In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.
China ; Equipment and Supplies ; Registries ; Risk Management

The critical control points in the production quality management of metal additive manufacturing medical devices,including personnel,hardware,design and development,procurement control,production management and quality control are summarized from the perspective of supervision.The typical cases are analyzed to provide reference for medical device regulatory authorities and enterprises.

Biodegradable heart occluder uses a biodegradable medical polymer material to replace or completely replace the metal material.After completing the repair function of the heart defect,the device is gradually degraded and safely absorbed by the human tissue.So it may minimize the risk of long-term complications that traditional metal heart occluder causing in the body after implantation.Based on the quality management concept of the entire lifecycle of medical device,this article briefly introduces design and development,as well as the product realization of biodegradable heart occluder.It analyzes the main risk points in design and production,and corresponding suggestions have been put forward.These suggestions are combined with the medical device good manufacturing practice and the appendix of implantable medical equipment to provide a reference for regulators and industry professionals.

This study summarizes the clinical application,technical characteristics,and production process of intravascular shockwave catheters.It collects statistics on adverse events of related products from the MAUDE database,analyzes the causes of adverse events and failure modes of intravascular shockwave catheters,and identifies risk points.Based on the whole life cycle management method of medical devices,combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices,the critical control points of such products in the design and development,manufacturing,sales,and use stages are discussed.

This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders(MAH).Through sorting and analyzing typical non-conformities,highlighting the main responsibilities of registrants,and clarifying the obligations and rights of relevant parties.Meanwhile,it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.

Objective To explore the diagnosis and treatment of non-tuberculosis mycobacteria (NTM) infection after cosmetic injection via scientific debridement surgery combined with regular application of anti-NTM drugs.Methods 14 patients who were infected with NTM after cosmetic injection and were not cured over a long period of time in other hospitals from 2012 to 2016.The patients were treated with VSD thorough surgical debridement,the bacterial type of NTM was identified by bacterial culture and PCR identification and anti-NTM drugs were systematically used according to the results of drug sensitivity.Results Fourteen patients who were treated with scientific debridement surgeries combined with regular anti-NTM drug treatment in our hospital for 2-4 months were discharged after their skin lesions were cleared and healed and they were continually treated with antiNTM drugs for 12 months.Fourteen patients were completely cured by using the above treatments without severe side effects,such as liver and kidney dysfunction,nervous system disorders and so on.Only colpitis mycotica occurred in 3 patients.In addition,one patient presented the decrease of leukopenia after using anti-NTM drugs for 2 months and continued to complete the treatment after we adjusted the treatment plan to returning the level of leukopenia to the normal.These 14 patients were followed up for 1-5 years with no recurrence of the lesion.The facial appearance of 12 patients were almost normal with slight scars.The facial surgery area of 2 patients were uneven and nearly recovered to normal facial appearance by tissue transplantation and photoelectric therapy.Conclusions For the NTM patients caused by invasive procedures such as injection,the comprehensive treatment program,which combined scientific debridement surgery and systematically targeted drug treatment,not only can effectively cure NTM infection,but also minimize secondary injury and restore the patients' appearance,which is worthy of clinical application.

Objective:To analyze the clinical effect of hyaluronidase injection through the facial artery in the treatment of vascular embolism such as skin ulceration and necrosis after cosmetic injection.Methods:Hyaluronidase was injected through facial artery in 13 patients who were diagnosed with vascular embolism after facial injection from January 2019 to May 2020. The facial artery was punctured with 22-gauge arterial blood collection needle or 19/23-gauge disposable venous infusion needle. The angle between the needle body and the skin varies depending on the patients’ weight, ranged 30°-45°. The needle was advanced slowly and pushed forward by 2-3 mm when blood backflow appeared in the needle core. After confirming the successful puncture of the facial artery, 0.5-1.5 ml hyaluronidase was slowly injected into the facial artery. The time of skin relaxation, tenderness relief, ulcer healing and wound recovery were observed. The pigmentation was observed and the Vancouver Scar Scale (VSS) was used to score the scars after 3-12 months.Results:A toal of 13 patients with vascular complications of hyaluronidase filler were retrospectively reviewed. The patients were 18-45-year-old(mean age, 35 years) and received hyaluronidase filler at private clinics. There were 12 women and 1 man. The time from onset to visit was 14 h to 4 d, with an average time of 2.5 d. Hyaluronidase was most commonly injected into the nasolabial folds (54%, 7 of 13). The second-ranked area is the nasalroot (23%, 3 of 13). These patients had skin swelling, necrosis, ecchymosis or black scabs during or after hyaluronidase injection. Some patients showed skin lesions combined with oral ulcer. After percutaneous facial arterial hyaluronidase injection, the local skin tissue injuries of the 13 patients were improved in time. The time of skin relaxation was (0.77±0.25) d, the time of tenderness relief was (1.23±0.64) d, the time of ulcer healing was (3.14±0.64) d and the time of wound recovery was (5.85±0.86) d. Patients were followed up for 3-12 months, with an average of 7 months. One patient had slight scar (VSS score of 1), two patients had only mild pigmentation (VSS score of 0), and the other ten patients had no scar and pigmentation (VSS score of 0).Conclusions:It is effective to improve local microcirculation and reduce skin tissue injury after percutaneous facial artery hyaluronidase injection in the treatment of skin injury caused by facial filler injection.

