8. Healthcare worker and patient safety
8.1 Healthcare worker safety
Risk prevention strategies are mandatory and should start by using instillation methods that minimise risk of contamination. The lowest risk in complexity, and in number of aseptic manipulations, is by making use of pre-mixed compounded sterile preparations [42]. The use of totally enclosed systems where practicable, carries the lowest risk for healthcare workers and patients [26, 43]. Important risk prevention strategies include:
- If enclosed systems are not available, we recommend that you outsource the reconstitution of the medication and the preparation of its administration device to a department that has a biological safety cabinet.
- Closed administration systems are available to connect syringes or bags containing the medication to the catheter, with and without Luer lock tips.
- Both intermittent and indwelling catheters can be used. In the case of a catheter without a Luer lock, an adaptor can be used to connect the catheter to the administration system.
- Ready-to-use closed systems are currently available for both MMC and BCG. Reconstitution of the dose can be carried out on-site, reducing the number of people exposed to the medication. While the risk of exposure is minimized, it does not fully eliminate the risk.
- Prior to the instillation procedure, the healthcare worker must assess the situation for potential risks of spillage and contamination for themselves or others. Depending on the situation, they will need to develop strategies to prevent this from happening.
- Assess whether the patient has signs of bladder spasm (for example, does the patient have a sudden urge to empty their bladder or episodes of incontinence?). If present, consider prescribing anticholinergic medication. In addition, if previous attempts have shown that a bladder spasm may occur, consider using an indwelling catheter with an inflated balloon instead of an intermittent catheter and ensure reduced fluid intake prior to treatment.
- Folding an absorbent pad around the catheter and the entire administration system before removing the catheter will considerably reduce the risk of skin exposure and contamination of the environment.
- To empty the catheter, connect a syringe with 5 ml of saline. 3 ml is sufficient to clear the system of medication.
- When the catheter is removed, the male patient may be recommended to use a condom catheter/external catheter or an incontinence pad in case of episodes of incontinence or to reduce contamination.
8.1.1 Guidance on preparation and handling for healthcare workers
The following table provides information on best practices for preparation and handling of BCG and MMC to ensure healthcare worker safety.
Table 4. Intravesical administration for chemotherapeutic and immunotherapies for healthcare workers
| Intravesical administration for chemotherapeutic and immunotherapies | |
|---|---|
| Universal precautions | Follow universal handwashing practices, including proper handwashing before and after contact with the drug/agent, patient’s waste, linens and equipment, the environment and before and after any glove use. |
| Catheterization technique | Aseptic and atraumatic technique is required when performing urethral catheterisation. |
| Personal protective equipment (PPE) | Gloves:
Gown:
Eye and face protection:
|
| Spill kit | Ensure a chemotherapy spill kit is readily available. Contents may contain:
|
| Eyewash station | Gentle flow of water for 15 minutes after splash exposure. |
| Waste container | Biohazardous or chemotherapy waste containers readily available. |
| Disposal | All equipment and material that has been in contact with BCG or MMC must be disposed of as biohazardous. |
| BCG preparation and cross-contamination prevention | To prevent cross-contamination, no other parental drugs should be prepared in the same area as BCG until the area has been properly decontaminated with the appropriate cleaner. |
Adapted from American Urological Association. (2020). Intravesical administration of therapeutic medication. American Urological Association. Retrieved 4 March 2025 from https://www.auanet.org/about-us/aua-statements/intravesical-administration-of-therapeutic-medication
8.1.3 Pregnant healthcare workers and workers receiving immunotherapy or chemotherapy
Reproductive effects associated with occupational exposure to antineoplastic agents are well-documented. Several studies of nurses found a significantly high proportion of adverse pregnancy outcomes when exposure to antineoplastic agents occurred during pregnancy. The nurses involved in these studies usually prepared and administered the drugs [26].
