National/international
Statutory regulations and Institutional licensing/voluntary system
Country, if national
Regulators/organizations providing the requirements
Keywords
Year of publication (between 2000 and 2015)
Brief description of assurance schemes
Focus of assurance
Internationally
Voluntary system
ISO
ISO 7151:1988
1988
Surgical instruments—Non-cutting, articulated instruments—General requirements and test methods
Internationally
Voluntary system
ISO
ISO 7153-1:1991
1991
Contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopedic surgery. It takes into account steel grades and chemical compositions
Surgical instruments—Metallic materials—Part 1: Stainless steel
Internationally
Voluntary system
ISO
ISO/DIS 7153-1
Under development
Standardization in the field of surgical instruments such as forceps, scissors, scalpels and retractors
Surgical instruments—Materials—Part 1: Metals
Internationally
Voluntary system
ISO
ISO 7153-1:1991/Amd 1:1999
1999
Internationally
Voluntary system
ISO
ISO 7740:1985
1985
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990
Instruments for surgery—Scalpels with detachable blades—Fitting dimensions
Internationally
Voluntary system
ISO
ISO 7741:1986
1986
This standard deals with materials, heat treatment and hardness of component parts, corrosion resistance, workmanship and cutting ability of scissors and shears used in the surgery and defines the test methods
Instruments for surgery—Scissors and shears—General requirements and test methods
Internationally
Voluntary system
ISO
ISO 13402:1995
1995
Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure
Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and thermal exposure
Internationally
Voluntary system
ISO
ISO 8828:2014
2014
ISO 8828:2014 specifies the recommended procedures for handling orthopedic implants, hereafter referred to as implants , from receipt at the hospital until they are implanted or discarded.
This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements.
This guidance does not apply to the implant manufacturer . However, it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers
Orthopedic implants
Internationally
Voluntary system
ISO
ISO 12891-1:2015
2015
ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control.
Note National or other regulations, which can be more stringent, can apply.
ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.
ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination , documentation, packing and shipping. It also provides guidance on infection control.
Note National or other regulations, which can be more stringent , can apply.
ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also
Retrieval and analysis of surgical implants—part 1: retrieval and handling
Internationally
Voluntary system
ISO
ISO 12891-2:2014
ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants.
ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants . The analysis is divided into three stages which are increasingly destructive.
ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants .
ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material
Retrieval and analysis of surgical implants—part 2: analysis of retrieved surgical implants
Internationally
Voluntary system
ISO
ISO/TR 14283:2004
ISO/TR 14283 provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose
Active or non-active implants
Internationally
Voluntary system
ISO
ISO/CD TR 14283
Under development
Implants for surgery
Internationally
Voluntary system
ISO
ISO 14607:2007
2007
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attribute s, materials, design evaluation, manufacturing, sterilization , packaging and information supplied by the manufacturer
Non-active surgical implants—mammary implants
Internationally
Voluntary system
ISO
ISO/WD 14607
Under development
Non-active surgical implants—mammary implants
Internationally
Voluntary system
ISO
ISO 14630:2012
2012
ISO 14630:2012 specifies general requirements for non-active surgical implants . ISO 14630:2012 is not applicable to dental implants, dental restorative materials , transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue .
With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture , sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements
Non-active surgical implants
Internationally
Voluntary system
ISO
ISO 16054:2000
2000
Minimum data sets for surgical implants
Implants for surgery
Internationally
Voluntary system
ISO
ISO 16061:2015
2015
ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture , sterilization, packaging, and information supplied by the manufacturer .
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants
Instrumentation for use in association with non-active surgical implants
Internationally
Voluntary system
ISO
ISO/WD 17327
Under development
Non-active surgical implants—implant coating
Internationally
Voluntary system
ISO
ISO/CD 19227
Under development
Cleaning of orthopedic implants—general requirements
Internationally
Voluntary system
ISO
ISO 10282:2014
2014
ISO 10282:2014 specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination . It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove.
