1 The medical device adverse event monitoring group is responsible for guiding the monitoring of medical device adverse events in our hospital.

2, medical personnel, such as the discovery of adverse events that may be related to medical devices, should fill in the Medical Device Adverse Event Report in time and report to the full-time monitor of undergraduate course room at the same time.

3, monitoring network information officer is responsible for undergraduate course room medical device adverse event monitoring publicity, collect medical device adverse event cases, and report to the full-time monitor.

4, full-time monitors found or received reports of medical device adverse events, should be timely to the scene for verification, to assist in the investigation, and fill in the Adverse Events Report Form, after verification, submitted to the medical device adverse events team for evaluation on a regular basis.

5. The medical device adverse event monitoring team regularly conducts preliminary review and discussion on the collected report form, which is summarized by full-time medical device adverse event monitoring personnel and uniformly reported to the municipal medical device adverse event monitoring center.

6. If serious rare or new cases of adverse events are found, they should be reported within 15 working days, and the death cases should be reported in time, and if necessary, they can be reported by leaps and bounds.

7. Unpublished monitoring data of adverse events in National Medical Products Administration shall not be disclosed to domestic and foreign institutions, academic groups or individuals.

Chapter I General Provisions

Article 1 In order to further standardize the use and management of medical devices in our city and ensure the safety and effectiveness of people's use of medical devices, these Provisions are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Administration of Medical Institutions, the Interim Provisions on the Administration of Pharmaceutical Affairs in Medical Institutions and relevant laws and regulations, combined with the actual situation of Wuwei City.

Article 2 Users of medical devices in Wuwei City must abide by these provisions in the procurement, acceptance, storage, maintenance, use and management of medical devices.

Article 3 The food and drug supervision and administration department of Wuwei City shall be responsible for the supervision and administration of the use of medical devices in the whole city. County (District) food and drug supervision and management department is responsible for the supervision and management of the use of medical devices within their respective administrative areas.

City and county (District) health administrative departments shall, within the scope of their respective duties, conduct administrative management and business guidance on the use of medical devices by medical institutions.

Chapter II Institutions, Systems and Personnel

Article 4 A medical institution that uses medical devices above Grade II (including Grade II) shall set up a medical device management department according to its business scope and scale, and be fully responsible for the quality management of medical devices such as procurement, acceptance and storage. Other users of medical devices shall designate special persons to be responsible for the quality management of medical devices such as procurement, acceptance and storage. Clinical departments are not allowed to purchase and use medical devices without authorization.

Article 5 Users of medical devices shall formulate corresponding quality management systems for all aspects of medical device management, define management responsibilities and objectives, and establish procedures for procurement, acceptance, storage, calibration, maintenance and use.

All systems and procedures should be comprehensive, specific and operable, and be decomposed into specific departments and specific posts.

The medical device quality management system shall at least include:

(a) the quality management system of departments at all levels and relevant personnel;

(2) The qualification examination system for medical device procurement suppliers;

(3) Medical device procurement and quality acceptance management system;

(4) Management system for storage and maintenance of medical devices;

(5) The management system of medical device outbound audit and allocation;

(six) the unqualified medical device management system;

(7) Risk notification and use management system for high-risk medical devices;

(eight) medical device quality accidents and adverse events reporting system;

(9) Disposable medical devices shall be destroyed after use.

Article 6 Personnel engaged in the management of medical devices shall be related professionals such as medicine, biomedical engineering, pharmacy, electronics and medical imaging. When many people form a medical device management department, the professional collocation should be reasonable.

Article 7 The person in charge of the medical device management department shall have corresponding qualifications:

(a) the person in charge of the medical device management department of a tertiary medical institution shall have a bachelor's degree or above or an intermediate title as mentioned in Article 6, and have more than four years of relevant work experience.

(two) the person in charge of the medical device management department of a secondary medical institution shall have a junior college degree or above mentioned in Article 6, and have more than three years of relevant work experience.

(three) the person in charge of the medical device management department of a first-class medical institution or the full-time management personnel shall have a technical secondary school degree or above or the primary title mentioned in Article 6.

(4) Outpatient departments, clinics, health centers (rooms) of enterprises and institutions, infirmary, health room and other medical device users shall have full-time and part-time medical device management personnel.

