AdvaMed Registry Principles
AdvaMed is committed to the principles of evidence-based medicine.
Stakeholders, such as patients, their caregivers, providers, payers, regulators,
and manufacturers share in the commitment to improve the quality and increase
the efficiency of healthcare. As medical device manufacturers, we recognize theneed to ensure that there is adequate and accurate information to guidehealthcare decision-making concerning the safety and effectiveness of medicalinterventions.
Registries are a mechanism to collect information about patient populations
being treated, the provider’s quality and processes of care, device performance,
and the clinical outcomes achieved. If designed and executed properly, a registry
can provide useful information about the safety and effectiveness of medicalinterventions. The purpose of these principles is to provide guidance to
AdvaMed member companies as they consider registry initiatives and to shareindustry’s perspectives with potential registry initiators in order to facilitate theprocess of registry formation.
A registry is defined as “an organized system that uses observational study
methods to collect uniform data (clinical and other) to evaluate specified
outcomes for a population defined by a particular disease, condition or exposure,and that serves one or more pre-determined scientific, clinical, or policy
purposes.”1 Registries are typically prospectively defined. A medical device
registry may be sponsored by a manufacturer, professional society, patientadvocacy group, government agency, provider group or a combination thereof.
A medical device registry may be designed to achieve one or more of thefollowing objectives:
1. Improve patient care and outcomes by understanding the effects ofproducts, health care professionals, facilities, patient populations andcare pathways.

1Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. 2nd ed.
(Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No.
HHSA29020050035I TO3.) AHRQ Publication No.10-EHC049. Rockville, MD: Agency for Healthcare
Research and Quality. September 2010

2. Improve patient access to new therapies by efficiently collecting data tosupport regulatory applications for expanded use and indications.
3. Obtain data to support coverage, reimbursement, and value analysis.
4. Evaluate the “real-world” safety and/or effectiveness of products
outside of randomized controlled clinical trials or other clinical study
designs.
5. Meet regulatory requirements for post-market data collection.
6. Reduce pre-and post-market burdens for data collection by providing
regulators with alternative methods to monitor the performance oftechnologies.
7. Aid in the assessment of effectiveness across multiple products ortherapies.
8. Develop hypotheses for further evaluation in controlled clinical trials.
9. Aid in the development or assessment of care guidelines.
To assure that the creation of a new registry is the appropriate mechanism
to meet the above objectives, several threshold questions need to beanswered:Is using a registry the least-burdensome means to collect the necessary
data to achieve the scientific objectives?
Do the objectives warrant the level of investment required to develop andmaintain a registry?
Are there reliable data collection instruments available to collect the dataneeded to achieve the objectives?
Will the registry have a stable and diverse source of funding to promote
long-term sustainability?

The following key principles should guide the development of any medical
device registry.
1. Formation of a data governance committee and written procedures fordata ownership, data access, and data use must be established for eachregistry before initiation. All stakeholders should be represented on thecommittee.
a. Sufficient safeguards should be established to ensure that valid data
are entered into the registry.

