, and diabetes.

For example, researchers have been able to generate large numbers of iPS cells from skin cells taken from an 82-year-old woman diagnosed with ALS. These cells could be directed to become motor neurons, which could be used to replace diseased nerve cells in a patient's spinal cord. This research proves that sufficient induced pluripotent cells can be produced from cells taken from an elderly patient. iPS cells might be used to develop treatments for other diseases which specifically affect the aged.

Sickle cell anemia has been reversed in mice using induced pluripotent stem cells derived from their own cells. Somatic cells were obtained from humanized sickle cell anemia mouse models. The cells were reprogrammed to iPS cells. The genetic defect was corrected in the pluripotent cells which were then differentiated into blood cell precursors. These normal blood-forming cells were then transplanted into the original mice, who subsequently recovered from sickle cell anemia.

This successful proof-of-concept in humanized sickle cell anemia mice points the way toward using iPS cells in the treatment of a wide variety of deadly diseases.

David Lemberg, M.S. in Bioethics, Albany Medical College, May 2010. Consultant, Author, Speaker. Research interests - health care and health care policy, reproductive technologies, genetics and genomics, K-12 science education Executive Producer, SCIENCE AND SOCIETY, http://scienceandsociety.net. Twitter - http://twitter.com/david_lemberg. Visit SCIENCE AND SOCIETY for cutting-edge interviews with Nobel Laureates, trendsetting industry executives, and best-selling authors in the fields of cancer research, genetics, health care policy, nanotechnology, and space exploration.