Recently, I had the pleasure of meeting Bob Rogers, Chief Executive Officer for Ivera Medical. Plastics Engineering and Development, Inc. (PEDI), is one of my clients and they manufacture the Ivera product called Curos™ Port Protector.
At PEDI, I was tasked with establishing the production and manufacturing controls for the Curos Port Protector, in accordance with the requirements of ISO 13485:2003 and 21 Part 820 Quality System Regulations. The Curos Port Protector is an innovative medical device that decontaminates needleless intravenous (I.V.) access ports, and helps to prevent touch and airborne contamination.
A real-life example of where the Curos Port Protector can be applied is with a PIC line, otherwise known as a peripherally inserted central catheter, which provides intravenous access that can be used for a prolonged period of time.
Currently, my wife Laurie and I are dealing with the failing health of my mother-in-law. Up until last week, she had spent four weeks of intensive care in Florida, prior to being transferred out to California, where my wife and I can make sure she is getting the care she needs. While she was in Florida, the nurses in intensive care at the hospital had spent three weeks drawing blood and injections from her arms. As a result, she had large black and blue bruising. After my wife and her sister voiced their concerns, she was given a PIC line that would eliminate the puncturing needed to draw blood and inject medicine. However, the end of the PIC line was always exposed to the atmosphere, with no protection, and it would lie on the garments or skin of my mother-in-law and would be touched by the nurses to draw blood or give shots.
Needless to say, she got an infection the second day after the PIC line was installed. The Infectious Disease Department identified it as an external infection. I personally witnessed a breach of cleaning procedures when the injections were given. They would give a quick swipe with an alcohol pad and inject. Yet, the procedure is to thoroughly wipe with the pad and wait 60 seconds to allow the alcohol to evaporate before the connection of an injection.
It was during this incident that recalled what Bob, the CEO of Ivera Medical, had told me about the purpose of the Curos Port Protector. It is a small item designed so the foil top would be torn off and the small threaded cap with a sponge soaked in 70% Isopropyl Alcohol (IPA) would be screw on a PIC line preventing any infectious contamination, and eliminating improper IPA swabbing by the hospital staff before injections or drawing blood.
The hospital could have prevented my mother-in-law from getting an infection, if only they had the Curos Port Protector! Last year, Ivera Medical got FDA approval to market the Curos Port Protector. Hopefully, more hospitals will start using this device so that patients regain their health quickly and do not get sicker from treatments that are intended to make them well again.
