Speaker panel: Manuel Alós, president, Spanish Association of Hospital Pharmacists;
Mariano Madurga, head of pharmacovigilance, Spanish Medicines and Healthcare Products Agency; Luis Mendarte, professor of pharmacy, Hospital Vall d’Hebron, Barcelona; Ángel Morales, radiologist and lawyer, Hospital Donostia,
San Sebastian; Catalina Nieto, radiology technician, Hospital Clínico San Carlos, Madrid;
José Manuel Martínez Sesmero, professor of pharmacy, Hospital Virgen de la Salud, Toledo;
Ramón Salazar, professor of pharmaceutical technology, University of Barcelona; Juan Calvo, radiologist, General Hospital of Asturias, Oviedo;
Laurence A Goldberg, pharmacy consultant and former non-executive director, National Patient Safety Agency, UK
With the move in Europe for intravenously administered pharmaceutical products to be supplied in prefilled formats, most pharmacists are aware of the safety advantages that they can confer. However, there remain instances in which other clinical departments continue to prepare and administer pharmaceutical-grade products under nonsterile conditions at the point of care – the preparation and administration of contrast media in radiology departments is one such example. Thus, many patients are being put at risk, yet this issue has attracted little attention.
Hospital Pharmacy Europe decided to host a roundtable discussion in Spain, a country where the use of such prefilled products is becoming more regular, despite the fact that most hospital purchasing decisions remain price-based and fail to involve the quantification or evaluation of patient safety features. The discussion involved a multidisciplinary panel of leading figures in hospital and clinical pharmacy, as well as radiology. Current contrast-media administration practices were investigated, prompting discussions on how the use of prefilled CT contrast syringes could simultaneously improve safety for Spanish patients and improve convenience and ease of use for imaging professionals.
Demonstrations of the different ways in which CT contrast media is administered in Spanish hospitals, experiences with prefilled syringes, as well as ways of implementing risk management strategies were all part of the day’s presentations.
Following the roundtable discussions, the participants concluded that more awareness is needed regarding safe ways of administering CT contrast media, and that administration systems are needed that minimise the risk of contamination and improve identification of errors in order to improve safety.
CT injector systems in current use
Catalina Nieto (Radiology Technician, Hospital Clínico San Carlos, Madrid) began the day’s proceedings by demonstrating the two CT injector systems in daily use at her institution: a traditional CT contrast agent injector filling from multidose bottles (CT-Injector Missouri; Ulrich Medical Systems); and an automated CT contrast injector (Optivantage DH®; Tyco Mallinckrodt) utilising prefilled CT contrast syringes (Optiray® prefilled syringes; Tyco Mallinckrodt). Although Optiray, like all other contrast media, is licensed as a pharmaceutical product under EMEA regulations, few of the attending pharmacists were aware of its prefilled presentation and the way in which the contrast media (in general) are used in daily practice. The demonstration of the way it is administered was of great interest for the roundtable attendees.
During the demonstrations each of the pharmacists, imaging professionals and infection control specialists was invited to comment on the hygiene and patient safety features of the two systems, while Ms Nieto answered technical questions, as well as queries relating to her own clinical experiences with the injectors. Questions from the panel made it clear that there are huge variations and discrepancies in current CT contrast administration practices across Spain.
Filling from multidose bottles
Non-imaging professionals on the roundtable panel were unpleasantly surprised to see the nonsterile conditions under which many Spanish CT examinations are carried out, when injectors filled directly from a multidose bottle of CT contrast are being used.
Multidosing of CT contrast media (ie, several consecutive injections from one contrast-agent container) is a practice fully accepted in Spain and used nationwide. Procuring large-volume CT contrast bottles seems to be cost-effective, and with injector systems such as the one demonstrated, automatic switching from empty to full contrast-agent containers during the injection can be carried out, which leads to significant time savings.
However, despite these advantages, direct administration of CT contrast medium from a multidose bottle may carry a risk of cross-contamination between patients.
