Medical devices general product safety

The role of Medsafe in ensuring the safe and effective use of therapeutic products is encapsulated by its mission statement Healthy New Zealanders, by regulating medicines and medical devices to maximise safety and benefit. As a small agency with limited resources, Medscife generally applies a risk assessment-based approach to regulatory control, in order to maximise the benefit risk equation for therapeutic products. 

For the purpose of improving safety and efficacy, there are three Specific Product Safety Directives for active implantable medical devices, for other medical devices, and for in-vitro diagnostic medical devices. There is also a General Product Safety Directive, intended for "all medical devices that are supplied in the course of a commercial activity for use by consumers" to which none of the three Specific Product Safety Directives can be applied. 

General medical devices are the responsibility of the Center for Devices and Radiological Health (CDRH). The CDRH is also responsible for assessing the safety of non-medical radiation-emitting products such as televisions, microwaves and mobile telephones. 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. 

There is no licensing or specific approval procedure for medical devices in New Zealand. Section 38 of the Medicines Act 1981, however, places restrictions on the sale of medical devices and details the powers of the Director-General of Health to request evidence on the safety of any device from the importer or manufacturer, and to recall any product from sale if necessary. Regulations 10 and 12 of the Medicines Regulations 1984 control the advertising and labelling of medical devices. 

The PFSB consists of a Secretary General, five divisions and one office. It ensures safety and efficacy of drugs, quasi-drugs and medical devices, editing as well policies regarding blood supplies, blood products, narcotics and stimulants. 

ISO 62366 2007 Medical devices - Application of usability engineering to medical devices [12] is a design and development standard which is harmonised with medical device compliance requirements in many territories. It is closely aligned to risk management standard ISO 14971 2012, essentially ISO 62366 explores in greater depth those hazards which arise from a product s usabifity characteristics. Whilst intended as a standard to support the manufacture of medical devices it contains a useful framework that could be utilised by manufacturers of general HIT products where the user interface is associated with a number of important safety related hazards. 

For those readers not familiar with the premarket requirements for medical devices it is generally, but not always, true that a Class I device may be marketed without prior FDA clearance. A Class II device typically requires prior FDA clearance, known as a 510(k). This is usually true as long as the device can be shown to be substantially equivalent to a device previously cleared by FDA for the same indicated use, or for which there is a preamendment device with similarities. The requirement to continuously compare a new product to one on the market in 1976 was modified in 1990 with the Safe Medical Devices Act (SMDA). The regulations have been modified to focus on whether devices are either considered to be safe and thus manageable with special controls , or whether their safety might be an issue if certain unanticipated risk factors have evolved with expanded use. For this reason it is imperative to conduct an early regulatory assessment for any new product, no matter how similar it may seem to an existing product. 

Risk Analysis takes all inputs and products to produce a list of risk items to be properly dealt with the appropriate measures. As a general rule, risks in medical devices are usually avoided or mitigated. On the contrary, direct acceptance of a risk is not an option except for cases of highly beneficial medical devices. Even in that case, it shall be possible only for the most superficial, harmless and improbable risks that can hardly be reduced or mitigated. Mitigation and avoidance can be achieved by means of additional requirements, safety checks, boundary control, labelling, etc. Furthermore, software can hardly reduce the severity of a risk, instead it can reduce its probability to happen and/or increase its visibility should it happen. In the end, all risk items should have been brought to an acceptable level of residual risk. 

Inclusion of the implantation and follow-up phases of the product life cycle in the risk control process. This would require safety management systems, which are in general not yet available in the medical device industry and health care. 

In general, it is people who manage each phase in the lifespan of a medical device, and these people should be identified and called on to participate in ensnring device safety. Several different groups of people are involved in the commercial process of delivering a medical device to its final user. The role of each participant in ensnring product safety is described below. 

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