Article 8 Personnel engaged in the management of medical devices shall master the relevant laws and regulations of medical devices, must attend relevant training, and master relevant laws and regulations and professional knowledge in time.

Medical device management departments and managers of medical institutions should be responsible for training the staff of other relevant departments of the hospital in medical device laws and regulations, and guide relevant departments to standardize the use and management of medical devices.

Chapter III Procurement and Acceptance of Medical Devices

Article 9 Users of medical devices must purchase medical devices (including Class I and Class II medical devices exempted from inspection) from enterprises with medical device production and operation qualifications. Users should ask for and keep the following copies of certificates stamped with the official seal of the supplier for future reference:

(1) Business license;

(2) License of medical device manufacturing enterprise (Note: the production of Class II and Class III medical devices must have a license; Only the first class of medical devices must be registered with the food and drug administration of provinces, municipalities and autonomous regions and fill in the Registration Form of the first class of medical device manufacturers or the License for Medical Device Business Enterprises;

(3) Medical device registration certificate and its attachments (medical device registration application form or medical device product production approval form);

(4) Certificate of conformity (the inspection report of this batch shall also be provided for disposable sterile medical devices);

(five) the original power of attorney of the legal representative of the enterprise, and the power of attorney shall specify the scope of authorization;

(six) the identity certificate of the salesperson.

Tenth medical device users should also pay attention to when purchasing medical devices:

(1) The medical device manufacturer's license (the first type medical device manufacturer's registration form) and the medical device dealer's license provided by the supplier must cover the range of products supplied.

(2) Different specifications and models of the same series of products shall be clearly recorded in the Medical Device Registration Form or the Medical Device Product Manufacturing Approval Form provided by them.

(3) The intended use purpose and application scope of the purchased medical devices must be consistent with the contents stipulated in the Application Form for Medical Device Registration or the Approval Form for Medical Device Production and its product registration standards.

(four) to verify the centralized bidding products, donated products, cooperative project products, experts' home visits, rental products and other medical devices, and obtain and keep valid certificates such as medical device registration certificates listed in Article 9 of these Provisions.

Article 11 Users of medical devices shall implement the system of inspection and acceptance of medical devices, establish a true and complete record of inspection and acceptance of medical devices, and ensure the traceability of each batch of products. Implantable high-risk medical devices should be traced back to every patient. The product name, specification, batch number or fuselage number, manufacturer, supplier, medical device production license number, medical device registration certificate number, validity period, purchase date, product appearance, whether there is Chinese printing and packaging or Chinese manual, certificate of conformity, etc. shall be indicated in the incoming acceptance record.

Twelfth medical device users in the use of implantable high-risk medical devices, but also should check and save the product sales personnel's identity documents and the sales authorization of the legal representative of the enterprise. The use of implantable high-risk medical devices should be able to trace the source of each batch of implanted products according to the warehousing records.

If the implantable high-risk medical device to be used is temporarily delivered by the supplier, it shall be checked and accepted before operation in accordance with the provisions of Article 10 of this chapter and recorded. The acceptance record must be signed by the acceptance personnel of the medical device management department of the medical institution, the head nurse or responsible nurse of the clinical department, the surgeon and the temporary distribution salesman, and a copy of the salesman's ID card is attached.

Thirteenth implantable high-risk medical devices should be filed for future reference, and the preservation time should not be less than the life span of medical device users; The purchase and acceptance records of equipment and medical devices shall be kept until the end of the service life of medical devices 1 year; The purchase and acceptance records of other medical devices shall be kept for at least 3 years.

Article 14 Medical institutions should have legal bills for purchasing and using medical devices, at least with the seal of the supplier, including the manufacturer, production batch number or serial number, specifications, quantity, price, date and other contents, as well as the attached list printed by computer or other legal bills.

Chapter IV Storage, Installation and Maintenance of Medical Devices

Fifteenth medical device users should set up corresponding warehouses according to the storage requirements of purchased medical devices, and the installation and use places should meet the product performance requirements.

The storage and installation of special equipment such as radioactive sources shall be carried out in strict accordance with relevant management regulations.

