Risks of using medical equipment

The main articles are:

• Medical Equipment (Russian Market)
• Medical Equipment (Global Market)

2022

Record number of medical equipment recalls with the most critical marriage in the US

In the United States, in 2022, a record number of recalls of medical equipment with the most critical marriage were made. In the terminology of the Food and Drug Administration (FDA), we are talking about first-class (Class I) recalls. This became known in early March 2023.

According to Sedgwick analysts, in 2022, the FDA conducted 70 reviews of first-class medical equipment, while in the previous five years, an average of 47 such reviews were recorded annually.

For the year, the FDA conducted 70 reviews of first-class medical equipment

In 2022, companies including Abbott, Baxter, GE HealthCare, Medtronic and Philips became the subject of Class I recalls. This category reserves problems in devices that could potentially lead to serious injury or death for patients.

In October-December 2022, the total number of recall campaigns for medical equipment in the United States increased by 8.1% year-on-year, and the number of recalled units of the device increased by about 10 million to reach 61.98 million.

The most common reason for the recall in 2022 was mislabeling, followed by quality. There has been a decline in recalls related to faulty software, which was the most common reason for recalls in 2021. If in 2021 there were 46 cases with software, then in 2022 the software had 15 reviews.

According to experts, the growth in the number of reviews may continue in 2023. Sedgwick analysts counted 135 reviews in January 2023, compared to a monthly average of 80 in the fourth quarter of 2022. The number of recalled devices also exceeds the fourth quarter of 2022.

As the health care system in the United States improves, market conditions for the provision of health services develop, researchers note, there is an increase in consumer requirements for the health care system in terms of the quality of medical care and, in particular, medical equipment as a component of it. So, on the one hand, in 2022, the need for completeness and quality of medical care from the population increases, and on the other hand, the requirements for the quality and reliability of medical equipment and devices from the FDA are growing. At the same time, the satisfaction of patients and doctors as the main consumers in the medical equipment market is the main indicator of the modern state of the healthcare system in the country.^[1]

Recall of defective medical equipment reaches maximum

On August 18, 2022, a report by Sedgwick was published, according to which the number of recalls of medical devices in the world reached its highest in the last two years in the second quarter of 2022, with security and software problems being cited as the main reasons.

There were 268 recalls in the second quarter of 2022, up 34% from the first quarter of 2022, the report said. The total number of recalls is about 10% higher than the quarterly average over the past five years.

For 2 years, the recall of defective medical equipment reached a maximum

Security concerns were the main reason for the recall, with 48 cases in the quarter. Software issues were the second main reason for the recall - 47, followed by mislabeling, quality issues and spare parts.

Quality problems affected 5 million units of products, which is the largest indicator among all other reasons. At the same time, two reviews accounted for 4 million units: recall of DNA collection kits (more than 2.17 million units) and recall of pads for defibrillators (more than 1.8 million units). Other reasons for the recall were safety, mislabeling, sterility and non-compliance of devices with technical requirements.

In the second quarter, the majority of reviews were for Class II - 234 reviews, followed by 21 Class I reviews and 13 Class III. Class I reviews accounted for only a small fraction of the total number of reviews in the second quarter of 2022, but this was the highest in more than 15 years, the report said.

Reviews of COVID-19 tests have also become a growing trend in the medical device industry. Companies such as Mesa Biotech and Celltrion have recalled products for reasons ranging from the risk of false negatives to distributing testing kits in the US without appropriate authorization.

In June 2022, North American Diagnostics recalled more than 122 thousand rapid testing kits for the COVID-19 antigen in the oral cavity, since the FDA did not issue permission to distribute them in the United States.

In the second quarter of 2022, nine recalls of disapproved or unsafe COVID-19 rapid tests were made, which affected about 982,483 units, according to a Sedgwick report.^[2]

2016: ECRI Forecast

In November 2016, ECRI Institute, a nonprofit organization specializing in health care issues, compiled a list of major technological hazards in medicine for 2017. With their research, experts wanted to warn medical institutions about important safety issues related to the use of medical equipment and systems. Each of the listed risk factors can be fatal.

Non-profit organization ECRI Institute, specializing in health problems, has compiled a list on the main hazards of a technological nature in medicine

1. Infusion administration of the drug can lead to the death of the patient if you ignore simple safety rules.

2. Insufficient cleaning of multi-component tools designed for reusable use can lead to infections.

3. Missed alarms during mechanical ventilation threaten patients with large complications.

4. Impaired breathing can cause an overdose of drugs (opioid analgesics and benzodiazepine receptor agonists) that inhibit functions of the central nervous system.

5. Heating and cooling systems for patients in operating rooms can cause infections, and surgeons need to remember this.

6. Due to software vulnerabilities, personal data leaks and life-threatening hacks of medical systems can occur.

7. Occupational radioactive exposure is a danger to hybrid operating rooms.

8. Errors in the operation of equipment used for automatic dose calculation and drug delivery can lead to a dangerous overdose or insufficient medication.

9. ECRI experts are asking medical institutions working with surgical stitching machines to closely monitor this equipment.

10. A malfunction of medical equipment often occurs due to the use of cleaning products and incorrect cleaning methods.^[3]

Notes