Release date: 2008-11-14
Medical Device recall is the main means of risk control after product launch. At the first China Medical Device Risk Management Seminar held recently, the responsible person of the National Center for Adverse Drug Reaction Monitoring for Medical Device Monitoring gave a detailed introduction to the current status of medical device recalls and related regulations.
The recall is not returned to the original factory
The person in charge said that the latest concept of medical device recall at this stage is a paragraph mentioned in the "Administrative Measures for Medical Device Recall" that was recently solicited for comments: "Medical device recall refers to the procedure for medical device manufacturers in accordance with regulations. Products that have been listed for sale in the form of safety hazards shall be subjected to warnings, inspections, repairs, relabeling, modification of specifications, software upgrades, replacements, recovery, destruction, etc. in accordance with prescribed procedures to eliminate the harm of their products."
It is understood that medical device recalls are different from general product recalls. Because of their high frequency, the causes are complex, so there are many recall measures. Most medical device recalls can be done through technical means, and the risks can be controlled within a reasonable area, not necessarily returned to the manufacturer. Recalls such as in-place modification of labels, instructions, upgrades, etc. can be carried out anywhere.
In addition, there are many ways to control risks of medical devices, mainly including design improvement of medical instruments and equipment, warning announcements, and strengthening maintenance and use training. When all actions fail to control the risk, the product will be withdrawn.
Medical device recalls are not widely recognized
According to the person in charge, medical device recalls have become commonplace in the world, but they are not widely recognized in China and have misunderstandings. For example, the center recently conducted a survey on recalls. When a regional regulatory agency heard that a device had recall information, it decided to immediately seal the device. The hospital also asked about whether the equipment was to be returned. Enterprises are worried that once their products are recalled, they will often be used by competitors and there will be various irregular competitions.
According to reports, the FDA has published medical device recall information since 2003. So far, there have been 391 first-level recalls, which means that the use of the device may cause serious health hazards. Since 2008, the agency has announced 1,347 recalls for primary, secondary and tertiary.
What are the recall regulations?
It is understood that China's medical device recall regulations are gradually improving. The "Special Provisions of the State Council on Strengthening the Safety Supervision and Management of Food and Other Products" promulgated on July 26, 2007, has a legal basis for recalling all products at the legislative level.
Article IX of the Special Provisions states that if a production enterprise discovers that its product has potential safety hazards and may cause damage to human health and life safety, it shall publish relevant information to the public, notify the seller to stop sales, and inform the consumer to stop using it. . If the seller finds that the products it sells have safety hazards and may cause damage to human health and life safety, it shall immediately stop selling the product, notify the manufacturer or supplier, and report to the relevant supervision department.
The Announcement of the State Food and Drug Administration on Further Strengthening the Relevant Matters Concerning the Monitoring of Medical Device Adverse Events (ie Document No. 406) stipulates that medical device manufacturers shall follow the suspected medical device adverse events occurring in China. Report on the requirements, and quickly conduct investigations, analyze the causes, and take corrective actions such as recalls when necessary to ensure the health and safety of patients and related personnel.
Document No. 406 also proposes that medical device manufacturers take corrective measures such as recalls for their products listed in China, including repairing, modifying, reorganizing, relabeling, modifying specifications, destroying, inspecting, replacing, etc. in situ and in different places to eliminate their products. Defects must be reported to the original food and drug supervision and administration department and the medical device for monitoring adverse event events at the same level.
The document stipulates that medical device manufacturers should promptly report the relevant situation and progress of recalls of Chinese listed products and similar products in foreign countries and Hong Kong, Macao and Taiwan. The original food and drug supervision and administration department and the same level of medical care Instrumental adverse event monitoring technology organization.
The person in charge said that this is the basis for the current medical device recall work. Explain which recalls are reported, who needs to report to them, and what the report is. In addition, not only sales of products, but similar products, recalled in China and abroad, must also be reported to the drug regulatory department.
In addition, in September 2005, the State Food and Drug Administration and other departments set up a drafting group for the “Administrative Measures for Medical Device Recallâ€. In November 2006 and March 2008, the “Measures†twice asked for opinions and it is expected to be introduced in the near future.
A case where the recall is not ideal
At the end of 2007, the FDA issued a second-level recall message in the United States stating that certain devices may fail when a company's digital radiography system is photographed at the bedside. After receiving this information, the National Center for Adverse Drug Reaction Monitoring launched a related investigation and asked the company to report the situation in China according to Document 406. The company reported that the center's materials said that because the standard matching diagnostic bed was used in China, the equipment would not cause damage to patients like foreign products. In order to maintain the consistency of the equipment, the company also upgraded equipment in countries and regions outside the United States. At that time, there were 91 units in the country and 81 units were put into use. Of the used devices, 47 have already been upgraded.
The center launched a survey on the effectiveness of the recall in June this year. Of the 81 users of the product, 68 product survey responses were collected. The results showed that 38 users did not receive the recall notice or customer notice issued by the company, and 32 of them did not receive the company's description of the product risk. In addition, three users reported that there had been an adverse event in which the U-arm of the device collided with the inspection bed.
This company basically maintained and upgraded the product, but did not inform the user of the risk, indicating that the company did not fully understand the product risk, and also believed that the U-arm collision check bed would not occur in China. In addition, the company's recall work is not standardized. The implementation of a recall operation must first inform the user of the risk information. The delivery of risk information is a key part of the recall process. Only in this way can we control the post-marketing risk for the first time.
This incident also reflected that the company's complaint reporting system and quality control system failed to operate effectively and did not collect suspicious adverse events. The company's recall in the United States is very standard, but the overall recall work in the country is not very satisfactory.
This incident also reminded domestic companies that they should face the importance of recall. Recall is an effective way to control the risk of medical devices, promote the advancement of production technology, and improve product design. The recall also reflects the integrity and social responsibility of the company. ——Shanghai Medical Device Industry Association
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