Article 16 The area and storage conditions of the medical device warehouse (cabinet) shall be suitable for the volume and storage requirements of medical devices. The medical equipment warehouse shall be located in the waiting area, qualified product area, unqualified product area and return area, and each area shall be clearly marked. The medical device inventory should be classified and stored with clear and standardized labels, and the environment inside and outside the medical device warehouse should be clean and hygienic.

Expired, invalid, deteriorated and obsolete medical devices shall be set up in special storage areas, and shall not be mixed with medical devices in use, with eye-catching identification marks and lists.

Article 17 A medical device warehouse shall be equipped with facilities such as protection from light, dust, moisture, pollution, insects and rats, and temperature and humidity adjustment.

Eighteenth medical device warehouse managers or medical device operators shall keep, maintain and calibrate medical devices as required, and make relevant records.

Medical devices used to provide numerical values shall be verified, calibrated or maintained according to regulations. Verification should be marked, and calibration should have reliable methods and records.

We should strengthen the maintenance and overhaul of long-term medical devices to ensure the safe, reliable and stable operation of products; Products that cannot guarantee stable, safe and reliable performance should be stopped in time.

Chapter V Use of Medical Devices

Article 19 Users of medical devices shall implement the reporting system of medical device adverse events, set up special institutions or assign special personnel to be responsible for the information collection and reporting of medical device adverse events used by their own units, and fulfill their reporting obligations of medical device adverse events according to law.

In case of serious adverse events caused by the use of disposable sterile medical devices, it shall report to the local county (district) food and drug supervision and administration department and the health administrative department within 24 hours after the incident. The medical institution shall report to the local county (district) food and drug supervision and administration department and the health administrative department by telephone or fax within 12 hours after the incident. After the occurrence of adverse events, medical institutions should immediately investigate and analyze the causes of adverse events, including product reasons, doctors' operation reasons or patients' own reasons, and fill in the Report Form of Suspected Medical Device Adverse Events (see annex 1) within/kloc-0 working days after the occurrence of adverse events, and report it to the local county (district) food and drug supervision and administration department and the health administrative department. At the same time, medical institutions shall truthfully report the adverse events of medical devices to the medical device production and operation enterprises, and assist the medical device production and operation enterprises to investigate the adverse events. The county (district) food and drug supervision and administration department shall immediately report to the US Food and Drug Administration and the Municipal Health Bureau after obtaining the information of the adverse events leading to death or serious injury, and the US Food and Drug Administration shall immediately report to the Gansu US Food and Drug Administration and the Gansu Provincial Medical Device Adverse Event Monitoring Center after receiving the report. Medical institutions have the responsibility to ensure the safety and effectiveness of medical device products. Before the cause of the adverse event is ascertained, the medical institution shall take the initiative to suspend the use of the stock products of the same manufacturer and batch number as the suspected medical device adverse event until the cause is ascertained.

Twentieth the use of medical devices should be strictly in accordance with the norms for the use of medical devices.

If it is found that the instructions for the use of medical devices have exaggerated propaganda or false propaganda, it shall report to the food and drug supervision and administration department in time.

Article 21 Before a medical institution uses implantable high-risk medical devices, the competent physician shall explain in detail the contraindications, possible adverse events and precautions to the patients and their families, truthfully inform the medical risks, answer the consultation, and sign an informed consent form. The informed consent shall at least include: the benefits of using implantable medical devices, possible risks, precautions and treatment after the risks occur.

Users of medical devices shall not deceive patients to accept products and services by exaggerating functions or false functions; If the specifications of the medical device products used are inconsistent with those specified in the medical device registration certificate, medical device registration certificate or medical device product manufacturing approval, they shall be regarded as unregistered products. The use of unregistered products will be punished according to the Regulations on the Supervision and Administration of Medical Devices.

Twenty-second medical device users should establish a record of disposable sterile medical devices (including implantable high-risk medical devices taken out through surgery) after use. When the used disposable sterile medical devices are destroyed, their parts should be made useless, disinfected and treated harmlessly, and records should be made.

Twenty-third clinical departments of medical device users shall fill in the receiving records when receiving implantable high-risk medical devices. Receiving records shall at least include enterprise name, product name, model specification, product number, product quantity, production batch number, sterilization batch number, product validity period, etc. , and signed by the entrusting party and the receiving party.

