Is your staff fully trained onnew medical devices? Is there documentation of their proficiency on the devices they use every day?
Medical staff training on medical devices is not optional, at least for the vendors that sell medical devices to you. FDACFR 820.25 states that every medical devicemanufacturerwill be able to document the necessary background, training, and experience of their employees to do their jobs.
Clinic managers can breathe a sigh of relief at this point. The educational requirements of the FDA circular and corresponding requirements of the international standardISO 13485:2016 aren't directed squarely at you. But they do mean that you can rely on your vendors to help you find the training your physicians, nurses, and support staff need.
Medical device training, of course, empowers your staff to bring the benefits of medical device innovation to patients. It undergirds a high standard of care. Ultimately, it makes the clinician, not the device, the hero of every patient success story.
But if things go wrong, and despite high levels of skill and dedicated efforts, sometimes they do, documented medical device training allows responsibility, liability, or culpability to be placed appropriately.
Here is a general rule for responsible medical staff training supervision:
If a procedure requires a document, there needs to be an audit trail to corresponding training.
But you do not necessarily have to maintain the documentation to which the audit trail leads.
This does not mean that your medical staff have to be taken away from patient care for endless hours of training. A lot of the responsibility for meeting standard of care requirements falls on your purchasing department, who should be tasked with validation and documentation of all equipment purchased, from the most expensive contrastrophore MRI scanner down to the least expensive disposable trocar.
FDA and ISO regulations make the manufacturer your ally in setting the agenda for your training sessions. They have access to reports from hundreds or thousands of users. They understand the use of their products in unusual situations. They can provide the information, and sometimes the personnel, for your medical staff training to run smoothly.
Joint Commission regulations classify new device training as an "acquired competency" that stands apart from the training required for a practitioner's entry into the profession. JCHA regulations also specify that clinicians and medical staff must confirm that any medical device is performing to manufacturer specifications.
"How do we know this is working?" is a question every user of a new medical device must be able to answer. An essential part of training, from the administrator's perspective, is being able to confirm the performance of every device for optimal patient care and minimization of risk to the organization providing care.
Some medical device training sessions have featured mind-numbing collections of dozens or even hundreds of PowerPoint slides. Others have essentially consisted of a moderator reading the product manual to busy medical personnel forced to take time away from administrative duties and patient care to be certified on a device.
Avoid these extremes. Here are seven points to keep in mind.
Remember, your care organization strives for consistent care and non-discriminatory access to resources. Be aware that training can reveal staff weaknesses. Be prepared to address the need to improve in a constructive manner and in an appropriate forum when it is revealed in medical device training.
Patient care is viewed holistically. Medical devices are maintained mechanically.
When you are introducing new devices or new programs to your medical staff, give them grounding in the form of checklists. Work with the vendor and experts already proficient in the new technology to identify salient skills and important signals for progressing through the use of the device. Give your staff an objective framework to confirm their success with the new device.
Some medical devices are tried and true, like basic surgical equipment. Others have a learning curve. Your staff may run into problems with the new medical device, or they may develop proficiencies beyond initial expectations that need to be shared with the team. The issue in sharing knowledge about the device, of course, is scheduling.
Consider different modes of delivery of continuing education for newly adopted medical devices.
Don't be hesitant to turn to your vendors and the manufacturers they represent for additional training options. They benefit from your success. They can offer you insights for maintaining your internal customer service training for their devices, and they can introduce you to device experts who can inform your professional experts in the use of the new technology.
Trocar Supplies offers an extension selection of trocars of every FDA-approved device material. We offerdisposable trocar andautoclavable trocar as well as trocar tray kits. For everything you need to know about trocars includingreusable trocars, disposable trocars, and the engineering and manufacturing of a trocar, please send us your questions online or call us at (937) 478-0469 for more information.
