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Non-sterile devices make patients sick

After a heart surgery Daniel Buchholz* believed his life would now be easier. Four years passed, until the Senior 2017 suddenly felt sick, as if he had contracted a flu. He was becoming weaker, and the Doctors fought for his life, but this spring, the man died. Laboratory values showed an infection with Mycobacterium chimaera, and a tuberculosis of a similar Bacillus.

Stefan Wagner lives* on the other hand, he can tell his story. Wagner and white since a young age, that he flap has a leaking heart. 48, as to him when it comes to skiing and Biking is always quicker the air goes out, he leaves in April 2014, his heart is in the Unispital Basel operate.

Soon, he takes up the fitness training again. He stands on the Crosstrainer and wonders: The pulse is higher than usual, for the same route it takes longer than it used to. In the spring of 2015, he wakes up at night, soaked in sweat, his pajamas soaking wet. Due to shortness of breath Wagner is admitted to the hospital. After a months-long doctors of the marathon finally got the correct diagnosis: infection with Mycobacterium chimaera. He also.

image to enlarge

guilt is presumed a device with bacteria-contaminated Surgery. In Switzerland at least 12 patients ill because of the bacteria in the world over 100. All of them were operated on the heart, always a cooling stand device of the global British manufacturer Livanova in the OP. Wagner's lawyer, the Basel Nicolai includes working for, is convinced: "The bacteria had come from a factory of the company Livanova". He wants to take action against the manufacturer.

hospital infections shirring in Europe each year, approximately 91 000 people. In Switzerland, there was from 1. October 2015 to 30. September 2017 over 57 000 cases of infection after surgery in 168 hospitals. The latest report by the National Association for quality development in hospitals and clinics (ANQ) and the Swissnoso, the national centre for infection prevention.

intestinal probes were stored in wardrobes in the Klinik Hirslanden in wood, such as, a report shows.

research indicates a possible source of infection, because the Problem with the heart-SURGERY unit is not an isolated case. From 2005 to 2018, the Swiss remedy, authority, Swissmedic, a total of 690 callbacks for non-sterile delivered medical products– the average of five warnings per month. Including 70 different implants were and 65 models of cardiac catheters. The results of the evaluation of the urgent calls from the Recherchedesk and the data team of Tamedia in the framework of the "Implant Files".

But that's not all. If medical devices in hospitals, in use, be respectful of the Disinfection rules. This inspection reports of the therapeutic products authority, Swissmedic, which has received this paper, having regard to the public law. In the first half of 2018, Swissmedic has issued against three Swiss-German hospitals measures for gross violations. The inspections took place in 2016. Are affected the cantonal hospital of Aarau, the University children's hospital Zurich and the Klinik Hirslanden in Zurich. Swissmedic categorized four possible levels of misconduct. The highest is the so-called "non-conformity". This is a "serious deviation" from the provisions of the remedies act. The control violations, your joined at the children's hospital in eight of such Law, at the Hirslanden there were four and in Aarau, three.

devices for intestinal examination are not sterile

A particular weakness of the reprocessing, i.e. cleaning and disinfection of endoscopes. The probes, the insertion of Physicians into the Interior of the body, in order to investigate, for example, the bowel, and minimally invasive minor procedures. Actually, you are a blessing for the patients – if you are a germ, would guaranteed to be free. The controls show a different picture. Frédy Cavin, President of the Swiss society for sterile supply, as an expert in inspections. He says: "Sometimes it is shocking what you can find."

The hospitals would use a weak disinfectant or the endoscopes devices to treat, not good enough, says Cavin. Often, the machines were not validated. "With the validation would have to be checked whether the device washes really well and disinfected." According to the inspection Reports such a validation were missing reports on all three hospitals. The children's hospital could not show that his rinse water germ.

The consequences can be serious. "If it makes reprocessing of endoscopes correctly, nor the germs of the patient is previously on the device," says Cavin.

warning on the Website of Swissmedic: A non-welded pouch of an implant.

To do this, you need to know: In the last years, the number of hospital infections to the intestine is increased interference dramatically. The ANQ Figures show. At 270 operations from October 2016 to October 2017 and every fifth Patient is infected.

the storage of the endoscopes according to the test reports a problem. Effective protection against germs would be hermetically sealed ensure completed cabinets with good ventilation and a so-called Hepa-Filter, is in Rapport. However, the probes can be plugged-in wardrobes to the part of careless in old, non-ventilated wood. Without Protective Cases. In addition to any other Material. So the inspectors found in the private Hirslanden clinic and the children's hospital. She complained of a too long retention time. In the children's hospital, they encountered a packaging material for sterile products, which was preserved in the so-called dirt zone.

The hospitals all point to the fact that the shortcomings had in the meantime been fixed. "The complaints do not mean that it used to be dangerous, or unsanitary," says Isabelle Wenzinger from the cantonal hospital Aarau. And in Hirslanden it means that the complained storage Cabinet for endoscopes is prophylactically by a model made of metal replaced.

expert calls for tougher sanctions against hospitals

The penalties against hospitals are relatively harmless. Buses do not. Swissmedic encourages you to correct the error immediately, and to pay charges for the expenses of the authority. The power for the clinic Hirslanden 1200 francs. The children's hospital of the Zurich University hospital has to pay 9200 Swiss francs. It required almost two years and multiple reminders until you corrected the offending errors.

The expert Cavin calls for tougher penalties. So far, the idea I have is that one will raise the awareness of the hospitals and the people schools mu?sse, will then improve the Situation. Therefore, the sanctions are rather mild. "We should be more stringent," he says. Swissmedic is responsive to the grievances: Bernhard Bichsel, head of the Department of medical devices, says: "As we push for Hygiene and reprocessing of endoscopes on defects, we will run to 2019 with a focus on action."

*name

notes: recherchedesk@tamedia.ch

(Sunday newspaper)

Created: 29.12.2018, 23:23 PM

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