Technical features aimed at preventing reflux of contrast medium are in place on this type of injector, but these features’ efficacy is difficult to assess and it appeared during discussions that clinician confidence in such systems was low. Other injectors on the market (not demonstrated at the roundtable) utilise empty syringes filled by hand from multidose bottles, which necessitates filling from open bowls at the point of care – a practice that reduces aseptic conditions and exposes the contrast media to potentially pathogenic airborne particulate contamination. Further problems are associated with the multidose setup. The multidose system’s much-vaunted ability to switch between empty and full bottles during the procedure often leads to system failure, so examinations have to be restarted. Moreover, direct high-pressure filling from a large bottle, rather than from a syringe, leaves the system susceptible to air bubbles. Multidose injectors are highly sensitive to bubbles and injection will automatically stop whenever bubbles are detected, however undesirable this may be at the time. In Ms Nieto’s estimation this was a daily occurrence in her department, rather than a weekly or monthly one. She also commented that with this system, which uses high flow rates, not all of her colleagues had confidence in the exact quantity of contrast administered and the real flow obtained during the procedure.
Use of prefilled CT syringes
Switching to discussing the prefilled CT syringe system, Ms Nieto quickly demonstrated advantages.
Firstly, hygiene is greatly improved: there is no need to fill syringes utilising the open-bowl technique at the point of care and there is no potential for cross-contamination between patients, as the syringe is genuinely a single-use device – it cannot be reloaded with contrast media even if one wishes to do so and is therefore disposed of following each procedure. It was pointed out that under current practice in Spain many supposedly single-use devices are in fact reprocessed or even reused – in direct contravention of EU standards and directives (although it should be noted that this is most certainly not a practice unique to Spain).
Secondly, there is no potential dosage error issue. Prefilled CT syringes are supplied in different volumes which are clearly labelled and, more importantly, automatically recognised by the injector’s intuitive programming. Potential dosing errors are further reduced via colour-coded packaging for each different volume of prefilled CT contrast.
Air bubbles are easily detected in prefilled syringes and the injector’s tilting function allows elimination of bubbles, minimising the risk of embolism. Because all the devices used on this type of injector are disposable, there is no possibility of contamination (whereas the contamination risk is high with the multidose-bottle setup, where only the infusion line or catheter connected to the patient is disposable). Another clear advantage of this system is that cleaning the injector is faster and simpler (one is not required to dismantle the injector and clean its elements one by one, as is the case with the multidose-bottle setup). This also means more time can be spent with the patient before the procedure.
Ms Nieto concluded that in her experience, switching to a prefilled contrast syringe system had been made easy by the fact that its use is intuitive. Using prefilled CT syringes also led to time savings, especially in emergency situations where staff have insufficient time to clean injectors properly – which can lead to cross-contamination.
Safe and sterile media administration
Luis Mendarte (Hospital Pharmacist, Hospital Vall
d’Hebron, Barcelona) emphasised the importance of working in sterile environments in order to avoid the problem of contamination in the setting of CT contrast media administration. A completely sterile environment at the point of care is hard to achieve, but working areas should be clean, handwashing guidelines should be followed, and the administration process should be as aseptic as possible.
Contrast media are usually administered by intermittent infusion in quantities of 50–100 ml over 5–10 minutes. To increase safety when administering contrast media by the intravenous route, five “rights” need to be considered:
- Patient (ie, a patient who has no contraindications to the contrast media or no evidence of allergies).
- Medicine administered.
- Dose administered.
- Route of administration.
- Time of administration.
In addition, the intravenous route is much more subject than others to problems of contamination – of both the infusion line/catheter and the solution injected. It is also important to calculate precisely the concentration of the contrast media to be administered as, again, calculation errors can have serious consequences.
Another way to address potential problems was by labelling the contrast media, to increase control measures and ensure, for example, that the product used has not passed its expiry date.
Dr Mendarte’s presentation and the subsequent roundtable discussions made it plain that as well as following clear, up-to-date procedures, using prefilled syringes considerably reduces such risks. Because all equipment in contact with fluids is single-use, there is no risk of contaminating the infusion line, and the solution injected into the patient has been prepared and packaged in a sterile environment outside the hospital. No problem related to labelling can occur because syringes have clear labelling showing both concentration – eliminating the risk of injecting the wrong concentration – and expiry date.
