Awareness Is Important
FDA recently issued draft guidance entitled “List of Highest Priority Devices for Human Factors Review,” informing medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA or 510(k)).
According to the guidance, it seems that FDA believes these device types have clear potential for serious harm resulting from use error, and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices.
It is possible that other device manufacturers for devices not covered by the guidance may undermine the importance of human factors to be considered during medical device design and development.
To encourage medical device manufacturers to consider human factors early in the process of medical device design and development for other types of devices, the following video provides the importance of human factors for hemodialysis as an example.
[youtube_advanced url=”https://www.youtube.com/watch?v=GPmWlvZk4jE” controls=”no” loop=”yes” rel=”no” modestbranding=”yes”]
Human Factors (HF) Data Should Be Included in the PMA or 510(k)s that Fall Under the Following Product Codes.
Unless the premarket submissions do not involve any changes to users, user tasks, user interface, or use environments from those of the predicates, HF data should be included in the regulatory submissions.
- Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM,OCL)
- Anesthesia machines (e.g., BSZ)
- Artificial pancreas systems (e.g., OZO, OZP, OZQ)
- Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC)
- Automated external defibrillators (e.g., MKJ, NSA)
- Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX,ONW)
- Implanted infusion pumps (e.g., LKK, MDY)
- Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
- Insulin delivery systems (e.g., LZG, OPP)
- Negative-pressure wound therapy (e.g., OKO, OMP) intended for use in the home
- Robotic catheter manipulation systems (e.g., DXX)
- Robotic surgery devices (e.g., NAY)
- Ventilators (e.g., CBK, NOU, ONZ)
- Ventricular assist devices (e.g., DSQ, PCK)
Hemodialysis systems, accessories, blood access devices and accessories are regulated under the following regulations.
21 CFR 876.5820 Hemodialysis system and accessories
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
21 CFR 876.5540 Blood access device and accessories
A blood access device and accessories is a device intended to provide access to a patient’s blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient’s blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.
Last Updated: 2016-04-21
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