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Safety and hygiene aspects of contrast media administration in Italy

A roundtable expert meeting held recently in Milan recommended a formal study to evaluate the use of prefilled syringes of contrast media in radiology to determine their safety and effectiveness.

Hospital Pharmacy Europe recently hosted a roundtable discussion on the safety and hygiene aspects of contrast media administration in Italy. The event involved a multidisciplinary group of expert clinicians, including radiologists, nurses and pharmacists.

The group discussed radiology practice at clinical level with particular emphasis on the safety aspects of radiological procedures and the risks of microbial contamination. There was discussion about the potential advantages of prefilled syringes of CT contrast media and a demonstration of the procedure for setup and use of the Covidien injector system, which uses prefilled syringes.

Adverse reactions and medication errors
Pharmacovigilance is not well developed in Italy, partly because of poor reporting and partly because of a lack of awareness of its importance and relevance, according to Daniela Scala (hospital pharmacist, Centre of Biotechnologies, Cardarelli Hospital). Whilst pharmacovigilance is important in identifying adverse effects of drug therapy, medication error monitoring is important to ensure that products and systems are safe in use.

There is a correlation between the complexity of the healthcare system and the number of errors in the healthcare setting, she said. Errors in clinical and diagnostic medicine are inevitable. Fallibility is a human factor and this cannot be changed, but working systems and programmes can be changed, Dr Scala explained. The objective is to make it more difficult to make errors and so to minimise the impact of errors. What can be done is to make it impossible to do certain things without certain requisites being in place, she added.

In discussion, participants said that radiology differs from other areas because drugs are used for diagnostic purposes, not for therapeutic effects, and doses are often in grams rather than milligrams. Patients visit radiology departments for periods of 10-30 minutes and then leave – and so an adverse reaction that appears hours or days afterwards can be missed.

There is no habit of pharmacovigilance in radiology and an  important step towards changing this situation would be the provision of information about reporting of adverse events in specialist training for all personnel who work in radiology, including doctors. The discussion ended with agreement amongst the participants that error reporting should be encouraged, standardised procedures should be introduced and computerised methods for error reporting should be implemented.

Safety and hygiene
The risks of infection from multidose vials are now well documented, explained Cesarina Curti (president, Italian Multidisciplinary Society for the Prevention of Hospital Acquired Infection (SIMPIOS). One example was the transmission of hepatitis C virus (HCV) infection in Ancona, Italy that was traced to a multidose vial of heparin.

Another example was three patients in a Florida hospital who also contracted HCV. They had all received saline flushes from a multidose saline vial on the same day. The most likely explanation was that the first flush, for a patient with chronic HCV, was insufficient and so the same syringe was used to draw up another dose of saline to complete the flush. This contaminated the contents of the vial, which was then used for subsequent patients. Often, the problem is not the absence of correct procedures, but failure to follow them due to heavy workloads, understaffing or both, noted Dr Curti.

Turning to transmission of infection through contrast media, Dr Curti said: “radiologists definitely know about this.” One published episode involved seven patients who developed malaria after undergoing CT scans on the same day.

The index patient had recently returned from Nigeria. During his CT scan there was a very brief interruption of the electric current, which allowed back flow of about 0.25ml of blood, resulting in contamination of the contrast medium. Subsequent patients received the contaminated product and developed malaria. “It was a very small amount, but enough, added Dr Curti.

Hand hygiene remains a key measure in prevention of infection. In hospitals there has been a good campaign on hand hygiene, especially cleansing with alcohol, which is definitely effective if the hands are not visibly contaminated, as is the case for operators in radiology.

Most hospitals have concentrated on wards and treatment areas but left out diagnostic departments such as radiology and nuclear medicine. They need to be included – awareness of hygiene measures needs to be raised in these areas because patients come and go between these areas and the wards.

Gloves are widely used in radiology, but gloves protect the staff and not the patient. They should be used in situations where required, but as soon as the operator goes to a different area or task gloves should be changed and hands washed. This is a situation where improvements are needed, she said.

Commenting on the use of nonreturn valves in the administration tubing, Dr Curti said she was unaware of any reports on their safety. “You have to understand that it is not a locked door. It is a door that could be open,” she said, and consequently, she still recommends the use of gloves.

Some radiologists had told Dr Curti that the use of the “open-bowl” technique, in which contrast media are poured into open bowls and then drawn up into syringes, was essential in angiography practice. The open bowls are at risk of bacterial contamination and there is also a danger that the contents might be confused with liquids in other open bowls, she suggested.

Dr Curti concluded that the administration of CT contrast media should be undertaken with close attention to hygiene and safety aspects to minimise the risk of contamination. In addition, the current lack of standardised procedures and protocols in radiology should be remedied through collaboration between radiologists and pharmacists. This would serve to protect both operators and patients.

Use of prefilled CT syringes
Time saving in preparation of injections of contrast media is one of the advantages of the Covidien injector system. “Once you know the machine you can have it prepared in a minute, compared to four to five minutes for the old system,” Andrea Marzaloni (imaging nurse, Infermi Hospital, Rimini) explained during a demonstration of the device.

“It is so easy and quick to use prefilled syringes. It is not like it used to be when we had injectors there, all dirty with contrast media; we do not see this anymore,” he continued. This ensures that changing from one contrast medium to another is a quick and easy procedure.

Mr Marzaloni pointed out that the syringes and tubing were single-use products, although he also reminded that group that poor hand hygiene could still put patients at risk of infection.

