Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Manadatory FDA Medwatch reporting by health professionals of all insulin pump malfunctions and not just those incidents eading to death

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

no

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

All diabetic patients who use insulin pumps.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Ideally insulin pumps help diabetic patients maintain better control of diabetes, and comply with health standards for good, stable management of blood sugar (BS)levels. Good, stable maintenace of BS improves quality and longevity of life without experincing health complications of poor BS control. (blindness, kidney failure, loss of limbs etc.)

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Improvement in patient quality and safety. Avoidance of death.

Describe any health-related risks, side effects, or harms that you are concerned about.

none

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Diabetes mellitus

AHRQ Priority Populations

• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

None

Importance

Describe why this topic is important.

I have direct personal and professional experience in this area. I like many health professionals and staff was of the belief that all medical device adverse events, device failures, and/or malfunctions required a mandatory reporting to at least the FDA or other regulatory agency, rather than voluntary/optional. Not having mandatory reporting in place is not a very good quality/safety checks and balances and puts patients and consumers at risk.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

The death of a loved one and the suggestion of a number of doctors who I have worked with on a number of levels professionally and personally have advised to do so. I am a healthcare safety professional and have done some preliminary research.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Yes, I have spoken with numerous personnel at the FDA in the reporting of adverse events and learned that the reporting of MEDWATCH medical device adverse event by health professionals is voluntary and mandatory reporting is only required in the event of death.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

All diabetic patients who use insulin pumps are vulnerable and dependant on all knowledge pertaining to the functionality of equipment, so as to made important life determining decisions, root cause analysis and corrective actions pertaining quality and sustaining of life.

Describe the timeframe in which an answer to your question is needed.

No set time frame. However, the expediting of this research will save lives.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Death for vulnerable chronically ill patients.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

All diabetic patients who use insulin pumps are vulnerable and dependant on all knowledge pertaining to the functionality of equipment, so as to made important life determining decisions, root cause analysis and corrective actions pertaining quality and sustaining of life.

Are you making a suggestion as an individual or on behalf of an organization?

Individual

Please tell us how you heard about the Effective Health Care Program

Dr. Augustus White