The use of containment safety devices offers improved handling conditions for cytotoxic compounds. This article describes the rationale for selection and implementation of the PCHIMX-1 device at a French hospital pharmacy unit
Centre Hospitalier Intercommunal de Créteil, France
Protecting healthcare workers from inadvertent exposure to hazardous drugs is a high priority. In our hospital, all cytotoxic preparations for cancer wards are centralised at the Pharmacy department with pharmaceutical responsibility, in a cleanroom (class C) with laminar airflow biological safety cabinets (class A). In 2009, we implemented a drug safety transfer device in order to prevent and reduce cytotoxic contamination when preparations (for example, methotrexate for ectopic pregnancy) were made outside the centralised cytotoxic preparation unit.(1)
Our priority is to protect healthcare workers when administering hazardous drugs to patients, in accordance with French preparation guidelines. In addition to observing existing precautions for the safety of healthcare workers, we implemented and evaluated the use of a safety device to protect workers, especially those administering cytotoxic drugs.
We chose the PCHIMX-1 device from Doran International (Figure 1). Many safety devices are available to improve anticancer chemotherapy preparation and administration. PCHIMX-1 comprises a Y-type extension line placed on the infusion line between the cytotoxic bag and infusion device rather than a system consisting of a connecting shaft for multiple administrations of cytotoxic drugs. The latter type of device allows the connection of several bags with rinsing bag and presents a potential risk for patients. In fact, the principal risks are interaction between the different drugs in the drip chamber, simultaneous administration of the cytotoxic drugs and disarming the drip chamber. PCHIMX-1 allows only one drug bag, which reduces the risk of mistakes during administration.(2)
The tubes are made of polymers without 2,2-diethylhexylphtalate or phthalate to limit container–contents interactions. Two clamps can be used to close the tubes. One of the tubes is connected to the chemotherapy bag. The other tube is a flush line to perform rinsing which is used to administer the entire volume of drug.(3) The distal extremity can be connected to any infusion device for administration by gravity-fed devices or infusion pumps. Other manufacturers market similar devices, but the PCHMX-1 device is the only one equipped with a safety cap that eliminates cytotoxic contamination.(4)
PCHMX-1 conforms to the latest recommendations for the preparation of cytotoxic infusion bags because it reduces the use of needles owing to the needle-free connector. According to Simon and colleagues,(5) the device does not have any influence on infusion flow but considerably enhances infusion quality through a simple process of flushing and rinsing the infusion line without disconnection. Moreover, the system ensures that the full quantity of medication prescribed is administered.
Before the implementation, we had confirmed that this type of device limits chemical contamination after administration and rinsing with a 100ml infusion bag, in accordance with the recommendations of the manufacturer.(6)
Implementation and assessment
The multidisciplinary team comprised respiratory and oncology department nurses, and pharmacists and pharmacy technicians, with the involvement of the manufacturer.
After one year of use, an assessment in the preparation unit and in the oncology and respiratory units was performed.
In the pharmacy department, where the chemotherapy medications are prepared and which is certified ISO 9001, a daily record of non-compliance is kept.
Non-compliance can be either that observed by the technician or non-compliance observed by the pharmacist who controlled the infusion bag before being sent to the ward. The main issues of non-compliance for the PCHIMX-1 device were: clamp not closed; clamps not at the well position in the cytotoxic tube; and vents not properly closed. These occurred early in the implementation process.
To detail current practices, we prepared anonymous questionnaires for nurses and pharmacy technicians to complete.
Eight pharmacy technicians and nine nurses (three in the oncology department and six in the respiratory department) replied to the questionnaire.
All of the pharmacy technicians used the syringe luer to put the drug into the bag. It reduces the use of needles and consequently the risk of injection.
Only one rinsed the valve systematically after the introduction of the cytotoxic drug, three when they introduced a small volume of liquid or when the drug is viscous, and two respondents never rinsed the valve. Globally, the PCHIMX-1 device satisfies all users in terms of safety, even if they do not observe time reductions during the preparation of the infusion bag.
According to the nurses, mode of use was different in the two wards. In the oncology department, nurses always rinsed the device with 50ml sodium chloride. In the respiratory department, nurses mainly used the inert liquid of the cytotoxic bag and used 50–100ml sodium chloride (according to prescribed protocols).
Respiratory nurses noted the risk of kinking the manifold. Oncology nurses described a leakage at the level of air intakes and difficulties with connection in the infusion. Most of the nurses were satisfied with the initial instruction given by the manufacturer and the referring pharmacist, and all were satisfied or very satisfied with the device. The PCHIMX-1 is considered very safe for administration of cytotoxics to patients and they are well aware that there is less risk of unnecessary contact with cytotoxic drugs.
PCHIMX-1 is a sterile medical device intended to improve the quality and safety of cytotoxic drug infusions, as well as influence manipulation times required for pharmacy technicians and nurses and infusion line outflow parameters. Collating the opinions of the healthcare workers using the PCHIMX-1 device was indispensable in evaluating its advantages and disadvantages. Our evaluation showed deviations in the way the device was used. Pharmacy technicians did not systematically rinse the luer after introduction of the drug, which can cause differences in concentration or dose. Nurses did not always rinse the manifold (which could be explained by the turnover of interim staff), giving rise to the risk of incompatibility between the drug and solvent. These results emphasise that changes in handling procedures and updated protocols are required.
- Protecting healthcare workers from inadvertent exposure to hazardous drugs is a priority.
- PCHIMX-1 is a sterile medical device intended to improve the quality and safety of cytotoxic drug infusions.
- A multidisciplinary evaluation (nurses/pharmacy technicians) was performed after one year of use at our facility.
- The evaluation showed differences in the way the device was used, and highlighted that changes in handling procedures and updated protocols were required.
- PCHIMX-1 guarantees that the complete prescribed dose of chemotherapy is administered without any change in infusion quality and adheres to latest recommendations concerning occupational exposure protection.
- Ribeiro-Crespel V et al. Safe preparation of methotrexate syringe outside a centralised cytotoxic preparation unit. Hosp Pharm Eur 2009;46:63–4
- Federspiel F et al. Arbres de connexion multiple pour l’administration des cytotoxiques : attention, danger! Euro-pharmat 2008. www.euro-pharmat.com/upload/Poster1-Bdx-08.pdf (accessed 25 April 2013).
- Simon N. Évaluation d’un nouveau dispositif medical destiné à la préparation et à l’administration des chimiothérapies anticancéreuses (PCHIMX®). Euro-pharmat 2007. www.euro-pharmat.com/documents/53.pdf (accessed 25 April 2013).
- Queruau T et al. Multiple-test assessment of devices to protect healthcare workers when administering cytotoxic drugs to patients. J Oncol Pharm Practice 2012;18:191–200.
- Simon N et al. Technical evaluation of a new sterile medical device to improve anticancer chemotherapy administration. Oncology Nurs Forum 2010;37(6):E370–6.
- Mai Ba C et al. Étude comparative de la contamination chimique de deux systèmes monobras destines à la perfusion des anticancéreux. 7ème journées de la Société Française de Pharmacie Oncologique, 2009.