Although risk management systems are in place, radiology professionals have major fears over harming patients, according to Ángel Morales (Radiologist and Lawyer, Hospital Donostia, San Sebastián). Four easy steps can be taken to manage risk:.
- Minimising/transferring, if harm occurs.
Everyone can make mistakes, but error-prone situations can be predicted, handled and prevented via adequate risk management, as individuals’ behaviour is influenced by how the organisation they work in is run. Errors can be avoided by analysing the reasons for their occurrence and cultivating a culture of learning from past errors – not just via alarm systems and notification of incidents that have already occurred, but also via pre-error notification systems. For instance, identifying problems with using an injector flags up the issue that errors will occur in using it, and helps find ways to prevent such errors.
Dr Morales identified two main points to consider in the CT contrast media administration setting: indication for use and patient consent. Radiology procedures must be justified, and contrast media only used when actually needed. There should be general, written protocols including instructions on which types of exploration require contrast agents, so the agents’ use is justified. In the absence of such protocols safety should be ensured by a written order from the radiologist (except in emergency situations). Regarding patient consent, radiology professionals must ensure they have complied with regulations and “transferred” the risk appropriately. Allergies must be investigated, plus previous reactions to contrast media, medicines, food or other substances. In other words, possible risks related to patients’ personal and professional circumstances need to be checked, and patients need to be identified and grouped according to risk level.
As well as preventing and reporting errors and serious adverse reactions, risk management also involves investigating infection and contamination.
Following Dr Morales’s presentation, panel members pointed out that in emergency situations, or when tiredness and stress set in after a long day, protocols and preventive measures such as the ones he described cannot always be followed – and this is when errors occur. Prefilled-syringe users emphasise the fact that such systems are safer than others and minimise risk in these exceptional situations, even though adverse events are still possible.
More choice makes administration safer
Juan Calvo (Radiologist, General Hospital of Asturias, Oviedo) explained that in a large hospital such as his own, the range of patients and needs is very wide. For the radiology department, this means different contrast media, of different concentrations and volumes, are needed in order to be adaptable for individual patients’ needs.
It is also even more important to eliminate cross-contamination risks in this setting, especially for immunodepressed patients such as transplant
and cancer cases.
Mr Calvo then detailed what radiologists in the large-hospital setting really need from CT contrast-media manufacturers: systems and products that eliminate contamination risk, are precise and versatile (ie, are available in a variety of concentrations), and can be injected quickly. Additionally, learning how to use these systems should be as easy as possible because a lot of people will be using them.
Mr Calvo said that in his department, prefilled syringes are being used because they answer all these needs. Some members of the roundtable panel believed prefilled syringes were not as cost-effective as multidose bottles. Mr Calvo explained that in the long term, using multidose bottles may not actually lead to any savings and that a lot of wastage occurs in this setting. This opinion was echoed by Ms Nieto, who explained that in order to prevent wastage of CT contrast media left at the bottom of large-volume multidose bottles after a day’s examinations, her department utilised small-volume CT contrast bottles. This practice not only leaves contrast administration open to the usual failings of multidose setups but also negates the inherent cost savings of bulk procurement.
It emerged from the roundtable discussions that administration of CT contrast media needs to be undertaken in a way that is safe and free of contamination risk. Although multidose bottle systems are still widely used (mainly for cost reasons), participants were given the chance to realise how unsafe they could be (especially in stressful and emergency situations), despite well-established procedures being in place, and how much safer prefilled syringes systems were.
Using prefilled syringes for administering CT contrast media has been acknowledged as good manufacturing practice in standards published by Spanish Ministry for Health, and the panel concluded that such syringes seem to be the way forward in administering CT contrast media as safely as possible.
Manuel Alós (President, Spanish Association of Hospital Pharmacists) concluded the roundtable discussions by saying that the prefilled syringe system of contrast media administration was key to patient safety and efficiency within CT procedures. He added that, during the selection of contrast administration systems, the following points needed to be considered:
- Cost savings through reduced preparation time.
- Reduced wastage of contrast media.
- Guaranteed selection and identification of the correct type/dosage of contrast media.
- Minimisation of contamination risk during preparation and handling.
- Minimisation of embolism risk.
According to Professor Alós, prefilled syringes of CT contrast media appear to fulfil each of these needs.