When administering MMC instillation, pregnant or lactating workers, or those receiving immunotherapy or chemotherapy are advised against not to do the following:
- prepare antineoplastic agents
- perform intravesical instillations
- clean up after spills
- handle cytotoxic waste
- care for patients experiencing heavy perspiration
- handle patient waste
Pregnant or lactating workers are permitted to care for patients being treated with antineoplastic agents if they do not come in contact with urine, stools or vomit. They can also change linens if no visible contamination is seen [32].
8.2 Patient safety
8.2.1 Care instructions for BCG and MMC
8.2.2 Skin contact
Intravesical agents must not be allowed to come in contact with the patient’s skin. If this does happen with MMC, the skin should be cleaned with water and soap. Contact with the eyes should also be treated with prolonged flushing with water (15 minutes). A physician should also always be notified. The same procedures apply to contact with BCG, and washing with soap and water is sufficient. Handwashing and rinsing of the perineum is advised after passing urine.
8.2.3 Toileting
Toilets are where the risk of contamination after preparation and administration of chemotherapeutic agents are highest [43]. High urinary urgency and incontinence are additional reasons for toilet contamination after intravesical instillation. In some countries, it is advised to flush the toilet twice with the lid closed, however, there is no evidence to support this precaution. Family members who handle contaminated excreta should wear gloves. If a private bathroom is not available for the patient in the home setting, one suggestion is that hazardous drug residue may be physically removed from the toilet seat and rim after use by wiping down with a sanitizing wipe [45]. More research is needed on how well sanitizing wipes in the home setting and routine cleaning in the institutional setting reduce surface contamination with hazardous drugs.
8.2.4 Contamination of clothes
Normal washing of clothes is safe for dealing with MMC and BCG contamination (see Section 7.5) [40, 46]. For further information on side effects, resuming normal activities, voiding and medication, see Chapter 11.
8.2.5 Pregnant patients
Pregnancy within six months after the therapy is not advised. Breast feeding during therapy with MMC or BCG is also contraindicated [17, 18, 47].
8.2.6 Fertility
Patients treated with BCG or MMC can show marked changes in sperm quality [48, 49]. Intravesical therapy with BCG has been shown to significantly decrease total sperm concentration, as well as sperm motility, which can affect fertility. Patients should be informed of this potential effect and advised to preserve sperm to avoid future fertility issues [49].
Patients treated with BCG or MMC are advised to use protective contraception (e.g. condoms) during sexual intercourse or to refrain from intercourse for one week after treatment, because excreta can remain in the body of patients undergoing BCG therapy [18].
| Recommendations | LE | GR |
|---|---|---|
| Assess the risk of handling antineoplastic and biological drugs and take suitable precautions to protect employees by identifying the hazards and deciding who might be harmed and how. | 4 | C |
| Follow local and hospital safety procedures to prevent exposure of patients and personnel to hazardous medication. | 4 | C |
| Prepare instillation medication in a pharmacy or use biological safety cabinet when a closed system is not used, to prevent exposure. | 4 | C |
| Use a closed system to reduce risk of exposure during drug administration | 3 | B |
| To reduce the risk of exposure during drug preparation and administration, personal protective clothing should be worn in accordance with local and hospital safety procedures. | 3 | B |
| All material that has been exposed to medication used in intravesical instillation should be considered contaminated and disposed of in accordance with local and hospital regulations and in a container specifically used for chemotherapeutic waste. | 4 | C |
| Protect reusable materials and furniture at risk of being contaminated during the intravesical instillation by protective absorbent pads. | 4 | C |
| All personnel involved in handling, transporting and cleaning materials used for intravesical instillations must be properly trained on the content and the risks involved. | 4 | C |
| Nurses should educate patients and caregivers on how to deal with the risk of exposure during and after the intravesical instillation. | 4 | C |
| Nurses should advise patients not to become pregnant within six months after treatment with BCG or MMC. | 4 | C |
| Pregnant or lactating healthcare workers caring for patients being treated with antineoplastic agents (MMC) should follow local guidelines when preparing or administering the drugs and cleaning spillages or waste. These workers should not come in contact with the patient’s urine, stools, vomit or heavy perspiration. | 4 | C |