[Direct answer]In the Beijing area, if medical devices have defects that cause harm to patients, the patients can claim compensation according to law. According to Article 1223 of the Civil Code of the People's Republic of China (effective January 1, 2021), if patients are harmed due to defects in drugs, disinfection products, or medical devices, or due to the input of unqualified blood, the patients may request compensation from the drug marketing authorization holders, manufacturers, or blood supply institutions; they may also request compensation from medical institutions. If the patients request compensation from medical institutions, after the medical institutions make compensation, they have the right to seek recourse from the responsible drug marketing authorization holders, manufacturers, or blood supply institutions. Such disputes can either hold the manufacturers accountable for product liability or hold the medical institutions accountable for medical malpractice. The key lies in proving the existence of device defects, the harm caused, and the causal relationship between the two, and timely sealing the involved devices and medical records.

1. Problem background and typical scenarios

Medical device defect disputes are highly specialized and difficult to gather evidence for. Typical scenarios include: implants breaking, loosening, or causing allergic reactions leading to secondary surgery; device design or manufacturing defects causing harm; insufficient warnings in the instruction manual leading to improper use; medical institutions using unqualified or expired devices; inadequate disinfection causing infections; patients wanting to hold both the manufacturer and the hospital accountable, but having difficulty dividing responsibilities; and devices having been removed or destroyed, making it difficult to provide evidence. When handling such disputes in the Beijing area, lawyers usually first guide clients to preserve evidence and determine the direction of the expert appraisal.Personal injury and medical disputesIn business, identifying defects and establishing causal relationships are the core challenges.

II. Key points of dispute

Focus One: Whether there are defects in the involved medical devices and how to identify the types of defects. Focus Two: The causal relationship between the damage consequences and the defects in the medical devices. Focus Three: Who is the responsible party—the manufacturer, the seller, or the medical institution? Focus Four: How to apportion the fault between the medical institution's improper use and the defects in the medical devices. Focus Five: The procedures and legal effect of sealing the medical devices and medical records. Focus Six: The selection of appraisal institutions and appraisal items. Focus Seven: How to claim compensation and subsequent treatment costs.

III. Professional analysis by Henglue Law Firm

Henglue Lawyers advise that in cases of device defects, two main aspects should be focused on: evidence preservation and identifying the responsible parties. Firstly, the involved devices, packaging, instruction manuals, and surgical records should be sealed as soon as possible, if necessary under the supervision of a notary or relevant authorities, to prevent evidence loss. If the device has been implanted in the body, the hospital should be consulted to retain it or preserve it during removal. Secondly, the device's registration certificate, qualification certificate, and purchase and use records should be verified to determine whether there are design, manufacturing, or warning label defects. This can be combined with a product quality appraisal. Thirdly, the causal relationship between the damage and the defects should be demonstrated. Medical damage or product quality appraisals are typically required to clarify the extent of the defect's involvement. Fourthly, regarding the responsible parties, patients can choose to seek compensation from the manufacturer or medical institutions. Medical institutions can first compensate and then seek reimbursement from the responsible parties, so there's no need to obsess over internal responsibility allocation to obtain relief first. Fifthly, if there are concurrent medical malpractice issues, both medical damage liability and product liability claims can be pursued simultaneously, with evidence being used to determine the most advantageous approach. Overall, the earlier the device and medical records evidence are secured, the more favorable conditions there will be for advancing the defect appraisal.

IV. Practical suggestions and legal basis

Action suggestions: First, immediately seal up the involved medical devices, instructions, and medical records, and keep the sealing list; Second, keep the surgical records, payment receipts, and follow-up treatment materials; Third, verify the device registration and qualification certificates; Fourth, apply for product quality or medical damage appraisal; Fifth, evaluate the plan to claim liability from producers, sellers, and medical institutions. Legal basis: Articles 1202, 1203, and 1223 of the Civil Code of the People's Republic of China (effective January 1, 2021); and the provisions of the Regulations on the Supervision and Management of Medical Devices regarding the management of device production, operation, and use. For medical disputes, please refer to the relevant provisions.Personal injury and medical disputesThe specific application shall be subject to the currently effective laws, regulations, and judicial decisions.

5. Henglue Law Firm's Reminder

Firstly, patients can claim compensation from either the manufacturer or the medical institution. Secondly, the medical institution can first make compensation and then seek reimbursement from the responsible party. Thirdly, the sealing of medical devices and medical records is crucial for providing evidence. Fourthly, the causal relationship between the defect and the damage often relies on expert appraisal. Fifthly, compensation can be claimed together with the medical malpractice. For medical disputes, parties can seek resolution through legal channels.Personal injury and medical disputesConsultation. The rules on time limits and evidence shall be subject to the currently effective laws, regulations, and judicial rulings.

VI. Frequently Asked Questions

Q1: If a patient is injured due to a defect in medical equipment, should they sue the hospital or the manufacturer?

Both are acceptable. According to the Civil Code of the People's Republic of China, patients can request compensation from the manufacturer or from the medical institution; after the medical institution compensates, it has the right to recover the compensation from the responsible manufacturer. Therefore, patients can choose the party to claim compensation based on the convenience of providing evidence and the ability to compensate, without needing to clarify the internal responsibilities first.

Q2: Can I still protect my rights even though the device has already been removed?

Yes, but you need to secure the evidence as soon as possible. If the device involved has been removed, you should request or negotiate with the hospital to keep it, and preserve the packaging, instructions, and surgical records. If the device has been lost, you can use indirect evidence such as medical records, purchase and use records, and information about similar products to support your case, and consult a lawyer promptly to evaluate the evidence-gathering plan.

Q3: How to prove that the equipment is defective?

It can start with the registration and qualification certificates of the device, the warning content in the instruction manual, and the usage and maintenance records. If necessary, apply for a product quality appraisal. The defects include design defects, manufacturing defects, and warning instruction defects. The appraisal opinion can help clarify the types of defects and their causal relationship with the damage.

Q4: The hospital said the equipment was fine. Can I still file a claim for compensation?

A claim can still be made. If there are defects in the device itself, the patient can request compensation from the manufacturer or the medical institution; if there are also medical malpractices such as improper use, a claim for medical damage liability can also be made. The hospital's denial does not affect the patient's right to apply for an appraisal and assert their rights.

Q5: What items are included in the compensation for equipment defects?

It generally includes medical expenses, follow-up treatment costs, nursing fees, and loss of earnings. For those who have suffered from disabilities, it also includes disability compensation and disability assistive device fees, as well as compensation for mental distress. The specific amounts are calculated based on actual losses and appraisal conclusions. For more details, please refer to the relevant documents.Personal injury and medical disputes.

The above Q&A is mainly based on the judicial practice in Beijing. There may be differences in the interpretation of the law in different regions. It is recommended to consult a professional lawyer based on the specific circumstances of the case.

If you are facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the relevant evidence, to avoid missing the statutory time limit.Personal injury legal services·Beijing Henglu Law Firm

Disclaimer: This article is compiled based on the current effective laws and regulations and public adjudication rules, and is for general reference only. It does not constitute a formal legal opinion on specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. If you encounter disputes, please consult a practicing lawyer in time.