پديدآورندگان :
توكلي گلپايگاني علي پژوهشگاه استاندارد , رزق دوست غلامحسين پژوهشگاه استاندارد , رضا مرضيه سازمان پژوهش هاي علمي و صنعتي ايران، آزمايشگاه تست تجهيزات پزشكي
كليدواژه :
وسايل پزشكي , مديريت كيفيت , مديريت ريسك , استاندارد ملي
چكيده فارسي :
در رويكرد نوين علم پزشكي، وسايل پزشكي به شكل گسترده¬اي چه در امر تشخيص و چه درمان نقش بسيار مهم و اساسي را بازي مي¬كنند و عملكرد صحيح اين تجهيزات بر ايمني، سلامت و زندگي بيماران و كاربران به طور محسوسي تاثيرگذار است. وجود يك سيستم مديريت كيفيتِ مؤثر به منظور اطمينان از ايمني و كارايي بهينه در وسايل پزشكي امري ضروري است. در رويكرد نوين پزشكي، سيستم¬هاي مديريت ريسك به طور كاملا آميخته¬اي با سيستم¬هاي مديريت كيفيت در راستاي موفقيت، اثربخشي و ارتقاء سطح ايمني در مراكز درماني و شركت¬هاي توليدكننده وسايل پزشكي شكل گرفته¬اند. ريسك در واقع تركيبي از احتمال وقوع يك حادثه خطرناك و شدت (پيامدهاي) ناشي از وقوع آن و درجه كشف آن مي باشد. مديريت ريسك كاربرد سيستماتيك سياست-هاي مديريتي، رويه¬ها و فرايندهاي مربوط به فعاليت¬هاي تحليل، ارزيابي و كنترل ريسك است. استاندارد ملي ايران به شماره 12136 تحت عنوان وسايل پزشكي ـ كاربرد مديريت ريسك در وسايل پزشكي براي توليدكنندگان وسايل پزشكي تدوين شده است كه در يك چارچوب كاري نظام¬مند، از تجربه، بينش و قضاوت خود براي مديريت ريسك عملكردي اين وسايل استفاده كنند. اين استاندارد به طور ويژه براي توليدكنندگان وسايل يا نظام¬هاي پزشكي تدوين شده و مي تواند به عنوان يك راهنماي اطلاعاتي براي توسعه و نگهداري نظام و فرآيند مديريت ريسك مورد استفاده قرار گيرد. [1,2]
پياده¬سازي يك سيستم مديريت ريسك اثربخش، نه تنها باعث اطمينان از ايمني تجهيزات پزشكي براي كاربران مي¬شود بلكه مي-تواند مسئوليت¬هاي قانوني سازندگان را كمتر كرده و علاوه بر كاهش هزينه¬هاي راهبري سيستم¬ها به دليل شناسايي و رفع مخاطرات قبل از توزيع در بازار فروش باعث افزايش سود نيز شود.
چكيده لاتين :
Nowadays, technology has played an important role in health area and development in the field of medical technology has resulted more accurate diagnostic and more effective treatment with less cost and recovery time. However, these improvements are also associated with safety risks. In this way, operators and patients are in contact with an increasing number of medical devices longer and more intensively then before. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public. It is important that all stakeholders understand the use of a medical device entails some degree of risk. ISIRI 12136 is a risk management standard for medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. The requirements contained in this standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. This standard was developed specifically for medical device/system manufacturers using established principles of risk management and deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity. It is accepted that the concept of risk has two components:
a) The probability of occurrence of harm;
b) The consequences of that harm, that is, how severe it might be.
Each stakeholder’s perception of the risk can vary greatly depending upon their cultural background, the socio-economic and educational background of the society concerned, the actual and perceived state of health of the patient, and many other factors. This standard specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control. By implementing and evaluating an effective risk management systems, manufacturer according to legal responsibility ensure to bring their products to market safe, on-time and within budget.
