Why to use disposable Medikro SpiroSafe flow transducer?

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	Why to use disposable Medikro SpiroSafe flow transducer?

Solution There are FOUR main reason why a doctor should use a disposable flow transducer, namely:

1. Patient Safety, Hygiene and Infection Control
2. Regulatory guidelines
3. Cost considerations
4. Performance

Patient Safety, Hygiene and Infection Control

In terms of patient safety the question is about cross contamination of infectious material from patient to patient. In direct contact there is a potential for transmission of upper respiratory disease, enteric infection and blood-borne infections. Although hepatitis and HIV contagion are unlikely via saliva, this is a possibility when there are open sores on the oral mucus, bleeding gums or hemoptysis. The most likely surfaces for contact are mouthpieces and / or flow transducers.

In indirect contact there is a potential for transmission of tuberculosis, various viral infections and possibly opportunistic infections and nosocomical pneumonia through aerosol droplets. One of the main concerns has been Tuberculin. The number of publications on the subject is limited, as most of the evidence has been indirect, You may find following paper of interest: "Hazaleus, R.E., J. Cole and M. Berdischewsk, 1981, Tuberculin skin test conversion from exposure to contaminated pulmonary function test apparatus, Resp. Care 26:53-55".

Dr. J.P. Leeming et al. have published a paper focusing on the circumstantial evidence that the contaminated Peak Flow Test equipment may be implicated in the increasing prevalence of Pseudomonas infection among cystic fibrosis patients.

Dr. F. Burgos et al. report in their paper that pneumotachometer based systems are less susceptible to bacterial contamination than water sealed spirometers.

It is well documented (several publications) that community hospital water supplies can be contaminated with Mycobacteria and Pseudomonas aeruginosa organisms. Thus, the potential exist for both patients and health care workers to deposit micro organisms onto spirometer surfaces, which could subsequently come into direct or indirect contact with other patients. This does not seem to pose a major threat to patients with competent immune system. However, it has been argued that immunocompromised patients may require only relatively small infective dose of either opportunistic organisms or common pathogens. I am sure that doctors in India are concerned about this as well.

Regulatory guidelines

American Thoracic Society in their Standardisation of Spirometry, 1994 Update, page 1116, state as follows:

"Mouthpieces, nose clips and any other equipment coming into direct contact with mucosal surfaces (SUCH AS MEDIKRO FLOW TRANSDUCER) should be disinfected, sterilised or discarded (i.e., disposable mouth pieces, nose clips etc.) after each use".

The European Respiratory Society state in their paper "Standardized Lung Function Testing, 1993, page 30" as follows:

"Where feasible disposable articles (e.g. mouthpiece, which may be fitted with a bacterial filter) should be used. Spirometers should be opened at the end of the day, cleaned mechanically and with appropriate disinfectant, and dried". This does not apply to Medikro spirometers, which use disposable flow transducers.

Cost considerations

The operator of a spirometer has three options to provide the patient a contamination free spirometer test:

a. The Flow Transducer of the spirometer should be disinfected separately for each patient. Or
b. The operator should use bacterial/viral filter in the spirometer. The filter should be discarded after the patient has used it. Or
c. The operator should use a disposable Flow Transducer. The transducer should be discarded after the patient has used it.

Our findings in Finland indicate that the option a. is the most expensive one, option b. is generally somewhat more cost-effective, and the option c. IS THE MOST COST-EFFECTIVE choice.

Some doctors ask, if they could disinfect the Medikro SpiroSafe flow transducer. As a manufacturer we do not recommend it for the following reasons:

1. Patient safety: we can not guarantee, that the disinfection has been carried out properly and successfully.
2. Cost: Disinfection is generally more expensive that a new Medikro SpiroSafe flow transducer when all costs of the disinfection process (material and work) are calculated.
3. Accuracy: Disinfection process may leave solid particles on the screen of Medikro SpiroSafe flow transducer. This will have a direct impact on the accuracy of the results. Also heating of the plastic transducer may cause changes in the flow characteristics of the transducer. This will also have a direct impact on the reliability of the measurements. Finally: any liquids left into the Transducer pressure laminas after the disinfection process may have an impact on the accuracy of the results.
4. Convenience: should the operator use a flow transducer after disinfection it should always be calibrated with a 3000 ml Medikro Calibration Syringe. A new Medikro SpiroSafe flow transducer does not require a separate calibration procedure.

Performance

Intensive testing of Medikro SpiroSafe flow transducer with PWG (Pulmonary Waveform Generator, manufactured by HM Custom Design & Mfg. L.C. Midvale, Utah 84047,USA) indicate that the Medikro SpiroSafe flow transducer is very accurate and precise. In fact it is the best transducer in the company history. The best compliment comes from our British competitor, who tested Transducers and sent back a comment: Most impressive!!!

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19 May 2009 12:43 PM

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