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Dear Mr. Murlikrishnan
I was asked to answer your question dating the first of January 2004 concerning the reprocessing of balloon angio catheters. Since there have been often questions similar to the one you mentioned I would like to give some more details on this topic. Unfortunately the answer to your question is more complex.
Due to limited resources in the healthcare systems as well as more and more medical devices being labeled as single-use by the medical device industry many hospitals worldwide try to reprocess so called single-use medical devices. The practice of reprocessing of medical devices has raised public health concerns, primarily regarding the potential risks of infection and device malfunction.
Certain types of medical devices have been traditionally marketed as reusable devices by industry. These include myriad conventional surgical instruments. A vast majority of high-quality medical devices, primarily those newly designed for invasive procedures, are designated for single use by their manufacturer.
But this designation does not automatically mean that reprocessing is not possible. Rather what it means is that the manufacturers of such devices have not devised a suitable validated reprocessing method and give no warranty for reuse of such products. But based on the legal provisions, reprocessing of these devises is permitted if appropriate processes are used.
Innovative technologies today permit safe reprocessing and reuse of many complex and high-quality medical devices, while assuring complete device quality and patient safety. By consistently using such technologies in hospitals and doctors' surgeries, for example the German health-care sector has been able to build up economic reserves to the tune of billions, without compromising the services rendered to patients.
There are some countries whose regulations are based on the labelling of the medical device as "single-use" or "multiple-use" by the manufacturer. Other countries, not only in Europe (e.g. USA, Australia, Canada), have adopted new regulations which allow reprocessing of medical devices by establishing requirements which ensure safety and quality of the medical device regardless of the original equipment manufacturer's labelling as single-use or multiple-use. In many countries there are still no regulations concerning medical device reprocessing.
As member of different associations that have an expertise on the reprocessing of medical device I had the opportunity to take part in the process of establishing regulations for reprocessing of medical device. One good example is the regulation in Germany where we have made positive experience.
New legal regulations, and specifically the Second Amendment to the German Medical Devices Act (2. MPGÄndG), the amended Medical Devices Operator Ordinance (MPBetreibV) and a binding guideline of the Robert Koch Institute (RKI) governing the hygiene requirements for reprocessing medical devices have made provision for a clear definition of the outline conditions governing the reprocessing of medical devices.
The associated requirements are thus explicitly specified and acknowledged as being decisive by the legislator in the designation given in Section 4(2) of 2 MPBetreibV.
The legal Framework for Reprocessing Medical Devices
Following this amendment, reprocessing can now be defined as follows: "Reprocessing of medical devices, which as per the applicable regulations must be used in a sterile condition or with only a low microbial count, consists of the cleaning, disinfection and sterilisation tasks, including the associated work practices as well as testing and restoration of the functional safety, performed after using them so that they can be reused" (Section 3(14), 2.MPGÄndG). MPG or its amended provisions do not distinguish between single-use and reusable medical devices. Processing "must be carried out with validated processes while observing the manufacturer's instructions, so as to furnish proof of the ongoing effectiveness of these processes and ensure that the safety and health of patients, users or third parties are not compromised" (Section 4 (2) MPBetreibV).
The requirements for the processing methods to be used are ultra exacting and often outside the scope of sterilisation facilities available to a hospital. The verification of functional capabilities as well as the hygiene safety of the respective device advocated by MPG cannot be conducted in a hospital setting in particular for the many highly specialised medical devices or for devices initially designated for single use by the manufacturer, due to a lack of technical facilities and available personnel. In such cases external specialist companies must be contracted to conduct reprocessing. This applies irrespective of whether single-use or reusable devices are involved.
In this respect in August 2001, at the same time as the Second Amendment to the German Medical Devices Act was being debated in Parliament, the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and of the Federal Institute for Drugs and Medical Devices (BfArM) issued a recommendation on the "Hygiene requirements for reprocessing medical devices". This recommendation known as the "RKI Guideline" sets out the reprocessing requirements to be observed in each case. The fundamentals of the detailed recommendations of this guideline with input from the RKI and BfArM complete the outline newly specified by the Second Amendment to the German Medical Devices Act. By introducing comprehensive regulatory mechanisms any shortcomings regarding the quality and safety of reprocessed medical devices are ruled out
Requirements for Reprocessing Critical Medical Devices with Validated Processes
The aforementioned RKI Guideline makes provision for risk assessment and classification of medical devices. Designated as "critical medical devices" are those devices "that penetrate the skin or mucosa, coming into contact with blood, inner tissues or organs". Furthermore, it is stated "structural and material details of the device design address stricter requirements to reprocessing". Based on this approach, one group is singled out from among the critical medical devices "for which particularly strict reprocessing requirements must apply".
These include, inter alia, "medical devices
- for which the effectiveness of cleaning cannot be assessed directly by means of visual inspection (e.g. due to long, narrow and especially dead-end lumens, lumens with only one opening (only dilution but no flushing possible), complex, poorly assessable surfaces that are thus difficult to clean);
- for which the effects of reprocessing (including transportation) cannot be ruled out for the medical device and its material properties (e.g. devices prone to kinking, sensitive surfaces) and which thus call for a greater investment for technical and functional tests
- for which the number of uses or reprocessing cycles have been restricted by the manufacturer".
Bearing in mind the need for "suitable, validated processes" as stipulated in Section 4 of MPBetreibV, the RKI Guideline recommends that "validation of the medical device" as well as "risk assessment and classification should be reasonable" and "conducted in accordance with the established rules of technology, while taking account of the current stock of knowledge and the state of the art".
Certain parameters are named with which proof can be furnished that reprocessing had been conducted such that "it guarantees that the respective specifications are met".
In any case I recommend to study the guidelines of the Robert-Koch-Institute which you will find on www.rki.de.
Special Reprocessors - Requirements for Maximum Quality
In Germany, reprocessors have set up business establishments specialising in medical device reprocessing. The reprocessed devices come from German - but increasingly also from other European - hospitals; formerly, many of these devices had to be deposed of due to a lack of suitable reprocessing techniques. These service companies have developed validated reprocessing methods that guarantee that the reprocessed medical devices leave their premises in an impeccable hygienic and functional condition; indeed, in some cases this state is vastly superior to that of the device when first supplied by the original manufacturer.
By using a unique coding system, the DataMatrix system, it must be ensured that the medical devices are returned to their respective owners - the hospital or user. What is important is that these specialist establishments bear liability for the reprocessed devices and guarantee that they assure a level of functionality and safety on a par with that of new devices.
For further information about the service of these reprocessors please take a look on the webside of for example the company VANGUARD www.vanguard.de.
I hope this could shed some light on the various aspects of this sometimes technical and complex issue.
Yours sincerely
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VANGUARD AG
MEDICAL SERVICES FOR EUROPE
Nikou Ghassemieh
Director, Health Policy
and Business Development
Friedrichstraße 78
10117 Berlin
Germany
Tel: +49 30 80484 412
Fax: +49 30 80484 445
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