The recalls number of osteosynthesis implants and joint replacement implants fluctuated from 2016 to 2021, the overall number remained rising and significantly higher than that from 2011 to 2015. However, the increasing recall number does not mean that the safety and efficacy of medical devices are decreasing. T. Steven Kurtz, et al. had predicted that demand for knee arthroplasty in the USA was expected to increase by 673% between 2005 and 2030 . The market scale of orthopedic implantable medical device in China is also expanding with revenue expected to reach 38.7 billion yuan by 2021 . The longer the implant stays in the body, the more metal ions are released, affecting human health and leading to higher revision rates. Therefore, the problems of devices implanted a decade ago may have gone undetected until now, which is why the number of recalls has increased from 2016 to 2021.
Further integration in the different branches of the same company reveals that recalls number of Zimmer Biomet, Johnson & Johnson, Smith & Nephew and Stryker accounted for more than 70% of the total. According to the 2018 data of the Orthopedic Big Data Editorial Office (OBDE), these four companies are all ranked in the first tier of the top 100 global companies, accounting for 58% of the industry's $51.2 billion market share [14,23]. In addition, recall awareness is another major factor. Developed countries and regions such as the USA, Canada and the European Union have established a complete medical device recall system earlier, which is beneficial for enterprises to establish quality system and actively promote the recall of defective products.
The recalls of the two implants have had a widespread impact around the world, covering almost all fields. Europe, the USA, Australia, and Southeast Asia had higher incidences, while Africa and the Middle East had lower incidences. We found that most economically advanced countries have been affected by the recall, while the impact on less developed countries is smaller. This can be explained by the fact that developed countries can afford higher medical expenses and promote utilizing high-priced medical devices, such as implants . In addition, the distribution of recall events is consistent with the distribution of bone disease prevalence. High-income countries such as Europe and the USA are the most affected by skeletal diseases with 441 million people, followed by the WHO Western Pacific region with 427 million and South-East Asia with 369 million .
There was no statistical difference in the recall reasons between the two implants. The main common causes were process control, packaging process control, and non-conforming materials or components. Most implants are highly precise and small with complex structures and multiple components, which are the objective factors prone to these problems . Except for small probability events, non-conforming materials or components are mainly caused by subjective factors, including carelessness in the procurement and sorting process, improper packaging in process control, especially the destruction of sterile barriers. In addition, the choice of surgical methods and doctors’ awareness of reporting are also important factors affecting the curative effects .
In contrast, the distribution of recall reasons varies among countries. The proportion of device design is significantly higher in the USA than in other three countries, which is consistent with the fact that most of the top giants are American companies. In China, labeling errors are very prominent. On the one hand, most of China’s mid-to-high-end medical devices are excessively dependent on imports . On the other hand, the regulatory authorities’ understanding and implementation standards of Article 42 of the Regulations on the Supervision and Administration of Medical Devices are not consistent . However, the laws and regulations have only prohibited provisions and no provisions for effective accountability, which makes them less deterrent.
The safety and efficacy of the medical device depends on whether the manufacturers, medical institutions, and supervisions can assume their responsibilities. Our results showed that the connection between manufacturers is not ideal, especially in process control, packaging process control and labeling errors. Meanwhile, many medical workers are reluctant to actively report adverse events, believing it is not their responsibility . Combining the medical device risk management model with our results, we emphasized eight recommendations to improve device safety. Suggestions 1-4 apply to manufacturers, 5-6 to medical institutions, and 7-8 to supervisions.
1. Materials and Components. For biodegradable materials, special attention should be paid on whether the implants will release harmful products such as the wear and corrosion during the biodegradation process. The company should set up the corresponding inspection department, strictly screen components, timely eliminate unqualified components, prevent them from flowing into the production line. In addition, it is also a good choice to build a reasonable and convenient component classification and placement system, which can effectively avoid confusion of materials or components.
2. Labels and Instructions. Detailed and readable labels and instructions are important in the regulation of medical device. When writing labels and instructions, the producer should consider the later identification, use and supervision to ensure that labels and instructions are accurate and effective. At the same time, the manufacturers should actively respond to the regulatory requirements, improve the inspection system for mismatched labels and instructions.
3. Packaging Process Control. Manufactures must strictly sterilize packaging materials and packaging process to ensure that sterility barriers are not damaged. At the same time, qualified full-time inspectors are required to undertake environmental monitoring, biological inspection and other quality control work. During the packing process, the staff should ensure that labels and glue on the surface are completely isolated from the devices.
4. Data Integrity of Medical Devices. The manufactures should establish a record control system through electronic information technology, including the label, storage, retrieval, preservation period and application requirements of the devices. In the event of device failure, manufacturers can use information retrieval to track faulty devices and recall it if necessary.
5. Purchase and Use. Medical institutions should standardize the procurement process to avoid unqualified devices entering the hospital. Before purchasing, the use of the product in the market should be fully investigated. At the same time, the relevant superintendent should be trained to ensure the quantity and quality of devices handover. Operators should strictly follow the instructions when using the device. In addition, aseptic operation is also an important step.
6. Training of Medical Workers. Hospitals should pay attention to the professional skills training of operators to improve the success rate of surgery. And it is important to increase the responsibility of healthcare professionals and timely reporting of adverse events to regulators and manufacturers to reduce continue risks. In addition, strengthening postoperative follow-up, dynamically mastering the changes of medical devices and patients' use feelings, is beneficial to ensure the long-term use of medical equipment and timely detection of possible adverse events [29-31].
7. Premarket Safety Assessment. A series of premarket safety assessments of medical devices are required, including the strength of connections, joints or sealing, tolerability and mechanical properties of implants. Besides, biocompatibility assessment and histopathological testing of the implants can not only detect toxic effects, but also assess the efficacy of the product. The assessment agency staff should report risk factors in a timely manner so that the producers can eliminate possible risks before the product is officially marketed.
8. Reporting and Regulating. Regulators should strengthen the supervision and develop a fast and simple medical device adverse event reporting system, and fully ensure the transparency of recall database information. Opening a special reporting line or reporting mailbox to quickly grasp adverse events is conducive to improving the reporting rate of adverse events.
This study comprehensively analyzed the recalls of Osteosynthesis implants and Joint replacement implants in the aspect of time periods, recall classes, recall companies, recall classification, affected areas, main countries and recall reasons, which not only helps to improve the safety and efficacy of medical devices, but also provides some useful insights for the risk management of medical devices. In addition, we designed a new medical device risk management model based on the McKinsey 7S model, and try to combine it with fishbone model to better analyze recall reasons of these two implants.
The main limitation is that many other types of recalls were not reported in our study. That's because these recalls are not reported to regulators, but directly to medical device providers. In addition, there is not sufficient data for further study. This is because the mandatory recall is not strong enough, some companies do not voluntarily recall defective devices, and consumers’ ignorance of the medical device recall system may also result in some defective devices not being reported.