Medical Device Regulatory Concerns

Sunday, December 05, 2010

همة شباب


الهمة هي العزم .. والعزم هو الرغبة والإصرار لتحقيق شيء ما .. والعزيمة هي أساس كل فعل وأوله ..

أما الأفعال التي تكون دون عزيمة فهي أقدار .. لا يثاب ولا يعاقب الإنسان عليها .. ولاينبغي أن يفخر الإنسان بإنجازاتها ..

ليس الفتى من قال أبي * إن الفتى من قال ها أنا ذا

وإن كانت الهمم والعزائم لا تحتاج إلى فعل وحركة خارجية ، لكنها تتطلب جهدا عالياً يبذله الإنسان عندما يعزم على أمر هو فاعله .. ولذلك فإننا لانجد الكثير من الأحلام تتحق .. ولا نجد كثيرا من الناس من يعزم على هذه الأحلام .. بل يدعها مثلما هي : أحلام يقظة !

ولأن الهمم تحتاج إلى هذه الطاقة العالية ، فإن الشباب هم أكثر من يعزم على الأمور.. وهم أكثر من يعمل .. لأن لهم طاقة توصلهم إلى عنان السماء ..

ولأن الأمم تحتاج إلى البناء والتطور المستمرين فإن حركة الأمم لا تتم إلا بهمم الشباب !

والعكس صحيح ..

فإذا أردنا أن نوقف مسير الأمم .. و نهدم بنيانها .. فإن الطريق هو تكسير همم هؤلاء الشباب .. حينا بقصد .. وحيناً من دون قصد ..

وتكسير الهمم لا يكون دائما بالمعاول .. بل يكون أحيانا بإشباع البطن حتى التخمة ..

وحتى لايتوثب الشباب النهوض .. أقول بأن الهمة صانعة المعجزات .. لكن وضوح الطريق أهم !!

ووضوح الطريق لا يكون إلا بالسير على هدى من نور ..

ولا نور إلا بحكمة .. ولا حكمة إلا بسبر الزمان .. وهذا لا يوجد إلا عند من صقلتهم الحياة.. وهؤلاء هم من تعدى الشباب .. وطلا شعره بطلاء الكهولة .. أو شاخ به الزمان على الإخلاص للوطن ..


في النهاية ..
المطلوب هو شحذ الهمم .. والتجهز للمسير .. لإعادة الكويت .. بهمة الشباب وخبرة الكهول .. وحكمة الشيخ الكبير .. ومن دون همة الشباب فلا عزاء للكهول ولا للشيوخ .. ولا للكويت ..
"عمار يا كويت " ..

Thursday, October 28, 2010

Medical Equipment Uptime Services


SIEMENS UPTIME Center Shanghai, China


Introduction
Since ancient days of history, usage of medical devices and instruments was a great tool to improve health of human; in diagnostics, therapy, or aid. Medical devices played big role in improving healthcare services.

However, same devices who help in development of healthcare, did impose risk into ones life. Weather it’s an electric shock, infection, or exposure to high levels of radiation dose, they all can be lethal. Of course this is not a wanted result from those devices and that’s why we call them malfunctions. Malfunctions in those devices can be due to the nature of some materials, bad design, or poorly integrated components

“UPTIME” a quality measure
Frankly speaking, making a perfect device which doesn’t go down is almost an impossible mission. Quality of medical devices range from low to high (in terms of durability). One way to measure durability of a medical device is to measure percentage of uptime to downtime of the device.
In maintenance contracts, hospitals do; often, state their desired uptime and vendors; often, quote based on that requirement.

Prediction of down time.
Non the less, there are ways to over come frequent down times. For example, monitoring the device for critical signs of break down. A classical way of doing this is sound. In mechanical systems, sound and vibration give a big clue about a problem in the motor, bearings, etc .. Today, in digital world, most medical devices are controlled using a digital controller which keeps log files of it’s communication messages with sub-components. Normally, a controller sends control messages to peripherals through an I/O device. If no response within particular time a job is retried again for a couple of times. If still no response operation is set as “fail” and an entry on a log file is written.
Thus, by keeping an eye onto these log files a one can predict a break down. In fact, vendors usually keep their eyes open on those log files remotely to pro-actively maintain their devices to full fill their customer’s uptime requirements. The later is just one example of different types of service agreements most medical device manufacturers provide. In Kuwait, unfortunately, we know only one of those many service agreements. Moreover, until today, no single medical device vendor established uptime service center in this region which means that downtime is no option for healthcare providers in this region. Solution is to require that in the hospital’s next service agreement.

Knoweldgebase
Another way of stopping a break down before happening is to watch others. Now days, technical forums and knowledge-base software help a lot in solving issues as well as alerting others who use the same device of some problem.
many medical vendors offer technical forums for their products. These forums are good sources for alerts about possible break downs and solutions to them. More forums are available through independent user groups who try to help each other. See example.

Independent Communities.

Vendors Communities

HelpDesk systems
Helpdesk systems are application which help in registering technical support calls, type failures, and all sorts of statistical data which can help in organizing helpdesk support, analysing failure frequency, and more.
SysAid V7.0 is an example of a free IT helpdesk, Knowledgebase and inventory systems. Using SysAid can help healthcare providers in keeping day-by-day inventory of their systems and is a great helpdesk support platform.

FDA Recall Database
Another great source for medical device alerts is the FDA Recall DataBase by FDA CDRH. FDA Recall database offers open access to all FDA recalls which are due to a registered event of patient threat incident. The FDA recall database contains reason for recall, affected systems by country and Serial no.
FDA accepts safety reports from any FDA registered medical device from anywhere in the world including Kuwait.
FDA provides additional services that help reducing safety hazards of medical devices; such as, MedSun: Medical Product Safety Network. MEDSUN is a service which brings awareness about reported safety hazards of medical devices and ways to overcomes those hazards.

Conclusion
Healthcare providers in Kuwait can still do a lot to enhance their medical device utilization, and reduce patient safety risks. Revising service agreements, monitoring FDA recalls, and implementing helpdesk and inventory systems will definitely improve patient safety and medical device utilisation.

Monday, October 11, 2010

MedSun: Medical Product Safety Network

MedSun Logo

The Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.

The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety. This website also provides public access to de-identified reports sent into the MedSun program, in addition to important safety information to MedSun participants and to the national clinical community about reported problems. You will see the current newsletter content on this Web page, or you may visit the MedSun Newsletters page to search past MedSun Newsletters.

Newsletter #53, October 2010


MedSun: Medical Product Safety Network