Following the demonstration, Enrico Cavagna (head of radiology department, Infermi Hospital, Rimini) and Pietro Pavlica (accident & emergency radiologist, University Hospital of Bologna) led a discussion of the potential pros and cons of  prefilled radiology syringes in different radiology procedures.

Appropriate preparation and handling of the CT media is critical. When intravenous injections are prepared in the patient area the risks of microbial contamination are increased by several factors including uncontrolled environment, poor aseptic technique and the preparation of syringes in advance.

Preparation in emergency situations is most likely to lead to medication administration errors, and sterility, safety and efficiency (in terms of time and risks associated with the administration) become crucial in this scenario.

Working conditions, with understaffing, lengthy procedures and heavy workloads can be stressful and increase the risk of errors. Prefilled syringes are useful in emergency situations – “When trauma patients are admitted, we are ready,” commented one participant.

Covidien also supplies empty syringes for the injector, so that the contrast medium of choice can be used. Others commented that storage and handling is easier with prefilled syringes. “We do not have all those glass vials to throw out – we do not have the mess – and it is easier for warehouse storage”.

Dr Cavagna stressed the importance of optimising the management of the inventory and financial resources. In addition, he had noticed significant financial and time management benefits due to the introduction of prefilled syringes, with an increase in daily radiology procedures. “We are performing more CTs due to increased efficiency. We find it works very well indeed,” he said.

Reviewing the potential advantages and disadvantages of prefilled contrast media syringes in the Italian healthcare system, Pierpaolo Pipan (radiologist, University of Trieste) explained that he had 18 months’ experience of their use.

When talking about contrast media, all aspects should be considered, including purchasing, transport, storage, disposal, wastage and costs. Quality management of CT contrast media and disposal of waste are two critical aspects for which specific training is needed, he said “Over and above economic savings, something we have enjoyed is the speed with which we can deal with each patient,” said Dr Pipan.

The vein is cannulated outside the CT room, so the patient enters the scan room with the line ready. Workflow in the scan room is then very quick. They have calculated that use of the injector saves three to four minutes per patient. Over 12 hours this amounts to a saving of one and a half hours, so more patients can be processed. “In terms of the organisation of the CT room, it has been a real step forward,” he said. Dr Pipan’s department now no longer uses glass vials, and so problems of breakage and waste are avoided.

The prefilled syringes currently available might not be suitable for obese patients, specifically those who weigh more than 90 kg. Such patients need higher doses of contrast media for ultrasound scans, noted Dr Pipan. Summarising his experience, Dr Pipan said: “It began as an attempt to improve efficiency in the room, to save time. The speed was surprising. We have managed to increase the numbers of patients.”

Considering the number of contrast media on the market and the increase in the number of diagnostic procedures, there is a need for studies evaluating the use of prefilled syringes in radiology, said Francesco Sardanelli (board member, Italian Medical Radiology Society (SIRM). Such studies could be important to support the implementation of these devices.

Participants also agreed that a multidisciplinary commission should be established to validate radiology procedures for contrast media administration to assess effectiveness and safety. In addition, the following points were agreed:

  • Procedures for handling contrast media should be standardised both to improve the quality of patient care and to protect operators.
  • When considering changing from multidose presentations to prefilled syringes, the following factors should be considered in relation to the two methods:
    • Risk of administration errors
    • Risk of microbial contamination during drug manipulation and administration.
    • Risk of cross-contamination
    • Labelling errors
    • Time available for procedures and workflow
    • Number of diagnostic procedures
    • Drug wastage
    • Staffing requirements
    • Inventory management
    • Costs (drug, devices, injectors).

In conclusion, participants strongly agreed that the use of  prefilled syringe could represent the future in radiology, in order to optimise time usage, minimise drug wastage, reduce costs and improve hygiene and safety aspects of drug handling.

Debate participants
Chair: Anna Carollo
Clinical Pharmacist, ISMETT, Palermo, Sicily

Daniela Scala
Pharmacist, Centre of Biotechnologies Hospital Cardarelli, Naples

Enrico Cavagna
Head of Radiology, Department of Infermi Hospital, Rimini

Stefano Braico
Head of Radiography, Monfalcone Hospital; Gorizia Council Member of the International Society of Radiographers and Radiological Technologists (ISSRT)

Andrea Marzaloni
Imaging Nurse, Infermi Hospital

Rimini Pietro Pavlica
A&E Radiologist, University Hospital, Bologna

Antonio Poli
Chief Medical Director, Saint Anna Hospital, Torino

Pierpaolo Pipan
Radiologist, Azienda Hospital, University Trieste (Lecturer in Contrast Media Practices) Hospital Pharmacy

Patrizia Marrone
Clinical Pharmacist, Hospital Arnas Civico, Palermo (Development Committee, Italian Society of Hospital Pharmacists – SIFO)

Piera Polidori
Chief Pharmacist, ISMETT (Member General Council European Society Clinical Pharmacists – ESCP)

Cesarina Curti
Director of Pharmacy, IRCCS Hospital San Raffaele, Milan, and President, Italian Multidisciplinary
Society for the Prevention of Hospital Acquired Infection – SIMPIOS

Pietro Finocchiaro
Chief Pharmacist, Hospital Arnas Civico, Palermo, and Secretary, Italian Society of Hospital Pharmacists

Francesco Sardanelli
Member of the Italian Medical Radiology Society (SIRM) National Board.

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