Recently, a dental clinic in Guangzhou, Guangdong Province was fined a huge amount by the regulatory department for "expired dental chairs", which attracted widespread attention and discussion in the industry.
According to the penalty announcement released on the official website of the Guangzhou Municipal People's Government, during the operation of the dental clinic, the party used 11 dental comprehensive treatment machines that exceeded the time limit to diagnose and treat patients. The production date of these treatment machines is 2016, the service life is 5 years, and the service life has exceeded by January 2022, each unit is 4,800 yuan, and the total value is 52,800 yuan. According to the "Regulations on the Supervision and Administration of Medical Devices", it is proposed to confiscate 11 expired dental comprehensive treatment machines and impose a fine of 265,000 yuan.
Manga: Takatake
"Expired dental chairs" is a bit of a novelty for many people, but in practice this phenomenon is not uncommon. The reporter of "Rule of Law Daily" interviewed a number of dental institutions in Beijing, Shandong, Guangdong and other places and found that many institutions have the problem of expired dental chairs, and some institutions even said that "dental chairs have never been replaced since their opening 20 years ago".
According to a number of interviewed industry insiders, according to the "Regulations on the Supervision and Administration of Medical Devices" and the "Guiding Principles for the Technical Review of the Registration of the Use Period of Active Medical Devices", the expiration date refers to "the period when the product can maintain its scope of use". This means that beyond the expiration date, the safety and effectiveness of the product cannot be guaranteed. Dental chairs belong to the second class of medical devices, and most dental chairs on the market are marked with a validity period of 5 years, which is based on the effectiveness of the mechanical device and the safety of the lifting switch. The regulatory authorities should deepen law enforcement inspections and punish those who find that dental medical institutions use "expired" medical devices.
I don't know that the dental chair has an expiration date
The dental chair is an indispensable basic equipment for the treatment of patients' teeth in dental medical institutions, with functions such as height adjustment, tilt adjustment and rotation adjustment, so that dentists can easily and efficiently carry out treatment.
The reporter recently visited a number of dental institutions in Chaoyang District, Haidian District and other places in Beijing and found that some institutions have a large number of dental chairs, but in recent years they have rarely been replaced, because "they can still be used if they are not broken"; nurses in some institutions and even individual dentists do not know that dental chairs have an expiration date.
The reporter walked into a dental medical institution in Chaoyang District, Beijing and saw that the institution has 6 dental chairs, which are distributed in various treatment rooms, and the surface of the dental chairs looks relatively clean. The expiration date is pasted on the nameplate of the dental chair, some of which are clearly marked as 5 years, and some of which have been worn. When the reporter was checking, a nurse came over and asked her if she knew the expiration date of the dental chair, and the other party shook her head and said she didn't know. "Does the dental chair still have an expiration date?" the nurse asked the reporter rhetorically.
In an oral implant center in Haidian District, Beijing, the reporter saw that the information showed that the store opened in 2004, with a total of 4 dental chairs, "all oral instruments are used and replaced by one person". When asked if he regularly replaces the dental chair, the doctor at the institution replied directly: "It has been open for nearly 20 years, and I have never changed it." ”
There is also a small dental medical institution that opened in 1999, claiming that the medical team is composed of doctors from tertiary hospitals. In the face of the reporter's question about the period of use of the dental chair, the front desk staff of the institution said vaguely: "The audit of medical institutions is very strict, and there will be no health and safety problems." ”
At the same time, the reporter called a number of dental institutions in Shandong, Guangdong and other places, and the reply was either "why can't you use the dental chair if it is not broken", or "I don't know if there is a period of use". Among them, although the customer service staff of a dental institution in Guangzhou knew that the dental chair could not be used beyond the expiration date, they believed that "what should I do after the dental chair is close to the expiration date, if it is still in good condition, it will be wasted directly".
Many places have been fined for overdue dental chairs
According to the Regulations on the Supervision and Administration of Medical Devices, a dental comprehensive treatment machine is a piece of equipment that is used for the purpose of treating patients. According to the classification of medical devices, dental chairs belong to Class II medical devices.
The regulations stipulate that medical device business enterprises and users shall not operate or use medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, and are expired, invalid or eliminated.
According to this, since the beginning of this year, many places have been punished for "expired dental chairs".
On April 11, the Market Supervision and Administration Bureau of Shaoshan City, Hunan Province issued an administrative penalty decision, and a dental clinic in Shaoshan City was punished for continuing to use five dental chairs in its business premises after exceeding the use period.
According to the publicity, the five dental chairs involved in the outpatient clinic are Class II medical devices used by the dental medical department for diagnosis, treatment and surgery, and the use period is 5 years. The outpatient clinic completed the installation of the five dental chairs on August 8, 2016 and April 27, 2018 respectively, and officially put them into use, and has reached the maximum period of effective use by March 2023. The total value of the expired dental chairs involved in the case was 50,600 yuan.
