Software of medical devices superintends: Mo Rangji is become superintend " short leg "

"Universum Medical - Holistic Medical Center

Software of medical devices superintends: Mo Rangji is become superintend " short leg "

2008-10-08

.
Software of medical devices has two main character: One, it is computer application software; 2, the use of it and medical devices is concerned. But need is clear is, not be all using the software that concern with medical devices is medical devices, national bureau ever issued civilization truly, rise only show collect a figure (data) , collect, file, the hospital runs the software that wait for action and does not involve data analysis, do not press government of medical devices, press government of medical devices with the software that handles medical devices at result analysis, control. That is to say, the software that controls function of medical devices only and analytic software just serve as management of medical devices.

Manage the current situation

.
Superintend with medicines and chemical reagents rise quite, medical devices is superintended all the time very fragile, it is superintendency process is medium " short leg " , among them, software is superintended is insufficient more, center a watch to superintend a level now severe shortage, superintendency equipment does not follow low, superintendency professional to go up, register examine and approve non-standard etc.

One, the superintendent deficient that has software of medical devices to manage knowledge.

.
Software of medical devices and common software are same, written tool divides 3 kinds big into machine language, assembly language, advanced language, popular advanced language has VB, VC, FoxPro, Delphi. These software are the computer of formal consist in that goes in order to command or in the other medium that put store, some is flat compiled machine language, it is completely by the 0 data with 1 composition, want to use or superintend it to move through computer only. And current superintendency team cannot be competent however software of medical devices superintends the task. Above all, what major of medical devices learns in superintendency team is very few, those who learn the computer is fewer, what know medical devices to know computer software again already is little then little, the task is superintended with medical devices on structure of occupation unworthily; Next, because suffer the effect of thought of heavy medicine light instrument, plus medical devices relevant knowledge reachs software kind knowledge is updated very fast, master harder, bring about superintendency team to go up and superintend the task in intellectual structure also unworthily.

2, the device that software of medical devices controls government is almost 0.

.
Software of medical devices is to put lay aside to digitlize a program mediumly in the computer, cannot see, feel do not wear, can pass moving computer ability to undertake superintendency to its only, so its superintendency cannot rely on to superintend the knowledge of personnel and experience solely, still must method of high-tech of have the aid of, take a technology and the way that supervisory photograph ties. But at present superintendency equipment of software of medical devices is done not have basically, superintendency personnel can adopt the software that will register certificate and actual application to undertake superintendency according to this kind of primitive means relatively only, develop illegally to those, of pilfer edition, random hits patch, random to upgrade the software of replacement is at a loss what to do.

3, software of medical devices is non-standard when register.

.
Software is registered have form of a few kinds of expression, it is alone serve as software with software name kind appliance is declared register card name; 2 it is to be in what name approval is with workstation, such-and-such system in registering card product composition and function column to register card; 3 it is equipment of built-in main body in, register card to go up to was not made clear. Among them, the 2nd, 3 kinds brought a lot of inconvenience to superintendency job, if register the version name that the product did not make clear in card, the production that did not make clear a product develops manufacturer. The 3rd kind registers a form to give superintend brought difficulty bigger, in register the presence that essential report does not give software on card, and the weapon that uses actually has software however, are these software belonged to register a product or did not register a product? Superintendency staff is judged very hard.

Case study

It is production more confused, supervisory difficulty is great.

.
The requirement that production of software of medical devices needs is not tall, it want software of a few a computer, computer to develop personnel only is OK to want software of a few a computer, computers to develop personnel only. The production of this kind of type is OK at any time, organize everywhere, and software is with data form consist in computer or on the other medium that put store, in half-baked before you know it is software of medical devices very hard, bring about production of software of medical devices to be superintended hard. In be superintended actually, the person that we ever discovered some appliance production, management manufacturer is used to let appliance feels this kind of medical devices is very advanced, belong to high-tech product, raise sale price thereby, add sale window, do sth without authorization adds software. The generator of these software is manufacturer of a few small-sized software, if some bureau is in some hospital to check discovery, the anaesthetic machine that its use is to pass computer to run software to come pilot, classics development investigates discovery, the developer of this software is the management company that sells this anaesthetic machine unexpectedly, and additional invoice collects fees software alone, investigated a sale one case to did not register record of software of medical devices thereby.

2 it is current concealment the gender is strong, be aware of not easily.

