Kiihdyttämö training provides a comprehensive knowledge package on medical device regulation, quality requirements, and risk management, from production to marketing. “Understanding regulation, as well as the lifecycle and procurement process of devices, would also benefit clinical doctors selecting devices in their decision-making,” emphasizes Annika Takala, responsible for medical devices at HUS.
Author: Minna Torppa
Kiihdyttämö assisted in drafting the in-house manufacturing guide.
Annika Takala, a device physician at the Quality and Patient Safety Unit of the Helsinki and Uusimaa Hospital District (HUS), completed the entire Kiihdyttämö training while drafting an in-house manufacturing guide for the university hospital’s needs. The motivation for the writing was Article 5 of the EU’s Medical Device Regulation (MDR) concerning in-house manufacturing, which began to apply on May 26, 2021.
Annika Takala
“I struggled with the writing process for eight months. Fortunately, I received support from experienced members of the working group. The Kiihdyttämö training was comprehensive and extremely important to me because it helped me understand the entirety of the medical device manufacturing process and the requirements set for in-house manufacturing. We received valuable materials from the training sessions, which I returned to repeatedly,” says Annika Takala.
The guide, published by HUS in early May, provides a general introduction to understanding what needs to be considered if, for example, a medical device is intended to be regularly used for a purpose other than that specified by the manufacturer. In March of this past spring, Annika Takala and Hannele Toroi from Clinipower also organized a half-day training session aimed at HUS doctors, clinicians, and nurses. Its purpose was to raise awareness among staff about recognizing the various forms of in-house manufacturing and the related challenges.
“The Kiihdyttämö training was comprehensive and extremely important to me because it helped me understand the entirety of the medical device manufacturing process and the requirements set for in-house manufacturing.”
“I think every single day about how to best promote device safety and expertise. I organize device safety training twice a year, present current issues to all employees on an open intranet site, and write about them in quality newsletters. These matters are also regularly discussed in quality and patient safety groups, including with management. But it’s only through a connection to practice that these issues become personally relevant to employees,” Annika Takala emphasizes.
What and why should a clinical doctor know about medical devices?
Annika Takala is responsible for the medical devices used by HUS’s 27,000 employees. “Our medical device register contains 150,000 hardware items, the assistive device register has tens of thousands of items, reusable surgical instruments processed through sterilization number perhaps 900,000, and disposable supplies in procurement and logistics registers likely amount to 70,000…,” Takala lists staggering figures. “This isn’t under anyone’s control, certainly not mine,” she sighs.
Annika Takala in the eye surgery device storage. Nurses must know how to prepare these devices for use by doctors.
In her work, Annika Takala has recognized how crucial it is for clinical doctors responsible for device procurement to understand medical device regulations. Both newly graduated and experienced doctors need training. “Procurement involves considering many factors. The device must be fully suitable for its intended purpose. Several aspects need attention, such as ensuring that single-use instruments cannot be procured as reusable or that the device can be cleaned in our hospital or at least in Finland.”
According to Annika Takala, HUS’s medical device register shows that multiple brands of devices have been acquired for the same purpose. There are also many different versions of the same device in use. The effort to manage this diverse device arsenal complicates device expertise, stresses employees, hinders staff transitions between departments, and, in the worst case, jeopardizes the safety of patients and workers.
In her work, Annika Takala has recognized how crucial it is for clinical doctors responsible for the content of device procurement to understand medical device regulations.
“Medical devices cannot be used intuitively; they require thorough familiarization. With the growing number of devices, no one can master them all,” Takala states. As an anesthesiologist, she knows that in the operating room, situations can arise daily where a specific device fails to function. According to her, device expertise among healthcare staff should be systematically advanced by integrating the promotion of device safety and operational skills into the activities of every unit. Such a pilot project is currently underway at HUS.
“In the future, the winners will be manufacturers who, after initial training, can commit to ensuring expertise through training in all their customers’ change situations. Winners will also be manufacturers who can provide various learning tools, such as virtual environments, and know how to create clear, concise instructions for their devices.”
