Heart valves and conduits

Shelhigh Inc. and Recent US FDA Action

Present Situation
As the situation stands currently, there appear to be no significant deficiencies in the manufacturing processes at Shelhigh which would compromise the safety of patients.

However, because of the ongoing legal situation, the FDA are not currently granting export licences.  We understand from the official UK distributor that the supply is not, as yet, critical, since they are still holding considerable stocks, as are other European distributors.  They indicate, however, that supplies could be intermittent for a short period of time, since they may have to obtain some stocks from European sources.

The MHRA issued advice directly to the Society of Cardiothoracic Surgeons and the British Association of Paediatric Surgeons in July 2007.

› Urgent Notice: Shelhigh products (13Kb)

The MHRA have issued further advice to the Society of Cardiothoracic Surgeons and the British Association of Paediatric Surgeons in May 2008

Although we have no information about resumption of manufacturing at the Shelhigh facility, there still appear to be sufficient supplies of heart valves and aortic conduits available for the foreseeable future.

Background
FDA
Shelhigh Inc. (based in the USA), manufactures cardiac, vascular and neurosurgical implants derived from bovine and porcine tissue e.g. Aortic / Mitral heart valves, conduits, surgical patches, arterial patches and dural patches.

On 17 April 2007, the US Food & Drug Administration (FDA) announced the “seizure” of all implantable medical devices produced by Shelhigh Inc. at the company’s manufacturing plant (as a result of an earlier 10 week inspection of the plant by the FDA, ending in December 2006).

The FDA stated that the company’s violations included: “manufacturing products in a facility with a poorly constructed clean room where sterilized devices are further processed; failure to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; failing to scientifically support product expiration dates”.

Shelhigh refuted the claims made against them by the FDA. Subsequently, an agreed application from both parties to the courts (known as a “Consent Order”) was accepted in June. Part of the agreement was that the FDA would not mandate a recall of product already placed on the market at this point as long as Shelhigh continued to co-operate with the FDA and that the manufacturer agreed to undertake the recommended changes to their production facility and relevant processes.

European Regulatory Status
In order for medical devices to be legally placed onto the European market, manufacturers are required to first CE mark their products in relation to the European Medical Devices Directive 93/42/EEC.

The Shelhigh devices are CE marked. Shelhigh Inc. utilise a Spanish Notified Body (NB) as part of their CE marking process.

The Spanish NB had audited the Shelhigh manufacturing plant in March 2007 and had looked at aspects of the sterilization processes. The NB did not find anything of major concern.

Following a joint review (between the MHRA and representatives from other European Competent Authorities) of the report produced by the NB, it was concluded that NB had fulfilled their inspection requirements as necessary and the outcome to continue their certifications with Shelhigh Inc. was appropriate.

Communication and the sharing of information between the European Competent Authorities did not reveal any signal that there had been or was any problem with Shelhigh devices on the European market.