62.26 (1) The Minister may require the manufacturer of a medical device — or any importer or distributor of a medical device — to provide the Minister with information for which the Minister is responsible if the Minister has reasonable grounds to believe that, The central issue in this context is whether the designation of the manufacturer as a “disposable medical device” is part of the specification or whether it is simply a restriction on use. or a definition of the term by the manufacturer. There are currently about 400,000 medical devices on the market. The majority of these items can be reused as medical treatment after proper professional preparation. (2) The following mandatory information about an incident involving a medical device under the control of a hospital shall be provided in writing to the Minister within 30 days after the day on which the incident involving a medical device is first documented at the hospital: (2) The requirement to report an incident outside Canada: does not apply unless the manufacturer has notified a regulatory authority in the country where the incident occurred of its intention to take corrective action or unless the regulatory authority has requested the manufacturer to take corrective action. According to § 4 Abs. 2 sentence 1 MPBetreibV, the reprocessing of medical devices intended for partially sterile or sterile application, taking into account the manufacturer`s specifications, must be carried out by means of appropriate procedures in such a way that the success of this procedure can be demonstrated and that the safety and health of patients, users and third parties are not jeopardised (unlike the reprocessing of medical devices which are not applied in a sterile, usually no more than B. measures to maintain the normal state (maintenance), i.e. simple cleaning). According to a decision of the Arnsberg Administrative Court, it is therefore not enough for a clinic to assume that medical devices treated in a steam sterilizer are sterile without a validated procedure . In 2010, the European Commission submitted a report to the European Parliament stressing that not all SUMDs are suitable for reprocessing and calling for regulation of the entire SUMD reprocessing cycle, from the collection of SUMD to the final delivery of SUMD, to ensure health and safety protection.24 Therefore, the European Parliament is considering amending existing legislation: which would regulate reprocessing as if it were the manufacturer. the restated SUMD (i.e. a first submission).
The proposed amendments would also allow the Commission to establish and regularly update a list of products or types of SUMDs unsuitable for reprocessing.25 (1) Subject to sub-regulation (2), an active diagnostic tool, including specialized software, that provides energy for imaging or monitoring physiological processes, is classified in Class II. 6 Before 1 November 2003, the manufacturer of a medical device for which a medical device authorisation was granted before the entry into force of this Ordinance shall provide the Minister with a copy of the quality assurance certificate referred to in para. 32(2)(f) and the declaration provided for in Art. 43(1) of the Medical Devices Ordinance. (3) (j) or paragraph 4(p) of these Regulations, as the case may be.] Provincial and territorial policies for the reprocessing of medical devices are usually based on the class of device. The internationally recognized classification system described by Spaulding, which groups products according to the risk of infection associated with the product, classifies medical devices as follows:2 Commercial reprocessing companies should prepare to phase out the supply of non-compliant products. By September 1, 2016, commercial reprocessors distributing refurbished medical devices to Canadian healthcare facilities must have applied for a licence, if applicable.9 The regulations apply to all commercially remanufactured SUMDs, whether reprocessed in Canada or abroad. Surveillance of hospital treatment will continue to be conducted at the provincial and territorial level. In Australia, the Therapeutic Goods Administration adopted regulations for hospitals and third-party processors of SUMD in 2003. Retransformers, or “retreatants” as described in the legislation, must meet the same regulatory standards as the original manufacturer and demonstrate that remanufactured SUMDs are as safe and efficient as the originally manufactured device.20 According to the Association of Medical Device Reprocessors, the number of hospitals in the United States and Australia that treat SUMDs in-house has declined significantly.
likely due to high cost and strict regulatory requirements.19,21 Every medical clinic needs infection prevention and control, and when medical device reprocessing takes place, clinic staff need training and education from the MDR. We recommend one of the following two courses. These courses are not administered by PSAC. Provincial and territorial health authorities have the authority to develop their own policies and guidelines for the reprocessing of SUMDs, and these guidelines vary greatly from jurisdiction to jurisdiction. In addition, Health Canada has established the following conditions for the refurbished device1: PSAC works with a multidisciplinary team of provincial infection prevention and control (IPC) experts and medical practitioners to develop our IPC and medical device requirements. They guide and advise us in preventing the transmission of infectious diseases in medical clinics. 88.1 Paragraphs 2 and 3 of section 61.2 and section 61.3 apply to medical devices to which this Part applies, except that references in these provisions to a holder of a market authorization for a therapeutic product are to be understood as references to the holder of an authorization granted under subsection 83(1). 6.
Within two business days after the day on which the manufacturer is again able to respond to the request for the specified medical device, the manufacturer or importer shall notify the Minister electronically of the manufacturer`s or importer`s ability to do so in a format that the manufacturer or importer determines or considers acceptable. (b) the designated medical device is authorized for sale by a regulatory authority in its jurisdiction or, if the device does not need to be authorized by a regulatory authority in its jurisdiction, complies with the applicable legal requirements in its jurisdiction; MEDEC, the Medical Devices Industry Association of Canada, has called for federal regulatory oversight of retired MEDs.