The Risks are Controllable

Prof. Dr. Axel Kramer

At the end of August the European Commission published its “report on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC”. The report bases mainly on the analysis of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and reveals essential risk potentials at reprocessing.

Now, those experts from Germany rise to speak, who engage themselves since years with the risk assessment of reprocessing of medical devices: the Expert Group for Safety in Medical Devices Reprocessing (smdr). The experts welcome the central claim of the European Commission for the improvement of patient safety. Notwithstanding, they think the report is unbalanced in many points. “It is good and important to allude to the risks, however, to be fair one has to say that professional reprocessing service providers control those risks”, states Prof. Axel Kramer, spokesman of the smdr and director of the Institute for Hygiene and Environmental Medicine at the University Clinic of Greifswald. “That though, the European Commission did not do.”

Thus claims the report the evaluation and validation of the entire reprocessing process of single use devices, but does not mention that in Germany it is regulated by law for a long time. “This claim is already included in the Medical Devices Operator Regulation and applies for the reprocessing of single use as well as reusable devices”, tells Axel Kramer.

Just the Validated Reprocessing Procedure Counts

For experts like Prof. Axel Kramer and Prov. Marc Kraft, Director of the Department of Medical Technology at the TU Berlin, the crucial criteria is that a product specific validated reprocessing procedure exists. If the product is marked as a single use or reusable device, in the end is irrelevant, as long as it is adhered to the framework requirement of reprocessing including the therefore required risk analysis. “Of course not every medical device is not able to be reprocessed, this unfortunately applies also for some devices, which the manufacturer designed for reuse”, says Marc Kraft. “Crucial is, if one can analyze the risk potential of the application and of the reprocessing with the help of a risk management process and can reduce those risks with suitable measures when necessary. If the validation of the reprocessing procedure succeeds, the reprocessed device will not cause any further risks at its application.” Hence, Kraft does not let count the falsely generalized argument by the European Commission, that the reuse of single use devices – in contrast to reusable medical devices – “is not without risk” in the aspect of health. “The validation of the reprocessing procedure has to exclude a raise in risk. In that case there are neither hygienic nor technical-functional threats”, thus Marc Kraft.

This is also valid with regard to prion contamination. The European Commission indicated in its record the peculiar problem of the elimination of prions. “[…] only aggressive cleaning methods, not compatible with the commonly used materials, can ensure complete prion inactivation”, the report states. Marc Kraft, who developed himself validated reprocessing procedures for a number of medical devices, says thereto: “While cleaning contaminations of the surface of medical devices are removed, regardless whether those are particles, microorganisms or prions. When the prions are removed of the surface, they do not need to be inactivated anymore, which is in fact more difficult than the inactivation of other pathogenic germs.” Axel Kramer notes in addition that with the implementation of Guanidine Thiocyanate exists a material compliant, safe possibility of protein decomposition.

The Number of Critical Incidents is Verifiable Low

In Germany single use devices are allowed to be reprocessed and reused if a product specific procedure validation exists and the reprocessing service providers adheres to the Medical Devices Operator Regulation and the joined recommendation of the RKI (Robert Koch Institute) and BfArM (Federal Institute for Drugs and Medical Devices). “The requirements for reusable as well as single use medical devices are the same. They are valid for users as well as external reprocessing service providers. There are several professional reprocessing service providers in Germany, who comply with those requirements”, says Dr. Christian Jäkel, specialist solicitor for Medical Law.”As the reports about critical incidents of the BfArM and the US administration show, the risk at professional reprocessing is not exalted.” The European Commission acknowledges that the number of documented critical incidents is low, yet it assumes, that not all critical incidents are reported. “For that reason this point stays speculative as well”, argues Jäkel.

Also the statement executed in the report, the reprocessing of single use medical devices leads to an unequal treatment of patients, the experts don’t want to allow to stand like that. “On the contrary, there are some therapies, like in the field of cardiologic electrophysiology, whose case-based lump sums do not cover the cost of materials of the necessary catheters”, means smdr-member Dr. Dipl. Oec. Colin M. Krüger, Assistant Medical Director at the Clinic for Surgery, Visceral- & Vascular surgery of the Vivantes Humboldt-Clinic in Berlin. “Those expensive therapeutically procedures could not be offered to all patients anymore today, if the therefore required instruments had to be newly bought every time.” Insofar the reprocessing of expensive medical devices contributes particularly to an equal treatment of all patients.

This is also underlined by the Health Economist Prof. Wilfried von Eiff of the Centre of Clinic Management at the University Münster. He says: “The report peculates the fact that the professional reprocessing contributes to the qualified accommodation of a bigger number of patients and therefore a reduction of cost motivated rationing.” Just like the European Commission Eiff criticizes: “A study is missing, which verifies the economic profit of a professional reprocessing with a product based validated procedure.”

Conclusion: The Risks are Controllable

“We take the risks, indicated in the report by the European Commission, and the involved threats for patients and users very seriously. If nothing else, because we engage ourselves since years with the requirements for a safe reprocessing of medical devices, we can ascertain that the indicated risks are controllable by the industry with validated reprocessing procedures and a product specific risk management. Therefore, no increased risk for the patient and the user exists with a proper and professional reprocessing. We would have wished that the European Commission had considered this aspect stronger in its report. “

01.10.2010

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