Alerte Ou Avis De Sécurité sur Cidex® OPA ortho-phthalaldehyde high level disinfectant solution

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Advanced Sterilization Products a Johnson & Johnson company.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

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  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
  • Numéro de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Repeated exposure to cidex® opa high level disinfectant solution, following manual re-processing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy. johnson & johnson has issued a product notification, contraindicating the use of cidex® opa for re-processing urological instrumentation for use in patients with a history of bladder cancer. a letter and revised instructions for use were issued on 27 april 2004 to all uk customers that have bought cidex® opa. a recent post-marketing surveillance review carried out by the company identified that, since the product was introduced in 1999, out of approximately 1 million urological procedures world-wide, there have been reports of 24 patients who have experience 'anaphylaxis-like' reactions after repeated cystoscopy (typically after 4-9 treatments). symptoms reported to the manufacturer included nausea, penile swelling, hypotension, vomiting, breathing difficulty, wheezing, rash, hives, eye irritation, dizziness and anaphylactic shock. in all of the above cases the manufacturer has indicated that the instruments had been manually re-processed. the evidence for manual re-processing being a significant risk factor is, therefore, compelling.
  • Action
    When re-processing urological instruments for use inpatients who have potential for repeated exposure: Do not use Cidex® OPA if a validated alternative is available. If no validated alternative to Cidex® OPA is available: carry out a risk assessment on the continued use of this disinfectant solution; ensure that measures are in place to minimise disinfectant solution residues (e.g. use of a validated endoscope washer-disinfector); plan and implement the replacement of this disinfectant solution with an alternative. Where no validated alternative to Cidex® OPA is available and there is potential for repeated exposure, carry out a risk assessment and options appraisal, taking into account the following factors: Risk factors In considering risks to patients: the risk of sensitisation is related to patterns of exposure. In this instance, repeated cystoscopy and ineffective removal of residues are important risk factors associated with the use of Cidex® OPA; bladder cancer is associated with reactions to Cidex® OPA, but this is likely to be due to repeated cystoscopy, rather than a risk factor per se. Bladder cancer is not associated with increased susceptibility to allergic disease; trauma associated with cystoscopy, particularly in male patients, may augment allergic reactions. In considering risks to users: the company has identified that healthcare workers have experienced irritation or possible allergic reactions due to exposure to Cidex® OPA. It is the company's view that, in most of these cases, the healthcare workers were not using the product in a manner consistent with the instructions for use; symptoms reported in healthcare workers do not appear to be indicative of Type I hypersensitivity. Risk control measures In the short term, residues of Cidex® OPA should be minimised, preferably by the use of a validated endoscope washer-disinfector cycle. If manual processing is carried out, ensure that the manufacturers' instructions for use are followed, in particular during rinsing. It is not appropriate to use a sensitiser in circumstances where repeat exposure is a possibility and where such use is avoidable. It is therefore necessary to identify an alternative to Cidex® OPA, a suspected sensitiser, in circumstances where there is potential for repeated exposure to patients. Any alternative must be validated for use and compatible with the device and, where applicable, the endoscope washer-disinfector, in line with each of the respective manufacturer's instructions for use. Further advice on decontamination, including the selection of materials and processes, is available in MHRA Device Bulletin DB 2002(05) 'Decontamination of Endoscopes' and NHS Estates publication HTM 2030 'Washer-Disinfectors - Design considerations'. [Note: endoscope washer-disinfectors may also be described as automated endoscope re-processors (AER)] DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM


  • Modèle / numéro de série
  • Description du dispositif
    Cidex® OPA ortho-phthalaldehyde high level disinfectant solution. Cidex® OPA ortho -phthalaldehyde high level disinfectant solution manufactured by Advanced Sterilization Products (ASP) a Johnson & Johnson company.
  • Manufacturer