Pro-IV Medical’s Smart Valve system – ‘If all of the parameters match, a key in the device mechanically opens the valve. It can’t open any other way. The valve is our competitive edge.’It was a prolonged hospital stay for his eight-year-old daughter that prompted Dr. Pierre Sharvit to develop a system to prevent intravenous drug and blood transfusion errors.
“Every time the nurse in the children’s oncology department came to give an infusion, I was very anxious,” said Sharvit, the CEO of Israeli startup Pro-IV Medical. “Every morning, afternoon, and evening for a week; the sequence of infusions is very important. What if the nurse or caregiver takes the third infusion bag instead of the second? It is very stressful to think that it may be the wrong infusion.”
Although he had only good things to say about the hospital, and his daughter has since recovered, Sharvit’s upsetting experience led him to look at the subject of erroneous transfusions and search the web to try to discover the extent of the problem.
He was shocked by the results. In the US alone, there are over 500 million intravenous infusions a year in US hospitals, the home therapy sector, nursing homes, and hemodialysis centers. Mistakes in IV administration there account for 35-40% of all medical errors during hospitalization. The annual cost for these errors is more than $17 billion.
A critical shortage of nurses, predicted to run into the hundreds of thousands in the next 10 years, will only exacerbate the problem. On one hospital visit, for instance, Sharvit was appalled to discover one nurse to 30 patients. “The potential for error was very high,” he told ISRAEL21c. “It’s a global problem.”
Sharvit decided to look for a solution. Originally trained as a veterinarian in Belgium, Sharvit also spent a couple of years in brain hormone research as a post-doc at the Weizmann Institute of Science in Rehovot. Using his knowledge of medicine and science, Sharvit approach Dr. Michal Devir, a biotech entrepreneur who has had extensive business experience heading a number of startup biotech companies, and told her about his plan to develop a pro-active IV safety system.
Devir, a former venture partner at VC fund Pitango Ventures, liked the idea, and in 2006 Devir and Sharvit founded Pro-IV Medical through the Misgav incubator, bringing Professor Jacob Nusbacher, an internationally known immuno-hematologist, and a consultant to the FDA, with a long career in the field of transfusion medicine, onto the team. Funding came from the government’s Chief Scientist, Trendlines (a private investment group), and other private investors.
The company’s first achievement has been developing the pro-active product PRIDE (Prevent Intravenous Drug Errors), a simple, easy to use solution to prevent errors in infusions, transfusions, and administering IV medication. PRIDE consists of a low-cost, disposable ‘smart valve’, an electronic handheld device, and a software program.
Drugs cannot be administered to the patient unless five “right” conditions are met: “It has to be the right patient; the right drug; the right dose; the right time; and the right route of administration,” explained Sharvit.
The novel valve is like a lock that opens only when the match between the patient, drug, and information system is verified. It is impossible to bluff the system, which requires bar codes for all patients and medications (which dovetails nicely with a new mandatory regulation in the US requiring all patients and all medications to have a bar code).
The nurse or caretaker uses the hand held device to scan a bar code with the patient’s identity, to access the electronic medical order, and to scan the bar code of the drug in the basket.
“We capture the doctor’s order (drug, dosage, time) from the host computer,” said Nusbacher, who has run blood banks for most of his professional career and for a time was the national director of the Canadian Red Cross Blood Service. “If all of the parameters match, a key in the device mechanically opens the valve. It can’t open any other way. The valve is our competitive edge.
“People in the health care system are very busy and stressed, and they are looking for short cuts. We want the operator close up, safety is needed at the point of care,” added Nusbacher. “I have seen tragedies where the wrong patient received a transfusion.”
Nusbacher believes the best way to market the Smart Valve system would be as part of the IV administration set, as an added safety feature. The valve would be in a small housing on the IV set. Pro-IV’s software engineers are also readying models with digital mechanisms.
Pro-IV expects to have a prototype ready within a month, and aims to start clinical trials in the last quarter of this year. According to Sharvit, major companies have already expressed interest in the product, and exploratory discussions are underway for development. He added that investor interest was piqued at a recent Market Reach meeting in Baltimore, sponsored by the Israel Development Council to foster business relations between Israel and Maryland.
“As we know, to err is human,” said Nusbacher. “Recently I spoke to the Chief of an Oncology Department who insisted that his department did not make errors. Two senior nurses, however, admitted that errors were made. They would be happy to be a test site for the product.”