Regulatory verification on safe use of cytotoxic drugs in veterinary clinics and animal hospitals.

BACKGROUND: Veterinarians are increasingly being asked to provide chemotherapy for veterinary patients. However, chemotherapy agents have cytotoxic effects that can pose a health risk to workers from exposure. There are no published studies examining cytotoxic drug (CTD) contamination in veterinary practices in Australia. METHODS: CTD use at 13 veterinary clinics and animal hospitals across New South Wales (NSW) was verified for compliance with Work, Health and Safety (WHS) legislation on the effectiveness of exposure control measures. Surface swab sampling was performed to detect the restricted carcinogen cyclophosphamide and seven other CTD. A total of 73 surface swab samples were collected from nine locations associated with CTD delivery, storage, treatment and waste disposal at four veterinary practices, with repeat sampling at two veterinary practices. RESULTS: Compliance with WHS legislation for systematic chemical management, including procedures for safe use of carcinogens, in veterinary practices was high: 4 of the 10 key clauses in WHS chemical management were complied with at all 13 verified workplaces. Surface contamination was detected in three locations, with levels of CTD contaminants ranging from 3.54 to 89 ng per sample. DISCUSSION: Results showed that, in general, there were safe systems in place to work with CTD in the veterinary practices that were verified in NSW. Areas for improvement were mainly in administrative measures related to hazardous chemical management. Particular attention should be given to raising awareness of the intrinsic hazards of CTD, through training and hazard information provision to staff.

Child toy safety: An interdisciplinary approach to unravel the microbiological hazard posed by soap bubbles.

In 2012 some children developed sepsis after playing together with a soap bubble toy. Microbiological testing revealed heavy contamination of the soap solution, which reasonably represented the vehicle of infection. We investigated the issue with a multidisciplinary approach: review of toy safety legislation; microbiological testing of additional samples; query of the RAPEX database for non-compliant soap bubbles; identification of major manufacturing districts. Microbiological contamination of industrial soap bubbles was widespread. Sixty-three notifications of batches contaminated by environmental microorganisms and opportunistic pathogens had been reported. The Chinese had a virtual monopoly of the soap bubble market. We identified two main manufacturing districts in Guangdong Province, both notable for degradation of their water resources. The use of untreated water for the industrial production of soap bubbles may explain the bacterial contamination. Existing legislation provides an unsatisfactory approach for managing microbiological hazards in sensitive toy categories and for identifying responsible parties in import and export of the products.

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.

[Legal basis and practice of examination of critical in vitro diagnostic devices]. / Rechtsgrundlagen und Praxis bei der Prüfung von kritischen In-vitro-Diagnostika.

In vitro diagnostic devices (IVD) are categorized into different risk classes depending on the potential consequences of false test results in transfusion medicine or on the individual patient. Test systems of higher risk may be assessed and examined by a third party in addition to the manufacturer's evaluation. The preapproval examination of essential performance features can assure minimum quality features prior to marketing of the IVDs. By batch testing the variation between different batches of an IVD is determined. Comparative testing in a re-evaluation scheme can define the current state of the art. The present European IVD directive stipulates batch testing for high-risk IVDs while the draft version of the new European IVD regulation also foresees independent product testing performed by European reference laboratories.

[Legal requirements concerning textile medical products]. / Problematika legislativních pozadavku na textilní zdravotnické prostredky pouzívané v operacních sálech.

Presently, more and more often the medical public is concerned with questions regarding use of textile products intended for multiple application at operating theatres. Such questions have been evoked especially by spreading information on restrictions regarding purchase and us of health care products or medical means made from cotton of intended for multiple application. Based on this information preference is given to significantly more expensive products intended for single-use only. This decision is being reasoned by conditions given by European standard EN 13795 reportedly prohibiting the application of cotton within health care. Since this piece of information is not precise, we would like to sum-up legislative situation within this area.

[Effect of quality assessment assurance in 2002 (before starting the German colorectal cancer screening programme by colonoscopy) on the quality of reprocessing of flexible endoscopes--a nationwide analysis]. / Effekt der Qualitätssicherungsvereinbarung von 2002 (bei Einführung der Vorsorgekoloskopie) auf die Qualität der Aufbereitung flexibler Koloskope - eine bundesweite Analyse.

BACKGROUND: International studies in the 1990 s and the HYGEA study from Germany in 2002 revealed prevalences of around 50 % of microbiological contaminations in reprocessed flexible endoscopes. Before introducing the colorectal cancer screening programme by colonoscopy in Germany in 2002, the Kassenärztliche Bundesvereinigung (KBV) and the key stakeholders of the public health insurance system agreed on a quality assessment assurance for reprocessing endoscopes where the qualification for refund for colonoscopies from the public health system was made conditional on adequate qualifications of the gastroenterologist; on a minimum number of performed procedures per year; and on adequate endoscope reprocessing documented by negative surveillance cultures two times per year. This study is an implementation and outcome evaluation of the quality assessment assurance in colonoscopy in Germany. METHODS: The following data - per year and per Kassenärztliche Vereinigung (KV) - were obtained from the KBV: the number of endoscopic units performing therapeutic and/or screening colonoscopies within each KV; the results of all microbiological surveillance tests of reprocessing quality (two per year per unit); the number of failed surveillance tests and re-tests; and the number of qualifications for refund from the public health system cancelled due to repeated failure of microbiological surveillance tests. RESULTS: The percentages of actually performed hygiene control tests (out of those prescribed by the assurance system) reached 95 % already in 2004 and remained above or close to this level thereafter. After the introduction of the quality assessment assurance, the percentage of failed microbiological surveillance tests dropped significantly and steadily from close to 17 % in 2003 to below 4 % in 2007. CONCLUSIONS: This study evidences 1. the successful implementation of the quality assessment assurance in Germany and 2. a substantial improvement in the quality of reprocessing flexible endoscopes achieved by these measures with a drop from 50 % of failed tests observed before the introduction in 2000 - 2001 to below 4 % in 2007.

[Safety of in-vitro diagnostics used in transfusion medicine. Experience of the BfArM until end 2005]. / Sicherheit von In-vitro-Diagnostika zum Gebrauch in der Transfusionsmedizin. Erfahrungen des BfArM bis Ende 2005.

The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVD) stipulates the marketing and post marketing surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions related to IVD, manufacturers have to inform the responsible Competent Authorities. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible Competent Authority for most IVD. Only a small subset of IVD for immune hematological and infectiological testing, as well as tissue typing specified in Annex II of the Directive, is under the responsibility of the Paul-Ehrlich-Institute (PEI). Until the end of 2005 the BfArM received a total of 653 notifications regarding IVD. From these 48 related to IVD used for diagnostics in transfusion medicine and tissue typing which are subject of this study. The investigated products included reagents (tests, calibrators and controls) used for immune hematological analysis as far as they are not under the responsibility of the PEI, analyzing instruments used for immune hematological testing, liquid handling systems for sample preparation and a small subset of analysing instruments and reagents for tissue typing. Most of the reports originated from manufacturers (n=27, 56.3%) and Competent Authorities (n=20; 41.7%) whereas other sources played only minor roles. Product failures were confirmed by the investigations of the manufacturers in 36 (75%) of the reported incidents. Reagents were frequently subject of manufacturing errors and biological contaminations, whereas analysing instruments were typically affected by software errors. In consequence, corrective actions were performed in the large majority of cases (n=37; 77.1%). These included customer information, product recalls, changes in production or quality management and software upgrades (the latter predominantly in cases of failures of analysing instruments). Our data suggest that the governmental system for marketing surveillance is an established tool to ensure product safety for IVD used in transfusion medicine.