Recommendations from
The Institute of Medicine Report:
HIV & the Blood Supply. An Analysis of Crisis Decision Making.

---

RECOMMENDATIONS

Recommendation 1:

The Secretary of Health and Human Services should designate a Blood Safety Director, at the level of a deputy assistant secretary or higher, to be responsible for the federal government's efforts to maintain the safety of the nation's blood supply.

Recommendation 2:

The PHS should establish a Blood Safety Council to assess current and potential future threats to the blood supply, to propose strategies for overcoming these threats, to evaluate the response of the Public Health Service to these proposals, and to monitor the implementation of these strategies. The Council should report to the Blood Safety Director (see Recommendation 1). The Council should also serve to alert scientists about the needs and opportunities for research to maximize the safety of blood and blood products. The Blood Safety Council should take the lead to ensure the education of public health officials, clinicians, and the public about the nature of threats to our nation's blood supply and the public health strategies for dealing with these threats.

Recommendation 3:

The Federal government should consider establishing a no-fault compensation system for individuals who suffer adverse consequences from the use of blood or blood products.

Recommendation 4:

Other federal agencies must understand, support, and respond to the CDC's responsibility to serve as the nation's early warning system for threats to the health of the public.

Recommendation 5:

The PHS should establish a surveillance system, lodged in the CDC, that will detect, monitor, and warn of adverse effects in the recipients of blood and blood products.

Recommendation 6:

Where uncertainties or countervailing public health concerns preclude completely eliminating potential risks, the FDA should encourage, and where necessary require, the blood industry to implement partial solutions that have little risk of causing harm.

Recommendation 7:

The FDA should periodically review important decisions that it made when it was uncertain about the value of key decision variables.

Recommendation 8:

Because regulators must rely heavily on the performance of the industry to accomplish blood safety goals, the FDA must articulate its requests or requirements in forms that are understandable and implementable by regulated entities. In particular, when issuing instructions to regulated entities, the FDA should specify clearly whether it is demanding specific compliance with legal requirements or is merely providing advice for careful consideration.

Recommendation 9:

The FDA should ensure that the composition of the Blood Products Advisory Committee reflects a proper balance between members who are connected with the blood and blood products industry and members who are independent of industry.

Recommendation 10:

The FDA should tell its advisory committees what it expects from them and should independently evaluate their agendas and their performance.

Recommendation 11:

The FDA should develop reliable sources of the information that it needs to make decisions about the blood supply. The FDA should have its own capacity to analyze this information and to predict the effects of regulatory decisions.

Recommendation 12:

When faced with a decision in which all options carry risk, especially if the amount of risk is uncertain, physicians and patients should take extra care to discuss a wide range of options.

Recommendation 13:

The Department of Health and Human Services should convene a standing expert panel to inform the providers of care and the public about the risks associated with blood and blood products, about alternatives to using them, and about treatments that have the support of the scientific record.

Recommendation 14:

Voluntary organizations that make recommendations about using commercial products must avoid conflicts of interest, maintain independent judgment, and otherwise act so as to earn the confidence of the public and patients.

Go to the HIV & Hemophilia Menu

Go to the HIV & You Menu

Go to the HIVpositive.us Main Menu

41