When the outpatient clinic purchased the dental chairs involved in the case, it did not establish a purchase inspection record system in accordance with the regulations, and did not record the name, model, production batch number, and expiration date of the dental chairs involved in the case, resulting in the outpatient clinic still using the five dental chairs to diagnose and treat dental diseases for patients after the use period expired. However, there have been no medical accidents that have caused damage to the patient's personal health or property due to the use of the expired dental chair involved in the case. In the end, the party was sentenced to make financial compensation to the patient who used the expired dental chair, and a total refund of more than 30,000 yuan was given.
Two months later, the Market Supervision and Administration Bureau of Dezhou City, Shandong Province also issued an administrative penalty decision, and a dental clinic in Pingyuan County was finally confiscated and fined nearly 30,000 yuan for the use of a combined dental comprehensive treatment machine for more than 7 months.
As soon as this announcement came out, the problem of expired use of dental chairs attracted widespread attention in the industry. As a large and expensive device, the provision of a five-year service life and mandatory scrapping has also been questioned as reasonable.
The reporter noticed that after the announcement of these punishments, many dental institutions have carried out self-inspection.
"If the regulatory penalties for the life of dental chairs become the norm, then the life cycle of dental chairs and the risk consequences that may bring high fines or even orders to suspend business will become an important consideration for the operating costs of institutions. Next, when we buy dental chairs, we may focus on cost-effective parameters such as registration expiration date and price. A staff member at a dental clinic in Guangzhou said.
A stomatist in a hospital in Beijing told reporters that the maintenance of the dental chair will make it more smooth at work, whether the dental chair is easy to use is related to the usual maintenance, and also related to the degree and frequency of its use, "some overused dental chairs are very difficult to use, and will make the sound of old equipment, but this situation is very rare, and the frequency of use of most dental chairs is not so high."
Policies should be improved to avoid waste
If a medical device such as a dental chair has exceeded its expiration date, but the equipment has not had any failure so far, and the performance is intact, and the measured value is within the normal range, can it continue to be used?
The reporter consulted the regulatory authorities on this, and the other party told the reporter that Article 39, Paragraph 2 (3) of the Regulations on the Supervision and Administration of Medical Devices stipulates that the instructions and labels of medical devices shall indicate the following matters: (3) The date of production, the period of use or the expiration date. At the same time, according to the "Guidelines for the Technical Review of the Registration of the Service Life of Active Medical Devices", the medical device registration applicant shall clarify the service life of the product in the registration materials and provide relevant verification information, and the service life of the active medical device refers to the period during which the medical device registration applicant ensures the safe and effective use of the product through risk management, and the product can maintain its scope of application within the period. The expiration date is the end of the period of use, after which the safety and effectiveness of the medical device cannot be guaranteed. The service life of an active medical device is from the date of the end product of the device to the expiration date, considering both the time period before the device is put into use and the time period after the device is put into use.
"After the expiration date, the safety and effectiveness of the medical device cannot be guaranteed. According to the provisions of Article 55 of the Regulations on the Supervision and Administration of Medical Devices, medical device users shall not use expired, invalid or obsolete medical devices. Otherwise, in accordance with the provisions of Article 86 of the Regulations, it will be subject to an administrative penalty of confiscation of expired medical devices and illegal gains, and corresponding fines. Said the above-mentioned person.
During the interview, some doctors also questioned: "According to the existing regulations, the dental chair that does not belong to the service life, even if there is no fault during use, the performance is intact, and the measured value is within the normal range, it is not allowed to be used, and it should be forcibly scrapped, is this a waste of resources?"
"There is no problem with the market supervision and administration department punishing expired equipment in medical institutions in accordance with the Regulations on the Supervision and Administration of Medical Devices. However, if the equipment is scrapped according to the marked expiration date, it is a pity for those who are still in normal use, have not been used many times, and have a high purchase value of the equipment itself. An expert engaged in the management of oral medical institutions said that the dental comprehensive treatment machine belongs to the second class of medical devices, and its attributes and danger are far lower than that of the third class of medical devices, such as common disposable syringes, so it is worth further thinking about whether it should be scrapped directly according to the marked validity period.
The above-mentioned experts call for judging whether the relevant dental chair needs to be scrapped by the actual use time or whether it is operating normally. In this way, the safety of patients can be guaranteed, and the circulation of poor quality dental chairs in the market can be avoided, rather than simply marking the expiration date.
There are also people in the industry who propose that it is a pity to scrap the dental chair that has exceeded the expiration date. If medical devices such as dental chairs are allowed to be refurbished, it will have positive significance in terms of saving resources and protecting the ecology. However, before the relevant policies came out, the insurance practice was to contact the original factory sales to see if it could be "traded-in" or scrapped when the dental chair was about to expire.
Author: All-media reporter Wen Lijuan, trainee reporter Ding Yi, intern Bi Ran