Biomedical Engineering Reference
In-Depth Information
devices. The goal of the QSR is to create a self-correcting system that reliably produces
robust device designs and production methods, ensuring that devices perform in a manner
consistent with their intended use. In many ways, the QSR has evolved into the glue that
holds the medical device regulatory process together from development through end of
use. Once a device is marketed, the corrective and preventive action (CAPA) provisions
of the QSR are closely related to compliance with the Medical Device Reporting (MDR)
regulations. An additional advantage of the QSR is that it follows the philosophy of the
international medical device standard, ISO 13485, which helps to enable device companies
that sell their product internationally to maintain common systems for most design- and
production-related activities. The manufacturing and quality processes also require specific
evaluations and procedures, all of which must be documented. Frequently, the FDA field
investigators will follow the quality system inspection techniques (QSITs) approach when
inspecting a device facility [10].
12.4 FDA Clearance of Robotic Surgery Systems
Following the success of the PUMA 560 robotic surgical arm used in nonlaparoscopic
delicate neurosurgical biopsy (1985), and later in laparoscopic cholecystectomy and
transurethral resection (1987), the first FDA approved (cleared in 1994) surgical robot
AESOP (Automated Endoscopic System for Optimal Positioning) was introduced
by Computer Motion, Inc. in 1990. In 1995, the Zeus robotic surgery system was
demonstrated by Computer Motion and tested on animals. By 2000, the Zeus was
equipped to hold 28 different surgical instruments, and in 2001 it received FDA approval.
In 1999, Intuitive Surgical Devices, Inc. commercialized the 'Leonardo' and 'Mona'
prototypes of their robotic surgical system, calling it the da Vinci System, and began mar-
keting it in Europe while awaiting FDA approval in United States. In 2000, the da Vinci
surgical system was approved by the FDA as the first robotic system for general laparo-
scopic surgery. FDA clearance was based on a review of clinical studies of safety and
effectiveness submitted by the manufacturer and on the recommendation of the General
and Plastic Surgical Devices Panel of the FDA's Medical Devices Advisory Committee.
References
1. Potter, R.J. (1967) Royal Samuel Copeland, 1868 - 1938: a physician in politics. PhD, Western Reserve
University, Cleveland, OH.
2. Food and Drug Administration (FDA) (2011) Compliance Policy Guides, CPG Sec. 440.100 Marketed
New Drugs without Approved NDAs and ANDAs.
3. Roy, S. (2002) BioMEMS for minimally invasive medical procedures. Presented at the The BioMEMS
2002 Conference, Boston, MA.
4. ASTM International (2000) ASTM Standard F1585.
Guide for Integrity Testing of Porous Barrier Medical
Packages
, West Conshohocken, PA (Withdrawn 2006).
5. ASTM International (2010) ASTM Standard F2097.
Guide for Design and Evaluation of Primary Flexible
Packaging for Medical Products
, West Conshohocken, PA.
6. British Standards Institution (2009) BS EN 868 - 5.
Packaging for Terminally Sterilized Medical Devices.
Sealable Pouches and Reels of Porous and Plastic Film Construction. Requirements and Test Methods
.
7. International Organization for Standardization (ISO) (2006) ISO 11607.
Packaging for Terminally Sterilized
Medical Devices
.