..Of software of medical devices current often do not take alone form, that is to say won‘t which medical devices manages an enterprise to be able to sell software of medical devices alone, they often bind a sale together with medical devices, the content that software of medical devices exists also can be not reflected in provides data, if check personnel to consult merely data or examine the medical devices that moving to the spot, can discover the existence of software of medical devices far from. Only thorough medical devices uses the site, examining medical devices is how to be operated, move, undertake communicating with operation personnel, just be informed this medical devices to have likely without software, this software is to use what record and save a data to still be used at control machine, auxiliary those who diagnose, the software that uses clearly namely needs to still need not be registered what register.

3 it is to use supervisory technology the demand is high.

.
The software of medical devices that registers certificate without the product originally is superintended very easily, but because register certificate to be written non-standardly, bring about cannot only by registering the not clear software is used this certainly software on certificate is without what register, to superintend brought difficulty. Additional, software is the data that the electron converts, in consist in computer, want this one to register the mark on card to understand software only, it can upgrade at will in the following use process replacement, hit a patch for the program at any time, because lack corresponding technology to control a medium, these changes are to cannot use naked eye to check know, lack corresponding superintendency equipment again at the same time, be aware of not easily to this kind of behavior so, superintend not easily.

Superintendency countermeasure

One, make software of medical devices superintend professional team, get used to the need that superintends new condition.

.
To get used to the requirement that software of medical devices superintends, must strengthen software of medical devices to superintend professional team construction. On one hand, undertake grooming to superintending personnel, groomed content includes knowledge of medical devices, electron knowledge, English knowledge, computer knowledge, software relevant knowledge, improve superintendency personnel quality with this; On the other hand, complement to superintend a team new blood, increase major of a few medical devices and the staff that computer major graduates.

2, increase software of medical devices to superintend hardware equipment, supervise the technology introduce software to superintend.

.
Increase software of medical devices to superintend hardware equipment, add for software of medical devices with electronic technology for example similar the electronic Yin Wen that seals an autograph, wanted to undertake altering to the software that already examined and approve only, the electron seals an autograph to be able to hint, and superintend equipment of superintendency hardware of personnel have the aid of can receive this information. Such word can be changed effectively to do sth without authorization, dozen patch, upgrade the behavior of software undertakes superintendency, put an end to do sth without authorization to upgrade from technical level this kind of behavior.

3, annotate on of careful of software of normative medical devices book, make superintend have according to but by.

..In register the detailed information such as limits of date of the manufacturer home that software of medical devices makes clear on card, name, version, action, the software that examines and approve along with all the others to those and medical devices especially, must be in register the report on card to go out to whether software registers information, make in supervisory management of medical devices, register card to be able to have very good basis effect.

4, the examination strength that enhances production of pair of medical devices, management unit, stop illegal action from fountainhead.

.
Increase the examination strength of production of pair of medical devices, management unit, the key examines his the production, medical devices that manage is accessary have software, if add the word that contains software, want to make clear this accessary software to whether need to register, if need to whether had been registered what register,wait a moment; Additional, whether does manufacturing company undertake upgrading undertaking checking without examining and approve to software to medical devices, because software upgrades,can be distinguished with different version name, can see with this whether software upgrades; To running a company, check its whether proper motion or entrust other to produce software of medical devices, sell an user together with medical devices.

5, the examination strength that increases pair of medical devices to use an unit, undertake to having the instrument of software the key is superintended.

.
Increase the supervisory examination strength of pair of use units, thorough medical devices uses the site, examine the use method of medical devices, communicate with the doctor that uses this weapon, the key examines the medical devices in using to whether use software to undertake operating, supervise the software that controls a method to be used to place with the technology in time to undertake be superintendencied effectively with administration, see its whether be registered, whether to put in do sth without authorization to upgrade, the behaviour that do sth without authorization changes.

6, production of perfect medical devices, manage, system of the education of use unit, early-warning.

.
To medical devices production, management unit undertakes relevant law laws and regulations is publicized, let them know do sth without authorization to manufacturing software, do sth without authorization is changed or upgrade the act of software violates, should assume relevant law responsibility, supervise and urge its are self-conscious and abide by the law production, manage; Undertake administrative grooming to medical establishment, let them understand software of medical devices presses government of medical devices, need to register, the product that should examine it when purchasing the medical devices that contains software registers certificate, look to whether be passed register, supervise and urge its strengthen software management. (Wang Zhangming) origin: Chinese medicine signs up for