2

b. Data integrity and security must be maintained both during the active
phase of the registry and after closure.
c. Data should be reviewed and analyzed in a systematic manner, asdefined by the protocol and analytical plan. The protocol should define
enrollment adequate to avoid population bias.
d. Strong consideration should be given to clearly defining end points.
e. There should be a process for adverse event adjudication.
f. Before the outset of the registry, rules governing review and access tothe data should be established, be well-defined, and be designed to
manage unanticipated future requests. Governing rules shouldconsider, if applicable:
i. Review and acceptance process for data requests and data
analysis plans, taking into consideration informed consent
restrictions, if any, and the objective of the initial registry.
ii. Controlled processes for data access and data release that take
into account data privacy, maintaining data integrity andtraceability as well as timing in relation to publication, market
approvals and patent protection.
iii. Guidelines for data transparency.
iv. A process for device specific safety data reporting, including
how information is shared with the manufacturer.
2. A well-balanced registry design requires a clear purpose, objectives,analysis plan, and term before data collection begins.
a. The purpose of the registry will determine the design, cost, and termof the registry.
b. Where needed to meet a research purpose, hypothesis-based
designs and powered sample size determinations may be appropriate.
Consideration must be given to the difficulty of longitudinal follow up
of registry participants.
c. For registries that collect information and do not involve a research
purpose, definitions of success (data collection, data quality,poolability, quantity, funding) and failure should be prospectivelydefined in the protocol. Failure to meet criteria should result in registry
termination as defined in the governance documents.
d. Key stakeholders must define a prospective process for consideringchanges in the registry after initiation including items such as datacollection, protocol revisions or funding.
e. An appropriate quality plan needs to be established including
monitoring, auditing, and validation of participating sites for complete,accurate and timely data collection.
f. Registries must collect sufficient data to identify, consider and allow
risk adjustment for modifiable risk factors such as social, demographicand disease-related factors.
g. Data on patient characteristics, patient medical conditions and comorbidities, facility characteristics, physician experience,3interventional technique and associated parameters, and device
characteristics (including unique device identifiers) should becollected to identify potential factors which affect patient outcomes.
h. The registry purpose and design should also recognize the uniquecharacteristics of the device innovation life-cycle.
i.
Device innovation is an iterative process and a device life-cycle
may conclude prior to a desired registry endpoint being
achieved.
ii.
The design of a long-term registry must recognize and manage
the potential for next generation devices entering the market
during the data collection period.
3. A robust evidence assessment should be performed prior todetermining whether the additional data that may be collected by aregistry are needed.
a. The evidence assessment should evaluate current literature andprevious studies, as well as identify existing data collection efforts andongoing studies and/or registries. These data sources should beevaluated and considered for their purpose, depth, rigor, and timing ofresults compared to the proposed registry.
b. Duplication of purpose, data to be collected, or analysis methods may
indicate that the proposed registry is redundant.
c. The evidence assessment should be relied upon in developing the planfor the proposed registry. The plan must identify the evidence gap tobe addressed by the registry and ensure that the data and analysis
provide a true public health benefit and justify the additional costs
associated with the registry.
d. The assessment should be shared with potential stakeholders,participants, and funders before registry design is developed, andbefore data collection is initiated. The societal cost of the registry mustbe justified by the knowledge to be gained from the defined analysis
plan.
4. Registry data may be shared upon request from qualified scientificand medical researchers for purposes benefiting public health or
patient care. A system should be implemented to receive and review
data requests prior to approving the release of any data.
a. The data governance committee will establish criteria for the review ofrequests and sharing of data. All requests for access to data will bereviewed according to these criteria. Recommended criteria include
the validity of the hypothesis, whether the data requested and analysis
plan will address the hypothesis and the qualifications of therequestor.
b. The data governance committee will establish a process for
submission of requests for sharing of data, including the information to
be included in the request. Recommended information includes the4

hypothesis to be tested, a description of the data being requested, thebenefit of the proposed work, the analysis plan, a publication andposting plan, qualifications and experience of the research team andany potential conflicts of interest, including how the data will be used
and the source of any funding.
c. The data governance committee will establish a process for protectionof the shared data to insure that researchers who are provided accessto registry data agree not to transfer the shared data or information toparties not identified in the research proposal.
d. Data requesters may be charged reasonable costs associated withdata sharing.
e. When there is a public health benefit to merging and analyzing datafrom multiple independent registries, the data governancecommittee(s) from each affected registry will establish criteria forreview and oversight of such projects. When extracting and analyzing
data from multiple registries, the data governance committee(s) will
ensure that:i. The original registry purpose and objectives are considered
to ensure the integrity and validity of any analyses or reportsthat are performed and to prevent inaccurate conclusions.
ii. The plan for extraction, aggregation, and analysis of the data
is valid.
iii. The plan includes the sharing of the analyses or reports withinvolved stakeholders.
5. Only the minimum data necessary for meeting the stated objectivesof the registry should be collected in order to reduce additional costs
for the healthcare system, and to maximize the likelihood of success.
a. The data to be collected for the registry should be well-defined andrelevant to the registry objectives.
b. Consideration should be made for aligning data collection to beconsistent with standard methodologies, where possible, to reduce theoverall burden.
6. A registry must comply with all applicable laws and regulatory
requirements.
a. Patient privacy should be protected.
b. All confidential manufacturer, physician, and hospital data must be
identified as confidential and protected from release.
c. Data provided to a registry does not negate facility, physician ormanufacturer obligations to make reports required under applicablelaws or regulations.
d. Unpublished registry data should be non-discoverable and should nototherwise be used in legal proceedings.
e. In choosing the best care for their patients, health care professionalsexercise their medical judgment and may use legally marketed

5products for off-label uses. The collection in a registry of off-label use
data does not represent off-label promotion by the product’smanufacturer. A registry may not be complete without inclusion of “realworld” information, which may include off-label use.
7. Policies should be established for the use and publication of registrydata by stakeholders and outside registry data users. These policies
should protect against unauthorized use of data and ensure
appropriate transparency.
a. Registries, which are in part financially supported by industry, shallprovide industry partners access to their complete data. Eachparticipating industry partner shall have access to its own data as well
as aggregated data (not including patient identifiers) from the entire
registry.
b. Registries may help identify important safety signals. When suchsignals are device specific, the signals should be reported to the
manufacturer’s complaint department prior to public disclosure. The
company, with input from the registry, should conduct a further
investigation and take action as appropriate.
c. Regulatory bodies should seek input from and share relevant
information with manufacturers prior to taking any regulatory action
based upon registry data including data aggregated from multiple
registries.
8. There should be a plan for the sustainable funding of the registrywhich includes all stakeholders as appropriate.
a. Parties who purchase registry products (custom reports) may becharged a reasonable fee.
Approved by GMTA December 20166