Objective:To analyze the clinical effect of hyaluronidase injection through the facial artery in the treatment of vascular embolism such as skin ulceration and necrosis after cosmetic injection.Methods:Hyaluronidase was injected through facial artery in 13 patients who were diagnosed with vascular embolism after facial injection from January 2019 to May 2020. The facial artery was punctured with 22-gauge arterial blood collection needle or 19/23-gauge disposable venous infusion needle. The angle between the needle body and the skin varies depending on the patients’ weight, ranged 30°-45°. The needle was advanced slowly and pushed forward by 2-3 mm when blood backflow appeared in the needle core. After confirming the successful puncture of the facial artery, 0.5-1.5 ml hyaluronidase was slowly injected into the facial artery. The time of skin relaxation, tenderness relief, ulcer healing and wound recovery were observed. The pigmentation was observed and the Vancouver Scar Scale (VSS) was used to score the scars after 3-12 months.Results:A toal of 13 patients with vascular complications of hyaluronidase filler were retrospectively reviewed. The patients were 18-45-year-old(mean age, 35 years) and received hyaluronidase filler at private clinics. There were 12 women and 1 man. The time from onset to visit was 14 h to 4 d, with an average time of 2.5 d. Hyaluronidase was most commonly injected into the nasolabial folds (54%, 7 of 13). The second-ranked area is the nasalroot (23%, 3 of 13). These patients had skin swelling, necrosis, ecchymosis or black scabs during or after hyaluronidase injection. Some patients showed skin lesions combined with oral ulcer. After percutaneous facial arterial hyaluronidase injection, the local skin tissue injuries of the 13 patients were improved in time. The time of skin relaxation was (0.77±0.25) d, the time of tenderness relief was (1.23±0.64) d, the time of ulcer healing was (3.14±0.64) d and the time of wound recovery was (5.85±0.86) d. Patients were followed up for 3-12 months, with an average of 7 months. One patient had slight scar (VSS score of 1), two patients had only mild pigmentation (VSS score of 0), and the other ten patients had no scar and pigmentation (VSS score of 0).Conclusions:It is effective to improve local microcirculation and reduce skin tissue injury after percutaneous facial artery hyaluronidase injection in the treatment of skin injury caused by facial filler injection.

Objective:To analyze the epidemiological characteristics of vascular complications induced by hyaluronic acid facial injection.Methods:Patients with vascular complication induced by facial hyaluronic acid facial injection were collected in the Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army from January 1, 2016 to October 1, 2021, including 5 males and 37 females. The age ranged from 16 to 70 (34±10) years. The clinical data, injection site, clinical symptoms and previous facial surgery history of the patients were analyzed and investigated.Results:Vascular complications occurred in 12 cases (28.6%). Nasolabial fold in 8 (19.0%) cases; Glabella in 6 (14.3%) cases; frontal part in 6 (14.3%) cases. There were 27 patients (64.3%) with a history of facial surgery. Furthermore, history of facial surgery had no effect on the clinical manifestations of vascular complications ( P>0.05). Among the 18 patients with visual impairment, 12 patients reported that the symptoms of ptosis, bulbar conjunctival congestion, and eye movement dysfunction had diminished after thrombolytic treatment, while 4 patients showed recovery to some extent in visual acuity. Likewise, 24 patients with blood circulation disorders were healed after treatment, with residual pigmentation and a slight scar left. Conclusions:Women aged 30 to 39 years old are the main target population of cosmetic surgery, as well as the most common population of vascular complications. Particular care should be taken in the nose, nasolabial fold, glabella and forehead areas of the operation. Patients with previous surgical history should be adequately informed before surgery, and postoperative observation time should be appropriately prolonged.

Objective To investigate and analyze the epidemiological and pathogenic characteristics on a case of human Streptococcus suis type 2 infection in Minhang District, Shanghai, and to provide evidence for early warning and prevention and control measures of rare and imported zoonotic acute infectious diseases in Shanghai. Methods By inquiring the patient medical history and epidemiological history and on-site environmental investigation, the infection route and source of the case were examined. The pathogenic culture of cerebrospinal fluid (CSF) was used to isolate Streptococcus suis, and Vitek2GP was used to identify the isolated strains. The PCR technique was used to detect species specific genes and virulence genes. Results The clinical manifestations of the patient were high fever with headache, nausea, vomiting and stiff neck. Blood tests showed a significant increase in c-reactive protein, an increase in lymphocyte percentage, and a decrease in platelet count. Head CT examination showed bilateral ethmoidal sinus and bilateral maxillary sinus inflammation, and significantly increased CSF white blood cell count and immunoglobulin. The case's CSF sample was positive for species specific genes (16SrRNA) and 2 virulence genes (cps-2j and ef). Conclusion This case was human Streptococcus suis type 2 with meningitis symptoms. Good prognosis was associated with timely diagnosis and treatment as well as the types of virulence factors. Medical institutions should identify early infection and take timely treatment as soon as possible to avoid severe illness and death cases. Departments of agriculture, health, market management, and others should consummate the reporting mechanism of animal epidemic situation, and establish necessary active sentinel monitoring.