Affected by the COVID-19 epidemic, many medical device users (such as medical institutions, family planning technical service institutions, blood stations, etc. ) is in an idle state. In order to improve the use efficiency of medical equipment and reduce the operating cost, medical equipment users put forward a medical equipment rental scheme, that is, the medical equipment renter obtains the right to use the medical equipment in use by paying the rent to the equipment rental unit. Then, is it feasible in law, what legal risks are faced and how to prevent them? Based on this, the author intends to put forward personal views on the basis of combing the legal risks of equipment leasing among medical device users.
First, the compliance of medical device users' equipment rental behavior
According to Article 4 1 of the Regulation on the Supervision and Administration of Medical Devices (revised 20 17), medical devices in use (second-hand medical devices) can be transferred among medical device users. The law does not clearly stipulate that users of medical devices can rent equipment. Then, is it illegal to establish a legal relationship of equipment leasing between medical device users? From the perspective of law and benefit, it is reasonable and feasible for medical device users to rent equipment, which does not violate the jurisprudence. First of all, although the law does not explicitly stipulate that in-use medical equipment can be leased among medical equipment users, it is also not explicitly prohibited. The legal effect of ownership transfer is greater than leasing (use right), so the law is free without prohibition. In-use medical equipment can be leased among medical equipment users as a civil subject. Secondly, affected by the epidemic situation in COVID-19, a large number of medical equipment is idle, which can not improve the efficiency of equipment use and is not conducive to the appreciation and preservation of unit assets. Taking equipment lease can not only retain ownership, but also create economic value. Finally, leasing equipment can meet the needs of equipment lessees, give full play to the value of leased equipment, and make up for the cost brought by procurement time limit and procedures, thus creating social benefits. Therefore, the author thinks that renting in-use medical devices among medical device users conforms to the needs of social practice, and has compliance, rationality and necessity.
Second, the legal risks of equipment leasing for medical device users.
Take the non-profit medical institutions organized by the government as an example. What kind of legal risks do the lessee and lessor face respectively?
Tenant risk
1, avoiding government procurement risks
If the equipment to be used is a non-profit medical institution, it may face the risk of evading government procurement regulations or violating the internal procurement system of hospitals, damaging the fair competition rights of other medical device business units, and may also face the risk of administrative supervision. If the total lease amount is higher than the equipment price during the lease period, there are problems of utility evaluation and cost calculation.
2. Safety risks of medical equipment in use.
Because the medical devices in use are transferred from the user rather than purchased from the medical device production and business operation unit, it may be difficult to ensure the safety and effectiveness of medical devices and increase the use risk of hospitals because it is impossible to check the qualification certificate, registration certificate or filing certificate, product description, service life, maintenance records and other contents, or fail to pass the inspection of qualified inspection institutions. If the use of medical equipment causes personal injury to a third person, because it is difficult to determine the degree of fault, the unit that intends to use the equipment may bear all legal responsibilities.
3, medical device manufacturers agree to continue to provide daily maintenance services. Because the location of equipment maintenance has changed, it may lead to an increase in maintenance costs, and some large equipment may also increase the cost of testing and operation.
4. Whether it is possible to obtain the licensing risk of price filing or technology access. Because the buyer of the equipment rents a hospital, not a hospital.
(2) The risks of the lessor
1. The equipment rental unit is not qualified.
Medical institutions do not have the qualification of equipment leasing, and renting equipment to collect rent is a non-profit activity, which may face administrative penalties from health departments and market supervision departments.
2. Financial management risks
No matter whether the equipment idle unit is a non-profit medical institution or not, it may be difficult to issue equipment lease bills because it does not have lease qualification, thus increasing the financial management risk of medical device users.