ISO 10282:2014 is intended as a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging , and storage procedures are outside the scope of ISO 10282:2014
Single-use sterile rubber surgical gloves
Internationally
Voluntary system
ISO
ISO 10334:1994
1994
Specifies the dimensions and mechanical properties and gives test methods. The mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion. Surface finish is not covered
Implants for surgery—malleable wires for use as sutures and other surgical applications
National
Voluntary system
The UK
Association of Breast Surgery (ABS) at BASO
Quality assurance guidelines for surgeons in breast cancer screening
1992 (first publication), updated in 1996, 2003, 2009
The guidelines are addressed principally to surgeons working in the screening program for breast cancer, who will use the guidelines in a personal capacity to audit their own activity
Breast cancer screening program
National
Voluntary system
Australia
Queensland Health, Governmental organization
VLAD system
VLAD charts provide an effective, easily visualized display of surgical performance and can be applied to pediatric cardiac surgery. Early detection of change , whether improvement or deterioration, is important for ongoing quality assurance within a cardiac surgery program
National
Voluntary system
The UK
Quality assurance program (QAP)
The implementation of a QAP improved quality of care in terms of consistency of patient selection and outcomes of surgery during a period of major reorganization of cancer services in London. The QAP framework presented could be adopted by other organizations providing complex surgical care across a large network of referring hospitals
International
Voluntary system
WHO
Surgical safety checklists:
The checklist identifies three phases of an operation, each corresponding to a specific period in the normal flow of work: Before the induction of anesthesia (“sign in”), before the incision of the skin (“time out”) and before the patient leaves the operating room (“sign out”). In each phase, a checklist coordinator must confirm that the surgery team has completed the listed tasks before it proceeds with the operation
National
Voluntary system
USA
Accreditation Association for Ambulatory Health Care (AAAHC)
Handbook for small office-based surgery practices
National
Statutory regulation and institutional licensing
The UK
Care Quality Commission (CQC)
CQC inspection is based on the following questions: (1) are services safe, (2) are services effective, (3) are services caring, (4) are services responsive to people’s needs, (5) are servies well-led
In general clinics but include surgical practices
International
Voluntary system
EU
European Union
European guidelines for quality assurance in breast cancer screening and diagnosis
National
Voluntary system
USA
American College of Surgeon
American College of Surgeons National Surgical Quality Improvement Program® (ACS NSQIP®)
Various surgical quality assurance programs within surgery, using four key principles required to measurably improve quality of care and increase value: (1) Standards, (2) Right Infrastructure, (3) Rigorous data, (4) Verification
Various surgical services e.g. National Accreditation Program for Breast Centers (NAPBC), Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASAQIP)
National
Voluntary system
UK
The Association for Perioperative Practice (AfPP)
Guidance on a number of perioperative issues e.g. best practice for safe handling of surgical sharps, PCC perioperative support worker, safer surgery checklist, etc.
Perioperative
National
Voluntary system
UK
The Royal College of Surgeons of England
Develop a range of guidance aimed to provide a robust framework for promoting good practice in surgery, professional development and effective delivery of surgical services e.g. guidance for individual surgeons and for the surgical team on professinalism and good practice, guidance on day-to-day working practices that facilitate and promote the delivery of effective services, and guidance and tools on appraisals and revalidation
National
Voluntary system
UK
The Royal College of Surgeons of Edinburgh (RCSEd)
RCSEd develops a range of guidance aimed to provide a robust framework for promoting good practice in surgery, professional development and effective delivery of surgical services
National
Statutory regulation and institutional licensing
Canada
Accreditation Canada
Accreditation Canada’s sector and service-based standards help organizations assess quality at the point of service delivery. They are based upon five key elements of service excellence : clinical leadership, people, process, information, and performance.
These standards contain the following sections :
Investing in surgical care services.
Engaging prepared and proactive staff .
Providing safe and appropriate services.
Maintaining accessible and efficient clinical information systems.
