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Health Robotics Announces Results of the European Union-Sponsored SafeChemo Project

Posted on: Monday, 5 January 2009, 08:00 CST

BOZEN, Italy, January 5 /PRNewswire/ -- Health Robotics today announced that the European Union (EU) Commission and eTen have made available the first results of the SafeChemo Project it sponsored at three of its pharmacies. The EU's SafeChemo objectives were to scientifically and independently establish if CytoCare(TM) (the world's first and only automated robotic system for the safe preparation of hazardous patient-specific IV medications) could improve patient safety for Oncology patients, eradicate injuries and contamination risks associated with handling Oncology IVs, and reduce costs as compared to manual compounding of cancer drugs.

"I'm delighted with the outcome of the SafeChemo project because it independently and scientifically authenticates CytoCare(TM) features and benefits, providing additional evidence of our success to prospective CytoCare(TM) customers, and comparing and contrasting these results with our competitors' claims that pharmacies should take great risks by solely relying on vendor's advertised specs and factory self-tests without the need for independent validations", said Werner Rainer, CEO of Health Robotics.

Asked about her overall impression, Ann Jacklin, Chief of Service, Pharmacy and Therapy Services at Imperial College Healthcare NHS Trust in London, stated: "Studies on CytoCare(TM) are now largely completed, including tests for filter integrity, particulate contamination, microbiological cleanliness of chambers, sterility of prepared doses, sterility of partially used vials, precision of preparation, correct vial recognition, accuracy of final-container labeling and software reliability. CytoCare(TM) is still the best in the world, there's nothing to beat it. CytoCare(TM) creates a beautiful aseptic environment, free of microorganisms and particles. Other robots push-and-pull or suck-and-blow, CytoCare(TM) represents a far greater level of complexity. We have also estimated direct costs savings of GBP180,000 per year just from reducing waste with partially used vials. Before CytoCare(TM), RSI [work-related upper limb disorder] affected most of our IV staff. At any given time we had at least one person resting and unable to undertake this type of work, significantly limiting the throughput of the aseptic unit. Technicians love working with CytoCare(TM), it improves their role and they feel better."

Staff shortages and pressure from the Joint Commission on Accreditation of Hospital Organizations (JCAHO) drove Capital Region Pharmacy to validate CytoCare(TM). Senior Scientist Dr. Vagn Handlos said: "We have been through all of the GMP procedures needed to take CytoCare(TM) into action. Regarding microbiological integrity, I have never seen anything better. We conducted tests using settle plates and swabbing the surfaces with growth media; there was no growth of microorganisms in any of the samples. On handling of particulate contamination, the robot gets an excellent score. There is no problem complying with class-A conditions and there is no leakage from the filters. Cross-contamination has also been tested using cyclophosphamide. We were unable to detect cyclophosphamide above a detection limit of one picogram*/ml after having handled multiple cyclophosphamide doses in concentrations of 1g/50ml."

Dr. Alicia Tavella, Oncology Pharmacist at the General Hospital of Bolzano stated: "the results of the validation tests for CytoCare(TM) have all met the required GMP standards. The system efficiently removes particulate and microbiological contamination.

* A picogram [pg] is a metric unit of mass equivalent to one trillionth (10-12) of 1 gram, or one millionth (10-6) of 1 microgram. Prior to CytoCare(TM) it was becoming increasingly difficult to recruit staff to undertake this work, often because of concerns about exposure to carcinogenic agents and the ever-present risk of repetitive strain injury (RSI) for staff. We also had experienced drug errors (when you are very busy it is easy to pick the wrong vial or bag) but with CytoCare(TM), correct vial and bag identification and picking is now assured with no errors. The use of CytoCare(TM) has also resulted in efficiency gains for the pharmacy. It has reduced the steps in the preparation process and the overall preparation time. Work-study results show that the technicians' time has been reduced from 80 hours to 12 hours. In addition, only one technician is required to operate CytoCare(TM) whereas two technicians are needed when chemotherapy IVs are manually prepared in a BSC, one to make the product and another one to look. A further benefit is that it takes less time to train a technician to work with CytoCare(TM) than to work in a BSC."

About Imperial College Healthcare NHS Trust, University of London, UK:

Imperial College Healthcare NHS Trust has a very strong history of education and research. It is the UK's first Academic Health Sciences Centre and the largest NHS Trust in the UK with combined annual production of around 27,000 patient-specific chemotherapy IV doses. It is composed of the teaching hospitals Charing-Cross, St, Mary's, Hammersmith, Queen Charlotte's and Chelsea, and Western Eye Hospital.

About RAP Capital Region Pharmacy, Copenhagen University Hospital:

Rigshospitalet Apoteket is the hospital pharmacy for the Capital Region of Denmark. RAP delivers pharmacy services under GMP regulations to 14 hospitals serving 2,300 wards [nurse stations]. The yearly turnover is EUR200 million, and the 460-staff includes 75 pharmacists and 230 technicians. RAP supports three centers for cancer treatment and prepares approximately 80,000 patient-specific chemotherapy IV doses annually.

About General Hospital of Bolzano, Italy:

The 850-bed General Hospital of Bolzano belongs to the Italian National Health Service and operates under the supervision of the Health Authority of the Province of Bolzano.

The hospital provides health care services to an integrated health network serving 7-hospitals with 206,729 inhabitants, distributed in an area of 1.525 sq. km. The pharmacy prepares about 25,000 patient-specific chemotherapy IV doses per year.

About Health Robotics:

Health Robotics is the global leading supplier of life-critical intra-venous medication preparation, compounding, and dispensing Robots, providing health care facilities around the world with robotic technology and software automation solutions. The world-leading solutions CytoCare(TM) (hazardous IVs) and i.v.STATION(TM) (non-hazardous IVs) have and will greatly contribute to ease global hospitals' & clinics' growing pressures to improve patient safety through effective and efficient production of sterile, safe, accurate, and ready-to-administer IVs, to decrease life-threatening medication errors and cross-contamination risks, and to work more efficiently, increase throughput, reduce waste and staff injuries, and contain spiraling costs.

SOURCE Health Robotics SRL

Source: PR Newswire

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