Article 24 When clinical departments of medical device users use implantable high-risk medical devices for patients, they must fill in the Implantable Medical Device Registration Form (see Annex II) in time after the operation, and at least ensure that the patients keep 1 copy, the medical device management department of the user keeps 1 copy, and the clinical departments (along with medical records) keep 1 copy.

The registration form for the use of implantable medical devices shall be signed and confirmed by the head nurse or the handling nurse, the department director or the surgeon, the patient himself or his family.

Chapter VI Management of Medical Devices

Twenty-fifth medical device users transfer the medical devices in use in the form of support. , and its products must be certified by the original manufacturer. The supplier must provide a copy of the product certificate stamped with the seal of the unit, and the buyer must keep it.

Article 26 Users of medical devices shall not engage in the following activities:

(1) Reusing disposable sterile medical devices;

(two) the use of substandard medical devices;

(3) Providing convenience for others to engage in medical device business activities in disguised form by leasing or providing venues;

(4) Selling medical devices in disguised form in the name of free consultation, consultation, trial, and paying debts in kind;

(5) passing off non-medical devices as medical devices or passing off other medical devices as medical devices;

(6) Forging the purchase and sale records of medical devices;

(seven) forgery, change the certificate, inspection report or production batch number;

(eight) illegal acquisition of medical devices;

(nine) unauthorized use of medical devices in clinical trials, or disguised use of medical devices under the guise of clinical trials;

(ten) to change the contents of the instructions, labels and packaging marks of medical devices without authorization;

(eleven) the use of medical devices, the instructions, labels and packaging labels are not in Chinese.

Twenty-seventh medical devices used by medical device users can not specify the products of the production enterprise, and it is regarded as using products without product registration certificate; If a product supplier cannot be specified, it shall be deemed as purchasing products from an enterprise without a Medical Device Manufacturing Enterprise License or a Medical Device Operating Enterprise License.

Twenty-eighth food and drug supervision and management departments at or above the county level have the right to supervise and deal with the medical device products involved in violation of these provisions in accordance with national laws and regulations.

Chapter VII Supplementary Provisions

Twenty-ninth medical devices mentioned in these Provisions include medical devices, medical materials and in vitro diagnostic reagents managed by medical devices.

Thirtieth medical device users mentioned in these Provisions refer to the following institutions and units:

(1) Hospitals, traditional Chinese medicine hospitals, maternal and child health centers, hospitals for the prevention and treatment of chronic diseases, sanatoriums, rehabilitation institutions, outpatient departments, clinics, health centers (rooms), medical offices, health rooms and community rehabilitation institutions that have obtained the Practice License of Medical Institutions in accordance with the Regulations on the Administration of Medical Institutions;

(2) Family planning service centers, family planning service stations, family planning service stations and other units that have obtained the Practice License of Family Planning Technical Service Institutions in accordance with the Regulations on the Administration of Family Planning Technical Services;

(3) Units that have obtained legal practice qualifications and use medical devices in accordance with other laws and regulations, such as drug rehabilitation institutions.

Thirty-first implantable high-risk medical devices mentioned in these Provisions refer to implantable medical devices, interventional medical devices, cosmetic filling products and other products that have entered deep tissues of the human body for a long time. For example: implantable plastic and cosmetic prosthesis materials, cardiovascular stents, heart valves, orthopedic internal fixation materials, implantable artificial organs (artificial esophagus, artificial blood vessels, artificial cones, artificial joints, etc. ), etc. If the state has other provisions on the classified management of implantable high-risk medical devices, such provisions shall prevail.

Article 32 The related concepts of medical device adverse events mentioned in these Provisions are:

(1) Adverse medical device events refer to any harmful events that occur under the normal use of medical devices approved for marketing and cause or may cause human injury.

(2) Reportable medical device adverse events refer to suspicious medical device adverse events that cause or may cause death or serious injury.

(3) Medical device adverse event monitoring refers to the process of discovering, reporting, evaluating and controlling suspicious medical device adverse events.

(4) Suspicious medical device adverse events refer to suspected but undiagnosed events.

(5) Serious injury refers to one of the following situations:

1, life-threatening;

2, leading to permanent damage to body function or body structure;

3. Medical measures must be taken to avoid the above-mentioned permanent injury or injury.

Article 33 These Provisions shall be interpreted by the US Food and Drug Administration of Wuwei City and the Health Bureau of Wuwei City.