Monitoring quality and achieving positive outcomes
National
Statutory regulation and institutional licensing
France
The Haute Autorité de santé (HAS)—or French National Authority for Health
Provides practice guidelines in general that also include surgery services
International
Voluntary system
EU
The European Union of Medical Specialists (Union Européenne des Médecins Spécialistes—UEMS)
The main activities of the EUMS can be summarized in four headings: Surgical training Standard of the Certificate of Completion of Specialist Training (CCST)
Continuing Medical Education in Surgery (Continuing Professional Development)
Surgical Quality Control
National
Statutory regulation and institutional licensing
USA
Centers for medicare and medicaid services (CMS)
Include conditions of participation for hospitals with surgical services, for example: (1) If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. (2) Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC
National
Voluntary system
USA
Joint Commission (JC)
Include standards on Surgical Site Infection (SSI)
Hospital acquired infections
National
Voluntary system
USA
Joint Commission (JC)
Include Surgical Care Improvement Project (SCIP)
National quality partnership of organizations interested in improving surgical care by significantly reducing surgical complications
National
Voluntary system
USA
Joint Commission (JC)
Office-based surgery accreditation
Smaller surgical practices
International
Voluntary system
Joint Commission International (JCI)
None found specific related to surgical services
International
Voluntary system
Accreditation Canada International
None found specific related to surgical services
National
Voluntary system
Canada
Accreditation Canada
Accreditation Canada’s sector and service-based standards are based upon five key elements of service excellence: clinical leadership, people, process, information, and performance
National
Voluntary system
Canada
Royal College of Physicians and Surgeons of Canada
Among their core functions is to accredit medical education under two broad categories: (1) the residency programs sponsored by Canada’s 17 medical schools, (2) and the learning activities pursued by physicians who engage in continuing professional development
Residency programs and learning activities pursued by physicians for professional development
The advantage of statutory regulations and institutional licensing as forms of assurance schemes is their visibility in that they mandate health care providers to change the way surgery is organized and practiced. For example, the surgical checklists introduced by the World Health Organization (WHO) , which were designed and implemented throughout the globe to help reduce surgical mortality and complications, have been part of many national regulations in the USA and Australia [10, 11]. Since 2012, the US Centers for Medicare & Medicaid Services (CMS) requires ambulatory surgery centers (ASC) to conduct quality reporting that includes the use of surgery checklists for all, not only Medicare, patients [12, 13].
Within voluntary schemes, it is worth noting that non-governmental, private sector regulators are rapidly gaining their influence in the way that surgery is practiced, billed and supervised [6]. For example, the Leapfrog Group [13] has become one of the most powerful forces in the private regulatory sector and provides excellent evidence on the impact of this sector on surgical care. Furthermore, specialty colleges or board and professional licensing bodies are key players in developing assurance schemes based on consensus into more uniform, regulated schemes . For example, there is a global trend in developing and implementing a scheme for physicians’ continuous professional development such as schemes to maintain physicians’ competence [14]. In Australia, as an example, the Royal Australasian College of Surgeons requires surgeons to maintain their skills, knowledge and competence by self-directed learning, teaching, researching, publishing scientific articles, and attending educational gatherings such as scientific meetings, workshops, and seminars. In most of western countries, surgeons must retain records to verify their competence and professional development [14].
The specialty colleges or boards can also potentially be the champions in closing the gap in the areas in need of regulations such as robotic surgery. Technology advancements in surgery are growing rapidly, for example, the scale and spread of 3-D organ and prosthetic printing. This growth creates an urgent need for assurance schemes to ensure the quality and safety of patients not being harmed from the technology. Currently, there are no standards, nationally or internationally, for assuring patients are not harmed during the use of robotic surgery. However, there is a growing consensus in this field, such as a consensus document produced by The Society of American Gastrointestinal and Endoscopic Surgeons [15, 16]. This consensus document provides guidance to surgeons wishing to perform robotic surgery to fulfill specific training prior to performing it.
Most surgical assurance schemes have a focus mainly on prescriptive, rather than performance-based frameworks. Whereas health care practitioners need assurance schemes that are performance-based to help them put systems thinking into practice. This is crucial to ensure that end-users receive the necessary treatment with the desired outcome. There remains an evidence gap forcing regulators to be ever vigilant about the safety and reliability of surgical services [9].
Outpatient/Ambulatory Surgery
National and international professional associations have published information about the quality of care provided in outpatient settings for their own specialties, there have been very few published studies, articles, or analyses about the overall quality of care in outpatient surgery settings. In addition, there is little information about the relative quality and safety of specific outpatient surgical procedures across the range of settings in which these surgeries are performed.