Continuous failure, procrastination and bureaucracy led to a significant delay in the registration procedures of medical equipment in Israel.
In some cases, it is a long wait for approval to use life-saving equipment.
Israel Hayom learned that the waiting period for new equipment has been extended to six months.
The data shows that difficulties are also found in registration procedures for existing medical equipment.
The waiting time in such a case may reach two and a half months.
The data was published following a request from the Union of Chambers of Commerce to the Ministry of Health, and by virtue of the Freedom of Information Law.
Procrastination and bureaucracy.
Operating room, illustration, photo: GettyImages
"heavy damage"
The delay leads to a shortage of equipment such as pacemakers, implants, equipment for catheters and surgeries, inhalation kits, crutches, surgical tools, contact lenses and more.
"Surgeries are being canceled due to a lack of equipment, the hospitals are afraid to admit it," says an official at the Association of Chambers of Commerce.
About six months ago, it was revealed that there was a shortage of epidurals in the health system, which could have led to significant difficulties in the hospitalization procedures of maternity patients.
Now it turns out that this also has something to do with the delay in registering the medical equipment, but in this case, senior officials at the Ministry of Health got involved in the issue and expedited the approval.
The union warns that there is a significant deterioration in the functioning of the medical department (accessories and devices). "There is chaos and paralysis, unavailability and lack of communication with the companies," said an official in the union. The need to destroy stocks, delay the launch of new technologies, and more."
Waiting time for approval, photo: GettyImages
The union contacted the Director General of the Ministry of Health, Moshe Bar Siman Tov, and asked to hold an urgent meeting with him, demanding the appointment of a designated professional in the ministry to handle the issue.
Still looking for a replacement
The Medical Equipment Division, which is responsible for issuing approvals for medical equipment, suffers from a shortage of personnel. In February 2022, the director of the division, Nadav Shafer, left the position, and so far no replacement has been found. The number of employees in the division is six in total. In the field, one gets the feeling that the delays in registering the equipment The medical ones are unreasonable. Following the union's request, the Ministry of Health revealed that between 2021 and 2022, the length of time for registering new medical equipment was extended by 137%.
The waiting time for medical equipment registration in 2022 jumped to 159 days, compared to 67 days in 2021.
The number of days that the ministry defined as a target for processing applications is 120 days, and 45 days is defined as the time when the applications are "waiting to be absorbed into the system".
"The registration times meet the legal requirement."
Ministry of Health, photo: Oren Ben Hakon
As for requests to change registration (change the label), the waiting time was extended by 71% - from 42 days in 2021 to 72 days in 2022 - despite a 36% decrease in the number of requests submitted in comparison between 2021 and 2022.
The average monthly number of requests to change registration in 2022 was 91, compared to 141 requests in 2021.
"Full transparency"
"The department's response times and handling of requests for registration, import and export of medical equipment meet the requirements of the Medical Equipment Law, and are published with full transparency on the website," the Ministry of Health said.
"At the same time, in order to develop and streamline the office's work, the director general instructed to carry out a staff work to examine the optimization of processes, and to focus the work of the AMR on promoting innovation and growth. In about two weeks there will be a meeting chaired by the director general of the office with the Chamber of Commerce, after several meetings were held in the office internal discussions".
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