Article 34 These Provisions shall come into force as of the date of promulgation.

Registration Form for the Use of Implantable Medical Devices

Patient's name, hospitalization number, operation time and surgeon's signature.

Product name specification/model Product tracking number/production batch number

Production unit production unit address production unit contact telephone number

Product information paste location:

Remarks:

First, disposable sterile medical devices

1, disposable sterile syringe

2. Disposable infusion set

3, disposable blood transfusion device

4. Disposable burette infusion set

5, disposable intravenous infusion needle

6. Disposable sterile needles

7. Disposable plastic blood bag

8. Disposable blood sampler

9. Disposable anesthesia puncture kit

Two. Orthopedic implants and medical devices

1, surgical implant joint prosthesis

2. Metal straight and irregular bone plates

3, metal bones, orthopedic nails

4. Metal orthopedic rod

5. Intramedullary needle and bone needle

6. Spinal internal fixation equipment

Third, the filler material.

1, breast filling material

2, intraocular filling materials

3, orthopedic filling materials

Four. Implantable medical equipment

1 intraocular lens

2. Artificial heart valve

3. Pacemaker

4, intravascular catheter and stent

Five, orthokeratology mirror

Sixth, the baby incubator

Seven, sanitary materials and dressings

1, medical protective clothing

2, medical protective mask

3. Collagen sponge

Eight, rubber condoms

Nine, plasma separation cup, plasma pipeline

Medical suture needle and thread

Eleven, CT, magnetic vibration, more than 200mA X-ray machine.

12. Monitor; electronic thermometer

Thirteen, artificial heart-lung machine

Fourteen, a one-time infusion analgesia pump; Insulin pump

Fifteen, polymer denture materials

Sixteen, hollow fiber dialyzer

XVII. Intervention materials

Eighteen, medical glue unqualified medical device management and quality (safety) accident reporting system.

First, unqualified medical devices may not be purchased, put into storage and used. Does not meet the statutory quality standards and relevant regulations.

Medical devices are all unqualified medical devices.

Two, inspectors found unqualified or suspicious drugs and medical devices in the process of acceptance inspection, should immediately stop.

Stop using it, seal it on the spot, and report it to the local food and drug supervision and administration department in time. According to the food and drug supervision and administration department

Before the law is dealt with, it shall not be returned or destroyed by itself.

Three, from the drug personnel in the process of storage, maintenance or deployment found unqualified or suspicious drugs and medical devices.

When, should immediately stop using. Those found to be unqualified shall be stored in the unqualified product area and reported to the food and drug supervision department when necessary.

Four, unqualified drugs, medical devices should be reported in accordance with the provisions of the loss and destruction, fill in the relevant documents of unqualified drugs reported loss, and fill in the record of drug reported loss.

Five, due to the inherent quality problems of drugs and medical devices or due to improper storage, prescription and other reasons, the drug is scrapped or

Threatening personal safety or even causing medical accidents are all quality accidents.

Six, the parties to the accident or the competent department shall write a written report on the day, content and consequences of the accident.

Seven, pharmacy practitioners should investigate the quality accident, on the basis of finding out the cause of the accident, write a written report in time, and submit it to the medical department in charge of the leadership. The medical office shall report to the food and drug supervision and administration department and the health administrative department within the specified time, and make corresponding treatment according to the consequences and effects of the accident.

Disposable sterile medical devices are destroyed after use.

One, disposable sterile medical devices are limited to one-time use, and repeated use is strictly prohibited; After use, it must be completely destroyed and cannot be reused.

Two, disposable sterile medical devices should be damaged after use, such as needles, droppers, catheters, syringes, push rods, etc. Needles should be stored separately, centralized after disinfection and harmless treatment, properly kept and not allowed to flow out.

Three, determine the person responsible for the destruction, recording and storage of disposable sterile medical devices.

Four, used disposable sterile medical device products should be destroyed in time, and fill in the destruction record.

Five, the person in charge of medical institutions shall timely review the destruction of disposable sterile medical devices and records.

Six, the damaged disposable sterile medical device products shall be recycled by the designated recycling company, and shall not be disposed of without authorization.

Remarks: The above system is only for reference of schools and hospitals. Each unit should formulate its own medical equipment management system according to the actual situation and put it on the wall.